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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—
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—
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—
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
I1Reg. 13 in force at 16.11.2005, see reg. 1(1)(a)
Paragraph 7 was substituted by regulation 9(1)(3)(b) of S.I. 2004/1157.