The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005

Amendment of Part II of Schedule 1 to the General Fees Regulations U.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 1	Column 2
Kind of application	Fee 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 1	Column 2
Kind of application	Fee payable
1 Complex registration application
(a) in respect of a medicinal product containing a single active ingredient	£4,500
(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

I1 Reg. 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.