2012 No. 134

Medicines

Fees And Charges

The Medicines (Products for Human Use) (Fees) Regulations 2012

Made23rd February 2012

Laid before Parliament29th February 2012

Coming into force1st April 2012

The Secretary of State for Health and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 19711 or, in the case of the Minister, the powers conferred by those provisions and now vested in him2.

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 19723 and section 56(1) and (2) of the Finance Act 19734. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products5.

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 19686, the Secretary of State for Health and the Minister for Health, Social Services and Public Safety have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

PART 1General

Citation and commencement1

These Regulations may be cited as the Medicines (Products for Human Use) (Fees) Regulations 2012 and come into force on 1st April 2012.

Interpretation2

These Regulations shall be interpreted in accordance with Schedule 1.

PART 2Capital Fees for Pre-Application Meetings

Interpretation of Part 23

In this Part—

“EU marketing authorization” means—
1. a
  a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;
2. b
  a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or
3. c
  a European Union marketing authorization; and
“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply.

Fee for scientific advice: application for, or variation to, EU marketing authorization4

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 authorization or an application for the variation of an EU marketing authorization, is—

a

£2,378, if the advice provided at that meeting consists of advice in connection with—

i

quality development only; or

ii

safety development only;

b

£2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;

c

£3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;

d

£3,917, 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

£4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.

Fee for scientific advice: classification of a medicinal product5

in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 27 to 32.

2

Unless regulation 28 applies, the fee in paragraph (1) is payable by the applicant.

Fee for applications for copy certificates of good manufacturing practice13

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 £67.

Fees for applications for certificates and copy certificates by exporters of medicinal products14

1

The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act10, is—

a

£148, if the applicant requests the certificate to be issued within 24 hours of receipt of the application; and

b

£67 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 £33.

PART 4Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Meaning of “set of applications”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 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.

Fees for applications for regulatory assistance under the mutual recognition procedure16

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 2 in connection with the application or set of applications.

Time for payment of fees under regulation 1617

Unless regulation 46 (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 pursuant to the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated.

PART 5Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections

Fees for variations of authorizations, registrations, licences and authorisations18

1

b

the licensing authority—

i

in consultation with other Member States concerned, have agreed, in accordance with Article 7(2)(b) of EC Regulation 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 authorization, 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 EC Regulation 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

In this regulation and Part 4 of Schedule 2—

“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorization and—
1. a
  at least one of the variations is a major variation of type II;
2. b
  subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
3. c
  the variations do not include a variation—
  1. i
    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 EC Regulation No. 1234/2008;
  2. ii
    which relates to a change which is referred to in paragraph 23 of Schedule 2 (Type II Complex Variation Application); or
  3. iii
    of a marketing authorization 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
4. d
  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 authorization and—
1. a
  at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;
2. b
  subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
3. c
  the variations do not include a variation of—
  1. i
    a kind referred to in paragraph 1 or paragraph 3 of Annex III to EC Regulation No. 1234/2008; or
  2. ii
    a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2; and
4. d
  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 authorization and—
1. a
  at least one of the variations is a variation to a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;
2. b
  subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
3. c
  the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to EC Regulation No. 1234/2008; and
4. d
  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 EC Regulation No. 1234/2008;
“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorization and—
1. a
  at least one of the variations is a minor variation of type IB;
2. b
  subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008;
3. c
  the variations do not include—
  1. i
    a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of EC Regulation No. 1234/2008; or
  2. ii
    a major variation of type II; and
4. d
  the variations may include one or more minor variations of type IA;
“minor variation of type 1A” has the meaning given in Article 2(2) of EC Regulation No. 1234/2008;
“minor variation of type 1B” has the meaning given in Article 2(5) of EC Regulation No. 1234/2008; and
“work sharing” means the work sharing procedure within the meaning of Article 20 of EC Regulation No. 1234/2008.

PART 6Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”21

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.

Fees for assessment of a set of proposed changes to labels and leaflets22

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 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 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 authorization for that product.

Time for payment of fees under regulation 2223

All sums payable by way of fees under regulation 22(1) must be paid by the time that the proposed changes are submitted to the licensing authority.

PART 7Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections

Fees for renewals of certain manufacturer’s licences24

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 £174.

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 197115 applies.

3

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 biotechnology17, 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 authorization relating to that product has been made in that other EEA State.

PART 9Capital Fees for Inspections

Fees for inspections27

1

Unless Part 16 of these Regulations applies, a fee is payable in accordance with—

a

paragraphs 1 to 7 of Schedule 3 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 regulation 24 or 30; and

b

paragraphs 1 and 8 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 28 or 29 applies, the fee in paragraph (1) is payable by the holder of, or as the case may be, applicant for, the authorization, registration, authorisation or licence in relation to which the inspection is made.

Payer of inspection fee (contract laboratories and API manufacturing sites)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.

Inspections in connection with multiple applications29

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 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, registration, authorisation, 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 27(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.

Fees for inspections relating to good clinical practice in clinical trials30

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, 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 requirements of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.

Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer’s licence31

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 27(1) must be paid—

a

in the case where regulation 31(3) applies, more than 3 hours and 30 minutes,

a further fee of the amount specified in paragraph 5(b) of Schedule 3 for each subsequent period of 3 hours and 30 minutes or less is payable by the applicant.

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 31, 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.

PART 10Periodic Fees for Authorizations, Registrations, Licences and Authorisations

Periodic fees33

1

Unless paragraph (4), (5) or (6) or Part 16 of these Regulations (revocations and savings) applies, the periodic fee must be paid for each fee period during which the marketing authorization, registration, authorisation 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 authorizations of a type referred to in Part 3 of Schedule 4 shall be treated 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 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 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 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 licence 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 licence or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.

Periodic fees for clinical trial authorisations34

1

Unless paragraph (3) 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 4.

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 Regulations18.

PART 11Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

Meaning of “good clinical practice accreditation scheme”35

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.

