Statutory Instruments
Medicines
Fees And Charges
Consumer Protection
Made
28th February 2008
Laid before Parliament
7th March 2008
Coming into force
1st April 2008
The Secretary of State for Health, the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971(1) or, in the case of the Ministers, the powers conferred by those provisions and now vested in them(2).
In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972(3) and section 56(1) and (2) of the Finance Act 1973(4). The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products(5).
The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.
In accordance with section 129(6) of the Medicines Act 1968(6), the Secretary of State for Health, the Department of Health, Social Services and Public Safety Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.
1. These Regulations may be cited as the Medicines (Products for Human Use-Fees) Regulations 2008 and shall come into force on 1st April 2008.
2.—(1) In these Regulations, unless the context requires otherwise—
“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(7);
“the 1994 Regulations” means the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994(8);
“the Act” means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;
“API manufacturer” means a person, other than the holder of a manufacturer’s licence, engaged in the manufacture or assembly of active substances used as starting materials in the manufacture of medicinal products;
“application”, in relation to a clinical trial authorisation, means a request for authorisation to conduct a clinical trial made in accordance with regulation 17 (request for authorisation to conduct a clinical trial) of the Clinical Trials Regulations, and “applicant”, in relation to such authorisation, means the person making the request;
“authorised medicinal product” means a medicinal product in respect of which a marketing authorization has been granted;
“blood product” means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;
“capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations;
“change of ownership application” means an application—
for—
a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization,
a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation,
a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration,
a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence, or
a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence;
which refers to particulars which are in all material respects identical to the particulars of the marketing authorization, manufacturing authorisation, traditional herbal registration, manufacturer’s licence, or wholesale dealer’s licence which is held by that other person; and
which includes a statement to the effect that that other person intends to cease the activities to which his marketing authorization, manufacturing authorisation, traditional herbal registration or licence relates and has consented in writing to the making of the application,
and in this definition particulars do not include particulars relating to the name and address of the applicant, the labelling of any medicinal product or the content of any leaflet relating to such a product;
“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—
to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
to identify any adverse reactions to one or more such products; or
to study absorption, distribution, metabolism and excretion of one or more such products,
with the object of ascertaining the safety or efficacy of those products;
“clinical trial authorisation” means authorisation of the conduct of a clinical trial—
by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving general medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving general medicinal products with special characteristics) of the Clinical Trials Regulations; or
which is treated as having been given by the licensing authority by virtue of Schedule 12 to those Regulations;
“Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004(9);
“Commission Regulation (EC) No. 1084/2003” means Commission Regulation (EC) No. 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State(10);
“Community marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No. 726/2004;
“concerned member State” means an EEA State, the competent authorities of which receive an application to obtain recognition, according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive, of a United Kingdom marketing authorization;
“conditions and principles of good clinical practice” means the conditions and principles specified in Schedule 1(conditions and principles of good clinical practice and for the protection of clinical trial subjects) to the Clinical Trials Regulations;
“contract laboratory” means a laboratory carrying out the examinations and tests referred to in—
paragraph 5A(2) of Schedule 2 (standard provisions for manufacturer’s licences and manufacturer’s licences of right) to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(11); and
Article 11(1) of Directive 2003/94/EC,
on behalf of the holder of a manufacturing authorisation, manufacturer’s licence or wholesale dealer’s licence, pursuant to Article 11(2) of that Directive and Article 20(b) of the 2001 Directive;
“Council Regulation (EEC) No. 2309/93” means Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(12);
“Directive 75/319/EEC” means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (13);
“Directive 2003/94/EC” means Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (14);
“EEA State” means a member State, Norway, Iceland or Liechtenstein;
“exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 (exemptions and exceptions from the provisions of regulation 3) to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;
“fee period” means the period beginning with the first day of April in any year and ending with the last day of March in the following year;
“Herbal Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005(15);
“herbal substances” has the meaning given by Article 1(31) of the 2001 Directive;
“holder”, in relation to a clinical trial authorisation, means—
in the case of an authorisation treated as having been given by the licensing authority by virtue of Schedule 12 (transitional provisions) to the Clinical Trials Regulations, the person acting as sponsor of the clinical trial for the purposes of those Regulations; or
in any other case, the person who made the request for that authorisation;
“homoeopathic medicinal product” means any medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;
“immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product;
“manufacturer’s licence” means a manufacturer’s licence which relates wholly or partly to medicinal products for human use;
“manufacturing authorisation” means a manufacturing authorisation granted for the purposes of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) of the Clinical Trials Regulations;
“marketing authorization” means, except in regulation 3—
a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;
a Community marketing authorization; or
a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the 1994 Regulations,
which relates to a medicinal product for human use;
“medicinal product” includes any medicinal product for human use to which the 2001 Directive applies and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act(16) which directs that Part II of the Act or the Clinical Trials Regulations shall have effect in relation to such substance or article;
“national homoeopathic product” means a homoeopathic medicinal product which –
does not satisfy the conditions set out in article 14(1) of the 2001 Directive; and
is indicated for the relief or treatment of minor symptoms or minor conditions in humans;
“operator”, in relation to a contract laboratory, means the person having control of the contract laboratory;
“orphan medicinal product” has the meaning given in article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products(17);
“parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of Community law relating to parallel imports;
“penalty fee” means a fee payable under regulation 41;
“periodic fee” means the fee payable under regulation 31 or 32 by the holder of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial authorisation for the holding of the authorization, registration, authorisation or licence;
“Periodic Safety Update Report” means a report prepared to meet the requirements of the 2001 Directive;
“product licence of right” means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act (18) which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act;
“Regulation (EC) No. 726/2004” means Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(19);
“relevant fee period” means any fee period during any part of which a marketing authorization, a traditional herbal registration, a clinical trial authorisation, manufacturing authorisation or licence in respect of which a periodic fee is payable is in force;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply other than–
a traditional herbal medicinal product, or
a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;
“special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 (standard provisions which may be incorporated in a manufacturer’s licence relating to the import of relevant medicinal products from a third country) to, or paragraph 3(2) of Schedule 4 (standard provisions which may be incorporated in a wholesale dealer’s licence) to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005(20);
“traditional herbal medicinal product” has the meaning given by Article 1(29) of the 2001 Directive;
“traditional herbal registration” means a registration granted by the licensing authority under the Herbal Regulations;
“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the 1994 Regulations;
“variation”—
in relation to—
a United Kingdom marketing authorization, or
a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to those Regulations,
means “variation to the terms of a marketing authorization” as defined in Article 3(1) of Commission Regulation (EC) No. 1084/2003;
in relation to a traditional herbal registration, means a variation of the provisions of a traditional herbal registration;
“wholesale dealer’s licence” means a wholesale dealer’s licence which relates wholly or partly to medicinal products for human use;
and Part 1 of Schedule 1 shall have effect for the purpose of interpreting that Schedule.
(2) For the purposes of these Regulations, a clinical trial authorisation is in force unless the licensing authority has—
(a)received notification of the conclusion of the clinical trial to which the authorisation relates, in accordance with regulation 27 (conclusion of clinical trial) of the Clinical Trials Regulations; or
(b)suspended or terminated the trial at all sites at which that clinical trial was conducted, in accordance with regulation 31 (suspension or termination of clinical trial) of those Regulations (21).
(3) In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation and any reference to an applicant for a variation to a marketing authorization includes a reference to a person who submits such a notification.
3. In this Part—
“clinical development” means the conduct of studies of a medicinal product in human subjects in order to—
discover or verify the effects of such a product;
identify any adverse reaction to such a product; or
study absorption, distribution, metabolism and excretion of such a product,
with the object of ascertaining the safety or efficacy of that product, in accordance with section 5 of Part 1 of Annex 1 to the 2001 Directive;
“EC marketing authorization” means—
a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;
a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
a Community marketing authorization;
“pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)—
the advice is in connection with an application for an EC marketing authorization, or is given with a view to a person making such an application, and relates to—
the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of the Title II of Regulation (EC) No. 726/2004,
the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive, or
a post-authorization safety study protocol;
the advice is given to the holder of a United Kingdom marketing authorization or a Community marketing authorization and relates to—
compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004,
the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive, or
a post-authorization safety study protocol;
“post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;
“product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EC marketing authorization;
“quality development” means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with section 3 of Part 1 of Annex 1 to the 2001 Directive;
“regulatory advice” means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Regulation (EC) No. 726/2004 and which falls within one or more of the descriptions specified in paragraphs (a) to (c)—
the advice is in connection with a change to the dates for renewal of one or more EC marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;
the advice is in connection with—
a referral pursuant to Article 30, 31 or 36 of the 2001 Directive, or
the procedure referred to in Article 35(2) of the 2001 Directive,
in relation to a product range; or
the advice is given to a person with a view to him making—
an application for the variation or renewal of one or more EC marketing authorizations, or
an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive,
in relation to a product range;
“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply; and
“safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with section 4 of Part 1 of Annex 1 to the 2001 Directive.
4. Unless regulation 5 or 44 apply, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EC marketing authorization or an application for the variation of a marketing authorization, is—
(a)£2,227, if the advice provided at that meeting consists of advice in connection with—
(i)quality development only, or
(ii)safety development only;
(b)£2,797, if the advice provided at that meeting consists only of advice in connection with clinical development;
(c)£3,099, if the advice provided at that meeting consists only of advice in connection with quality and safety development;
(d)£3,669, if the advice provided at that meeting consists of advice in connection with—
(i)quality and clinical development, or
(ii)safety and clinical development;
(e)£4,542, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.
5.—(1) Unless regulation 44 applies, the fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is —
(a)£2,797, if the advice relates to a product which if reclassified will be available on general sale; and
(b)£3,699, if the advice relates to a product which if reclassified will be available without a prescription from a pharmacy.
(2) For the purposes of this regulation a product is on general sale if it is a medicinal product of a description, or falling within a class specified in an order made under section 51 (general sale lists) of the Act(22).
6. Unless regulation 44 applies, the fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by his undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,227.
7.—(1) Unless regulation 44 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is —
(a)£3,699, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;
(b)£3,099, in any other case.
(2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the aggregate of times spent by each individual engaged in preparing for or attending the meeting on behalf of the authority.
8. Unless regulation 44 applies, the fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,227.
9. Unless regulation 44 applies, the fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,797.
10.—(1) Unless regulation 44 applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,579.
(2) A person who—
(a)is or is to be a sponsor of a clinical trial;
(b)manufactures medicinal products;
(c)is or is to be responsible for placing medicinal products on the market; or
(d)acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),
is a specified person for the purpose of paragraph (1).
(3) A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to—
(a)scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;
(b)the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;
(c)the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Community; or
(d)other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EC marketing authorization has been granted for that product or a product of that type.
(4) This regulation does not apply to a meeting for the purpose of providing only any advice specified in regulations 4 to 9.
(5) In this regulation—
“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;
“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices (23);
“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;
“regulatory issues” means issues relating to the application of any Community instrument relating to EC marketing authorizations or to medical devices, or any enactment which implements such an instrument;
“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;
“sponsor” shall be construed in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations(24);
and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—
(a)obtaining an EC marketing authorization, or making a variation to an EC marketing authorization, for that product or a product of that type, or
(b)obtaining an EC design-examination certificate within the meaning of paragraph 4.3 of Annex II to Directive 93/42/EEC or an EC type-examination certificate within the meaning of paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.
11. Unless regulation 44 applies, all sums payable by way of fees under regulations 4 to 10 must be paid within 14 days following written notice from the licensing authority requiring payment of those fees.
12.—(1) Unless regulation 44, or 48 applies, the application fee for a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is—
(a)the fee prescribed for that application in Part 2 of Schedule 1; and
(b)in respect of an inspection of a site made in connection with that application the fee payable in accordance with regulations 27 to 29.
(2) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
13. The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £63.
14.—(1) The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act(25), is —
(a)£141, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and
(b)£63 in any other case.
(2) The fee in sub-paragraphs (a) and (b) is for three identical signed certificates.
(3) The fee payable by the applicant for a copy of the certificate referred to in paragraph (1) is £31 for a certified copy of the certificate.
15. For the purposes of this Part and Part 3 of Schedule 1, a “set of applications” means—
(a)a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in other EEA States, but only if all the applications relate to applications for marketing authorizations in other EEA States that have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive; or
(b)a number of applications to competent authorities of other EEA States for marketing authorizations relating to a single United Kingdom marketing authorization, but only if all the applications have the same 90 day assessment period for the purposes of Article 28.4 of the 2001 Directive.
16. Unless regulation 44 applies, the fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 1 in connection with the application or set of applications.
17. Unless regulation 39 or 44 applies, all sums payable by way of fees under regulation 16 must be paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated.
18.—(1) Unless regulations 44 or 48 applies, the fee for an application—
(a)under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the 1994 Regulations(26) for the variation of a United Kingdom marketing authorization;
(b)under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;
(c)under section 30 (variation of licence on application of holder) of the Act(27) for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or
(d)under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations(28) for the variation of a manufacturing authorisation,
is the fee mentioned in paragraph (2).
(2) The fee referred to in paragraph (1) is—
(a)the fee prescribed in Part 4 of Schedule 1 in connection with the application; and
(b)in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29.
(3) Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.
19.—(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(29) relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).
(2) The fees referred to in paragraph (1) are—
(a)the fee prescribed in paragraph 23 of Part 4 of Schedule 1 in connection with that amendment; and
(b)in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29.
20.—(1) Unless paragraph (2) applies, a separate fee is payable in respect of each variation of each provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence applied for in any one application.
(2) A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorization, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.
21. For the purposes of this Part and Part 5 of Schedule 1, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—
(a)if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
(b)those changes are submitted to the licensing authority at the same time.
22.—(1) Unless paragraph (2) or regulation 44 apply, where—
(a)a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or
(b)a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
the fee payable by the holder of that authorization or licence is the fee prescribed in Part 5 of Schedule 1 in connection with that change.
(2) Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.
23. Unless regulation 44 applies, all sums payable by way of fees under regulation 22 (1) must be paid at the time when the proposed changes are submitted to the licensing authority.
24.—(1) Unless regulation 44 applies, the fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £165.
(2) The licence referred to in paragraph (1) is one—
(a)which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorization or a product licence; and
(b)to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(30) applies.
(3) But if an inspection of a site is made in connection with the application an inspection fee of £273 is also payable by the applicant.
25. Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence or a wholesale dealer’s licence so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part of these Regulations is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had he made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.
26.—(1) Unless regulation 44 applies, where—
(a)an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and
(b)the United Kingdom is to provide regulatory assistance acting as reference member State in relation to that application,
the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 1 in connection with that regulatory assistance.
(2) The procedures referred to in paragraph (1) are—
(a)the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(31) and in Articles 17 and 18 of the 2001 Directive;
(b)the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;
(c)the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;
(d)referral to the Committee for Propriety Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(32), if the opinion of the Committee in accordance with Article 4.1 of that Directive was given before 1st January 1995.
(3) For the purposes of this regulation and Part 6 of Schedule 1, the United Kingdom provides regulatory assistance acting as reference member State if—
(a)the licensing authority prepares or updates an assessment report in respect of the medicinal product to which the renewal application relates in order to make it available to the competent authorities of another EEA State; and
(b)an application to renew the marketing authorization relating to that product has been made in that other EEA State.
27.—(1) Unless regulation 44 or 48 applies, a fee in accordance with paragraphs 1 to 7 of Schedule 2 is payable for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulations 24 or 30.
(2) Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of or applicant for, as the case may be, the authorization, registration, authorisation or licence in relation to which the inspection is made.
28. Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or, as the case may be, that API manufacturer.
29.—(1) Where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a)in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or
(b)by more than one applicant for such an authorisation or licence,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, authorisation, licence or registration.
(2) In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).
(3) Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a)in more than one manufacturer’s licence or manufacturing authorisation; or
(b)by more than one applicant for such a licence or authorisation,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.
(4) But this regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
30. Unless regulation 44 applies a fee in accordance with paragraphs 2 and 3 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—
(a)is—
(i)conducting, or has conducted, a clinical trial, or
(ii)performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),
in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or
(b)has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.
31.—(1) Unless paragraphs (2), (4), (5) or (6) or regulation 44 or 48 applies, the periodic fee must be paid for each fee period during which the authorization, registration, authorisation or licence is in force, even if it is in force for only part of that fee period.
(2) Marketing authorizations of a type referred to in Part 3 of Schedule 3 shall be treated for the purposes of paragraph (1) as if they were one marketing authorization and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorizations.
(3) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 3 and, for the purposes of that Part, Parts 1 and 2 of that Schedule have effect.
(4) No periodic fee is payable in respect of the fee period during which a marketing authorization or a traditional herbal registration is first granted unless the authorization or registration is granted pursuant to—
(a)a change of ownership application; or
(b)an application for a marketing authorization or traditional herbal registration which—
(i)is for a product for which an authorization or registration has expired,
(ii)will contain identical provisions to those contained in the expired authorization or registration,
(iii)is made by the person who held the expired authorization or registration, and
(iv)is made no later than three months after the expiry of the authorization or registration referred to in sub-paragraph (i),
and, in each case, a periodic fee has not been paid in respect of that fee period in connection with the expired marketing authorization or a traditional herbal registration.
(5) An authorization, registration, authorisation or licence which is in force is treated for the purposes of this regulation as not being in force during any part of a fee period if—
(a)at least three months before the commencement of that fee period, the holder of that authorization, registration, authorisation or licence has given written notice to the licensing authority indicating that he wishes it to cease to have effect before the commencement of that period; and
(b)no products are sold, supplied or manufactured pursuant to that authorization, registration authorisation or licence within that fee period.
(6) No periodic fee is payable in respect of the fee period during which a manufacturing authorisation, a manufacturer’s or wholesale dealer’s licence is first granted unless—
(a)that authorisation or licence is granted pursuant to a change of ownership application; and
(b)a periodic fee has not been paid in respect of that fee period in connection with the manufacturing authorisation or manufacturer’s or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.
32.—(1) Unless paragraph (3) or regulation 44 applies, the holder of a clinical trial authorisation must pay the periodic fee for each fee period during which the authorisation is in force, even if the authorisation is in force for only part of that fee period.
(2) The periodic fee is the fee prescribed in paragraph 16 of Part 3 of Schedule 3.
(3) No periodic fee is payable in respect of the fee period during which the clinical trial to which the authorisation relates was authorised by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving medicinal products with special characteristics) of the Clinical Trials Regulations(33).
33. In this Part—
“good clinical practice accreditation scheme” means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection; and
“Phase I trials” are clinical trials to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
34.—(1) The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £120.
(2) The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £63.
35.—(1) The fee payable by an applicant or holder of an authorization who gives notice under paragraph 11 (right to be heard by a person appointed or to make further representations) or 16 (right to be heard by a person appointed) of Schedule 2 to the 1994 Regulations(34) of his wish to appear before or be heard by a person appointed by the licensing authority is £10,000.
(2) But the licensing authority will refund to that person—
(a)60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed;
(b)100% of that fee if the decision notified by the licensing authority in accordance with sub-paragraph (10) of paragraph 17 (hearing before person appointed) of Schedule 2 to the 1994 Regulations is—
(i)not to revoke, vary or suspend the authorization, or
(ii)to grant or renew the authorization in accordance with the application submitted under regulation 4(1) (applications for the grant, renewal or variation of a UK marketing authorization) of the 1994 Regulations.
36. The fee in regulation 35 is payable at the time the notice is given.
37. Any sums which under the provisions of these Regulations become payable by way of, or on account of, fees must be paid to one of the Ministers.
38.—(1) Except where regulation 11, 17, 23 or 36 applies and subject to paragraph (2) and to regulations 39 and 44, all sums payable by way of capital fees under these Regulations in connection with any application must be paid at the time of the application.
(2) All sums payable by way of fees in respect of inspections made either in connection with an application for, or during the currency of, an authorization, licence or certificate must be paid within 14 days following receipt of written notice from the licensing authority requiring payment of those fees.
39.—(1) Schedule 4 shall have effect with respect to the capital fee payable in connection with an application made by or on behalf of a small company.
(2) For the purpose of these Regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified under the heading “Small company” in section 247(3) (qualification of company as small or medium-sized) of the Companies Act 1985(35); and
(a)its balance sheet total (as defined in section 247(5) of that Act) is not more than the amount for the time being specified under the heading “Small company” in section 247(3) of that Act; or
(b)the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 247(3) of that Act.
40. All periodic fees must be paid on the first day of the fee period to which they relate.
41.—(1) Subject to paragraph (2), if a person has failed to pay a periodic fee at the time it should have been paid under regulation 40, a penalty fee is payable by that person.
(2) A penalty fee is payable only if after 60 days following written notice from the licensing authority requiring payment of that fee, the fee remains unpaid.
(3) Unless regulation 42 applies, the penalty fee is—
(a)£100 where the total periodic fee unpaid by a person after 60 days following the notice referred to in paragraph (2) exceeds £200; or
(b)£50 where the total periodic fee unpaid by a person after such period does not exceed £200.
(4) In paragraph (3), the “total periodic fee” means the aggregate of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.
42. If the periodic fee and penalty fee under regulation 41 (“the outstanding amount”) have not been paid within 90 days following the written notice from the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 41(3) plus £5 for each day of the period which—
(a)begins with the day 90 days from the date of the written notice; and
(b)ends with the day before that on which payment of the outstanding amount is actually made.
43. The licensing authority may refund or waive payment of the penalty fee, or reduce the amount payable, where it is satisfied that the holder of the authorization, registration, authorisation or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 41(2) or 42.
44.—(1) If after a capital or periodic fee is paid it becomes apparent that—
(a)a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or
(b)a higher fee should have been paid, the balance due shall be payable within 14 days following written notice from the licensing authority to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned requiring payment of that balance.
(2) The licensing authority shall, to the extent provided in Schedule 5 in relation to capital fees or in Schedule 6 in relation to periodic fees—
(a)adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or
(b)refund the whole or part of any fee already paid.
45. Where any sum due by way of, or on account of, any fee or any part thereof payable under these Regulations remains unpaid by the holder of a product licence or a product licence of right, a manufacturer’s licence or a wholesale dealer’s licence, the licensing authority may serve a written notice on him requiring payment of the sum unpaid and, if after a period of one month from the date of service of such notice, or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence until such sum has been paid.
46. All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.
47.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(36) are amended as follows.
(2) In regulation 14 (fees for variation of certificates)—
(a)in paragraph (1)(a), for “£110” substitute “£127”;
(b)in paragraph (1)(b)(i), for £110” substitute “£127”;
(c)in paragraph (1)(b)(ii), for “£55” substitute “£63.50”;
(d)in paragraph (2)(a), for “£237” substitute “£250”;
(e)in paragraph (2)(b)(i), for “£237” substitute “£250”;
(f)in paragraph (2)(b)(ii), for “”£237” substitute “£250”;
(g)in paragraph 2(b)(iii), for “£120” substitute “£127”; and
(h)in paragraph 2(b)(iv), for “£60”, substitute “£62.50”.
(3) In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£19” substitute “£22”.
(4) In the table in Schedule 2 (fees for applications for the grant of certificates of registration)—
(a)in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—
(i)for “£155” substitute “£164”,
(ii)for “£466” substitute “£492”,
(iii)for “£488” substitute “£516”, and
(iv)for “£770” substitute “£813”.
(b)in column (3) (fees for other applications)—
(i)for “£383” substitute “£405”,
(ii)for “£686” substitute “£725”,
(iii)for “£622” substitute “£657”, and
(iv)for “£1,007” substitute “£1,064”.
(5) In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States)(37), in paragraph 2—
(a)in sub-paragraph (a), for “£279” substitute “£295”; and
(b)in sub-paragraph (b), for “£365” substitute “£386”.
48.—(1) The Regulations listed in Schedule 7 are revoked to the extent specified in that Schedule.
(2) But—
(a)in relation to capital fees, the Medicines (Products for Human Use – Fees ) Regulations 1995(38) continue to apply as if they had not been revoked to any application or inspection made before the date on which these Regulations come into force;
(b)the Medicines (Products for Human Use – Fees ) Regulations 1995 continue to apply as if they had not been revoked to any periodic fee payable in relation to a fee period ending before the date on which these Regulations come into force;
(c)paragraph (1) does not affect any proceedings constituted under the revoked Regulations for the recovery of any fees due as debts to the Crown.
(3) For the purpose of this regulation “capital fee” and “periodic fee” have the same meaning as is given in the Medicines (Products for Human Use – Fees ) Regulations 1995.
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister for Health,
Department of Health
27th February 2008
Michael McGimpsey
Minister for Health, Social Services and Public Safety
27th February 2008
Michelle Gildernew
Minister for Agriculture and Rural Development
28th February 2008
Alan Campbell
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
26th February 2008
Regulations 2 (1), 12 (1) (a), 16, 18(1), 19 (1), 22(1), 26(1).
1. In this Schedule—
“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);
“active ingredient from a new source” means an active ingredient in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;
“certificate of registration” means a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(39);
“complex application” means an application, other than a major application, for a marketing authorization where the application falls within one or more of the descriptions specified in sub-paragraphs (a) to (s)—
the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;
the application relates to a medicinal product containing a new combination of active ingredients that have not previously been included in that combination in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product containing a new excipient;
the application relates to a medicinal product that is intended to be administered by a route of administration different from that used in the administration of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product which is a controlled release preparation and is not a simple application;
the application relates to a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
unless a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application, the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other marketing authorization which the application holds in respect of that product;
the application is for the grant of a marketing authorization for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other marketing authorization which the applicant holds;
the application is for the grant of a marketing authorization for a medicinal product which is to be delivered by way of a metered dose inhaler;
the application is for the grant of a marketing authorization for a medicinal product which is in a powdered form and is to be delivered by way of inhalation;
the application relates to a medicinal product—
which is administered to the site of action or absorption by a method which has not previously been authorised in relation to any authorised medicinal product which contains the same active ingredient as the product in question, and
in respect of that other product, a marketing authorization (other than a product licence of right) has previously been granted;
the application is an application for a marketing authorization to which Article 10(3) of the 2001 Directive applies;
the application is an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;
the application is—
for an extension of an existing marketing authorization which fulfils the conditions set out in Annex II to Commission Regulation (EC) No. 1084/2003, and
includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
the application—
is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive, and
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
the application is an application for a marketing authorization to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applies;
“complex registration application” means an application for a traditional herbal registration relating to a medicinal product containing an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;
“decentralised procedure application” means a major application, a complex application, a standard application or a simple application for a marketing authorization for a medicinal product in respect of which at the time of the application—
a marketing authorization has not been granted in any EEA State; and
an application for a marketing authorization has been made in more than one EEA State pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive;
“EC marketing authorization” means—
a marketing authorization, or
an authorization issued by the competent authorities of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;
“eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive;
“eCTD format application” means an application made using the MHRA portal and in relation to which the accompanying particulars and documents are presented in eCTD format;
“European reference product application” means an application for a marketing authorization to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies;
“major application” means an application for a marketing authorization relating to a medicinal product containing a new active ingredient;
“the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”;
“mutual recognition procedure incoming application” means a major application, a complex application, or a standard application for a marketing authorization for a medicinal product in respect of which—
a marketing authorization has already been granted in another EEA State; and
recognition of that marketing authorization is sought from the licensing authority by way of the grant of a marketing authorization in the United Kingdom, pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive;
“new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
“new excipient” means—
except in Part 2, paragraph 11 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—
which is intended to be administered by the same route of administration as the product in question, and
in respect of which a marketing authorization (other than a product licence or right), a certificate of registration or a traditional herbal registration has previously been granted,
except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in food or in a food product;
in Part 2, paragraph 11 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product which is intended to be administered by the same route of administration as the product in question and in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted, except that—
in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in food or in a food product, and
in the case of a medicinal product intended for external use only, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in a cosmetic product;
“Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;
“Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—
does not have an EC marketing authorization; or
has an EC marketing authorization, but—
there has been a change—
to the process of manufacture of the product or its active ingredient, or
of manufacturer of that product or substance, or
the product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorization;
“Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;
“reduced registration application category I” means an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea;
“reduced registration application category II” means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows—
the application relates to a medicinal product which is presented in the form of a herbal tincture;
the application relates to a medicinal product which is presented in the form of an essential oil;
the application relates to a medicinal product which is presented in the form of a fatty oil; or
the application relates to a medicinal product which contains only herbal substances in a capsule;
“simple application” means—
an application for a marketing authorization to which Article 10c of the 2001 Directive applies; or
an application made no later than three months after the expiry of a marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization;
“standard application” means any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a parallel import licence;
“standard registration application” means any application for the grant of a traditional herbal registration which is not a complex registration application, a reduced registration application category I, a reduced registration application category II or a change of ownership application;
“TSE risk ingredient from a new source” and “TSE risk excipient from a new source” mean an active ingredient or excipient, respectively, which has been manufactured from raw materials of ruminant origin or which has had raw materials of ruminant origin used in its manufacture and in respect of which—
the application names as manufacturer a manufacturer not previously named as the manufacturer of that ingredient or excipient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and
no European Pharmacopoeia certificate of suitability covering the excipient has been submitted with the application;
“vitamin or mineral from a new source” means a vitamin or mineral in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that vitamin or mineral included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted.
2.—(1) Unless paragraphs 3, 4, 6 or 7 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table is—
(a)if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table; or
(b)if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.
Fees for marketing authorization applications
Column 1 Kind of application | Column 2 Fee payable if application is in eCTD format | Column 3 Fee payable if application is not in eCTD format | ||||
|---|---|---|---|---|---|---|
| 1. Major application | ||||||
| (a) | in respect of an application relating to an orphan medicinal product to which point 6 of Part 2 of Annex 1 to the 2001 Directive applies | £30,101 | £31,576 | |||
| (b) | which is a mutual recognition procedure incoming application | £63,198 | £66,295 | |||
| (c) | which is a European reference product application | £63,198 | £66,295 | |||
| (d) | which is a decentralised procedure application where the United Kingdom is a concerned member State | £90,671 | £95,114 | |||
| (e) | which is a decentralised procedure application where the United Kingdom is a reference Member State | £138,145 | £144,914 | |||
| (f) | in any other case | £93,907 | £98,491 | |||
| 2. Complex application | ||||||
| (a) | which is a mutual recognition procedure incoming application | £17,546 | £18,406 | |||
| (b) | which is a European reference product application | £17,546 | £18,406 | |||
| (c) | which is a decentralised procedure application where the United Kingdom is a concerned member State | £25,068 | £26,296 | |||
| (d) | which is a decentralised procedure application where the United Kingdom is a reference Member State | £40,461 | £42,444 | |||
| (e) | in any other case | £25,962 | £27,228 | |||
| 3. Standard application | ||||||
| (a) | which is a mutual recognition procedure incoming application | £6,430 | £6,745 | |||
| (b) | which is a European reference product application | £6,430 | £6,745 | |||
| (c) | which is a decentralised procedure application where the United Kingdom is a concerned member State | £9,191 | £9,642 | |||
| (d) | which is a decentralised procedure application where the United Kingdom is a reference Member State | £17,779 | £18,650 | |||
| (e) | in any other case | £9,519 | £9,984 | |||
| 4. Simple application | ||||||
| (a) | which is a decentralised procedure application where the United Kingdom is a concerned member State | £2,596 | £2,722 | |||
| (b) | in any other case | £2,596 | £2,722 | |||
| 5. Application for a parallel import licence | Not applicable | £1,815 | ||||
| 6. Change of ownership application | Not applicable | £448 | ||||
(2) Each reference in paragraphs 3, 5 and 6 to an amount payable under paragraph 2 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.
3.—(1) Unless paragraph 5 applies, where an application, other than a major application, includes a reclassification element, an amount of –
(a)£8,264 if the application is an eCTD format application; or
(b)£8,666, if the application is not an eCTD format application,
is payable in addition to the amount payable under paragraph 2 in respect of that application.
(2) For the purposes of this paragraph and paragraph 6, an application includes a reclassification element if—
(a)the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or
(b)the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.
(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a Community marketing authorization and which—
(a)has the same active ingredient, route of administration and use;
(b)has the same strength or a higher strength;
(c)has the same dosage or daily dosage, or a higher dosage or daily dosage; and
(d)is for sale or supply at the same quantity or a greater quantity,
as the medicinal product in relation to which the application is made.
4. Where a major application is made by a person who holds a clinical trial certificate for a medicinal product which contains the same active ingredient as the medicinal product in respect of which the marketing authorization is applied for, the fee payable under regulation 12(1)(a) in connection with the application is reduced by the amount of the application fee paid for the clinical trial certificate.
5.—(1) In this paragraph—
“joint development” means the development by two or more applicants for marketing authorizations relating to medicinal products—
each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission; and
the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; and
in respect of which applications for marketing authorizations have been received by the licensing authority within one month of each other;
“primary applicant” means—
that party to a joint development who first makes an application for a marketing authorization relating to a new active ingredient which was the subject of that joint development; or
that party to a joint development who first makes an application for a marketing authorization relating to a different dosage form or strength of that new active ingredient;
“secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorization relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.
(2) Unless sub-paragraph (3) applies, where a joint development relates to a medicinal product and two or more applications for marketing authorizations are submitted to the licensing authority by parties to the joint development, the fee payable under regulation 12(1)(a) is the amount payable in respect of a major application under paragraph 2 plus—
(a)in respect of the first or only marketing authorization applied for by that secondary applicant, the amount payable in respect of a complex application under paragraph 2;
(b)in respect of each additional marketing authorization applied for by that secondary applicant which relates to a medicinal product of the same dosage form, the amount payable in respect of a standard application under paragraph 2;
(c)in respect of the first additional marketing authorization applied for by that secondary applicant relating to that medicinal product which is of a different dosage form, the amount payable in respect of a complex application under paragraph 2 and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 2.
(3) Where a joint development relates to a medicinal product and an application for an additional marketing authorization is submitted by both the primary applicant and the secondary applicant, both or all of which applications relate to identical dosage forms and strengths of the product—
(a)where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 12(1)(a) by the secondary application is that in respect of a standard application under paragraph 2;
(b)where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 12(1)(a) by the secondary applicant is that in respect of a simple application under paragraph 2.
6.—(1) Unless sub-paragraphs (2), (3) or (4) apply, where an application for a marketing authorization is for more than one such authorization each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 12(1)(a) is an amount equal to the aggregate of the amounts payable under paragraph 2 in respect of a separate application for each such authorization.
(2) If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 2 plus—
(a)in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 2;
(b)in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 2; and
(c)in respect of each additional marketing authorization applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 2.
(3) If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 2 plus—
(a)in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 2;
(b)in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 2; and
(c)in respect of each additional marketing authorization applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 2.
(4) If the application includes any applications for marketing authorizations that include a reclassification element, the amount payable is the amount payable in accordance with sub-paragraphs (1) to (3) plus—
(a)in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable under paragraph 3(1); and
(b)in respect of each other marketing authorization applied for that includes a reclassification element, £778, except in the case of an eCTD format application in which case the additional amount payable is £744.
7.—(1) In connection with an application for a marketing authorization for a national homoeopathic product prepared from not more than 5 homoeopathic stocks, the fee payable under regulation 12(1)(a) is the amount set out in Column (2) in the Table below opposite the description in Column (1) appropriate to that application.
(2) In connection with any other application for a marketing authorization for a national homoeopathic product, the fee payable under regulation 12(1)(a) shall be the amount set out in Column (3) in the Table below opposite the description in Column (1) appropriate to that application.
(3) This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.
| Column (1) | Column (2) | Column (3) | ||
|---|---|---|---|---|
| Description of application | Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks | Fees for other applications | ||
| 1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation | £531 | £753 | ||
| 2. An application in respect of a product which is either— | £832 | £1,044 | ||
| (a) | prepared solely from repeat stocks; or | |||
| (b) | is of a repeat formulation | |||
| 3. Any other application | £1,120 | £1,350 | ||
(4) Each reference in sub-paragraphs (5) to (7) to an amount payable under sub-paragraph (1) or (2) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.
(5) Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—
(a)not used in the manufacture of a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and
(b)not referred to in the European Pharmacopoeia or any national pharmacopoeia of a member State,
an amount of £2,216 is payable in addition to the amount payable under sub-paragraph (1) or (2) in respect of that application.
(6) Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £7,393 is payable in addition to the amount payable under sub-paragraph (1) or (2) in respect of that application.
(7) Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients or excipients from a new source, an amount of £653 is payable in addition to the amount payable under sub-paragraph (1) or (2) in respect of that application.
(8) In this paragraph—
“formulation” does not include the formulation of a homoeopathic stock;
“homoeopathic marketing authorization” means a marketing authorization granted by the licensing authority in respect of a national homoeopathic medicinal product;
“identical” means—
in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and
in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;
“product” includes a series of products each of which is prepared from identical homoeopathic stocks;
“repeat formulation” means—
the formulation of a product which is identical to the formulation of another product—
in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization, or
to which the applicant has, by the holder of the certificate of registration or the homoeopathic marketing authorization which relates to it, been authorised in writing to make reference for the purposes of this application; or
where more than one application is made by the same applicant on the same occasion in respect of products of identical formulations, for the purposes of the second and any subsequent of those applications which the licensing authority considers, the formulation of the product to which the first of those applications which is considered by the licensing authority relates; and
“repeat stock” means—
a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product—
in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization, or
in respect of which another person holds a certificate of registration or a homoeopathic marketing authorization to which, for the purposes of his application, the applicant has been authorised in writing to make reference by the person (or, if more than one, each of the persons) who supplied information to the licensing authority in connection with the application for the marketing authorization which relates to that product.
8.—(1) The fee payable under regulation 12(1)(a) in connection with an application for a manufacturer’s licence or a manufacturing authorisation is—
(a)£169, in a case to which sub-paragraph (2) applies;
(b)£319, in the case of a change of ownership application; and
(c)£2,911, in any other case.
(2) This sub-paragraph applies to the case of an application for a manufacturer’s licence which is limited solely to the manufacture or assembly of medicinal products which are to be sold or supplied in circumstances to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 applies.
9.—(1) Unless sub-paragraphs (2) or (6) apply, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer’s licence is £1,670.
(2) Where this sub-paragraph applies, the fee payable under regulation 12(1) (a) is £715.
(3) Sub – paragraph (2) applies where an application for a wholesale dealer’s licence—
(a)relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15 per cent of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;
(b)does not relate to anything done in a registered pharmacy but where the total turnover of the sale by way of wholesale dealing of authorised medicinal products does not exceed £35,000; or
(c)relates only to medicinal products falling within a description or class specified in an Order which is for the time being in force made under section 51(1) (general sale lists) of the Act(40).
(4) For the purposes of sub-paragraphs (3) (a) and (b) “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.
(5) But sub-paragraph (2) does not apply where the applicant has not held a wholesale dealer’s licence during the 12 month period preceding the date of the application unless at the time of making the application it is reasonable for the applicant to believe —
(a)in the case of an application for a wholesale dealer’s licence which relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and which amounts to wholesale dealing, that such dealing will constitute no more than 15 per cent of the gross amount of the total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence; or
(b)in the case of an application for a wholesale dealer’s licence which does not relate to anything done in a registered pharmacy, that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and
he so informs the licensing authority when he makes his application.
(6) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £369.
10.—(1) Unless sub-paragraphs (3) and (4) apply, the fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation for a clinical trial of a kind described in column 1 of the following Table is the fee specified in the corresponding entry in column 2 of that Table.
Column 1 Kind of clinical trial | Column 2 Fee payable |
|---|---|
| Phase I trial | £2,146 |
| Phase II or Phase III trial where the medicinal product being tested is unknown to the licensing authority | £4,040 |
| Phase II or Phase III trial where the product being tested is known to the licensing authority | £3,283 |
| Phase IV trial | £252 |
(2) For the purposes of that Table, a medicinal product is known to the licensing authority if—
(a)the product has an EC marketing authorization; or
(b)the product does not have an EC marketing authorization, but where—
(i)another pharmaceutical form or strength of that product has an EC marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the holder of that authorization,
(ii)another medicinal product containing the same active substance has an EC marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the manufacturer of that other product, or
(iii)a clinical trial in which that product is, or was, being tested or used has been authorised by the licensing authority in accordance with Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (41).
(3) Where the application is in relation to a clinical trial in which the medicinal products being tested or used are the same as those being tested or used in a clinical trial—
(a)in respect of which the applicant made a request for authorisation; and
(b)which has been authorised by the licensing authority for the purposes of the Clinical Trials Regulations,
the fee payable in connection with that application is £252.
(4) Where—
(a)the medicinal product to be tested in the clinical trial to which the application relates has been used in another clinical trial that has been authorised, or is to be treated as having been authorised, by the licensing authority for the purposes of the Clinical Trials Regulations; and
(b)the sponsor of that other trial authorises the licensing authority to refer to the dossier submitted in relation to that product in accordance with paragraph 11 of Schedule 3 to those Regulations,
the fee payable in connection with that application is £252.
11.—(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in Column 1 of the following Table is the fee specified in the corresponding entry in Column 2 of that Table—
| Column 1 | Column 2 | |||
|---|---|---|---|---|
| Kind of application | Fee payable | |||
| 1. Complex registration application | ||||
| (a) | in respect of a medicinal product containing a single active ingredient | £4,986 | ||
| (b) | in any other case | £7,480 | ||
| 2. Standard registration application | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £2,493 | ||
| (b) | in any other case | £3,740 | ||
| 3. Reduced registration application category II | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £831 | ||
| (b) | in any other case | £1,247 | ||
| 4. Reduced registration application category I | ||||
| (a) | in respect of a medicinal product containing 3 or fewer active ingredients | £555 | ||
| (b) | in any other case | £831 | ||
| 5. Change of ownership application | £448 | |||
(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.
(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—
(a)£1,108, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application;
(b)£2,216, in any other case,
is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £7,394 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £657 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,216 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.
12. In this Part, a reference to—
(a)an application to the licensing authority for regulatory assistance means a reference to—
(i)a single application of that type, or
(ii)a set of applications of that type,
relating to a single United Kingdom marketing authorization; and
(b)an application for a marketing authorization in a concerned member State means a reference to—
(i)a single application of that type, or
(ii)a set of applications of that type in a number of concerned member States,
relating to a single United Kingdom marketing authorization.
13. The fee payable under regulation 16 in connection with an application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in a concerned member State is—
(a)if the application in the concerned member State, had it been in the United Kingdom, would have been a major application—
(i)in respect of the first application for regulatory assistance to the licensing authority, a fee of £42,090, and
(ii)in respect of each other application for regulatory assistance to the licensing authority, a fee of £27,648;
(b)if the application in the concerned member State, had it been in the United Kingdom, would have been a complex application—
(i)in respect of the first application for regulatory assistance to the licensing authority, a fee of £10,883, and
(ii)in respect of each other application for regulatory assistance to the licensing authority, a fee of £7,221;
(c)if the application in the concerned member State, had it been in the United Kingdom, would have been a standard application—
(i)in respect of the first application for regulatory assistance to the licensing authority, a fee of £4,333, and
(ii)in respect of each other application for regulatory assistance to the licensing authority, a fee of £3,611; and
(d)if the application in the concerned member State, had it been in the United Kingdom, would have been a simple application, in respect of each application for regulatory assistance to the licensing authority, a fee of £2,593.
14. In this Part of this Schedule—
“administrative variation application” means an application by a traditional herbal registration holder to vary a traditional herbal registration where the variation applied for falls within one of the following sub-paragraphs—
a change of either or both of the name and the address of the holder of the registration;
a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the registration where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;
the removal from the registration of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;
“BROMI variation” means a notification of, or an application for, a variation to the terms of a marketing authorization which is not within the subject matter or scope of Commission Regulation (EC) No.1084/2003 and which—
is submitted using the MHRA portal;
is for a change set out in the BROMI variations guidance;
complies with the conditions to be fulfilled set out in the check list which relates to that change in the BROMI variations guidance; and
is accompanied by the documents which the BROMI variations guidance specifies must be provided with the application for the change;
“BROMI self-certification variation” means a BROMI variation for a change which is designated a Self Certification Procedure type in the check list in the BROMI variations guidance;
“BROMI Type IA variation” means a BROMI variation for a change which is designated a IA Procedure type in the check list in the BROMI variations guidance;
“BROMI Type IB variation” means a BROMI variation for a change which is designated a IB Procedure type in the check list in the BROMI variations guidance;
“BROMI variations guidance” means version 2.1 of the document published by the licensing authority on its website in February 2008, entitled “BROMI Dossier Requirements For Type IA And Type IB UK National Notifications” and dated November 2007(42);
“complex variation application” means an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes—
a change in that product’s active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;
a change in that product’s excipients which involves the addition of one or more TSE risk excipients from a new source; or
a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application;
“Extended Type II Complex Variation Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) so that the medicinal product is indicated for use—
in a therapeutic area for which the product was not previously indicated for use; or
in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests;
“new excipient variation application” means an application, other than a complex variation application, by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of the medicinal product to add a new excipient;
“new indication variation application” means an application to vary a marketing authorization for a national homoeopathic product, so that product is indicated for a therapeutic use not previously covered by that authorization;
“reclassification variation application” means an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—
is to be available only from a pharmacy, where previously it was available only on prescription; or
is to be available on general sale, where previously it was available only on prescription or only from a pharmacy;
“standard variation application” means an application by a traditional herbal registration holder to vary a traditional herbal registration which is not a complex variation application, a new excipient variation application or an administrative variation application;
“standard variation application for a homoeopathic product” means an application for a variation of a marketing authorization for a national homoeopathic medicinal product which requires—
the replacement of an excipient used in the manufacture of the product;
the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;
a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;
a change to the method of manufacture of a homoeopathic stock included in the product;
a change to the specification of any reagent of excipient used in the manufacture of the product;
a change to the finished product specification of the product;
a change to the test procedure for any raw material used in the manufacture of the product;
a change to the test procedure for the product;
a change to the test procedure for the container or other form of packaging immediately in contact with the product;
a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;
a change to the shape of the container in which the product may be placed on the market;
an additional pack size in which the product may be placed on the market;
a change to the approved storage conditions for the product;
a change to the shelf life of an unopened container of the product after the container has been opened for the first time;
a change to the dimensions of an approved dosage form of the product (for example, tablets); or
a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive;
“Type IA Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IA within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;
“Type IB Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IB within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;
“Type II Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—
a reclassification variation;
a Type IA Application;
a Type IB Application;
a Type II Complex Variation Application;
an Extended Type II Complex Variation Application; or
a change to which Annex II to Commission Regulation (EC) No. 1084/2003 applies;
“Type II Complex Variation Application” means an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change—
in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation (EC) No. 1084/2003 applies—
a change which necessitates in- vivo bioavailability studies to be performed on that product,
a change in that product’s preservative system, or
a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or
which is considered a “major variation” within the meaning given in Article 3.3 of Commission Regulation (EC) No. 1084/2003 and which is—
supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests, or
accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or
in the composition, manufacture or use of a medicinal product to which—
paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product, or
paragraph (i) of that definition would so apply and the change is not a variation which satisfies conditions 1, 3 and 4 specified in point 14 of Annex I to Commission Regulation (EC) No. 1084/2003 (change in the manufacturer of the active substance or starting material/reagent/intermediate in the manufacturing process of the active substance where no European Pharmacopoeia certificate of suitability is available).
15. Subject to paragraphs 17 to 19 and 26 to 28, the fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table is—
(a)if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table;
(b)if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.
Column 1 Kind of application | Column 2 Fee payable if in eCTD format | Column 3 Fee payable for application not in eCTD format | |
|---|---|---|---|
| 1. Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation | |||
| (a) | Type IA Application | £278 | £292 |
| (b) | Type IB Application | £556 | £583 |
| (c) | Type II Application | £900 | £944 |
| (d) | Type II Complex Variation Application | £14,586 | £15,298 |
| (e) | Extended Type II Complex Variation Application | £36,290 | £38,062 |
| 2. Other variation applications | |||
| (a) | BROMI Self Certification Application | £176 | £178 |
| (b) | Type IA Application | £180 | £188 |
| (c) | BROMI Type 1A Application | £180 | £188 |
| (d) | Type 1B Application | £280 | £296 |
| (e) | BROMI Type 1B Application | £280 | £296 |
| (f) | Type II Application | £744 | £778 |
| (g) | Type II Complex Variation Application | £8,412 | £8,824 |
| (h) | Extended Type II Complex Variation Application | £25,962 | £27,228 |
| (i) | Reclassification variation Application | £8,264 | £8,666 |
16.—(1) subject to sub-paragraph (3), if an application to vary a marketing authorization of a kind described in sub-paragraph (2) is—
(a)the first application to vary a marketing authorization;
(b)made within 5 years of the date of grant of the marketing authorization; and
(c)an application to authorise use of the medicinal product in a new therapeutic area,
the fee payable for that application is the fee payable under regulation 18(1) and the difference between that fee and the fee which would have been payable if the application had been a major application.
(2) In this paragraph a marketing authorization is one which has been granted in accordance with an application to which point 6 of part II of Annex 1 to the 2001 Directive applies or which is in respect of an orphan medicinal product.
(3) Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorization relates to a therapeutic area, in respect of which the applicant would be entitled (had he not already held a marketing authorization) to apply for a marketing authorization to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product.
17.—(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 18(1) in connection with the application for variation of a marketing authorization is £778, unless the application is an eCTD format application, in which case the fee payable under regulation 18(1) is £744.
(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorization relates—
(a)is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or
(b)is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.
(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a Community marketing authorization and which—
(a)has the same active ingredient, route of administration and use;
(b)has the same strength or a higher strength;
(c)has the same dosage or daily dosage, or a higher dosage or daily dosage; and
(d)is for sale or supply at the same quantity or a greater quantity,
as the medicinal product in relation to which the variation application is made.
18. The fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization in respect of a national homeopathic product is—
(a)£250, where the application is a standard variation application for a homeopathic product;
(b)£388, where the application is a new indication variation application; and
(c)£127, for any other application.
19.—(1) The fee payable under regulation 18(1) in connection with an application for variation of a parallel import licence is –—
(a)£8,666 if, were the marketing authorization not a parallel import licence, the application for the variation would be a reclassification variation application to which paragraph 17 of this Schedule does not apply;
(b)£176 if the application is one to which sub-paragraph (2) applies; and
(c)£360, in any other case.
(2) This sub paragraph applies where the variation applied for falls within one of the following sub-paragraphs—
(a)a change of either or both of the name and the address of the holder of the licence;
(b)a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;
(c)the removal from the licence of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;
(d)the removal from the licence of details of any of the activities to which the licence relates;
(e)the removal from the licence of details of any of the medicinal products which the holder of the licence is authorized to import;
(f)the addition or deletion of the name and address of the suppliers of the medicinal product to which the licence relates, or a change in the name, the address, or both the name and address, of the suppliers of that product;
(g)unless paragraph 7 of Schedule 5 applies, a change consequential upon any or any combination of the following—
(i)a change of ownership of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,
(ii)a change to the number of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,
(iii)a change to the name of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,
(iv)a change to the address of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted,
(v)a change to the number of the marketing authorization for the product in the country where the product originates,
(vi)a change of ownership of the marketing authorization for the product in the country where the product originates,
(vii)a change to the name of the holder of the marketing authorization for the product in the country where the product originates,
(viii)a change to the address of the holder of the marketing authorization for the product in the country where the product originates,
where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, if the marketing authorization was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 18 of this Schedule applies.
20. Unless paragraph 26 applies, the fee payable under regulation 18(1)(c) or (d) in connection with an application for variation of a manufacturing authorisation or a manufacturer’s licence is—
(a)£238, in the case of a manufacturer’s licence referred to in paragraph 8(2) of Part 2 of this Schedule; and
(b)£476, in any other case,
unless the fee in paragraph 21 is payable.
21. The fee payable under regulation 18(1)(c) or (d) in connection with an application for variation of a manufacturing authorisation or a manufacturer’s licence is £238 in respect of each variation applied for which constitutes a change to the authorisation or licence not requiring an inspection or medical, scientific or pharmaceutical assessment.
22. Unless the fee in paragraph 23 is payable or paragraph 26 applies, the fee payable under regulation 18(1)(c) in connection with an application for a variation of a wholesale dealer’s licence is £450.
23. The fee payable under regulation 18(1)(c) in connection with an application for variation of a wholesale dealer’s licence is £238 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.
24.—(1) The fee payable under regulation 19(1) in connection with a notice of amendment relating to amendment to the dossier accompanying a request for authorisation to conduct a clinical trial is —
(a)£252, if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only ;
(b)£505, if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only; or
(c)£757, if the amendments relate to all three parts of the dossier specified in sub-paragraph (2) only.
(2) The parts of the dossier specified in paragraph (1) are—
(a)the part containing the summaries of the chemical, pharmaceutical and biological data relating to the medicinal product tested or used in the trial;
(b)the part containing the summaries of the non-clinical, pharmacological and toxicology data on that product; and
(c)the part containing the summaries of the available data from previous clinical trials of, and human experience with, that product.
25. Unless paragraph 26 applies, the fee payable under regulation 18(1) in connection with an application for variation of a traditional herbal registration is—
(a)£247, if the application is a standard variation application;
(b)£654, if the application is a complex variation application;
(c)£7,394, if the application is a new excipient variation application;
(d)£156, if the application is an administrative variation application.
26. Unless paragraphs 27 or 28 apply, where more than one application by the same applicant is made at the same time for the variation of a marketing authorization, a traditional herbal registration, a manufacturer’s licence, or a wholesale dealer’s licence and where the applications are for identical variations, the fee payable under regulation 18(1)—
(a)in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule;
(b)in connection with each of the other applications is 50 per cent of that amount.
27. Where more than one Type II Complex Variation Application or Extended Type II Complex Variation Application is made at the same time by the same applicant for the variation of a marketing authorization, the fee payable under regulation 18(1)—
(a)in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of the Schedule;
(b)in connection with each of the other applications where the applications are for identical variations and in respect of which no further medical, scientific or pharmaceutical assessment is required is the amount which would be payable if the application was a Type II Application.
28. Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 18(1)—
(a)if one or more of the applications is an application to which paragraph 17 does not apply—
(i)in connection with the first application to which paragraph 17 does not apply, is the appropriate amount specified in this Part of the Schedule,
(ii)in connection with each other application to which paragraph 17 does not apply, is £778, and
(iii)in connection with each other application to which paragraph 17 does apply, is £389;
(b)in any other case—
(i)in connection with the first application, is the appropriate amount specified in this Part of the Schedule, and
(ii)in connection with each other application, is £389.
29. In this Part—
(a)“clinical particulars”, in relation to a medicinal product, means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in paragraph 4 of Article 11 of the 2001 Directive;
(b)the “BROMI labels and leaflets self-certification guidance” means the document entitled “Guidance on Changes to Labelling and Patient Information Leaflets For Self – Certification” published by the licensing authority on its website on 28th January 2008(43).
30.—(1) Unless paragraph 31 applies, the fee payable under regulation 22(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is —
(a)£524, in respect of a product which is the subject of a United Kingdom marketing authorization other than a parallel import licence; and
(b)£332, in respect of a product which is the subject of a parallel import licence.
(2) But if the proposed changes in respect of a product to which the fee in sub-paragraph (a) applies are submitted in accordance with the BROMI labels and leaflets self – certification procedure the fee payable under regulation 22(1) is £188.
(3) For the purpose of this paragraph changes are submitted in accordance with the BROMI self -certification procedure if they are of a type described in the BROMI labels and leaflets self-certification guidance and comply with the conditions set out in relation to those changes in that guidance.
31.—(1) This paragraph applies where more than one set of proposed changes falling within regulation 22(1) is submitted by the same marketing authorization holder at the same time and where—
(a)the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or
(b)the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.
(2) Where this paragraph applies, the fee payable under regulation 22(1) is —
(a)in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 30; and
(b)in connection with each of the other sets of proposed changes, 50 per cent of that amount.
32. Unless paragraph 33 applies, the fee payable under regulation 26(1) in connection with regulatory assistance provided by the United Kingdom acting as reference Member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in regulation 26(2), is —
(a)£9,803, if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorization was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference Member State; or
(b)£756, in any other case.
33.—(1) This paragraph applies if more than one application falling within regulation 26(1) is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal.
(2) The fee payable under regulation 26(1) for applications to which sub-paragraph (1) applies is—
(a)if the applications fall within paragraph 32(a)—
(i)for the first application considered by the licensing authority, the amount specified in paragraph 32(a), and
(ii)£756, for each other application;
(b)if the applications fall within sub-paragraph (1) of paragraph 32(b)—
(i)for the first application considered by the licensing authority, the amount specified in paragraph 32(b), and
(ii)£378, for each other application.
Regulations 27(1), 30
1. In this Schedule—
(a)if an inspection is made at a site which is outside the United Kingdom, the fee for the inspection is increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters’ fees) reasonably incurred by him in respect of that inspection as a result of its being at a site outside the United Kingdom;
(b)for the purposes of paragraphs 3(1)(c), 4(1)(c) and 6(1)(c) in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day; and
(c)if an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the aggregate of times spent by each inspector in making the inspection.
2.—(1) The fee for an inspection made at a site is—
(a)£2,452, if the time taken to make the inspection is not more than 7 hours; and
(b)thereafter £1,226, for every additional period of 3 hours and 30 minutes or less taken to make the inspection.
(2) But sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.
3.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a manufacturer’s licence or during the currency of such a licence, is—
(a)£920, if the time taken to make the inspection is not more than 3 hours;
(b)£1,496, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and
(c)if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,496.
(2) Sub–paragraph (1) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.
4.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of an API manufacturer pursuant to Article 111(1)(a) of the 2001 Directive, is—
(a)£920, if the time taken to make the inspection is not more than 3 hours;
(b)£1,496, if the time taken to make the inspection is more than 3 hours but not more than 1day; and
(c)if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days to make the inspection by £1,496.
(2) Sub-paragraph (1) applies if the site inspected is wholly concerned with the manufacturer or assembly of starting material for use in the manufacture of traditional herbal medicinal products.
5. Except in the case of an inspection falling within paragraphs 6 or 7, the fee for an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence, is —
(a)£1,792, if the time taken to make the inspection is not more than 7 hours; and
(b)£896, for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.
6.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence is—
(a)£690, if the time taken to make the inspection is not more than 3 hours;
(b)£1,266, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and
(c)if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,266.
(2) Sub–paragraph (2) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.
7.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer’s licence is £896.
(2) Sub-paragraph (1) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes; and
(a)the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products falling within a description or class specified in an Order made under section 51(1) (general sale lists) of the Act;
(b)the site relates to a registered pharmacy as referred to in paragraph 9(3) of Part 2 of Schedule 1; or
(c)the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.
(3) In paragraph (c) of sub–paragraph (2), “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.
(4) But if the reason paragraph (c) of sub-paragraph (2) applies is because the applicant has not held a wholesale dealer’s licence during the 12 month period preceding the date of the application sub– paragraph (1) does not apply unless—
(a)at the time of making the application it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and
(b)he so informs the licensing authority when he makes his application.
Regulations 31(2), (3), 32 (2)
1. In this Schedule—
“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;
“complex application” has the same meaning as in Schedule 1;
“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—
which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—
a different dosage form of that drug or substance; or
of the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; and
in respect of which an application for a marketing authorization was made before the determination of the application for the marketing authorization for that drug or substance;
“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) of a description or falling within a class specified in an Order made under section 51(1) (general sale lists) of the Act;
“limited use drug” means a medicinal product in respect of which an application for a marketing authorization has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product;
“maintenance fee” means the periodic fee payable where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; and
that the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; or
where the medicinal product had been manufactured or imported into the United Kingdom during the period referred to in (a) above, that turnover did not exceed £1,000 during that period;
“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;
“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) which is neither a prescription only medicine nor a general sale list medicine;
“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an Order made under section 58(1) (medicinal products on prescription only) of the Act;
“reduced rate fee” means the periodic fee payable where the turnover relating to a medicinal product being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does not exceed £35,000 in the relevant calendar year;
“standard fee” means the periodic fee payable where the turnover relating to a medicinal product, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does exceed £35,000 in the relevant calendar year; and
“turnover” means the amount calculated in accordance with Part 2 of this Schedule.
2.—(1) Subject to sub-paragraph (2), “turnover” means, for the purposes of calculating the periodic fee payable in connection with the holding of a marketing authorization for a relevant fee period, the gross value at manufacturer’s prices of all medicinal products to which the authorization relates which are sold or supplied in the United Kingdom by the holder of the authorization during the period of 12 months preceding the commencement of the relevant fee period.
(2) For the purposes of calculating the periodic fee payable in connection with the holding of marketing authorizations mentioned in Part 4 of this Schedule for a relevant fee period, the quantity of products taken for the purposes of sub-paragraph (1) is the aggregate of all the products to which the authorizations relate.
3. For the purposes of paragraph 2, manufacturer’s prices are the following—
(a)for products sold or supplied by the authorization holder to wholesalers or to distributors or assemblers named in the marketing authorization, which he has manufactured or obtained from the manufacturer, the prices charged for the supply;
(b)for products sold or supplied by the authorization holder to retailers, which he has manufactured or obtained from the manufacturer, the prices so charged for the supply less an amount which, in the opinion of the licensing authority, represents the difference between those prices and the prices which would have been charged, in accordance with the practice prevailing during the relevant year, by a wholesaler for the product; or
(c)for products sold or supplied by the authorization holder which he has neither manufactured nor obtained from the manufacturer, the price which he paid for the supply.
4.—(1) For the purpose of satisfying the licensing authority for the purposes of Part 3 of this Schedule, an applicant shall, if requested, state the amount of the turnover, calculated in accordance with the preceding paragraphs of this Part of this Schedule.
(2) Where the authorization holder fails to furnish evidence of the amount of annual turnover to the satisfaction of the licensing authority, the licensing authority may require the authorization holder to furnish an auditor’s certificate containing such evidence.
(3) If within one month of the date by which such certificate is required to be furnished, or such longer period as the licensing authority may allow, the authorization holder has failed to furnish such certificate, the sum payable by way of periodic fees for the relevant fee period in question shall be equal to the fee provided for in paragraphs 10 and 13 of Part 3 of this Schedule or shall be such lesser sum as the licensing authority may specify in a written notice served on the authorization holder.
5. Unless paragraphs 6 to 10 apply, the fee payable under regulation 31(3) in connection with the holding of a marketing authorization relating to a medicinal product of a kind described in Column 1 of the following Table is the applicable fee specified in the corresponding entry in Column 2 of that Table.
Column 1 Kind of product | Column 2 Fee payable | |||
|---|---|---|---|---|
| 1. New Active Substance | £21,108 | |||
| 2. Other kinds of Medicinal Product— | ||||
| (a) | Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989 | £8,692 | ||
| (b) | Prescription Only Medicine | |||
| (i) | Standard Fee | £2,174 | ||
| (ii) | Reduced Rate Fee | £1,085 | ||
| (iii) | Maintenance Fee | £352 | ||
| (c) | Pharmacy Medicine | |||
| (i) | Standard Fee | £951 | ||
| (ii) | Reduced Rate Fee | £476 | ||
| (iii) | Maintenance Fee | £176 | ||
| (d) | General Sale List Medicine | |||
| (i) | Standard Fee | £393 | ||
| (ii) | Reduced Rate Fee | £195 | ||
| (iii) | Maintenance Fee | £85 | ||
| (e) | Herbal Remedy | £108 | ||
| (f) | National homoeopathic product | £77 | ||
| (g) | Homoeopathic or anthroposophic product which is the subject of a licence of right | £70 | ||
6. But, in the case of an article or substance to which Part II of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971(44), the fees payable under regulation 31(3) in connection with the holding of a marketing authorization or licence are —
(a)£483, in the case of a standard fee;
(b)£239, in the case of a reduced rate fee; or
(c)£101, in the case of a maintenance fee.
7. Unless paragraph 8 applies, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 31(3) is—
(a)£8,692 where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance;
(b)£5,868, in any other case.
8.—(1) The fee specified in—
(a)paragraph 5 for a new active substance; and
(b)in paragraph 7 for a derivative of a new active substance,
is only payable for the five relevant fee periods following that in which the marketing authorization is granted.
(2) The fee payable in accordance with entry 2(a) of the Table set out in paragraph 5 is only payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorization is granted.
(3) Where a marketing authorization is surrendered and at the same time another marketing authorization held by the authorization holder is varied so as to include in that other authorization the provisions of the first authorization the fee payable —
(a)for the five relevant fee periods following the fee period during which the marketing authorization is granted is the fee specified at entry 1 of the Table set out in paragraph 1, where the first authorization relates to a new active substance;
(b)in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 2(a) of that Table.
(4) In respect of fee periods following those referred to in sub-paragraphs (1) to (3) of this paragraph, the periodic fees are the appropriate fees for the kind of medicinal product in question specified in entries 2(b), (c) or (d) of the Table set out in paragraph 5.
(5) In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug—
(a)where turnover exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable is the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;
(b)where turnover does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 2(b) (i) of the Table set out in paragraph 5.
9. Where a marketing authorization relates to any two or more of the kinds of medicinal product described in entries 2(b), (c) or (d) of Column 1 of the Table in paragraph 5, the fee payable under regulation 31(3) shall be the maintenance fee specified in relation to those the relevant entries in Column 2 of that Table.
10. Where a reduced rate fee or a maintenance fee may be payable in respect of any relevant fee period and an authorization holder does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable by him shall, where applicable, be the standard fee for each description of medicinal product in respect of which a marketing authorization is held by the authorization holder.
11.—(1) The fee payable under regulation 31(3) in connection with the holding of a manufacturer’s licence is £435.
(2) The fee payable under regulation 31(3) in connection with the holding of a manufacturing authorisation is £435.
(3) The fee payable under regulation 31(3) in connection with the holding of a manufacturer’s licence which relates to the import of exempt imported products from a third country is the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 15.
12.—(1) Subject to sub-paragraph (2) and to paragraphs 13 and 16, the fee payable under regulation 31(3) in connection with the holding of a wholesale dealer’s licence is £267.
(2) The fee payable under regulation 31(3) is £160 where the wholesale dealer’s licence-
(a)relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15 per cent of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;
(b)does not relate to anything done in a registered pharmacy, where the total turnover of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or
(c)relates to general sale list medicines only.
(3) For the purposes of sub -paragraph (2) the total turnover shall be calculated in accordance with Part 2 of this Schedule and the references to “marketing authorization” and “authorization holder” in Part 2 shall be construed as if they were references to “wholesale dealer’s licence” and “licence holder”, respectively.
13. Where in respect of any relevant fee period, the holder of a wholesale dealer’s licence does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable by him shall be the fee prescribed in paragraph 12(1).
14. The fee payable under regulation 31(3) in connection with the holding of a wholesale dealer’s licence which relates to exempt imported products is the fee payable in accordance with paragraphs 12 and 13 and an additional amount calculated in accordance with paragraph 15.
15.—(1) The additional amount referred to in paragraph 11(3) and 14 in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.
Column 1 Number of special import notices | Column 2 Additional amount |
|---|---|
| 1 to 100 | £114 |
| 101 to 1,000 | £568 |
| 1,001 to 10,000 | £5,682 |
| 10,001 to 25,000 | £19,312 |
| 25,001 to 50,000 | £42,032 |
| 50,001 to 100,000 | £85,200 |
| 100,001 to 150,000 | £142,059 |
| 150,001 to 200,000 | £198,800 |
| 200,001 or more | £284,000 |
(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.
16. The fee payable under regulation 32(2) in connection with the holding of a clinical trial authorisation is £326.
17. The fee payable under regulation 31(3) in connection with the holding of a traditional herbal registration is £91.
18. Parallel import licences in respect of medicinal products for which separate marketing authorizations have been granted pursuant to the provisions of the 2001 Directive in two or more member States of the European Community, which have no differences having therapeutic effect, from a medicinal product in respect of which a single marketing authorization has previously been granted in the United Kingdom.
Regulation 39(1)
1. In this Schedule a reference to an application is to an application made by or on behalf of a small company.
2. In connection with a major application for a marketing authorization for which the fee payable is that specified in entry 1(f) of the Table in paragraph 2 of Part 2 of Schedule 1, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 25 per cent at the time of the application and as to 75 per cent within 30 days following written notice from the licensing authority that the application has been determined.
3. In connection with a complex application for a marketing authorization, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50 per cent at the time of the application and as to 50 per cent within 30 days following written notice from the licensing authority that the application has been determined.
4. In connection with an application to which paragraph 6 of Part 2 of Schedule 1 applies, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—
(a)as to 50 per cent of the aggregate payable in accordance with that paragraph at the time of the application; and
(b)as to 50 per cent of that aggregate within 30 days following written notice from the licensing authority that the application has been determined.
5. As regards the fee payable under regulation 16 in connection with an application—
(a)to which paragraph 13(a) of Part 3 of Schedule 1 applies—
(i)25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated, and
(ii)75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;
(b)to which paragraph 13(b), (c) or (d), of Part 3 of Schedule 1 applies—
(i)50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated, and
(ii)50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,
if the applicant so requests in writing.
6. In connection with an application for a traditional herbal registration, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50 per cent at the time of the application and as to 50 per cent 12 months after that time.
7. In connection with a complex variation application or a new excipient variation application to vary a traditional herbal registration, the fee payable under regulation 18(1) shall, if the applicant so requests in writing, be payable as to 50 per cent at the time of the application and as to 50 per cent within 12 months after that time.
8. In connection with an application for a manufacturer’s licence, manufacturing authorisation or a wholesale dealer’s licence the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50 per cent at the time of the application and as to 50 per cent 12 months after that time.
9. In connection with an application for a marketing authorization, traditional herbal registration, manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50 per cent within the period of 14 days referred to in regulation 38(2) and as to 50 per cent 12 months after that date.
Regulation 44(2)
1. Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any capital fees payable under these Regulations in connection with an application for the grant of a marketing authorization or a manufacturer’s licence relating to a medicinal product falling within that class or description and made during that period or, if the period will, or is likely to, exceed 3 months of that period, shall be waived.
2.—(1) Where—
(a)an application for a marketing authorization includes a reclassification element with the meaning of paragraph 3 of Part 2 of Schedule 1; and
(b)the licensing authority is satisfied that the reclassification element does not require consideration by a committee established under section 4 (establishment of committees) of the Act(45) or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act(46),
50% of the additional amount payable under paragraph 3(1) or 6(4)(a) of Part 2 of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.
(2) Where—
(a)an application for variation of a marketing authorization is a reclassification variation application (not being an application falling within paragraph 17 of Part 4 of Schedule 1); and
(b)the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,
50% of the fee payable under paragraph 15 and entry 2(g) of the table referred to in that paragraph or of the fee payable under paragraph 28(a)(i) of part 4 of Schedule 1shall be refunded, or if it has not yet been paid, shall be waived.
(3) Where—
(a)an application for variation of a parallel import licence falls within paragraph 19(1)(a) of Part 4 of Schedule 1; and
(b)the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,
50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.
(4) For the purposes of sub-paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act where—
(a)the licensing authority is satisfied that the application does not require consideration by such a committee or the Commission; and
(b)the committee or the Commission are consulted only by virtue of, or in accordance with, paragraph 5 of Schedule 2 to the 1994 Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations).
3. Where at the specific written request of the licensing authority or in response to the imposition of an urgent safety restriction under regulation 8 of the Herbal Regulations, an application is made for the variation of a traditional herbal registration so as to—
(a)restrict any one or more of the indications, dosage or target population; or
(b)add a new contraindication or a warning or both of these,
as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 18(1) shall be refunded or, if it has not yet been paid, shall be waived.
4.—(1) Subject to sub-paragraph (2) , where an application for the grant of, or for a variation to, a marketing authorization or traditional herbal registration, or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—
(a)if the application or notice has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90 per cent;
(b)except in a case to which sub-paragraph (c) applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50 per cent;
(c)if a request for further information in connection with the application has been made by the licensing authority under section 44(1) (provision of information to licensing authority) of the Act(47) or in pursuance of a Community provision which applies to applications for marketing authorizations or traditional herbal registrations, 25 per cent.
(2) If an application for the grant of, or for a variation to, a marketing authorization or traditional herbal registration, or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act, no refund or waiver of the fee payable under regulation 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be made under this paragraph.
5. Where an application for the grant of, or for a variation to, a manufacturing authorisation or a manufacturer’s or a wholesale dealer’s licence is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 12(1)(a) or 18(1) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—
(a)if the application is withdrawn before any inspection in connection with that application has been made, 90 per cent; or
(b)if such an inspection has been made, 50 per cent.
6. Where an application for the grant of a marketing authorization or traditional herbal registration, or an application for a clinical trial authorisation is refused by the licensing authority and—
(a)the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and
(b)if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3;
there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.
7. The fee payable for an application to vary a parallel import licence shall be waived if the application is made only —
(a)because of a change to the number of an authorization granted pursuant to the provisions of the 2001 Directive by another member State for a product to which the licence relates; and
(b)so that the number of that authorization shown on the licence can be changed.
8.—(1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorization in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 3, the fee payable under regulation 18(1) shall be refunded or waived.
(2) Subject to sub -paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.
(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 26 and 27 of Part 4 of Schedule 1, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs makes provision for the higher or highest fee.
9.—(1) In relation to an application for a clinical trial authorisation in relation to a Phase I trial or a Phase II or Phase III trial, the fee payable in respect of such an application may be reduced in accordance with the following sub-paragraphs.
(2) Where the licensing authority is satisfied that the investigational medicinal product dossier submitted in accordance with paragraph 11 of Schedule 3 to the Clinical Trials Regulations does not require a full medical, scientific or pharmaceutical assessment, the fee may be reduced by an amount which the authority considers to be the cost of the assessment work which is not required.
(3) The fee payable may not be reduced below £100.
(4) Where the fee has been reduced by the licensing authority but the applicant has paid the full fee, the amount by which the fee has been reduced shall be refunded to the applicant.
(5) In this paragraph “Phase I trial” and “Phase II or Phase III trial” have the same meaning as in Schedule 1.
10.—(1) Where the licensing authority holds a meeting referred to in regulation 4 in order to provide scientific advice with a view to a person making an application other than a major application or an application for a paediatric use marketing authorisation the fee shall be waived if —
(a)sub-paragraphs (2) or (3) apply to the application; and
(b)the meeting is held solely for the purpose of providing advice in relation to the application.
(2) This sub-paragraph applies to the application if —
(a)the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication; and
(b)no other product which has the same active ingredient and is intended to be used in accordance with the same indication and for the same part of the paediatric population as the product in question has previously been granted a marketing authorization.
(3) This sub- paragraph applies to the application if—
(a)the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication;
(b)as a result of the application the medicinal product will be available in a formulation which the licensing authority considers to be of significant benefit to that population in comparison to other medicinal products on the market in the United Kingdom; and
(c)no other product which has the same active ingredient and is in the same formulation as proposed for the product in question has previously been granted a marketing authorization.
(4) In this paragraph—
(a)a medicinal product is authorised for a paediatric indication if it is authorised for use in part or all of that part of the population aged between birth and 18 years and the details of the authorised indication are specified in the summary of characteristics drawn up in accordance with Article 11 of the 2001 Directive(48);
(b)“major application” means an application for a marketing authorization relating to a medicinal product containing a new active ingredient;
(c)“paediatric use marketing authorization” means a marketing authorization granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product;
(d)“supplementary protection certificate” means a certificate granted under Council Regulation (EEC) No. 1768/92 concerning the creation of a supplementary protection certificate for medicinal products(49)and a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.
Regulation 44(2)
1. Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorization, traditional herbal registration or licence in respect of which such a fee has been paid is either surrendered at the specific written invitation of the licensing authority, or is revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorization, traditional herbal registration or licence, the licensing authority shall refund to the applicant the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorization, traditional herbal registration or licence up to the date of such surrender or revocation.
2.—(1) This paragraph applies to periodic fees payable in connection with a manufacturer’s licence or a wholesale dealer’s licence which relates to exempt imported products.
(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.
(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.
3. Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.
Regulation 48(1)
| (1) Regulations revoked | (2) References | (3) Extent of revocation |
|---|---|---|
| The Medicines (Products for Human Use – Fees) Regulations 1995 | S.I. 1995/1116 | The whole Regulations |
| The Medicines (Products for Human Use – Fees) Amendment Regulations 1996 | S.I. 1996/683 | The whole Regulations |
| The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 | S.I. 1998/574 | Regulations 4 and 5 and the Schedule |
| The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000 | S.I. 2000/592 | Regulation 4 and the Schedule |
| The Medicines (Products for Human Use – Fees) Amendment Regulations 2000 | S.I. 2000/3031 | The whole Regulations |
| The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001 | S.I. 2001/795 | Regulations 5 and the Schedule |
| The Medicines (Codification Amendments etc.) Regulations 2002 | S.I. 2002/236 | Regulation 16 |
| The Medicines for Human Use Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002 | S.I. 2002/542 | Regulation 5 and the Schedule |
| The Medicines for Human Use and Medical Devices (Fees Amendment)Regulations 2003 | S.I. 2003/625 | Regulation 4 and the Schedule |
| The Medicines for Human Use and Medical Devices (Fees Amendments)Regulations 2004 | S.I. 2004/666 | Regulations 4 to 15 and the Schedule |
| The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004 | S.I. 2004/1157 | The whole Regulations |
| Medicines for Human Use (Fees Amendments) Regulations 2005 | S.I. 2005/1124 | The whole Regulations |
| The Medicines for Human Use (Fees Amendments) (No. 2) Regulations 2005 | S.I. 2005/2979 | The whole Regulations |
| The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 | S.I. 2006/494 | Regulation 2 and the Schedule |
| The Medicines for Human Use (Fees Amendments) Regulations 2006 | S.I. 2006/2125 | Regulations 2 to 4 |
| The Medicines for Human Use and Medical Devices (Fees Amendments) (No. 2) Regulations 2007 | S.I. 2007/803 | Regulations 3 to 11 and the Schedule |
(This note is not part of the Regulations)
These Regulations revoke and re-enact in consolidated form, with some amendments, The Medicines (Products for Human Use-Fees) Regulations 1995 (“the 1995 Regulations”) and make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”).
These Regulations make provision for the fees payable under the Medicines Act 1971, and other fees payable in respect of Community obligations relating to marketing authorizations, licences and certificates in respect of medicinal products for human use.
The fees prescribed in the Regulations are revised on an annual basis following consultation and are based on an assessment of the costs associated with the functions in association with which fees are charged. The fees prescribed in the Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 17th October 2007. A summary of the consultation responses is published on the MHRA’s website (www.mhra.gov.uk). In general, the fee levels are higher than those previously in force, although in some cases they are lower. Some specific increases have been targeted in priority areas. More generally the average rate of increase is 7.3%.
Parts 2 to 9 and 11and 12 and Schedules 1 and 2 provide for capital fees to be payable in connection with pre-application meetings; applications for, or variations to marketing authorizations, manufacturer’s licences, wholesale dealer’s licences, clinical trial authorisations, traditional herbal registrations and certificates permitting the export of medicinal products; assistance in obtaining or renewing marketing authorizations in other EEA States; the assessment of labels and leaflets; renewals of certain manufacturer’s licences and for inspections. Most of the fees were previously provided for by the 1995 Regulations. But these Regulations add the following new categories of fees—
(a)a new category of fee is introduced in regulation 5 for pre – application meetings held to provide scientific advice in connection with the classification of a medicinal product as one which will available on general sale or without prescription from a pharmacy;
(b)a new category of fee is introduced in regulation 34 for membership of the accreditation scheme operated by the licensing authority in relation to Phase 1 trials and for a certificate of membership of the scheme;
(c)a new category of fee is introduced in regulation 36 for applicants or authorization holders who give notice under paragraph 11 or 16 of Schedule 2 to the Medicines (Products for Human Use) Marketing Authorisations Etc Regulations 1994 of their wish to appear before or be heard by a person appointed by the licensing authority;
(d)by regulation 12(1)(a) and paragraph 3(1) of Part 2 of Schedule 1, an application which includes a reclassification element and is not a major application attracts a lower fee if it is an eCTD format application than if it is not an eCTD format application(50);
(e)by regulation 18(1) and paragraph 15 of Part 4 of Schedule 1 applications for the variation of a marketing authorization which is not within the subject matter or scope of Commission Regulation (EC) No. 1084/2003 attract a lower fee than would otherwise apply, if they are “BROMI variations”. That is to say if they are submitted using the MHRA portal(51), for a change set out in the BROMI variations guidance(52) and comply with the conditions and are accompanied by the documents which that guidance specifies apply or should be provided with the variation;
(f)by regulation 18(1) and paragraph 18 of Part 4 of Schedule 1, certain variation applications which include a reclassification element may also attract a lower fee if they are eCTD format applications;
(g)by regulation 22(1) and paragraph 30 of Part 5 of Schedule 1 a lower fee than would otherwise apply, applies in relation to the consideration by the licensing authority of a set of proposed changes to the labelling or package leaflet of a medicinal product if they are of a type described in the BROMI labels and leaflets self – certification guidance (53) and comply with the conditions set out in that guidance in relation to the changes;
(h)by regulation 12(1)(a) and paragraph 10 of part 2 of Schedule 1, these Regulations also introduce a new category of medicinal product for the purpose of attracting the lower application fee for clinical trials authorisations which applies to products known to the licensing authority. This new category comprises a product which is or was being tested or used in a clinical trial which has been authorised by the licensing authority in accordance with Directive 2001/20/EC.
These Regulations make changes to the way the fees for inspections are charged. In the 1995 Regulations the amount of the fee charged for an inspection depended on the type of inspection carried out. By regulations 27 and 30 and Schedule 2 to these Regulations the amount of the fee charged for an inspection depends on the time taken to make the inspection.
Schedule 2 to these Regulations also introduces a definition of the term “turnover” for the purpose of the fee prescribed in paragraph 7 of the Schedule for an inspection made in connection with the grant, variation or renewal of a wholesale dealer’s licences in cases where the total turnover in respect of sales by way of wholesale dealing does not exceed £35,000.
Part 10 of and Schedule 3 to these Regulations impose periodic fees to be payable in connection with the holding of marketing authorizations, manufacturer’s licences, registrations, authorisations and wholesale dealer’s licences. The amount of the periodic fess varies according to the type of product and in some cases according to turnover.
Administrative provisions (Part 13, Schedules 4, 5 and 6 ) deal with time of payment and waiver or refund of both capital and periodic fees in specified circumstances. Special arrangements are provided in relation to the time of payment of capital fees by small companies. Schedule 4 of these Regulations re- enacts the provisions relating to the time for payment of Capital Fees in Schedule 4 of the 1995 Regulations.
Part 14 of these Regulations makes amendments to increase fees specified in regulations 14 and 15 and Schedules 2 and 2A of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994. The average rate of increase is 5.6%.
Part 15 of these Regulations revokes the earlier Regulations relating to fees for medicinal products for human use and also makes saving provisions.
A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the MHRA at Market Towers, 1 Nine Elms Lane, London SW8 5NQ and copies have been placed in the libraries of both Houses of Parliament.
1971 c.69; as amended by section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 and by regulation 44 of, and Schedule 8 to, S.I. 2006/2407, which contains a definition of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence or for the variation or renewal of such a licence under Part II of the 1968 Act include reference to an application for a marketing authorization under the 1994 Regulations or for the variation or renewal of such an authorization.
In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(7) of S.I. 2002/794. In the case of the Minister for Health, Social Services and Public Safety and the Minister for Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Departments for which the Ministers are responsible were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I. 1).
C.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
OJ No. L311, 28.11.2001, P.67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council, OJ No. L33, 8.2.2003, p.30, Commission Directive 2003/63/EC, OJ No. L159, 27.6.2003, p.46, Directive 2004/24/EC of the European Parliament and of the Council, OJ No. L136, 30.4.2004, p.34, Regulation (EC) No. 1901/2006 of the European Parliament and of the Council, OJ No. L378, 27.12.2006, p.1.
S.I. 1994/3144; relevant amending instruments are S.I. 2000/795, 2002/236, 2003/ 2321, 2004/3224 and 2005/50, 1710 and 2759.
S.I. 2004/1031; relevant amending instruments are S.I. 2005/2754 and 2759 and 2006/1928 and 2984.
OJ No. L 159, 27.6.2003, p.1.
S.I. 1971/972 to which relevant amendments have been made by S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.
OJ No. L 214, 24.8.1993. This Regulation has been replaced by Regulation (EC) No 726/2004.
OJ No. L 147, 9.6.1975, p.13. This Directive has been codified and assembled with others into Directive 2001/83/EC.
OJ No. L 262, 14.10.2003, p.22.
Amendments have been made to these sections by S.I. 2004/1031 and S.I. 2006/2407.
OJ No. L18, 22.1.2000, p.1.
Repeals and amendments to section 7 have been made by S.I.1977/1050, 1983/1724, 1992/604, 1994/276, 2004/1031, 2005/50, 2005/2753, and 2006/2407.
OJ No. L136, 30.4.2004, p.1.
Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.
Amendments have been made to section 51 by S.I. 2006/2407.
OJ No. L 169, 12.7.93, p.1. This Directive has been amended by Directive 2000/70/EC of the European Parliament and of the Council (OJ No. L313, 13.2.2000, p.22), Directive 2001/104/EC of the European Parliament and of the Council (OJ No. L6, 10.1.2002, p.50) and Directive 2007/47/EC of the European Parliament and of the Council (OJ No. L 247, 21.9.2007, p.21).
Regulation 3 has been amended by S.I. 2006/1928.
Section 50 has been amended by S.I. 2004/1031.
Amendments to regulation 4 have been made by S.I. 2001/795, 2002/236, 2005/2759 and 2006/1952.
Section 30 was substituted by S.I. 2005/2789.
Amendments to regulation 44 have been made by S.I. 2006/1928.
Amendments to regulation 24 have been made by S.I. 2006/1928.
S.I. 1971/1450; amendments which are not relevant have been made to article 2.
OJ No. L 22, 9.2.1965, p 369. This Directive has been codified an assembled with other into Directive 2001/83/EC.
OJ No. L15, 17.1.1987, p.38. This Directive has been repealed by Council Directive 93/41/EEC, OJ No. L 214, 24.8.1993, p.40.
Regulation 19 has been amended by S.I. 2005/2754.
Schedule 2 was substituted by S.I. 2005/1094.
C.6. Relevant amendments have been made by section 13(1) of the Companies Act 1989 (c.40) and by S.I. 1992/2452, 1996/189, 2004/16 and 2004/2947. On 1st February 2008 the figures specified in section 247(3) under the heading “small company” applying to turnover, balance sheet total and numbers of employees respectively were, £5.6 million, £2.8 million and 50.
S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 1998/574, 1999/566, 2003/625, 2005/2753, 2006/494 and 2007/610 and 803.
Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2007/610.
S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 2005/2753, 2006/494 and 2007/610.
Section 51(1) has been amended by S.I. 2006/2407.
OJ No. L121, 1.5.2001, p.34. This Directive has been amended by Regulation (EC) No 1901/2006, OJ No. L 378, 27.12.2006, p.1 to which amendments which are not relevant to these Regulations have been made.
A copy of the guidance may be downloaded from the website at www. mhra. gov.uk or may be obtained , by writing to the licensing authority at Market Towers, 1 Nine Elms Lane, London SW8 5NQ, or by sending an email to info@mhra.gsi.gov.uk.
A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1 Nine Elms Lane, London SW8 5NQ or by sending an email to info@mhra.gsi.gov.uk.
S.I. 1971/1267; Part II of the Act is applied by Article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.
Amendments and substitutions to section 4 have been made by S.I. 2004/103, 2005/1094 and 2006/2407.
Section 2A was inserted by S.I. 2005/1094.
Amendments to section 44 have been made by S.I. 2005/1094 and 2006/2407.
Article 11 has been amended by Regulation (EC) No. 1901/2006 (OJ L 378, 27.12.2006, p.1).
OJ L 182, 2.7.1992, p1 which has been amended by Regulation (EC) No. 1901/2006 (OJ L 378, 27.12.2006, p.1).
“eCTD format application” is defined in Part 1 of Schedule 1 of these Regulations.
“the MHRA portal” is defined in Part 1 of Schedule 1 of these Regulations.
The BROMI variations guidance is version 2.1 of the document entitled “BROMI Dossier Requirements For Type IA and Type IB UK national Notifications, published by the licensing authority on its website in February 2008 and dated November 2007. The document may be downloaded from or the licensing authority’s website at www.mhra.gov.uk and copies can be obtained by writing to the licensing authority at Market Towers, 1 Nine Elms Lane, London SW8 5NQ, or by sending an e-mail to info@mhra.gsi.gov.uk.
The BROMI labels and leaflets self – certification guidance means the document entitled “Guidance on Changes to Labelling and Patient Information Leaflets For Self – Certification” published by the licensing authority on its website on 28th January 2008. A copy of the guidance may be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1 Nine Elms Lane, London SW8 5NQ or by sending an e-mail to info@mhra.gsi.gov.uk.