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" "TSE Directive" means Commission Directive 1999/104/EC amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products[8];
"TSE variation application" means an application (other than a complex application as defined in Schedule 1 or an application which seeks to demonstrate compliance by cross-referring to data held by the relevant authority) to vary - 
(a) a marketing authorisation to comply with regulation 6(1)(f) of the Marketing Authorisation Regulations 1994[9]; or

(b) a product licence to render unnecessary the service of a notice under section 24(1A) of the Act to bring about the expiry of the licence for failure to comply with the criteria of the Annex to the TSE Directive;".

    (3) At the end of regulation 5(1) (applications for variation of marketing authorisations etc), there shall be added the words "unless the application is covered by regulation 7".

    (4) For regulation 7 (variation at the invitation of the relevant authority), there shall be substituted the following regulation:

Variation applications for which no fee is payable
     7. No fee is payable in respect of - 

(a) a TSE variation application; or

(b) an application for a variation made at the express written invitation of the relevant authority.

    (5) In Schedule 1, Part I (interpretation), in the definition of "emergency vaccine application", the words "marketing authorisation or" shall be deleted.

    (6) In Schedule 1, Part II (application fees), in Table A, opposite the words "emergency vaccine application" in column (1), there shall be deleted from column (2) the figure "£40".

    (7) In Schedule 1, Part IV (variation fees), in column (1) of Table E, in the third item, the words "authorisation or" shall be deleted.

    (8) In Schedule 7 (waiver, reduction or refund of fees) - 

(a) in paragraph 2(a), there shall be inserted after the word "granted", the words "or varied" and in paragraph 2(b) there shall be inserted after the word "for" at the first place where it occurs, the words ", or for a variation of,"; and

(b) at the end of paragraph 4, there shall be inserted the following sub-paragraph - 

    " (3) Where a TSE variation application has been made before the coming into force of the Medicines (Products for Animal Use - Fees) (Amendment) Regulations 2001 the relevant authority shall refund or, where no payment has been made, waive any fee payable in connection with that application under regulation 5.".

Hayman
Minister of State Ministry of Agriculture, Fisheries and Food

25th April 2001



Signed by authority of the Secretary of State for Health


Hunt
Parliamentary Under-Secretary of State Department of Health

25th April 2001


Bairbre de Brún
Minister of Health, Social Services and Public Safety

1st May 2001


Bríd Rodgers
Minister of Agriculture and Rural Development

2nd May 2001



We consent


Jan Dowd and Greg Pope
Two of the Lords Commissioners of Her Majesty's Treasury

2nd May 2001

[2] In the case of the Minister of Agriculture, Fisheries and Food (so far as concerns functions previously vested in the Secretaries of State respectively concerned with agriculture in Scotland and - in consequence of S.I. 1978/272 - Wales), by virtue of articles 2(2) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999 (S.I. 1999/3142); in the case of the Secretary of State concerned with health in England (so far as concerns functions previously vested in the Secretaries of State respectively concerned with health in Scotland and - in consequence of S.I. 1969/388 - Wales), by virtue of articles 2(1) and 5 of, and the Schedule to, the Transfer of Functions (Medicines and Poisons) Order 1999; in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10(1)(b) of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) and article 3(4) and (6) of the Departments (Northern Ireland) Order 1999 (S.I. 1999/283 (N.I. 1)).back

[3] See section 129(6) of the Medicines Act 1968 as extended to include Regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.back

[4] S.I. 1972/1811.back

[5] 1972 c. 68.back

[6] S.I. 1998/2428 amended by S.I. 1999/2512, 2000/2250.back

[7] OJ No. L159, 3.6.98, p. 31.back

[8] OJ No. L3, 6.1.2000, p. 18.back

[9] S.I. 1994/3142; the relevant amendment is made by S.I. 2000/776.back

 © Crown copyright 2001