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

Type Ni-Statutory-Rule

Publication 2012-02-23

State In force

Jurisdiction Northern Ireland

Department Government Printer for Northern Ireland

Source legislation.gov.uk

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Made: 23rd February 2012

Laid before Parliament: 29th February 2012

Coming into force: 1st April 2012

In accordance with section 129(6) of the Medicines Act 1968[^f00006], 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 1 — General

Citation and commencement

1

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

Interpretation

2

These Regulations shall be interpreted in accordance with Schedule 1.

PART 2 — Capital Fees for Pre-Application Meetings

Interpretation of Part 2

3

In this Part—

“EU marketing authorization” means— a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations; a marketing authorization granted by the competent authority of an EEA State other than the United Kingdom in accordance with the 2001 Directive; or a 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 authorization

4

Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing 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 product

5

(1) The fee payable by a person with whom the licensing authority holds a meeting to provide scientific advice in connection with the classification of a relevant medicinal product, is—

(a) £2,986, if the advice relates to a product which, if reclassified, will be available on general sale; and

(b) £3,917, if the advice relates to a product which, if reclassified, will be available without a prescription from a pharmacy.

(2) For the purposes of this regulation, a product is on general sale if it is a medicinal product of a description or falling within a class specified in an Order made under section 51 (general sale lists) of the Act[^f00007].

Fee for advertising advice

6

The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide advice before the publication of advertising of a medicinal product by that holder’s undertaking on whether that advertising conforms to the requirements of Title VIII of the 2001 Directive, is £2,378.

Fee for pharmacovigilance advice

7

(1) The fee payable by a person with whom the licensing authority holds a meeting in order to provide pharmacovigilance advice is—

(a) £3,917, in a case where the time taken by the licensing authority to prepare for and attend the meeting is more than six hours;

(b) £3,308, in any other case.

(2) The time taken by the licensing authority for the purposes of paragraph (1) shall be the total time spent by each individual engaged in preparing for or attending the meeting on behalf of the licensing authority.

Fee for advice on labelling or leaflets

8

The fee payable by the holder of one or more marketing authorizations with whom the licensing authority holds a meeting in order to provide advice on proposed changes to the labelling or the package leaflets of the medicinal products to which those authorizations relate, is £2,378.

Fee for regulatory advice

9

The fee payable by the holder of a marketing authorization with whom the licensing authority holds a meeting in order to provide regulatory advice to that person, is £2,986.

Fee for advice for other purposes

10

(1) Unless paragraph (4) applies, the fee payable by a person specified in paragraph (2) with whom the licensing authority holds a meeting for a purpose specified in paragraph (3) is £4,810.

(2) A person who—

(a) is, or is to be, a sponsor of a clinical trial;

(b) manufactures medicinal products;

(d) acts on behalf of, or provides advice or assistance to, a person referred to in sub-paragraphs (a) to (c),

is a specified person for the purpose of paragraph (1).

(3) A meeting referred to in paragraph (1) is for a specified purpose if it is held to provide advice in relation to—

(a) scientific or regulatory issues relating to the development of a medicinal product or a type of medicinal product;

(b) the design of pharmaceutical or pre-clinical tests, or clinical trials, for a medicinal product or a type of medicinal product;

(c) the management of risk in relation to a medicinal product or a type of medicinal product which is under development, or is being marketed in the European Union; or

(d) other scientific or regulatory issues relating to a medicinal product or a type of medicinal product after an EU marketing authorization has been granted for that product or a product of that type.

(4) Paragraph (1) does not apply in the case of a meeting where the purpose of such a meeting is to provide only advice specified in regulations 4 to 9.

(5) In this regulation—

“Directive 93/42/EEC” means Council Directive 93/42/EEC concerning medical devices[^f00008];

“medical device” has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;

“medicinal product” includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

“regulatory issues” means issues relating to the application of any EU instrument relating to EU marketing authorizations or to medical devices, or any enactment which implements such an instrument;

“risks” means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;

“sponsor” shall be interpreted in accordance with regulation 3 (sponsor of a clinical trial) of the Clinical Trials Regulations[^f00009];

and a reference to the development of a medicinal product or a type of medicinal product is a reference to development for the purposes of—

(a) obtaining an EU marketing authorization, or making a variation to an EU marketing authorization, for that product or a product of that type; or

(b) obtaining a design-examination certificate of the type mentioned in paragraph 4.3 of Annex II to Directive 93/42/EEC or a type-examination certificate of the type mentioned in paragraph 5 of Annex III to that Directive, for a medical device incorporating that product or a product of that type.

