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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Medicines (Products for Animal Use - Fees) (Amendment) Regulations 2004 URL: http://www.bailii.org/uk/legis/num_reg/2004/20043081.html |
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| Made | 16th November 2004 | ||
| Laid before Parliament | 24th November 2004 | ||
| Coming into force | 17th December 2004 |
(4) In Schedule 4, after paragraph 2 and its table, insert:
(2) Where sub-paragraph (1) applies the application fee shall be -
Transitional provisions
3.
- (1) These Regulations shall not apply in respect of any application made before the date these Regulations come into force.
(2) Paragraph (1) does not apply where an inspection is made after the date these Regulations come into force in connection with an application made before that date, in which case the inspection fee payable is that due under these Regulations.
Ben Bradshaw
Parliamentary Under Secretary of State, Department for Environment, Food and Rural Affairs
11th November 2004
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
L.S.
D C Gowdy
Permanent Secretary, Department of Health, Social Services and Public Safety
11th November 2004
Sealed with the Official Seal of the Department of Agriculture and Rural Development
L.S.
Pat Toal
Permanent Secretary, Department of Agriculture and Rural Development
11th November 2004
We consent.
Joan Ryan
Nick Ainger
Two of the Lords Commissioners of Her Majesty's Treasury
16th November 2004
Regulation 2(2) corrects an error introduced by the principal Regulations, relating to the fees for applications for assistance in connection with mutual recognition applications: the principal Regulations provided that the first such application made in each six-month cycle after grant would incur only a basic fee. These regulations provide that an additional charge for the sixth and each additional Member State covered by such applications is also payable.
Regulation 2(3) corrects an error introduced by the principal Regulations relating to the inspection fees for biological products. The principal Regulations arguably provided that the only inspection fees payable for such products were those set out in paragraph 3 of Schedule 2 where the circumstances described in that paragraph applied. The effect of these Regulations is that the fees for inspections of biological products are those set out in paragraph 2 of that Schedule, unless paragraph 3 applies.
Regulation 2(4) corrects an omission from the principal Regulations relating to application fees for registration of homoeopathic veterinary medicinal products. This regulation reduces the fees payable in the circumstances described from £620 and £800, depending on the number of homoeopathic stocks contained, as taken from the "any other application" row of the table in paragraph 2 of Schedule 4 of the principal Regulations, to £130 and £305 respectively.
Regulation 3 (transitional provisions) provides that the Regulations (save for the exception in paragraph (2) of that regulation) only apply to applications made after the Regulations come into force.
A Regulatory Impact Assessment was prepared for the principal Regulations and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3LS. No new assessment was prepared since these Regulations introduce no additional impacts on the cost of business to those envisaged when the principal Regulations were made.
[2] "The Ministers" is defined in section 1(1) of the Medicines Act 1968 (following amendment by article 5(1) and paragraph 15(3) of Schedule 1 to the Ministry of Agriculture, Fisheries and Food (Dissolution) Order 2002 (S.I. 2002/794)) as the Secretary of State acting jointly with the Ministers for Northern Ireland specified in paragraphs (a) and (b) of section 1(1) namely the Minister of Health and Social Services for Northern Ireland and the Minister of Agriculture for Northern Ireland. Section 95(5) of and paragraph 10(1)(b) of Schedule 12 to the Northern Ireland Act 1998 (c.47) provides that references in existing legislation to a minister in charge of a particular Northern Ireland Ministry are to be construed as references to the Northern Ireland Minister in charge of that Northern Ireland Department. The Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland were renamed the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development respectively by article 3(4) and (6) of the Departments (Northern Ireland) Order 1999 (S.I. 1999/283 (N.I. 1) and retained their previous functions by virtue of section 95(5) of the 1998 Act. Paragraph 4(1)(b) of the Schedule to the Northern Ireland Act 2000 (c. 1) has effect during suspension of devolved government pursuant to section 1(8) of that Act: it provides that the functions of a Northern Ireland Minister who was in charge of a Northern Ireland Department immediately before the coming into force of section 1 of the Act may be discharged by that Department subject, according to paragraph 4(1)(f) of the Schedule, to the direction and control of the Secretary of State. Section 1(8) of the 2000 Act is in force by virtue of article 2 of the Northern Ireland Act (Suspension of Devolved Government) Order 2002 (S.I. 2002/2574).back
[6] 1968 c. 67. This subsection applies by virtue of section 1(3) of the Medicines Act 1971.back
[7] OJ No. L31, 1.2.2002, p. 1.back