Fees for applications for membership and certificates36

1

The fee payable by an applicant for membership of the good clinical practice accreditation scheme is £126.

2

The fee payable by an applicant for a certificate of membership of the good clinical practice accreditation scheme is £67.

PART 12Capital Fee for a Person Appointed Hearing

Fee for a person appointed hearing37

1

The fee payable by an applicant or holder of an authorization, licence, authorisation or certificate of registration or sponsor or investigator who gives notice, under any of the provisions specified in paragraph (2), of their wish to make further representations to the licensing authority or appear before or be heard by a person appointed by the licensing authority, is £10,000.

2

The specified provisions are—

a

section 21(11) (licence under Part I of the Act where the appropriate committee are consulted), 22(3) (licence under Part I of the Act where the appropriate committee are not consulted or have been consulted but have not given a provisional opinion) or 27(3) (licence of right) of the Act, and paragraph 5 (product licence) or paragraph 6 (licence under Part 2 of the Act other than a product licence) of Schedule 2 to the Act19;

b

paragraph 3 of Schedule 5 (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)20 and paragraph 4 of Schedule 8 (procedural provisions relating proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations) to the Clinical Trials Regulations21;

c

paragraph 12 (traditional herbal registration), paragraph 17 (variation of registration) or paragraph 20 (decision to refer application to the Committee) of Schedule 2 to the Herbal Regulations;

d

paragraph 11 (marketing authorizations) or paragraph 16 (Type II variation applications) of Schedule 2 to the Marketing Authorisation Regulations22; or

e

paragraph 12 of Schedule 5 (procedural provisions relating to the grant, renewal, variation, revocation and suspension of certificates of registration) to the Homoeopathic Regulations23.

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;

b

100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the licensing authority is—

i

not to revoke, vary, suspend or terminate, as the case may be, the authorization, licence, authorisation or certificate of registration; or

ii

to grant or renew, as the case may be, the authorization, licence, authorisation or certificate of registration.

Time for payment under regulation 3738

The fee prescribed in regulation 37 is payable at the time the notice is given.

PART 13Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

Interpretation39

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—
1. a
  a single application of that type, or
2. b
  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—
1. a
  a single application of that type, or
2. b
  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—
1. a
  an EC registration has been granted in an EEA State; and
2. b
  an application for an EC registration has been made in more than one EEA State under Article 28(1) and (3) 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—
1. a
  in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and
2. b
  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—
1. a
  an EC registration has already been granted in another EEA State; and
2. b
  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) of the 2001 Directive;
“product” includes a series of products each of which is prepared from identical homoeopathic stocks;
“set of applications” means—
1. a
  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
2. b
  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—
1. a
  the replacement of an excipient used in the manufacture of the product with a comparable excipient;
2. b
  the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;
3. c
  a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;
4. d
  a minor change to the method of manufacture of a homoeopathic stock included in the product;
5. e
  a change to the specification of any reagent or excipient used in the manufacture of the product;
6. f
  a change to the finished product specification of the product;
7. g
  a change to the test procedure for any raw material used in the manufacture of the product;
8. h
  a change to the test procedure of the product;
9. i
  a change to the test procedure for the container or other form of packaging immediately in contact with the product;
10. j
  a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;
11. k
  a change to the shape of the container in which the product may be placed on the market;
12. l
  an additional pack size in which the product may be placed on the market;
13. m
  a change to the approved storage conditions for the product;
14. n
  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;
15. o
  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
16. p
  a change following modification to the manufacturing authorisation.

2

In this Part—

a

any expression which is defined in the Act shall have the same meaning which it has in the Act;

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 section 132(3) of the Act (general interpretation provisions); 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.

Fees for applications made at the invitation of the licensing authority40

No fee shall be payable under this Part in connection with an application for the grant or variation of a certificate of registration under the Homoeopathic Regulations where the application is made at the specific request of the licensing authority.

Fees for applications for certificates41

1

The fee payable by a person who makes an application for the grant of a certificate of registration under regulation 4 of the Homoeopathic 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.

Fees for variations of certificates42

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 £133, and

ii

in respect of each other application so considered, a fee of £67;

b

in any other case, a fee of £133.

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 £263;

ii

in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £263;

iii

in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £133;

iv

in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £67;

b

in any other case, a fee of £263.

Time for payment of fees43

1

Any fee payable under regulation 41(1) or 42 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 41(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.

PART 14Administration

Payment of fees to Ministers44

Any sum payable under these Regulations must be paid to one of the Ministers.

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 a period of 14 days commencing on the date of the written notice issued by the licensing authority requiring payment of those fees; and

b

in connection with any application, must have been paid at the time of the application or before.

Time for payment of capital fees – applications made by small companies46

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 under the heading “Small company” in item 1 in section 382(3) (qualification of company as small) of the Companies Act 200624 and the conditions in paragraph (3) are met.

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 authorization held by the applicant was granted under the Marketing Authorisation Regulations.

5

Where the licensing authority determines that the marketing authorizations in respect of the medicinal product in question or the marketing authorization 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.

Time for payment of periodic fees48

All periodic fees must be paid by the first day of the fee period to which they relate.

Penalty fees for late payment of periodic fees49

1

Subject to paragraph (2), if a person has failed to pay a periodic fee by the time it has become payable under regulation 48, 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 50 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 authorizations, registrations, authorisations or licences held by that person.

Daily penalty fees for late payment of periodic fees50

If the periodic fee and penalty fee under regulation 49 (“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 49(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.

Refund or waiver of fees under regulation 49 or 5051

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 49(2) or 50.

Adjustment, waiver, reduction or refund of fees52

1

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 2010” substitute “Medicines (Products for Human Use) (Fees) Regulations 2012”.

Amendment of the Homoeopathic Regulations56

The Homoeopathic Regulations are amended by omitting the following definitions in regulation 1(2)26 (citation, commencement and interpretation)—

a

“administrative variation”,

b

“the Board”,

c

“concerned member State”,

d

“set of applications”, and

e

“standard variation”.