Time for payment of fees under regulations 4 to 10

11

All sums payable by way of fees under regulations 4 to 10 must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of those fees.

PART 3 — Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections

Fees for applications for authorizations, licences or certificates etc.

12

(1) Unless Part 16 of these Regulations (revocations and savings) applies, the application fee for a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturer’s licence, a manufacturing authorisation, a wholesale dealer’s licence or a clinical trial authorisation is—

(a) the fee prescribed for that application in Part 2 of Schedule 2; and

(b) in respect of an inspection of a site made in connection with that application, the fee payable in accordance with regulations 27 to 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 practice

13

The fee payable by an applicant for a certified copy of a certificate of good manufacturing practice issued pursuant to Article 111(5) of the 2001 Directive is £67.

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

14

(1) The fee payable by an applicant for a certificate issued under section 50 (export certificates) of the Act[^f00010], 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 4 — Capital 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 procedure

16

The fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing 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 16

17

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

Fees for variations of authorizations, registrations, licences and authorisations

18

(1) Unless Part 16 of these Regulations (revocations and savings) applies, the fee for an application—

(a) under regulation 4 (applications for the grant, renewal or variation of a United Kingdom marketing authorization) of the Marketing Authorisation Regulations[^f00011] for the variation of a United Kingdom marketing authorization;

(b) under regulation 6 (consideration and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration) of the Herbal Regulations for the variation of a traditional herbal registration;

(c) under section 30 (variation of licence on application of holder) of the Act[^f00012] for the variation of a product licence, a manufacturer’s licence or a wholesale dealer’s licence; or

(d) under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations[^f00013] for the variation of a manufacturing authorisation,

is the fee mentioned in paragraph (2).

(2) The fee referred to in paragraph (1) is—

(a) the fee prescribed in Part 4 of Schedule 2 in connection with the application; and

(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.

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

Fees for amendments to clinical trial authorisations

19

(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations[^f00014] relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).

(2) The fees referred to in paragraph (1) are—

(a) the fee prescribed in paragraph 44 of Schedule 2 in connection with that amendment; and

(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 27 to 29 and 31.

Applications for multiple variations

20

(1) Unless paragraph (3) or (5) applies, a separate fee is payable in respect of each application to vary each term of a marketing authorization.

(2) Unless paragraph (5) applies, a separate fee is payable in respect of each variation of each provision of a traditional herbal registration, manufacturing authorisation or licence applied for in any one application.

(3) A separate fee is not payable for each application to vary a term of a marketing authorization which—

(a) falls within the same type of group application; or

(b) the licensing authority—

(i) in consultation with other Member States concerned, have agreed, in accordance with Article 7(2)(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;

(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— at least one of the variations is a major variation of type II; subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008; the variations do not include a variation— of a kind referred to in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to EC Regulation No. 1234/2008; which relates to a change which is referred to in paragraph 23 of Schedule 2 (Type II Complex Variation Application); or of a marketing 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 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— at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2; subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008; the variations do not include a variation of— a kind referred to in paragraph 1 or paragraph 3 of Annex III to EC Regulation No. 1234/2008; or 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 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— 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; subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008; 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 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— at least one of the variations is a minor variation of type IB; subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) of EC Regulation No. 1234/2008; the variations do not include— a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of EC Regulation No. 1234/2008; or a major variation of type II; and the variations may include one or more minor variations of type IA;

“minor variation of type 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 6 — Capital 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 leaflets

22

(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 22

23

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

Fees for renewals of certain manufacturer’s licences

24

(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 1971[^f00015] applies.

(3) Where an inspection of a site is made in connection with the application referred to in paragraph (1) an inspection fee of £287 is also payable by the applicant.

Fees for renewals in terms which are not identical to the existing authorization, licence or registration

25

Where an applicant applies for renewal of a—

(a) marketing authorization (other than a European Union marketing authorization);

(b) traditional herbal registration, or

so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had the applicant made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.

PART 8 — Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

Fees for regulatory assistance for certain marketing authorizations

26

(1) Where—

(a) an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and

(b) the United Kingdom is to provide regulatory assistance acting as reference Member State in relation to that application,

the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2 in connection with that regulatory assistance.

