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Amendment of Part II of Schedule 1 to the General Fees RegulationsU.K.

13.—(1) Part II of Schedule 1 to the General Fees Regulations (capital fees for applications for authorizations, licences and certificates) is amended as follows.

(2) In paragraph 1, for the Table in sub-paragraph (1) substitute the following Table—

Table

Column 1Column 2
Kind of applicationFee payable
1 Major application

(a)in respect of any application relating to an orphan medicinal product or a product to which point 6 of Part II of Annex 1 to the 2001 Directive applies

£25,802

(b)which is a mutual recognition procedure incoming application

£56,218

(c)which is a European reference product application

£56,218

(d)which is a decentralised procedure application where the United Kingdom is a concerned Member State

£80,698

(e)which is a decentralised procedure application where the United Kingdom is the reference Member State

£115,098

(f)in any other case

£80,698
2 Complex application

(a)which is a mutual recognition procedure incoming application

£15,689

(b)which is a European reference product application

£15,689

(c)which is a decentralised procedure application where the United Kingdom is a concerned Member State

£22,366

(d)which is a decentralised procedure application where the United Kingdom is the reference Member State

£31,219

(e)in any other case

£22,366
3 Standard application

(a)which is a mutual recognition procedure incoming application

£5,820

(b)which is a European reference product application

£5,820

(c)which is a decentralised procedure application where the United Kingdom is a concerned Member State

£8,272

(d)which is a decentralised procedure application where the United Kingdom is the reference Member State

£11,813

(e)in any other case

£8,272
4 Simple application

(a)which is a decentralised procedure application where the United Kingdom is a concerned Member State

£2,337

(b)in any other case

£2,337
5 Application for a parallel import licence£1,493
6 Change of ownership application£366

(3) In paragraph 3(1), in the definition of “joint development” omit “Medicines”.

(4) Paragraph 5 is amended as follows—

(a)after paragraph (1)(a) insert the following paragraph—

(aa)in a case to which sub-paragraph (3) applies, £1,402;; and

(b)after sub-paragraph (2) insert the following sub-paragraph—

(3) This sub-paragraph applies to the case of an application for a manufacturer’s licence which is limited solely to the import of medicinal products from third countries..

(5) After paragraph 7 (clinical trial authorisations)(1) insert the following paragraph—

Traditional herbal registrations

8.(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 4(a) in connection with an application for a traditional herbal registration of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table—

Table

Column 1Column 2
Kind of applicationFee payable
1 Complex registration application

(a)in respect of a medicinal product containing a single active ingredient

£4,500

(b)in any other case

£6,750
2 Standard registration application

(a)in respect of a medicinal product containing 3 or fewer active ingredients

£2,250

(b)in any other case

£3,375
3 Reduced registration application category II

(a)in respect of a medicinal product containing 3 or fewer active ingredients

£750

(b)in any other case

£1125
4 Reduced registration application category I

(a)in respect of a medicinal product containing 3 or fewer active ingredients

£500

(b)in any other case

£750
5 Change of ownership application£366

(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, there shall be payable in addition to the amount payable under sub-paragraph (1) in respect of that application—

(a)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, a fee of £1,000;

(b)in any other case, a fee of £2,000.

(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £6,672 shall be 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 £590 shall be 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 £2,000 shall be payable in addition to the amount payable under sub-paragraph (1) in respect of that application..

Commencement Information

I1Reg. 13 in force at 16.11.2005, see reg. 1(1)(a)

(1)

Paragraph 7 was substituted by regulation 9(1)(3)(b) of S.I. 2004/1157.