Joint Committee on Statutory Instruments First Report


APPENDIX II

Memorandum by the Ministry of Agriculture, Fisheries and Food

MEDICINES (PRODUCTS FOR ANIMAL USE - FEES) REGULATIONS 1998

(S.I. 1998/2428)

1.  The Committee by letter dated 11 November 1998 has requested a memorandum on the following point:

    In relation to paragraphs 1 (Table A), 2 (Table B) and 3 of Part II of Schedule 1, please indicate the amount of the fees before these Regulations came into force, and the reasons for any increases.

Response

2.  For the convenience of the Committee, the fees in question both before and after the above Regulations came into force are summarised in the tables below. As the Committee is aware, the previous fees were set by the Medicines (Products for Animal Use - Fees) Regulations 1997 ("1997 Regs").

Paragraph 1 of Part II of Schedule 1 (Table A)

Kind of application
Application for a product licence or a Type A marketing authorisation (1997 Regs)
Application for a product licence or a Type A marketing authorisation

 (1998 Regs)
Application for a Type B marketing authorisation (1997 Regs)
Application for a Type B marketing authorisation (1998 Regs)
£
£
£
£
Major
15,100
18,120
8,000
10,000
Complex
8,760
10,515
4,800
6,000
Standard
3,780
4,540
2,400
3,000
Abridged Standard
 3,780

 3,545


Simple
1,260
1,260
800
800
Emergency Vaccine
 40

 40


Paragraph 2 of Part II of Schedule 1 (Table B)

Kind of application Application for an Article 15.2 marketing authorisation

(1997 Regs)

Application for an Article 15.2 marketing authorisation

(1998 Regs)

£ £
Major 8,760 10,515
Complex 3,780 4,540

Paragraph 3 of Part II of Schedule 1

Application to convert Article 15.2 marketing authorisation to full marketing authorisation

 (1997 Regs)
Application to convert Article 15.2 marketing authorisation to full marketing authorisation

(1998 Regs)
£
£
Para. 3(a)
6,340
7,605
Para. 3(b)
4,980
5,975

3.  The purpose of the fee increases is to achieve full cost recovery wherever possible, based on the time actually spent on average, as calculated from work recording results, in dealing with particular types of applications. The fee increases, in so far as they exceed an allowance for inflation, cover a combination of costs incurred as a result of a change from temporary to purpose-built accommodation and the employment of extra scientific staff to meet the levels of service set out in the 1998/99 Ministerial targets.

4.  Where efficiencies achieved have resulted in a reduction in time spent in dealing with particular applications, e.g. the abridged standard application in Table A, the corresponding fee has been reduced.

5.  This Memorandum is submitted on behalf of the Ministry of Agriculture, Fisheries and Food and is being copied to the Department of Health, the Northern Ireland Office, the Scottish Office and the Welsh Office.

16th November 1998


 
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