(2) The procedures referred to in paragraph (1) are—

(a) the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products[^f00016] and in Articles 17 and 18 of the 2001 Directive;

(b) the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;

(c) the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;

(d) referral to the Committee for Proprietary Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology[^f00017], 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 9 — Capital Fees for Inspections

Fees for inspections

27

(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 applications

29

(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 trials

30

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 licence

31

(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 advance of an application; or

(b) at the time that application is made.

(2) Except where paragraph (3) applies, the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(a) of Schedule 3.

(3) In a case where—

(a) the site to be inspected falls within the description specified in paragraph 7(1)(a) or (b) of Schedule 3; or

(b) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000 (within the meaning given in paragraph 7(2) of that Schedule),

the inspection fee payable as a consequence of paragraph (1) shall be the amount specified in paragraph 5(b) of Schedule 3.

Adjustment and refund of inspection fees in respect of a wholesale dealer’s licence

32

(1) If the inspection in respect of an application for a wholesale dealer’s licence takes—

(a) in the case where regulation 31(2) applies, more than 7 hours; or

(b) 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 10 — Periodic Fees for Authorizations, Registrations, Licences and Authorisations

Periodic fees

33

(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 authorisations

34

(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 Regulations[^f00018].

PART 11 — Capital 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 certificates

36

(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 12 — Capital Fee for a Person Appointed Hearing

Fee for a person appointed hearing

37

(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 Act[^f00019];

(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)[^f00020] 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 Regulations[^f00021];

(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 Regulations[^f00022]; 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 Regulations[^f00023].

(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 37

38

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

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

Interpretation

39

(1) In this Part—

“administrative variation” means a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;

“application” means an application for the grant of a certificate of registration;

“application to the licensing authority for regulatory assistance” in relation to a single certificate of registration means— a single application of that type, or a set of applications of that type;

“application for an EC registration in a concerned Member State” in relation to a single certificate of registration means— a single application of that type, or a set of applications of that type in a number of concerned Member States;

“decentralised procedure application” means an application relating to a homoeopathic medicinal product in respect of which at the time of the application— an EC registration has been granted in an EEA State; and an application for an EC registration has been made in more than one EEA State under Article 28(1) and (3) of the 2001 Directive;

“EC registration” means a registration granted by a competent authority of an EEA State in accordance with the procedure set out in Article 14 of the 2001 Directive;

“formulation” does not include the formulation of homoeopathic stock;

“identical” means— in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;

“mutual recognition procedure incoming application” means an application relating to a homoeopathic medicinal product in respect of which— an EC registration has already been granted in another EEA State; and recognition of that certificate is sought from the licensing authority by way of the grant of a certificate of registration in the United Kingdom, under the procedure in Articles 28 and 29(1) to (3) of the 2001 Directive;

“product” includes a series of products each of which is prepared from identical homoeopathic stocks;

“set of applications” means— a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or a number of applications to competent authorities of other EEA States for EC certificates of registration relating to a single certificate of registration, where those applications all have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; and

“standard variation” means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal products to which that certificate relates— the replacement of an excipient used in the manufacture of the product with a comparable excipient; the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent; a change to the qualitative composition of the container or other form of packaging immediately in contact with the product; a minor change to the method of manufacture of a homoeopathic stock included in the product; a change to the specification of any reagent or excipient used in the manufacture of the product; a change to the finished product specification of the product; a change to the test procedure for any raw material used in the manufacture of the product; a change to the test procedure of the product; a change to the test procedure for the container or other form of packaging immediately in contact with the product; a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State; a change to the shape of the container in which the product may be placed on the market; an additional pack size in which the product may be placed on the market; a change to the approved storage conditions for the product; a change to the shelf life of an unopened container of the product or to the shelf life of the product after the container has been opened for the first time; a change to the dimensions of an approved dosage form of the product (for example, tablets) which does not entail a change to the quantitative composition or the mean mass of the product; or a change following modification to the manufacturing authorisation.

(2) In this Part—

(a) any expression 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 authority

40

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 certificates

41

(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 certificates

42

(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 fees

43

(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 14 — Administration

Payment of fees to Ministers

44

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

Time for payment of capital fees in connection with applications or inspections

45

(1) All capitals fees under these Regulations shall be payable in accordance with—

(a) the specified provisions in paragraph (2) where appropriate, and

(b) paragraph (3).

(2) The specified provisions are—

(a) regulation 10 (pre-application meetings);

(b) regulation 16 (regulatory assistance);

(d) regulation 31 (inspections in respect of wholesale dealer’s licence);

(e) regulation 37 (person appointed hearings); and

(f) regulation 46 (small companies).

(3) All fees payable under this regulation—

(a) in respect of inspections made either in connection with an application for, or during the currency of, an 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 companies

46

(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 2006[^f00024] and the conditions in paragraph (3) are met.

(3) The conditions for the purposes of paragraph (2) are—

(a) the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount for the time being specified under the heading “Small company” in section 382(3) of that Act; or

(b) the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading “Small company” in section 382(3) of that Act.

Payment of fees in respect of a traditional herbal registration

47

(1) Where an application is made for the grant of a traditional herbal registration—

(a) in accordance with regulation 5 (applications for the grant or renewal of a traditional herbal registration) of the Herbal Regulations;

(b) on the grounds specified in paragraph (2); and

the fee payable under regulation 12 shall be refunded or, if it has not been paid, shall be waived.

(2) For the purposes of paragraph (1), the specified grounds are—

(a) that the marketing authorization in respect of the medicinal product in question; or

(b) in the case of a corresponding product the marketing authorization relating to product Y (as defined in paragraph (4)),

is to be revoked.

(3) A medicinal product falls within this paragraph if—

(a) a marketing authorization held by the applicant was granted under the Marketing Authorisation Regulations in respect of that medicinal product; or

(b) that medicinal product is a corresponding product.

(4) For the purposes of paragraph (3), a corresponding product is a product which is characterised by having—

(a) the same active ingredients, irrespective of the excipients used or reduction in the number or quantity of active ingredients;

(b) the same or similar intended purpose, equivalent strength and posology; and

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 fees

48

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 fees

49

(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 fees

50

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 50

51

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 fees

52

(1) If after a capital or periodic fee is paid it becomes apparent that—

(a) a lesser fee should have been paid, the excess shall be refunded to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned; or

(b) a higher fee should have been paid, the balance due shall be payable within a period of 14 days commencing on the date of the written notice issued by the licensing authority to the applicant or, as the case may be, the holder of the authorization, registration, authorisation or licence concerned requiring payment of that balance.

(2) The licensing authority shall, to the extent provided in Schedule 7 in relation to capital fees or in Schedule 8 in relation to periodic fees—

(a) adjust, waive payment of or reduce any fee or part of a fee otherwise payable under these Regulations; or

(b) refund the whole or part of any fee already paid.

Suspension of licences and authorisations

53

(1) Where any sum due by way of, or on account of, any fee or any part of a fee payable under these Regulations remains unpaid by the holder of a—

(a) product licence or a product licence of right;

(b) manufacturer’s licence;

(d) wholesale dealer’s licence,

the licensing authority may serve a written notice on the holder requiring payment of the sum unpaid.

(2) If after a period of one month commencing on the date of service of the notice referred to in paragraph (1), or such longer period as the licensing authority may allow, the said sum remains unpaid, the licensing authority may forthwith suspend the licence or, as the case may be, the authorisation until such sum has been paid.

Civil proceedings to recover unpaid fees

54

All unpaid sums due by way of, or on account of, any fees payable under these Regulations shall be recoverable as debts due to the Crown.

PART 15 — Consequential Amendments

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

55

(1) The Medicines for Human Use (Clinical Trials) Regulations 2004[^f00025] are amended as follows.

(2) In regulation—

(a) 17(2)(b)(ii) (request for authorisation to conduct a clinical trial),

(b) 24(10) (amendments by the sponsor),

(d) 44(8) (variation of manufacturing authorisation),

Amendment of the Homoeopathic Regulations

56

The Homoeopathic Regulations are amended by omitting the following definitions in regulation 1(2)[^f00026] (citation, commencement and interpretation)—

(a) “administrative variation”,

(b) “the Board”,

(d) “set of applications”, and

(e) “standard variation”.

PART 16 — Revocations and Savings

The Medicines (Products for Human Use) (Fees) Regulations 2010

57

(1) Subject to paragraphs (2) to (4), the Medicines (Products for Human Use) (Fees) Regulations 2010[^f00027] (“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 Regulations

58

(1) The Homoeopathic Regulations are revoked to the following extent.

(2) In regulation 1 (citation, commencement and interpretation) paragraph (4)[^f00028] is revoked.

(3) Regulations 12 to 18, Schedule 2, 2A and 3[^f00029] 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.

SCHEDULE 1 — INTERPRETATION

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 use[^f00030];

“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— for— a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization; a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation; a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration; a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence; or a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence; which refers to particulars which are in all material respects identical to the particulars of the marketing authorization, manufacturing authorisation, traditional herbal registration, manufacturer’s licence, or wholesale dealer’s licence which is held by that other person; and which includes a statement to the effect that 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— discover or verify the effects of such a product; identify any adverse reaction to such a product; or study absorption, distribution, metabolism and excretion of such a product, with the object of ascertaining the safety or efficacy of that product, in accordance with section 5 of Part 1 of Annex I to the 2001 Directive;

“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; to identify any adverse reactions to one or more such products; or to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products;

“clinical trial authorisation” means authorisation of the conduct of a clinical trial— by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving general medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving general medicinal products with special characteristics) of the Clinical Trials Regulations; or which is treated as having been given by the licensing authority by virtue of Schedule 12 to those Regulations;

“Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004[^f00031];

“complex application” has the meaning given in paragraph 5 of Schedule 2;

“concerned Member State” means for the purpose of— 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; 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— paragraph 5A(2) of Schedule 2 (standard provisions for manufacturer’s licences and manufacturer’s licences of right) to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971[^f00032]; and Article 11(1) of Directive 2003/94/EC, on behalf of the holder of a manufacturing authorisation, manufacturer’s licence or wholesale dealer’s licence, pursuant to Article 11(2) of that Directive and Article 20(b) of the 2001 Directive;

“Council Regulation (EEC) No. 2309/93” means Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products[^f00033];

“Directive 2003/94/EC” means Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use[^f00034];

“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 [^f00035];

“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 products[^f00036];

“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 2005[^f00037];

“holder”, in relation to a clinical trial authorisation, means— in the case of an authorisation treated as having been given by the licensing authority by virtue of Schedule 12 (transitional provisions) to the Clinical Trials Regulations, the person acting as sponsor of the clinical trial for the purposes of those Regulations; or in any other case, the person who made the request for that authorisation;

“homoeopathic medicinal product” means any medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or 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 1994[^f00038];

“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— a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations; a European Union marketing authorization; or a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the 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 1994[^f00039];

“medicinal product” includes any medicinal product for human use to which the 2001 Directive applies and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act[^f00040] which directs that Part II of the Act or the Clinical Trials Regulations shall have effect in relation to such substance or article;

“national homoeopathic product” means a homoeopathic medicinal product which— does not satisfy the conditions set out in Article 14(1) of the 2001 Directive; and is indicated for the relief or treatment of minor symptoms or minor conditions in humans;

“operator”, in relation to a contract laboratory, means the person having control of the contract laboratory;

“orphan medicinal product” has the meaning given in Article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products[^f00041];

“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— 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 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)— 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— 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; the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive; or a post-authorization safety study protocol; the advice is given to the holder of a United Kingdom marketing authorization or a European Union marketing authorization and relates to— compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004; the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive; or a post-authorization safety study protocol;

“post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;

“product 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 Act[^f00042] 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 Agency[^f00043];

“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)— 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; the advice is in connection with— a referral pursuant to Article 30, 31 or 36 of the 2001 Directive; or the procedure referred to in Article 35(2) of the 2001 Directive, in relation to a product range; or the advice is given to a person with a view to that person making— an application for the variation or renewal of one or more EU marketing authorizations; or an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive, in relation to a product range;

“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— a traditional herbal medicinal product; or a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;

“repeat formulation” means— the formulation of a product which is identical to the formulation of another product— in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization; or to which the applicant has, by the holder of the certificate of registration or the homoeopathic marketing authorization which relates to it, been authorised in writing to make reference for the purposes of this application; or where more than one application is made by the same applicant on the same occasion in respect of products of identical formulations, for the purposes of the second and any subsequent of those applications which the licensing authority considers, the formulation of the product to which the first of those applications which is considered by the licensing authority relates;

“repeat stock” means— a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product— in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization; or in respect of which another person holds a certificate of registration or a homoeopathic marketing authorization to which, for the purposes of his application, the applicant has been authorised in writing to make reference by the person (or if more than one, each of the persons) who supplied information to the licensing authority in connection with the application for the certificate of registration or a homoeopathic marketing authorisation which relates to that product; or 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 2005[^f00044];

“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”— in relation to— a United Kingdom marketing authorization; or a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to 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; 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 Regulations[^f00045].

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

PART 1 — General: interpretation and categories of applications and variations

Interpretation

1

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— a marketing authorization; or 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;

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