PART 16Revocations and Savings

The Medicines (Products for Human Use) (Fees) Regulations 201057

1

Subject to paragraphs (2) to (4), the Medicines (Products for Human Use) (Fees) Regulations 201027 (“the 2010 Regulations”) are revoked.

2

The savings introduced by regulation 52(2), (3) and (4) of the 2010 Regulations shall continue to apply as if those paragraphs of that regulation had not been revoked.

3

The 2010 Regulations shall continue to apply as if they had not been revoked—

a

in relation to capital fees payable under the 2010 Regulations in respect of any application or inspection made before the date on which these Regulations come into force; and

b

to any periodic fee payable under the 2010 Regulations in relation to a fee period ending before the date on which these Regulations come into force.

4

The revocation of the 2010 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 2010 Regulations shall continue to apply as if they had not been revoked.

The Homoeopathic Regulations58

1

The Homoeopathic Regulations are revoked to the following extent.

2

In regulation 1 (citation, commencement and interpretation) paragraph (4)28 is revoked.

3

Regulations 12 to 18, Schedule 2, 2A and 329 are revoked.

4

The Homoeopathic Regulations shall continue to apply as if they had not been revoked to the extent specified under paragraphs (2) and (3)—

a

in relation to any application or inspection made before the date on which these Regulations come into force; and

b

to any fee period ending before the date on which these Regulations come into force.

5

Any revocation under paragraphs (2) or (3) shall not affect any proceedings under the Homoeopathic Regulations for the recovery of any fees due as debts to the Crown and for the purposes of those proceedings, the Homoeopathic Regulations shall continue to apply as if they had not been revoked.

Signed by authority of the Secretary of State for Health.

Earl HoweParliamentary Under-Secretary of State,Department of Health20th February 2012

Edwin PootsMinister for Health, Social Services and Public Safety23rd February 2012

Michael FabricantBrooks NewmarkTwo of the Lords Commissioners of Her Majesty’s Treasury22nd February 2012

SCHEDULE 1INTERPRETATION

Regulation 2

Interpretation

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 use30;
“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;
“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);
“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;
“the Board” means the Advisory Board on the Registration of Homoeopathic Products;
“capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations;
“certificate of registration” means a certificate for the purposes of the Homoeopathic Regulations;
“change of ownership application” means an application—
1. a
  for—
  1. i
    a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization;
  2. ii
    a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation;
  3. iii
    a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration;
  4. iv
    a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence; or
  5. v
    a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence;
2. b
  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
3. c
  which includes a statement to the effect that the other person intends to cease the activities to which the 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 development” means the conduct of studies of a medicinal product in human subjects in order to—
1. a
  discover or verify the effects of such a product;
2. b
  identify any adverse reaction to such a product; or
3. c
  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 I to the 2001 Directive;
“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—
1. a
  to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
2. b
  to identify any adverse reactions to one or more such products; or
3. c
  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—
1. a
  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
2. b
  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 200431;
“complex application” has the meaning given in paragraph 5 of Schedule 2;
“concerned Member State” means for the purpose of—
1. a
  regulation 12 and Part 2 of Schedule 2 (capital fees for Applications for Authorizations, Licences, Registrations and Certificates), 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;
2. b
  regulation 18 and Part 4 of Schedule 2 (capital fees for applications for variations of authorizations, Licences and Registrations), an EEA State, the competent authority of which has received an application for a variation to the terms of a marketing authorization under the procedure laid down in EC Regulation No. 1234/2008 for a medicinal product in respect of which an authorization was granted by that competent authority, other than the reference Member State;
“contract laboratory” means a laboratory carrying out the examinations and tests referred to in—
1. a
  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 197132; and
2. b
  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 Products33;
“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 use34;
“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 35;
“EC Regulation No. 1234/2008” means Commission Regulation (EC) No. 1234/2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products36;
“EEA State” means a Member State, Norway, Iceland or Liechtenstein;
“European Union marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No. 726/2004;
“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 Marketing Authorisation 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;
“good clinical practice” means the conditions and principles of good clinical practice specified in Schedule 1 to the Clinical Trials Regulations;
“good distribution practice” means the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03) published by the European Commission pursuant to Article 84 of the 2001 Directive;
“good manufacturing practice” means the principles and guidelines of good manufacturing practice set out in Directive 2003/94/EC;
“good pharmacovigilance practice” means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission pursuant to Article 106 of the 2001 Directive;
“herbal substances” has the meaning given by Article 1(31) of the 2001 Directive;
“Herbal Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 200537;
“holder”, in relation to a clinical trial authorisation, means—
1. a
  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
2. b
  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 by any pharmacopoeia used officially in a Member State;
“homoeopathic marketing authorization” means a marketing authorization granted by the licensing authority in respect of a national homoeopathic medicinal product;
“Homoeopathic Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 199438;
“immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product;
“licensing authority” shall be interpreted in accordance with section 6 of the Act;
“major application” has the meaning given in paragraph 10 of Schedule 2;
“manufacturer’s licence” means a manufacturer’s licence falling within the meaning of section 8(2) of the Act 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—
1. a
  a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;
2. b
  a European Union marketing authorization; or
3. c
  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 Marketing Authorisation Regulations,
which relates to a medicinal product for human use;
“Marketing Authorisation Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 199439;
“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 Act40 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—
1. a
  does not satisfy the conditions set out in Article 14(1) of the 2001 Directive; and
2. b
  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 products41;
“parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the Marketing Authorisation 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 European Union law relating to parallel imports;
“penalty fee” means a fee payable under regulation 49;
“periodic fee” means the fee payable under regulation 33 or 34 by the holder of—
1. a
  a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence; or
2. b
  a clinical trial authorisation in respect of 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;
“pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)—
1. a
  the advice is in connection with an application for an EU marketing authorization, or is given with a view to a person making such an application, and relates to—
  1. i
    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 Title II of Regulation (EC) No. 726/2004;
  2. ii
    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
  3. iii
    a post-authorization safety study protocol;
2. b
  the advice is given to the holder of a United Kingdom marketing authorization or a European Union marketing authorization and relates to—
  1. i
    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;
  2. ii
    the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive; or
  3. iii
    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 licence” means a product licence falling within the meaning of section 7 of the Act;
“product licence of right” means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act42 which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act;
“product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EU 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 I to the 2001 Directive;
“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 Agency43;
“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 sub-paragraphs (a) to (c)—
1. a
  the advice is in connection with a change to the dates for renewal of one or more EU marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;
2. b
  the advice is in connection with—
  1. i
    a referral pursuant to Article 30, 31 or 36 of the 2001 Directive; or
  2. ii
    the procedure referred to in Article 35(2) of the 2001 Directive,
  in relation to a product range; or
3. c
  the advice is given to a person with a view to that person making—
  1. i
    an application for the variation or renewal of one or more EU marketing authorizations; or
  2. ii
    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;
“relevant fee period” means any fee period during any part of which a marketing authorization, traditional herbal registration, 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—
1. a
  a traditional herbal medicinal product; or
2. b
  a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;
“repeat formulation” means—
1. a
  the formulation of a product which is identical to the formulation of another product—
  1. i
    in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization; or
  2. ii
    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
2. b
  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;
“repeat stock” means—
1. a
  a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product—
  1. i
    in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization; or
  2. ii
    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 certificate of registration or a homoeopathic marketing authorisation which relates to that product; or
2. b
  where more than one application is made by the applicant on the same occasion in respect of products prepared from identical homoeopathic stocks, for the purposes of the second and any subsequent of those applications which the licensing authority considers, the homoeopathic stock used in the preparation of the product to which the first of those applications which is considered by the licensing authority relates;
“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;
“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
“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 200544;
“total value” means the gross amount of the total sales made during the period of 12 months preceding the date of the application;
“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;
“turnover” in relation to wholesale dealing means the gross amount of the total sales made during the period of 12 months preceding the date of the application;
“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;
“variation”—
1. a
  in relation to—
  1. i
    a United Kingdom marketing authorization; or
  2. ii
    a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the Marketing Authorisation Regulations,
  means “variation to the terms of a marketing authorization” as defined in Article 2(1) of EC Regulation No. 1234/2008;
2. b
  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 falling within the meaning of section 8(3) of the Act which relates wholly or partly to medicinal products for human use.

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 Regulations45.

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.

SCHEDULE 2CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES

Regulations 12(1)(a), 16,18(1), 19(1), 22(1), 26(1)

PART 1General: interpretation and categories of applications and variations

Interpretation1

In this Schedule—

“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;
“EU marketing authorization” means—
1. a
  a marketing authorization; or
2. b
  an authorization issued by a competent authority of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;
“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”;
“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—
1. a
  except in Part 2, paragraph 33 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—
  1. i
    which is intended to be administered by the same route of administration as the product in question; and
  2. ii
    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 Union) as an approved ingredient or additive in food or in a food product;
2. b
  in Part 2, paragraph 33 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—
  1. i
    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 Union) as an approved ingredient or additive in food or in a food product; and
  2. ii
    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 Union) 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—
1. a
  does not have an EU marketing authorization; or
2. b
  has an EU marketing authorization, but—
  1. i
    there has been a change—
    1. aa
      to the process of manufacture of the product or its active ingredient; or
    2. bb
      of manufacturer of that product, or
  2. ii
    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;
“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—
1. a
  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
2. b
  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.

A new excipient variation application is 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 application13

A new indication variation application is 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.

Parallel Import Licence application14

1

An application for a Simple Parallel Import licence means an application for a parallel import licence in respect of a proposed importation of a medicinal product (“P”) which is similar to a medicinal product (“R”) in respect of which a marketing authorisation has already been granted in the United Kingdom.

2

For the purposes of sub-paragraph (1) “similar” means—

a

the manufacturer of P and the manufacturer of R are either the same company or belong to the same group of companies or, in the case of independent companies, agreements have been concluded with the same licensor; and

b

product P and R are manufactured according to the same formulation, using the same active ingredients, have the same pharmaceutical form and have no differences that will result in a difference in the therapeutic effect.

3

An application for a Complex Parallel Import licence means an application for a parallel import licence which is not a Simple Parallel Import licence and the application is in respect of a medicinal product—

a

containing a new excipient;

b

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;

c

which is a controlled release preparation;

d

which is 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;

e

which is 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;

f

containing an active ingredient which, unless that active ingredient is covered by a European Pharmacopoeia certificate of suitability, is not manufactured by a manufacturer of the active ingredient which is included in the medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

g

which is an influenza vaccine;

h

which is to be delivered by way of a metered dose inhaler;

i

which is in powder form and is to be delivered by inhalation;

j

which falls within the description of the medicinal product set out in Article 10(3) of the 2001 Directive;

k

where the sole or primary evidence for the safety and efficacy of that product consists of published scientific literature;

l

in respect of which a marketing authorization has not been made pursuant to Article 10, 10a or 10c of the 2001 Directive by the competent authority in the Member State of exportation, and the application includes the results of pre-clinical tests or clinical trials within the meaning of Article 8(3)(i) of the 2001 Directive; or

m

in respect of which a marketing authorization to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applied in the Member State of exportation.

4

An application for a Standard Parallel Import licence means an application for a parallel import licence which is not a Complex Parallel Import licence or a Simple Parallel Import licence.

5

An application shall not fall within the meaning of sub-paragraph (1), (3) or (4) where the applicant and the holder of the marketing authorization in the Member State of exportation in respect of which the medicinal product in question relates are a parent undertaking and subsidiary undertaking within the meaning of section 1162 (taken together with section 1161 of, and Schedule 7 to) the Companies Act 200646.

Reclassification variation application15

A reclassification variation application is an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—

a

is to be available only from a pharmacy or on general sale, where previously it was available only on prescription; or

b

is to be available on general sale, where previously it was available only from a pharmacy.

Reduced registration application16

1

A reduced registration application category I is 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.

2

A reference to a 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—

a

the application relates to a medicinal product which is presented in the form of a herbal tincture;

b

the application relates to a medicinal product which is presented in the form of an essential oil;

c

the application relates to a medicinal product which is presented in the form of a fatty oil; or

d

the application relates to a medicinal product which contains only herbal substances in a capsule.

Simple application17

A simple application is an application—

a

for a marketing authorization to which Article 10c of the 2001 Directive applies; or

b

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 application18

A standard application is 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 application19

A 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.

Standard variation application20

A standard variation application is 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 medicinal product21

A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorization for a national homoeopathic product which requires—

a

the replacement of an excipient used in the manufacture of the product;

b

the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

c

a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

d

a change to the method of manufacture of a homoeopathic stock included in the product;

e

a change to the specification of any reagent or excipient used in the manufacture of the product;

f

a change to the finished product specification of the product;

g

a change to the test procedure for any raw material used in the manufacture of the product;

h

a change to the test procedure for the product;

i

a change to the test procedure for the container or other form of packaging immediately in contact with the product;

j

a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a Member State;

k

a change to the shape of the container in which the product may be placed on the market;

l

an additional pack size in which the product may be placed on the market;

m

a change to the approved storage conditions for the product;

n

a change to the shelf life of an unopened container of the product after the container has been opened for the first time;

o

a change to the dimensions of an approved dosage form of the product (for example, tablets); or

p

a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.

Type IB and Type II Applications22

1

sub-paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in paragraph 5 of this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or

ii

sub-paragraph (i) of that definition would so apply and the change is not a minor variation of type IA or a minor variation of type IB within the meaning of EC Regulation No. 1234/2008.

PART 2Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates

Marketing authorizations24

1

Unless paragraphs 25, 26, 28 or 29 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 the fee specified in the corresponding entry in column 2 of that table.

Fees for marketing authorization applications

Column 1 Kind of application
Column 2 Fee payable
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			£32,135
	(b)			which is a mutual recognition procedure incoming application			£67,468
	(c)			which is a European reference product application			£67,468
	(d)			which is a decentralised procedure application where the United Kingdom is a concerned Member State			£96,797
	(e)			which is a decentralised procedure application where the United Kingdom is a reference Member State			£139,235
	(f)			in any other case			£100,252
2. Complex application
		(a)			which is a mutual recognition procedure incoming application		£18,732
		(b)			which is a European reference product application		£18,732
		(c)			which is a decentralised procedure application where the United Kingdom is a concerned Member State		£26,762
		(d)			which is a decentralised procedure application where the United Kingdom is a reference Member State		£40,780
		(e)			in any other case		£27,716
3. Standard application
		(a)			which is a mutual recognition procedure incoming application		£6,864
		(b)			which is a European reference product application		£6,864
		(c)			which is a decentralised procedure application where the United Kingdom is a concerned Member State		£9,812
		(d)			which is a decentralised procedure application where the United Kingdom is a reference Member State		£17,920
		(e)			in any other case		£10,162
4. Simple application
		(a)			which is a decentralised procedure application where the United Kingdom is a concerned Member State		£2,771
		(b)			which is a decentralised procedure application where the United Kingdom is a reference Member State		£9,275
		(c)			in any other case		£2,771
5. Parallel import licence applications
			(a)			in respect of a simple parallel import licence	£1,937
			(b)			in respect of a standard parallel import licence	£7,201
			(c)			in respect of a complex parallel import licence	£19,650
6. Change of ownership application							£478

2

Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.

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.

Fees where person holds clinical trial certificate26

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.

Joint development27

1

In this paragraph—

“joint development” means the development by two or more applicants for marketing authorizations relating to medicinal products—
1. a
  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;
2. b
  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
3. c
  in respect of which applications for marketing authorizations have been received by the licensing authority within one month of each other;
“primary applicant” means—
1. a
  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
2. b
  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 24 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 24;

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 24;

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 24 and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 24.

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 24;

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 24.

Application for multiple authorizations28

1

Unless sub-paragraph (2), (3) or (4) applies, 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 total of the amounts payable under paragraph 24 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 24 and—

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 24;

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 24; 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 24.

3

If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 24 plus—

a

b

c

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) and—

a

in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable in respect of the relevant category of reclassification variation application under paragraph 25(1); and

b

in respect of each other marketing authorization applied for that includes a reclassification element, £794.

5

For the purposes of sub-paragraph (4), a “reclassification element” has the meaning given in paragraph 25(2).

Authorisation for a national homoeopathic product29

1

In this paragraph—

“formulation” does not include the formulation of a homoeopathic stock;
“identical” means—
1. a
  in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and
2. b
  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.

2

This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.

3

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.

4

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.

Fees for homoeopathic marketing authorization applications

Column 1			Column 2	Column 3
Description of application			Fee for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fee 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			£558	£791
2. An application in respect of a product which is either—			£874	£1,096
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation
3. Any other application			£1,176	£1,418

5

Each reference in sub-paragraphs (6) to (8) to an amount payable under sub-paragraph (3) or (4) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

6

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 £2,328 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

7

Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £7,766 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

8

Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients from a new source or TSE risk excipients from a new source, an amount of £686 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

Manufacturer’s licences and authorisations30

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

£178 in a case to which sub-paragraph (2) applies;

b

£335 in the case of a change of ownership application; and

c

£3,057 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 197147 applies.

Wholesale dealer’s licences31

1

Unless sub-paragraph (2) or (5) applies, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer’s licence is £1,754.

2

Where this sub-paragraph applies, the fee payable under regulation 12(1)(a) is £751.

3

Subject to sub-paragraph (4), 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% 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 Act48.

4

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% 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 that applicant so informs the licensing authority when the application is made.

5

The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £388.

Clinical trial authorisations32

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.

Fees for clinical trial authorisation applications

Column 1 Kind of clinical trial	Column 2 Fee payable
Phase I trial	£2,255
Phase II or Phase III trial where the medicinal product being tested is unknown to the licensing authority	£4,244
Phase II or Phase III trial where the product being tested is known to the licensing authority	£3,448
Phase IV trial	£265

2

For the purposes of that table, a medicinal product is known to the licensing authority if—

a

the product has an EU marketing authorization; or

b

the product does not have an EU marketing authorization, but where—

i

another pharmaceutical form or strength of that product has an EU 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 EU 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 use49.

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 £265.

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 £265.

Traditional herbal registrations33

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.

Fee for application for traditional herbal registration

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	£5,237
	(b)		in any other case	£7,857
2. Standard registration application
	(a)		in respect of a medicinal product containing 3 or fewer active ingredients	£2,619
	(b)		in any other case	£3,928
3. Reduced registration application category II
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£873
		(b)	in any other case	£1,310
4. Reduced registration application category I
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£583
		(b)	in any other case	£873
5. Change of ownership application				£478

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

£1,164, 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; or

b

£2,328, 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 £7,767 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 £690 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 £2,328 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

PART 3Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Outgoing mutual recognition applications34

a

is a change set out in the document entitled “UK National MA Variations Guidance” published by the licensing authority and available on its website on 30th November 200951; and

b

complies with the procedures and conditions to be fulfilled as set out in that document,

and the expressions “National Type 1B Application”, “National Type II Application”, “National Type II Complex Variation Application”, “National Type II Extended Complex Variation Application”, “National Type IB Minor Variation Group Application”, “National Type II Major Variation Group Application” and “National Type II Major Variation Complex Group Application” shall be interpreted accordingly.

Table 1Fees for applications for variations of marketing authorizations falling within the scope of EC Regulation No. 1234/2008

Column 1 Kind of variation					Column 2 Fee payable
1. Application for a single kind variation
	(a)	Type IB Application where—
		(i)	the UK is a concerned Member State		£300
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£594
	(b)	Type II Application where—
		(i)	the UK is a concerned Member State		£794
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£962
	(c)	Type II Complex Variation Application where—
		(i)	the UK is a concerned Member State		£8,981
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£15,571
	(d)	Extended Type II Complex Variation Application where—
		(i)	the UK is a concerned Member State		£27,716
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing		£38,744
2. Applications for a Group
	(a)	Minor Variation (Type IB) Group Application where—
		(i)	the UK is a concerned Member State	£672
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£1,324
	(b)	Major Variation (Type II) Group Application where—
		(i)	the UK is a concerned Member State	£1,786
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£2,158
	(c)	Major Variation (Type II) Complex Group Application where—
		(i)	the UK is a concerned Member State	£9,738
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£16,465
	(d)	Major Variation (Type II) Extended Complex Group Application where—
		(i)	the UK is a concerned Member State	£28,401
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£39,693

Table 2Fees for UK national variation applications

Column 1 Kind of national variation	Column 2 Fee payable
1. National Type 1B Application	£300
2. National Type II Application	£794
3. National Type II Complex Variation Application	£8,981
4. National Type II Extended Complex Variation Application	£27,716
5. National Type IB Minor Variation Group Application	£672
6. National Type II Major Variation Group Application	£1,786
7. National Type II Major Variation Complex Group Application	£9,738
8. National Type II Major Variation Extended Complex Group Application	£28,401

Table 3Fees for reclassification variation applications

Column 1 Kind of reclassification variation
Application falling within the category described in—
	(a)	paragraph 15(a)	£12,961
	(b)	paragraph 15(b)	£8,822

Column 1

Kind of reclassification variation

Column 2

Fee payable

Application falling within the category described in—

(a)

paragraph 15(a)

£12,961

(b)

paragraph 15(b)

£8,822

Variation of marketing authorizations36

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) together with 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 I 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 the applicant 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.

Reclassification of marketing authorizations37

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 £794.

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

2

For the purposes of sub-paragraph (1)(c) an application for an administrative variation is where the variation applied for falls within one of the following 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; or

g

unless paragraph 8 of Schedule 6 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, or

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 38 of this Schedule applies.

Manufacturer’s authorisations and licences40

Unless the fee in paragraph 41 is payable or paragraph 46 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

£250 in the case of a manufacturer’s licence referred to in paragraph 30(2); and

b

£500 in any other case.

Variation of manufacturer’s authorisations and licences41

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 £250 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.

Wholesale dealer’s licences42

Unless the fee in paragraph 43 is payable or paragraph 46 applies, the fee payable under regulation 18(1)(c) in connection with an application for a variation of a wholesale dealer’s licence is £473.

Variation of wholesale dealer’s licence43

The fee payable under regulation 18(1)(c) in connection with an application for variation of a wholesale dealer’s licence is £250 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.

c

Minor Variation (Type IB) Group Application; or

d

Major Variation (Type II) Group Application.

3

The fee referred to in sub-paragraph (1)—

a

in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and

b

in connection with each of the other applications is 50% of that amount.

Complex Variation Applications47

In this paragraph, “clinical particulars” 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.

2

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

i

£10,465 for the first application considered by the licensing authority; and

ii

£807 for each other application;

b

if the applications fall within paragraph 51(b)—

i

£807 for the first application considered by the licensing authority; and

ii

£405 for each other application.

SCHEDULE 3FEES FOR INSPECTIONS

Regulations 27(1), 30,31(2), 32(1)

General provisions relating to fees for inspections1

1

In this Schedule, a reference to 1 day means a period of 7 hours.

2

For the purposes of paragraphs 3(2)(c), 4(2)(c), 6(2)(c) and 8, in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day.

3

Where an inspection is made at a site which is outside the United Kingdom, the fee for the inspection shall be 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 the inspector in respect of that inspection as a result of its being at a site outside the United Kingdom.

4

If an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the total amount of time spent by each inspector in making the inspection.

Fees: general2

1

The fee for an inspection made at a site is—

a

£2,583, if the time taken to make the inspection is not more than 1 day; and

b

thereafter, £1,292 for every additional period of 3 hours and 30 minutes or less taken to make the inspection.

2

Sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.

Traditional herbal medicinal products3

1

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.

2

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

£967 if the time taken to make the inspection is not more than 3 hours;

b

£1,571 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 £1,571.

Sites concerned with starting materials for traditional herbal medicinal products4

1

Sub-paragraph (2) applies if the site inspected is wholly concerned with the manufacture or assembly of starting material for use in the manufacture of traditional herbal medicinal products.

2

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

£967 if the time taken to make the inspection is not more than 3 hours;

b

£1,571 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 to make the inspection by £1,571.

Wholesale dealer’s licence: general5

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

if the time taken to make the inspection is not more than 1 day, £1,882; and

b

if the time taken is 1 day or more, £1,882 for the first day and £941 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

Wholesale dealer’s licence: traditional herbal medicinal products6

1

Sub–paragraph (2) applies if the site inspected is wholly concerned with the wholesale dealing of traditional herbal medicinal products.

2

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

£724 if the time taken to make the inspection is not more than 3 hours;

b

£1,330 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 £1,330.

Regulation 33(2) and (3), 34(2)

PART 1Interpretation

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;
“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—
1. a
  which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—
  1. i
    a different dosage form of that drug or substance; or
  2. ii
    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
2. b
  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;
“lower fee” means the periodic fee payable—
1. a
  where 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
2. b
  in relation to a medicinal product that has been manufactured or imported into the United Kingdom during the period referred to in (a) above, where the value of the product sold or supplied during that period did not exceed £1,000; and
3. c
  in relation to a prescription only product, where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; or
4. d
  in relation to a pharmacy medicine or a general sale list medicine, the periodic fee payable during the relevant fee 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 in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;
“standard fee” means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000; and
“total value of the product” means the amount calculated in accordance with Part 2 of this Schedule.

PART 2Value of the Product Sold or Supplied

Determining the total value of the product2

For the purposes of this Schedule, the “total value of the product” means, the gross value at manufacturer’s prices of all medicinal products to which the authorization relates that are sold or supplied in the United Kingdom by the holder of that authorization during a period of 12 months preceding the commencement of the relevant fee period.

Manufacturer’s prices3

For the purposes of paragraph 2 manufacturer’s prices means—

a

for products manufactured or obtained, sold or supplied by the authorization holder to wholesalers or to distributors or assemblers named in the marketing authorization, which that holder 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 that holder has manufactured or obtained from the manufacturer, the prices which, in the opinion of the licensing authority, the authorization holder would have charged, in accordance with the practice prevailing during the relevant year, to a wholesaler of the product; or

c

for products sold or supplied by the authorization holder which that holder has neither manufactured nor obtained from the manufacturer, the price which he paid for the supply.

Information requirements4

1

The authorisation holder shall determine the total value of product sold or supplied in accordance with paragraphs 2 and 3 and provide such information to the licensing authority if required to do so.

2

The licensing authority may additionally require an auditor’s certificate verifying the authorisation holder’s determination of the value of products sold or supplied.

3

If an auditor’s certificate has not been provided to the licensing authority within one month of it being required, or such longer period that the authority may allow, the periodic fee shall be calculated in accordance with sub-paragraph (4).

4

The 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, such lesser sum as the licensing authority may specify in a written notice served on the authorization holder.

PART 3Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations5

Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(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.

Periodic fees for holding marketing authorization

Column 1 Type of Medicinal Product				Column 2 Fee payable
1. New Active Substance				£23,025
2. Parallel Import				£300
3. Others
	(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		£9,481
	(b)	Prescription Only Medicine
		(i)	Standard Fee	£2,371
		(ii)	Reduced Rate Fee	£1,183
		(iii)	Lower Fee	£300
	(c)	Pharmacy		£300
	(d)	General Sale List		£300
	(e)	Herbal remedy		£75
	(f)	Traditional herbal registrations		£75
	(g)	National homoeopathic product		£75
	(h)	Homoeopathic or anthroposophic product which is the subject of a licence of right		£75

Marketing authorization: where Part 2 of the Act applies6

b

in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 3(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 3(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 the total value of the product sold or supplied 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 the total value of the product sold or supplied 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 3(b)(i) of the table set out in paragraph 5.

Authorisation for two or more kinds of medicinal product9

Where a marketing authorization relates to any two or more medicinal products of a kind described in entries 3(b), (c) or (d) of column 1 of the table in paragraph 5, the fee payable under regulation 33(3) shall be the lower of the fee specified as corresponding to those entries in column 2 of that table.

Reduced fees10

Where a reduced rate fee or a lower fee may be payable in respect of any relevant fee period and an authorization holder does not submit information about the total value of the product sold or supplied in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable 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.

Manufacturer’s licences or manufacturing authorisations11

1

Unless sub-paragraph (3) applies, the fee payable under regulation 33(3) in connection with the holding of a manufacturer’s licence is £457.

2

The fee payable under regulation 33(3) in connection with the holding of a manufacturing authorisation is £457.

3

The fee payable under regulation 33(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.

Wholesale dealer’s licences12

1

Subject to sub-paragraph (2) and to paragraphs 13 and 16, the fee payable under regulation 33(3) in connection with the holding of a wholesale dealer’s licence is £281.

2

The fee payable under regulation 33(3) is £168 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% of the total value 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 value 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 value 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 interpreted as if they were references to “wholesale dealer’s licence” and “licence holder”, respectively.

Wholesale dealer’s licences: evidence13

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 fee period to the satisfaction of the licensing authority, the periodic fee payable shall be the fee prescribed in paragraph 12(1).

Wholesale dealer’s licences: exempt imported products14

The fee payable under regulation 33(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.

Additional amount for manufacturer’s licences and wholesale dealer’s licences which relate to exempt imported products15

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.

Additional periodic fee in connection with exempt imported products

Column 1 Number of special import notices	Column 2 Additional amount
1 to 20	£126
21 to 100	£505
101 to 1,000	£2,020
1,001 to 5,000	£10,100
5,001 to 20,000	£25,250
20,001 to 50,000	£50,500
50,001 to 100,000	£101,000
100,001 or more	£151,500

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.

Clinical trial authorisations16

The fee payable under regulation 34(2) in connection with the holding of a clinical trial authorisation is £342.

Traditional herbal registrations17

The fee payable under regulation 33(3) in connection with the holding of a traditional herbal registration is £75.

PART 4Types of Marketing Authorization for which only One Periodic Fee is Payable

Parallel import licences18

In a case where a parallel import licence has been granted by the licensing authority the periodic fee relating to that licence is payable once only.

SCHEDULE 5FEES FOR CERTIFICATES OF REGISTRATION

Regulation 42(1) and (2)

Column (1)			Column 2	Column 3
Type 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.		£172	£425
2	An application in respect of a product which is either—		£517	£761
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation.
3	A mutual recognition procedure incoming application.		£542	£690
4	A mutual recognition outgoing application (regulatory assistance).		£310	£405
5	A decentralised procedure application where the UK is a concerned Member State.		£465	£608
6	A decentralised procedure application where the UK is the reference Member State.		£930	£1,217
7	Any other application.		£854	£1,118

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.

Application for traditional herbal registration6

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% at the time of the application and as to 50% within 12 months after that time.

Traditional herbal registration: complex variation7

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% at the time of the application and as to 50% within 12 months after that time.

Application for manufacturer’s licence, manufacturing authorisation or wholesale dealer’s licence8

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% at the time of the application and as to 50% within 12 months after that time.

Inspection fees in connection with applications9

In connection with an application for a marketing authorization, traditional herbal registration, manufacturer’s licence or manufacturing authorisation, 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% within the period of 14 days referred to in regulation 45(1)(b) and as to 50% within 12 months after that date.

SCHEDULE 7WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

Regulation 52(2)

Interruptions of manufacture, assembly, sale or supply1

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.

Reclassification2

1

Where—

a

an application for a marketing authorization includes a reclassification element within the meaning of paragraph 25 of Part 2 of Schedule 2; 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 Act54 or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act55,

50% of the additional amount payable under paragraph 25(1)(a) or (b) or 28(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 37 of Part 4 of Schedule 2); and

b

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.

if such an inspection has been made, 50%.

Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation7

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.

Parallel import licence8

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.

Surrender of marketing authorization at same time as a variation application9

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 4, 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 46 and 47 of Part 4 of Schedule 2, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs make provision for the higher or highest fee.

Clinical trial authorisation10

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.

5

In this paragraph, “Phase I trial” and “Phase II or Phase III trial” have the same meaning as in paragraph 1 of Schedule 2.

Regulation 52(2)

Refund on surrender or revocation of authorization, registration or licence1

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—

a

surrendered at the specific written invitation of the licensing authority; or

b

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 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.

Adjustment and refund: licences relating to exempt imported products2

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 4, 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 4, 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.

Refunds: treated as having been paid on account3

EXPLANATORY NOTE

(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 2010 (“the 2010 Regulations”). They make amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Regulations”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Clinical Trials Regulations”).

These Regulations make provision for the fees payable under the Medicines Act 1971 and other fees payable in respect of EU 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 and based on an assessment of the costs associated with a range of licensing requirements and functions. The fee amounts specified in these Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 21st December 2011. A summary of the consultation responses is published on the MHRA’s website (www.mhra.gov.uk).

In general these Regulations provide for fee reductions in some areas, simplification measures and amendments to facilitate better administrative practice.

Parts 2 to 9 and 11 and 12 and Schedules 2 and 3 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 inspections. Most of the fees were previously provided for by the 2010 Regulations (as amended).

However, these Regulations also—

a

provide a 10% reduction in fees for applications under decentralised procedure where the UK is the Reference Member State;

b

simplify the fee structure for capital fees payable for authorizations, licenses, registrations and certificates so that there is no price differential between applications made electronically and others.

Part 10 and Schedule 4 provide for periodic fees in connection with authorizations, registrations and licenses. Schedule 4 includes amendments to—

a

clarify how the total value of products sold or supplied is to be determined;

b

introduce a “lower fee” in respect of periodic fees for prescription only medicines;

c

replace the 3 types of periodic fees previously payable in connection with pharmacy or general sale medicines with a single fee set at the same level as the lower fee for prescription only medicines;

d

replace the 3 types of periodic fees for parallel import licenses with a single fee; and

e

provide a single fee rate for herbal, homoeopathic and traditional herbal medicinal products licenses.

Part 13 and Schedule 5 provides for fees in relation to homoeopathic medicinal products. In particular, the fee provisions from the Homoeopathic Regulations have been consolidated into these Regulations.

Part 14 and Schedule 6, 7 and 8 deal with the time for payment and waiver or refund of both capital and periodic fees in specified circumstances. These Regulations make provision for payments to be made in advance of any application or the fee becoming due to the licensing authority.

Part 15 of these Regulations make consequential amendments to—

a

the Clinical Trials Regulations to update cross-references to these Regulations; and

b

the Homoeopathic Regulations to remove some obsolete definitions from those regulations.

Part 16 of these Regulations revokes and makes savings provisions in relation to—

a

earlier Regulations relating to fees for medicinal products for human use; and

b

parts of the Homoeopathic Regulations.

An impact assessment of the effect that this instrument will have on the costs of business is available from the MHRA at 151 Buckingham Palace Road, London SW1W 9SZ and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk