# The Medicines (Products for Animal Use — Fees) (Amendment) Regulations 1996 S.I. 1996/2196 · made 21 August 1996 These Regulations amend the Medicines (Products for Animal Use — Fees) Regulations 1995 so as to alter the fees payable in connection with the grant, variation and renewal of animal test certificates, consequent on the Animal Test Certificates Regulations 1996. Made under: Medicines Act 1971 (Section 1) ## Introductory text MEDICINES Made 21st August 1996 Laid before Parliament 23rd August 1996 Coming into force 13th September 1996 The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of the powers conferred by section 1(1) and (2) of the Medicines Act 1971 and now vested in them and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations, hereby make the following Regulations: ## 1 Title and commencement These Regulations may be cited as the Medicines (Products for Animal Use — Fees) (Amendment) Regulations 1996 and shall come into force on 13th September 1996. ## 2 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 The Medicines (Products for Animal Use — Fees) Regulations 1995 shall be amended in accordance with regulations 3 to 7 below. ## 3 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 In regulation 2(1) (Interpretation) in the definition of “complex application”for the words “a marketing authorisation, product licence or animal test certificate”there shall be substituted the words “a marketing authorisation or product licence”. ## 4 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 In Schedule 1, in Part I (Interpretation), after the definition of “category III application”there shall be inserted the following definition: ““food-producing animals”means animals whose flesh or products are intended for human consumption;.” ## 5 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 In Schedule 1, Part II, for paragraph 6 (fees for applications for animal test certificates), there shall be substituted the following paragraph: “6 The fee for an application for an animal test certificate in relation to a medicinal product, other than a biological product, which is for administration to food-producing animals shall be £600, and in any other case shall be £250..” ## 6 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 In Schedule 1, Part IV, for paragraph 6 (fees for an application for the variation of an animal test certificate), there shall be substituted the following paragraph: “6 (1) The fee for an application for the variation of an animal test certificate shall be £200..” ## 7 Amendment of the Medicines (Products for Animal Use — Fees) Regulations 1995 In Schedule 1, Part V, paragraph 3 (fee for an application for renewal of an animal test certificate), for the figure “£525”there shall be substituted the figure “£90”. ## 8 Transitional provision Nothing in these Regulations shall apply to an application made before the date these Regulations come into force. ## Signature Signed by authority of the Secretary of State for Health Gerald Malone Minister of State, Department of Health 16th August 1996 Signed by authority of the Secretary of State for Wales Jonathan Evans Parliamentary Under Secretary of State, Welsh Office 21st August 1996 Lindsay Parliamentary Under Secretary of State, Scottish Office 12th August 1996 Tony Baldry Minister of State, Ministry of Agriculture, Fisheries and Food 7th August 1996 Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 15th day of August 1996 L.S. F. A. Elliott Permanent Secretary Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 20th day of August 1996 L.S. J. Murray Permanent Secretary We consent, Bowen Wells Simon Burns Two of the Lords Commissioners of Her Majesty’s Treasury 12th August 1996 ## Explanatory note (This note is not part of the Regulations) These Regulations amend the Medicines (Products for Animal Use — Fees) Regulations 1995 so as to alter the fees payable in connection with the grant, variation and renewal of animal test certificates, consequent on the Animal Test Certificates Regulations 1996. Two new fees, of £600 and £250, are set for different types of application for the grant of a certificate (regulations 4 and 5). Formerly there was a single fee of £4,400. A new fee of £200 is set for applications for the variation of certificates (regulation 6). Formerly there was a range of fees from £110 to £1,150. A new renewal fee of £90 is set (formerly the fee was £525) (regulation 7). A consequential amendment is also made (regulation 3). These Regulations do not apply to applications made before their coming into force (regulation 8). A Compliance Cost Assessment has been prepared and a copy has been placed in the library of each House of Parliament and copies can be obtained from the Veterinary Medicines Directorate, Woodham Lane, Addlestone, Surrey, KT15 3NB. --- Source: https://www.legislation.gov.uk/uksi/1996/2196 (the official version) Page: https://openlegislation.uk/medicines-products-for-animal-use-fees-amendment-regulations-1996 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.