- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
1.—(1) These Regulations may be cited as the Medicines (Products for Human Use) (Fees) Regulations 2013.
(2) Unless paragraph (3) applies these Regulations shall come into force on 1st April 2013.
(3) The following regulations shall come into force on the coming into force of Regulations made under section 2(2) of the European Communities Act 1972 to implement provisions related to importers, manufacturer’s and distributors of active substances as provided for by Article 52a and persons brokering medicinal products as provided for by Article 85b of Directive 2001/83/EC(1)—
(a)12(1), insofar as it relates to a broker’s registration or an active substance registration;
(b)18(1)(c);
(c)20;
(d)21;
(e)29(1)(a), insofar as it relates to a broker’s registration or an active substance registration;
(f)36;
(g)37(7), insofar as it relates to a broker’s registration or an active substance registration;
(h)40(1), insofar as it relates to a broker’s registration or an active substance registration and (2)(c);
(i)48(2)(e);
(j)Schedule 2, paragraphs 32, 33, 46 and 47;
(k)Schedule 3, paragraphs 8 and 9;
(l)Schedule 7, paragraph 6 insofar as it relates to a broker’s registration or an active substance registration.
2. These Regulations shall be interpreted in accordance with Schedule 1.
3. In this Part—
“EU marketing authorisation” means—
a United Kingdom marketing authorisation granted by the licensing authority under Part 5 (marketing authorisations) of the Human Medicines Regulations;
a marketing authorisation granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
a European Union marketing authorisation; and
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.
4. Unless regulation 5 applies, 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 EU marketing authorisation or an application for the variation of an EU marketing authorisation, is—
(a)£2,445, if the advice provided at that meeting consists of advice in connection with—
(i)quality development only; or
(ii)safety development only;
(b)£3,070, if the advice provided at that meeting consists only of advice in connection with clinical development;
(c)£3,401, if the advice provided at that meeting consists only of advice in connection with quality and safety development;
(d)£4,027, 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)£4,985, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.
5.—(1) 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)£3,070, if the advice relates to a product which, if reclassified, will be available on general sale; and
(b)£4,027, 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 subject to general sale within the meaning of regulation 5(1) of the Human Medicines Regulations (classification of medicinal products for general sale).
6. The fee payable by the holder of a marketing authorisation with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by that holder’s undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,445.
7.—(1) The fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is—
(a)£4,027, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;
(b)£3,401, in any other case.
(2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the total time spent by each individual engaged in preparing for or attending the meeting on behalf of the licensing authority.
8. The fee payable by the holder of one or more marketing authorisations 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 authorisations relate, is £2,445.
9. The fee payable by the holder of a marketing authorisation with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £3,070.
10.—(1) Unless paragraph (4) 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 £4,945.
(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 Union; or
(d)other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorisation has been granted for that product or a product of that type.
(4) Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only advice specified in regulations 4 to 9.
(5) In this regulation—
“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices(2);
“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;
“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 EU instrument relating to EU marketing authorisations 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 interpreted in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations(3);
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 EU marketing authorisation, or making a variation to an EU marketing authorisation, for that product or a product of that type; or
(b)obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.
11. All sums payable by way of fees under regulations 4 to 10 must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
12.—(1) Unless Part 16 of these Regulations (revocations and savings) applies, the application fee for a marketing authorisation (other than a European Union marketing authorisation), a parallel import licence, a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence, a clinical trial authorisation, a broker’s registration or an active substance registration is—
(a)the fee prescribed for that application in Part 2 of Schedule 2; and
(b)in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 29 and 31 to 36.
(2) Unless regulation 31 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 issued under Article 111(5) of the 2001 Directive is £68.
14.—(1) The fee payable by an applicant for a certificate issued under regulation 31 (certification of manufacturer’s licence) of the Human Medicines Regulations, is—
(a)£152, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and
(b)£68 in any other case.
(2) The fee in paragraph (1)(a) and (b) is for three identical signed certificates.
(3) The fee payable by the applicant for a certified copy of the certificate referred to in paragraph (1) is £34.
15. For the purposes of this Part, 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 authorisation in other EEA States, but only if all the applications relate to applications for marketing authorisations 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 authorisations relating to a single United Kingdom marketing authorisation, 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. 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 authorisation in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 2 in connection with the application or set of applications.
17. Unless regulation 49 (applications made by small companies) applies, all sums payable by way of fees under regulation 16 must have been paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated.
18.—(1) Unless Part 16 of these Regulations (revocations and savings) applies, the fee mentioned in paragraph (2) applies for an application—
(a)under the Human Medicines Regulations, under regulation—
(i)29 (variation of licence on application of holder);
(ii)68 (revocation, variation and suspension of UK marketing authorisation);
(iii)135 (revocation, variation and suspension of a traditional herbal registration) but only in relation to a variation of such a registration;
(b)to vary a parallel import licence;
(c)to vary a broker’s registration or an active substance registration;
(d)under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations(4) for the variation of a manufacturing authorisation.
(2) The fee referred to in paragraph (1) is—
(a)the fee prescribed in Part 4 of Schedule 2 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 29, 31, 32, 34 and 36.
(3) Unless regulation 31 applies, the fee referred to 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(5) relating to amendment of the protocol or the dossier related to a request for authorisation in accordance with paragraphs 10 or 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 48 of Schedule 2 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 29, 31, 32, 34 and 36.
20.—(1) A fee of £257 is payable by the holder of a broker’s registration who provides, in accordance with any Regulations in connection with that registration—
(a)any report that must be submitted relating to that registration, or
(b)any notification that must be submitted about changes relating to that registration.
(2) The fee in paragraph (1) is payable for each report or notification of change made in connection with that broker’s registration.
21.—(1) A fee of £257 is payable by the holder of an active substance registration who provides, in accordance with any Regulations in connection with that registration—
(a)any report that must be submitted relating to that registration, or
(b)any notification that must be submitted about changes relating to that registration.
(2) The fee in paragraph (1) is payable for each report or notification of change made in connection with that active substance registration.
22.—(1) Unless paragraph (3) or (5) applies, a separate fee is payable in respect of each application to vary each term of a marketing authorisation.
(2) Unless paragraph (5) applies, a separate fee is payable in respect of each variation of each provision of a traditional herbal registration, manufacturing authorisation or licence applied for in any one application.
(3) A separate fee is not payable for each application to vary a term of a marketing authorisation which—
(a)falls within the same type of group application; or
(b)the licensing authority—
(i)in consultation with other member States concerned, have agreed, in accordance with Article 7(2)(c) of Commission Regulation (EC) No 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article; and
(ii)have agreed fall, or should be treated as falling, within the same type of group application.
(4) For the purposes of paragraph (3) the reference to a group application means an application which is a—
(a)Minor Variation (Type IB) Group Application;
(b)Major Variation (Type II) Group Application;
(c)Major Variation (Type II) Complex Group Application; or
(d)Major Variation (Type II) Extended Complex Group Application.
(5) A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorisation, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.
(6) In a case where a recommendation on the classification of a variation is made in accordance with Article 5 of Commission Regulation (EC) No 1234/2008, the fee payable for the application made in respect of that variation shall be the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation.
(7) Unless paragraph (8) applies, in this regulation and Part 4 of Schedule 2—
“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a major variation of type II;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;
the variations do not include a variation—
of a kind referred to in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;
which relates to a change which is referred to in paragraph 23 of Schedule 2 (Type II Complex Variation Application); or
of a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2 (Extended Type II Complex Variation Application); and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB;
“Major Variation (Type II) Complex Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;
the variations do not include a variation of—
a kind referred to in paragraph 1 or paragraph 3 of Annex III to Commission Regulation (EC) No 1234/2008; or
a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2; and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB or one or more major variations of type II;
“Major Variation (Type II) Extended Complex Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a variation to a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;
the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; and
the variations may include minor variations of type IA, minor variations of type IB or other major variations of type II or a variation relating to a change referred to in paragraph 23(a), (b) or (c) of Schedule 2;
“major variation of type II” has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008;
“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a minor variation of type IB;
subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;
the variations do not include—
a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; or
a major variation of type II; and
the variations may include one or more minor variations of type IA;
“minor variation of type IA” has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008;
“minor variation of type IB” has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and
“work sharing” means the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.
(8) From 4th August 2013, in this regulation and Part 4 of Schedule 2—
“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a major variation of type II;
subject to sub-paragraph (c), the variations fall within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008 (as amended);
the variations do not include a variation—
of a kind referred to in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;
which relates to a change which is referred to in paragraph 23 of Schedule 2 (Type II Complex Variation Application); or
of a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2 (Extended Type II Complex Variation Application); and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB;
“Major Variation (Type II) Complex Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;
subject to sub-paragraph (c), the variations fall within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008 (as amended);
the variations do not include a variation of—
a kind referred to in paragraph 1 or paragraph 3 of Annex III to Commission Regulation (EC) No 1234/2008; or
a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2; and
the variations may include one or more minor variations of type IA or one or more minor variations of type IB or one or more major variations of type II;
“Major Variation (Type II) Extended Complex Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a variation to a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;
subject to sub-paragraph (c), the variations fall within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008 (as amended);
the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; and
the variations may include minor variations of type IA, minor variations of type IB or other major variations of type II or a variation relating to a change referred to in paragraph 23(a), (b) or (c) of Schedule 2;
“major variation of type II” has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008;
“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorisation and—
at least one of the variations is a minor variation of type IB;
subject to sub-paragraph (c), the variations fall within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008 (as amended);
the variations do not include—
a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; or
a major variation of type II; and
the variations may include one or more minor variations of type IA;
“minor variation of type IA” has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008;
“minor variation of type IB” has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and
“work sharing” means the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.
(9) In this regulation—
“Commission Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 as in force on the 1st April 2013;
“Commission Regulation (EC) No 1234/2008 (as amended)” means Commission Regulation (EC) No 1234/2008 as amended by Commission Regulation (EU) No 712/2012(6) from 4th August 2013.
23. For the purposes of this Part and Part 5 of Schedule 2, 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.
24.—(1) Unless paragraph (2) applies, 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 authorisation (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 authorisation or licence is the fee prescribed in Part 5 of Schedule 2 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 authorisation for that product.
25. All sums payable by way of fees under regulation 24(1) must be paid by the time that the proposed changes are submitted to the licensing authority.
26.—(1) The fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £178.
(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 authorisation or a product licence; and
(b)to which regulation 169 (mixing of general sale medicinal products) of the Human Medicines Regulations applies.
(3) Where an inspection of a site is made in connection with the application referred to in paragraph (1) an inspection fee of £295 is also payable by the applicant.
27. Where an applicant applies for renewal of a—
(a)marketing authorisation (other than a European Union marketing authorisation);
(b)traditional herbal registration, or
(c)manufacturer’s licence,
so as to contain provisions which are not identical to those in the authorisation, registration or licence as in force at the date of the application, the fee payable under this Part is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had the applicant made a separate application for variation of that authorisation, registration or licence in respect of each provision which is not identical.
28.—(1) Where—
(a)an application is made to the licensing authority for the renewal of a United Kingdom marketing authorisation 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 2 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(7) 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 Proprietary 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(8), 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 2, 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 authorisation relating to that product has been made in that other EEA State.
29.—(1) Unless regulation 30 or Part 16 of these Regulations applies, a fee is payable in accordance with—
(a)paragraphs 1 to 9 of Schedule 3 for inspection of any site made in connection with an application for, or during the currency of, a marketing authorisation, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence, a broker’s registration or an active substance registration except for an inspection for which a fee is payable under regulation 26 or 33;
(b)paragraph 10 of Schedule 3 for any inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—
(i)good manufacturing practice;
(ii)good clinical practice;
(iii)good pharmacovigilance practice; or
(iv)good distribution practice.
(2) Unless regulation 31 or 32 applies, the fee in paragraph (1) is payable by the holder of, or as the case may be, applicant for, the authorisation, registration or licence in relation to which the inspection is made.
30.—(1) Where an inspection is made of a pharmacovigilance service provider and that inspection is not related to anything done under regulation 29(1)(a), a fee is payable in accordance with paragraphs 1 and 2 of Schedule 3.
(2) The fee in paragraph (1) is payable by the pharmacovigilance service provider who is the subject of an inspection.
(3) In this regulation a “pharmacovigilance service provider” means a provider of pharmacovigilance services to a marketing authorisation holder.
31. 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.
32.—(1) Unless paragraph (4) applies, 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 authorisation, clinical trial authorisation, traditional herbal registration; or
(b)by more than one applicant for such an authorisation, registration or licence,
the fee for the inspection referred to in regulation 29(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorisation, registration or licence.
(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 29(1) is payable in equal proportions by each applicant.
(4) This regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
33. A fee in accordance with paragraph 2 of Schedule 3 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 good clinical practice, under 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 requirements of good clinical practice are satisfied or adhered to, under regulation 28(2) of those Regulations.
34.—(1) All sums payable by way of fees in respect of any inspection of a site in connection with an application for a wholesale dealer’s licence under regulation 29(1) must be paid—
(a)in advance of an application; or
(b)at the time that application is made.
(2) Except where paragraph (3) applies, the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(a) of Schedule 3.
(3) The inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 7(3) of Schedule 3 where—
(a)the site to be inspected falls within the description specified in paragraph 7(1)(a) or (b) of Schedule 3; or
(b)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 (within the meaning given in paragraph 7(2) of that Schedule).
35.—(1) If the inspection in respect of an application for a wholesale dealer’s licence takes longer than the standard period, a further fee of the amount specified in paragraph 5(b) of Schedule 3 is payable by the applicant for each subsequent period of 3 hours and 30 minutes or less.
(2) The fee payable under paragraph (1) must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
(3) The licensing authority shall refund the whole of the inspection fee paid where, after an inspection fee is paid as a consequence of regulation 34, the application for a wholesale dealer’s licence is withdrawn—
(a)before a date on which the inspection is due to take place is arranged with or notified to the applicant; or
(b)in the case where a date on which the inspection is due to take place is fixed, 15 or more days before the date on which that inspection is due to take place.
(4) In this regulation “standard period” means—
(a)in the case where regulation 34(2) applies, a period of more than 7 hours; or
(b)in the case where regulation 34(3) applies, a period of more than 3 hours and 30 minutes.
36.—(1) All sums payable by way of fees in respect of any assessment or inspection of a site in connection with an application for a broker’s registration or an active substance registration under regulation 29(1) must be paid in advance of an application or at the time the application is made.
(2) The inspection fee payable as a consequence of paragraph (1) shall be—
(a)in relation to broker’s registrations, the amount specified in paragraph 8(1) of Schedule 3;
(b)in relation to active substance registrations, the amount specified in paragraph 9(1) of Schedule 3.
37.—(1) Unless paragraph (4), (5), (6) or (7) or Part 16 of, or Part 4 of Schedule 4 to, these Regulations applies, the periodic fee must be paid for each fee period during which the authorisation, registration or licence is in force, even if it is in force for only part of that fee period.
(2) For the purposes of paragraph (1), marketing authorisations of a type referred to in Part 3 of Schedule 4 shall be treated as if they were one marketing authorisation and only one periodic fee in respect of each relevant fee period is payable in connection with the holding of such authorisations.
(3) The periodic fee is the appropriate fee prescribed in Part 3 of Schedule 4 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 authorisation or a traditional herbal registration is first granted unless the authorisation or registration is granted because of—
(a)a change of ownership application; or
(b)an application for a marketing authorisation or traditional herbal registration which—
(i)is for a product for which an authorisation or registration has expired;
(ii)will contain identical provisions to those contained in the expired authorisation or registration;
(iii)is made by the person who held the expired authorisation or registration; and
(iv)is made no later than three months after the expiry of the authorisation or registration referred to in 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 authorisation or a traditional herbal registration.
(5) An authorisation, registration 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 authorisation, registration 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 under that authorisation, registration 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 licence or wholesale dealer’s licence is first granted unless—
(a)that authorisation or licence is granted because of 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 licence or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.
(7) No periodic fee is payable in respect of a clinical trial authorisation, broker’s registration or active substance registration.
38. 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 1 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.
39.—(1) The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £130.
(2) The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £69.
40.—(1) A fee of £10,000 is payable by an applicant or holder of an authorisation, licence, certificate of registration, broker’s registration, active substance registration or sponsor or investigator who gives notice, under any of the provisions specified in paragraph (2), of their wish to—
(a)make further representations to the licensing authority or appear before or be heard by a person appointed, or
(b)propose that there should be a review upon oral representations.
(2) The specified provisions are—
(a)in the Human Medicines Regulations—
(i)regulation 27(3)(b) (procedure where licensing authority propose to suspend, revoke or vary licence);
(ii)paragraphs 11(1), 13(1)(a), 23(2) and 30(2) of Schedule 11 (advice and representations);
(iii)paragraph 3(8) of Schedule 32 (transitional provisions and savings in relation to product licences of right);
(b)in the Clinical Trials Regulations—
(i)paragraph 3(1)(a) of Schedule 5(9) (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trails);
(ii)paragraph 4(1)(a) of Schedule 8(10) (procedural provisions relating proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations);
(c)provisions in Regulations allowing a representation, appearance, hearing or review in connection with a broker’s registration or active substance registration.
(3) 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 or the review upon oral representations;
(b)100% of that fee if, in respect of the hearing before the person appointed or the review upon oral representations, the decision notified by the licensing authority is—
(i)not to revoke, vary, suspend or terminate, as the case may be, the authorisation, licence or certificate of registration; or
(ii)to grant or renew, as the case may be, the authorisation, licence or certificate of registration.
41. The fee prescribed in regulation 40 is payable at the time the notice is given.
42.—(1) In this Part—
“administrative variation” means a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;
“application” means an application for the grant of a certificate of registration;
“application to the licensing authority for regulatory assistance” in relation to a single certificate of registration means—
a single application of that type, or
a set of applications of that type;
“application for an EC registration in a concerned member State” in relation to a single certificate of registration means—
a single application of that type, or
a set of applications of that type in a number of concerned member States;
“decentralised procedure application” means an application relating to a homoeopathic medicinal product in respect of which at the time of the application—
an EC registration has been granted in an EEA State; and
an application for an EC registration has been made in more than one EEA State under Article 28(1) and (3)(11) of the 2001 Directive;
“EC registration” means a registration granted by a competent authority of an EEA State in accordance with the procedure set out in Article 14 of the 2001 Directive;
“formulation” does not include the formulation of homoeopathic stock;
“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;
“mutual recognition procedure incoming application” means an application relating to a homoeopathic medicinal product in respect of which—
an EC registration has already been granted in another EEA State; and
recognition of that certificate is sought from the licensing authority by way of the grant of a certificate of registration in the United Kingdom, under the procedure in Articles 28 and 29(1) to (3)(12) of the 2001 Directive;
“product” includes a series of products each of which is prepared from identical homoeopathic stocks;
“set of applications” means—
a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or
a number of applications to competent authorities of other EEA States for EC certificates of registration relating to a single certificate of registration, where those applications all have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; and
“standard variation” means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal products to which that certificate relates—
the replacement of an excipient used in the manufacture of the product with a comparable excipient;
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 minor change to the method of manufacture of a homoeopathic stock included in the product;
a change to the specification of any reagent or 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 of 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 or to the shelf life 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) which does not entail a change to the quantitative composition or the mean mass of the product; or
a change following modification to the manufacturing authorisation.
(2) In this Part—
(a)any expression used in this Part which is defined in the Human Medicines Regulations shall have the same meaning which it has in those Regulations;
(b)any expressions which are also used in the 2001 Directive shall have the same meaning as they have in the 2001 Directive and related expressions shall be interpreted accordingly;
(c)any reference to doing anything in accordance with a certificate of registration shall be interpreted in accordance with regulation 8(1) of the Human Medicines Regulations (general interpretation); and
(d)any reference to the holder of a certificate of registration shall be interpreted as a reference to the holder of such a certificate which is for the time being in force.
43. No fee shall be payable under this Part in connection with an application for the grant or variation of a certificate of registration under Part 6 (certification of homoeopathic medicinal products) of the Human Medicines Regulations where the application is made at the specific request of the licensing authority.
44.—(1) The fee payable by a person who makes an application for the grant of a certificate of registration under regulation 103 (application for certificate of registration) of the Human Medicines Regulations shall be the fee specified in the Table in Schedule 5 to these Regulations according to the type of application.
(2) The fee payable by a person who makes an application or set of applications to the licensing authority for regulatory assistance in connection with obtaining recognition in accordance with the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in another EEA State, shall be the fee specified in item 4 of the Table in Schedule 5 to these Regulations.
45.—(1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration shall be—
(a)where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations—
(i)in respect of the first application considered by the licensing authority, a fee of £137, and
(ii)in respect of each other application so considered, a fee of £69;
(b)in any other case, a fee of £137.
(2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration shall be—
(a)where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations—
(i)in respect of the first application considered by the licensing authority, a fee of £270;
(ii)in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £270;
(iii)in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £137;
(iv)in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £69;
(b)in any other case, a fee of £270.
46.—(1) Any fee payable under regulation 44(1) or 45 shall be payable to the licensing authority—
(a)in advance of the application; or
(b)at the time the application for grant or variation of the certificate of registration is made.
(2) Any fee payable under regulation 44(2) shall be payable to the licensing authority—
(a)in advance of any request; or
(b)at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under Article 28(2) of the 2001 Directive for an assessment report to be prepared or updated.
47. Any sum payable under these Regulations must be paid to one of the Ministers.
48.—(1) All capital fees under these Regulations shall be payable in accordance with—
(a)the specified provisions in paragraph (2) where appropriate, and
(b)paragraph (3).
(2) The specified provisions are—
(a)regulation 11 (time for payment of fees under regulations 4 to 10);
(b)regulation 16 (regulatory assistance);
(c)regulation 24 (change to labels and leaflets);
(d)regulation 34 (inspections in respect of wholesale dealer’s licence);
(e)regulation 36 (inspections in respect of brokers and active substance registrations);
(f)regulation 40 (fee for a review upon oral representations or a person appointed hearing); and
(g)regulation 49 (small companies).
(3) All fees payable under this regulation—
(a)in respect of inspections made either in connection with an application for, or during the currency of, an authorisation, licence or certificate must be paid within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees;
(b)in respect of any other application, must have been paid at the time of the application or before.
49.—(1) Schedule 6 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 total value of products it has sold or supplied for the financial year is not more than the amount for the time being specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006(13) and the conditions in paragraph (3) are met.
(3) The conditions for the purposes of paragraph (2) are—
(a)the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount for the time being specified in item 2 in section 382(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 in item 3 in section 382(3) of that Act.
50.—(1) The fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived where an application is made for the grant of a traditional herbal registration—
(a)in accordance with regulation 127 (application for the grant of a traditional herbal registration) of the Human Medicines Regulations;
(b)on the grounds specified in paragraph (2); and
(c)in respect of a medicinal product which falls within the description in paragraph (3).
(2) For the purposes of paragraph (1), the specified grounds are—
(a)that the marketing authorisation in respect of the medicinal product in question; or
(b)in the case of a corresponding product the marketing authorisation relating to product Y (as defined in paragraph (4)),
is to be revoked.
(3) A medicinal product falls within this paragraph if—
(a)a marketing authorisation held by the applicant was granted under Part 5 of the Human Medicines Regulations in respect of that medicinal product; or
(b)that medicinal product is a corresponding product.
(4) For the purposes of paragraph (3), a corresponding product is a product which is characterised by having—
(a)the same active ingredients, irrespective of the excipients used or reduction in the number or quantity of active ingredients;
(b)the same or similar intended purpose, equivalent strength and posology; and
(c)the same or similar route of administration,
as a medicinal product (“product Y”) in respect of which a marketing authorisation held by the applicant was granted under Part 5 of the Human Medicines Regulations.
(5) Where the licensing authority determines that the marketing authorisations in respect of the medicinal product in question or the marketing authorisation in respect of product Y should not be revoked, the fee payable under regulation 12 which has been refunded or waived shall become payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.
51. All periodic fees must be paid by the first day of the fee period to which they relate.
52.—(1) Subject to paragraph (2), if a person has failed to pay a periodic fee by the time it has become payable under regulation 51, a penalty fee is payable by that person.
(2) A penalty fee is payable only if, after a period of 60 days commencing on the date of the written notice (“the notice”) issued by the licensing authority requiring payment of that fee, the fee remains unpaid.
(3) Unless regulation 53 applies, where a periodic fee remains unpaid after 60 days commencing on the date of the notice, the penalty fee is—
(a)£100 where the total unpaid fee exceeds £200; or
(b)£50 where the total unpaid fee does not exceed £200.
(4) In paragraph (3), the “total periodic fee” means the total of all the periodic fees payable by a person in connection with all the authorisations, registrations or licences held by that person.
53. If the periodic fee and penalty fee under regulation 52 (“the outstanding amount”) have not been paid within a period of 90 days commencing on the date of the written notice issued by the licensing authority, the amount of penalty fee payable shall be the amount specified in regulation 52(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.
54. 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 authorisation, registration or licence was not responsible for the failure to pay the periodic fee within the period specified in regulation 52(2) or 53.
55.—(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 authorisation, registration or licence concerned; or
(b)a higher fee should have been paid, the balance due shall be payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority to the applicant or, as the case may be, the holder of the authorisation, registration or licence concerned requiring payment of that balance.
(2) The licensing authority shall, to the extent provided in Schedule 7 in relation to capital fees or in Schedule 8 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.
56.—(1) Where any sum due by way of, or on account of, any fee or any part of a fee payable under these Regulations remains unpaid by the holder of a—
(a)product licence or a product licence of right;
(b)manufacturer’s licence;
(c)manufacturer’s authorisation; or
(d)wholesale dealer’s licence,
the licensing authority may serve a written notice on the holder requiring payment of the sum unpaid.
(2) If after a period of one month commencing on the date of service of the notice referred to in paragraph (1), or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence or, as the case may be, the authorisation until such sum has been paid.
57. 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.
58.—(1) The Medicines for Human Use (Clinical Trials) Regulations 2004(14) are amended as follows.
(2) In regulation—
(a)17(2)(b)(ii) (request for authorisation to conduct a clinical trial),
(b)24(10) (amendments by the sponsor),
(c)38(3)(b) (application for manufacturing authorisation),
(d)44(8) (variation of manufacturing authorisation),
for “Medicines (Products for Human Use) (Fees) Regulations 2012” substitute “Medicines (Products for Human Use) (Fees) Regulations 2013”.
59.—(1) Subject to paragraphs (2) to (4), the Medicines (Products for Human Use) (Fees) Regulations 2012(15) (“the 2012 Regulations”) are revoked.
(2) The savings introduced by regulation 57(2) to (4) and 58(4) and (5) of the 2012 Regulations shall continue to apply as if those paragraphs of those regulations had not been revoked.
(3) The 2012 Regulations shall continue to apply as if they had not been revoked in relation to—
(a)capital fees payable under the 2012 Regulations in respect of any application or inspection made before the date on which these Regulations come into force; and
(b)any periodic fee payable under the 2012 Regulations in relation to a fee period ending before the date on which these Regulations come into force.
(4) The revocation of the 2012 Regulations shall not affect any proceedings under those Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the 2012 Regulations shall continue to apply as if they had not been revoked.
60.—(1) Subject to paragraphs (2) and (3), the Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012(16) (“the 2012 Amendment Regulations”) are revoked.
(2) The 2012 Amendment Regulations shall continue to apply as if they had not been revoked in relation to—
(a)fees payable under the 2012 Amendment Regulations in respect of any application or inspection made before the date on which these Regulations come into force; and
(b)any periodic fee payable, or not payable as the case may be, under the 2012 Amendment Regulations in relation to a fee period ending before the date on which these Regulations come into force.
(3) The revocation of the 2012 Amendment Regulations shall not affect any proceedings commenced under those Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the 2012 Amendment Regulations shall continue to apply as if they had not been revoked.
61. The instruments mentioned in Schedule 9 are revoked to the extent specified.
Signed by authority of the Secretary of State for Health.
Earl Howe
Parliamentary Under-Secretary of State,
Department of Health
1st March 2013
Edwin Poots
Minister for Health, Social Services and Public Safety
7th March 2013
Robert Goodwill
Desmond Swayne
Two of the Lords Commissioners of Her Majesty’s Treasury
7th March 2013
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys