The Medicines (Products for Animal Use—Fees) Regulations 2004

Made: 21st October 2004

Laid before Parliament: 26th October 2004

Coming into force: 17th November 2004

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Citation, commencement and scope

1

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Interpretation

2

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Applications for authorisations, licences and certificates

3

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Specific batch control

4

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Applications for assistance in connection with mutual recognition

5

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Applications for variation of authorisations, licences and certificates

6

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Applications for renewal of authorisations, licences and certificates

7

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Site inspections

8

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Marketing authorisations and product licences: annual fees

9

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Manufacturer’s licences: annual fees

10

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Wholesale dealer’s licences: annual fees

11

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Registration of homoeopathic veterinary medicinal products

12

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Fees for references to the Veterinary Products Committee or to the Medicines Commission

13

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Payment of fees

14

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Late payment of annual fees

15

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Suspension of licences and certificates

16

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Waiver, reduction or refund of fees

17

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Revocation

18

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Transitional provisions

19

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SCHEDULE 1 — Fees relating to applications for the grant, variation and renewal of marketing authorisations, product licences, manufacturer’s licences, wholesale dealer’s licences and animal test certificates

PART 1 — Interpretation

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PART 2 — Fees Relating to Applications for the Grant of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences, Animal Test Certificates and Export Certificates

Marketing authorisations and product licences

1

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2

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3

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Manufacturer’s licences

4

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Wholesale dealer’s licences

5

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Animal test certificates

6

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Marketing authorisations (parallel import)

7

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Export Certificates

8

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PART 3 — Fees Relating to Applications for Assistance in Connection with Mutual Recognition Applications

1

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2

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PART 4 — Fees Relating to Applications for the variation of Marketing Authorisations, Product Licences, Manufacturer’s Licences, Wholesale Dealer’s Licences and Animal Test Certificates

1

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2

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Mutually recognised marketing authorisations

3

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Manufacturer’s licences

4

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Wholesale dealer’s licences

5

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Animal test certificates

6

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PART 5 — Fees Relating to Applications for the Renewal of Marketing Authorisations, Product Licences, Manufacturer’s Licences and Animal Test Certificates

Marketing authorisations and product licences

1

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Manufacturer’s licences

2

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Animal test certificates

3

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Article 26.3 marketing authorisations

4

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SCHEDULE 2 — Fees relating to site inspections

Interpretation

1

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Fees

2

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3

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4

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SCHEDULE 3 — Marketing authorisations and product licences: annual fees

Calculation of turnover

1

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2

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Calculation of annual fees

3

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4

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5

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6

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SCHEDULE 4 — Fees relating to applications for registration of homoeopathic veterinary medicinal products

Interpretation

1

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Fees relating to applications for registration

2

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Waiver or refund of fees

3

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SCHEDULE 5 — Marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission

1

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2

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SCHEDULE 6 — Waiver, reduction or refund of fees

1

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2

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3

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4

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Signed

Ben Bradshaw — Parliamentary Under Secretary of State, — Department for Environment, Food and Rural Affairs — 2004-10-15

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

D C Gowdy — Permanent Secretary, — Department of Health, Social Services and Public Safety — 2004-10-14

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Gerald Lavery — Deputy Secretary, — Department of Agriculture and Rural Development — 2004-10-15

We consent.

Nick Ainger — Joan Ryan — Two of the Lords Commissioners of Her Majesty’s Treasury — 2004-10-21

Explanatory note

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Footnotes

[^f00001]: 1971 c. 69 as amended by section 21 of the Health and Medicines Act 1988 (c. 49); by virtue of section 1(3) of the Medicines Act 1971 expressions in that section have the same meaning as in the Medicines Act 1968 (c. 67) (see the following footnote).

[^f00002]: “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).

[^f00003]: 1972 c. 68.

[^f00004]: S.I. 1972/1811

[^f00005]: 1973 c. 51.

[^f00006]: 1968 c. 67. This subsection applies by virtue of section 1(3) of the Medicines Act 1971.

[^f00007]: OJ No. L31, 1.2.2002, p. 1.

[^f00008]: OJ No. L311, 28.11.2001, p. 1.

[^f00009]: OJ No. L1, 3.1.94, p. 1.

[^f00010]: For latest amendments see OJ No. L130, 29.4.2004, p. 3.

[^f00011]: OJ No. L214, 24.8.93, p. 1.

[^f00012]: OJ No. L55, 1.3.95, p. 7, repealed by Regulation (EC) No. 1084/2003 (OJ No. L159, 27.6.2003, p. 1).

[^f00013]: OJ No. L159, 27.6.2003, p. 1.

[^f00014]: S.I. 1994/3142, amended by S.I. 1997/654, 1998/1048, 1999/3142, 2000/776 and 2002/269.

[^f00015]: S.I. 1970/1304.

[^f00016]: OJ No. L317, 6.11.81, p. 1, repealed by Directive 2001/82/EC.

[^f00017]: S.I. 1997/322

[^f00018]: S.I. 1998/2428.

[^f00019]: S.I. 1999/2512.

[^f00020]: S.I. 2000/2250.

[^f00021]: S.I. 2001/1669.

[^f00022]: S.I. 2001/3751.

[^f00023]: S.I. 2002/2569.

[^f00024]: S.I. 2003/2957.

[^f00025]: S.I. 1971/1450.

2A

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Editorial notes

[^key-fb36ba28324ed59ccaa07c27bfb94352]: Regulations revoked (30.10.2005) by The Veterinary Medicines Regulations 2005 (S.I. 2005/2745), reg. 1(a), Sch. 8 Pt. 1 (with Sch. 8 Pt. 4)