The Medicines (Medicated Animal Feeding Stuffs) Regulations 1992
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MEDICINES The Medicines (Medicated Animal Feeding Stuffs) Regulations 1992
1.(1) These Regulations may be cited as the Medicines (Medicated Animal Feeding Stuffs) Regulations 1992 and shall come into force on 30th January 1992. (2) The Medicines (Medicated Animal Feeding Stuffs) Regulations 1989[5] and the Medicines (Medicated Animal Feeding Stuffs) (Amendment) Regulations 1990[6] are hereby revoked.
2.(1) In these Regulations, unless the context otherwise requires
(2) Without prejudice to section 11 of the Interpretation Act 1978[12], references in these Regulations to the incorporation of a medicinal product in an animal feeding stuff shall be construed as provided in section 40(11) of the Act. (3) Any reference in these Regulations to a numbered regulation or Schedule shall be construed as a reference to the regulation or Schedule which bears that number in these Regulations.
3.(1) For the purposes of these Regulations the registrar and the Department shall each continue to keep a Register
(2) Where a person who, whilst carrying on a business elsewhere than in Northern Ireland, makes an application in writing to the registrar on or after the date these Regulations come into force for his name to be entered in Part A or Part B of the Register, in respect of any premises on which any medicinal product is to be incorporated in an animal feeding stuff by him in the course of that business or, in the case of a person using mobile mixing equipment, in respect of the premises where that equipment is normally kept, the registrar shall, subject to paragraphs (7) and (8) below, enter his name in Part A or Part B of the Register in respect of those premises. (3) Where a person who, whilst carrying on a business in Northern Ireland, makes an application in writing to the Department on or after the date these Regulations come into force for his name to be entered in Part A or Part B of the Register, in respect of any premises on which any medicinal product is to be incorporated in an animal feeding stuff by him in the course of that business or, in the case of a person using mobile mixing equipment, in respect of the premises where that equipment is normally kept, the Department shall, subject to paragraphs (7) and (8) below, enter his name in Part A or Part B of the Register in respect of those premises. (4) Subject to paragraphs (9) and (11) below, a person whose name is entered in the Register in respect of any premises shall, in order to retain his name in the Register in respect of those premises in any year subsequent to the year in which his name is first entered in it, in the month of July in any such year make an application in writing to the registrar or the Department (as the case may be) for his name to be retained in the Register in respect of those premises. (5) Subject to paragraphs (10) and (11) below, a person whose name is removed from the Register in respect of any premises by reason only tha the failed either to make proper application for the retention of his name in the Register pursuant to paragraph (4) above or to pay the fee due in respect of the retention of his name in the Register pursuant to paragraph (9) below may, in order to restore his name to the Register in respect of those premises, make an application in writing, within 11 months of the expiry of the registration, to the registrar or the Department (as the case may be) for his name to be restored to the Register in respect of those premises. (6) There shall be paid to the registrar or the Department
(7) The registrar or the Department shall refuse to enter in the Register the name of any person in respect of any premises unless
(8) The registrar, with the approval of the Minister, or the Department, may refuse to enter in the Register the name of any person in respect of any premises if, in the opinion of the registrar or the Department (asthe case may be), that person cannot demonstrate that he has complied with the provisions of the Code of Practice referred to in paragraph (7) (a) (ii) or (7) (b) (ii) above as appropriate. (9) The registrar or the Department shall refuse to retain in the Register in any year subsequent to the year in which his name is first entered in it the name of any person in respect of any premises unless that person has paid to the registrar or the Department (as the case may be) on or before 31st July in that year the fee specified in paragraph (6) (b) (i) or (ii) above as appropriate for the retention of his name in the Register. (10) The registrar or the Department shall refuse to restore to the Register the name of any person in respect of any premises unless that person, having made proper application pursuant to paragraph (5) above, has paid to the registrar or the Department (as the case may be) the fee specified in paragraph (6) (c) (i) or (ii) above as appropriate for the restoration of his name to the Register. (11) The registrar, with the approval of the Minister, or the Department, may refuse to retain in or to restore to, or may remove from, the Register the name of any person in respect of any premises if, in the opinion of the registrar or the Department (as the case may be), that person has failed to comply with any of the provisions of the Code of Practice referred to in paragraph (7) (a) (ii) or (7) (b) (ii) above as appropriate. (12) In respect of any premises the registrar or the Department may remove from the Register the name of any person entered in it, at the request of that person. (13) The registrar and the Department shall each furnish to the Minister, on or before 1st October in each year, a copy of the Register kept thereby certified to be a true copy of that Register as at a date specified in the certificate, not being later than 1st September in the year in question and, pending the furnishing of a further copy of the Register in the following year, shall furnish to the Minister at monthly intervals copies of amendments made to the Register in each month following the date so specified.
4.(1) No person shall, in the course of a business carried on by him, incorporate in an animal feeding stuff a medicinal product of any description, except a veterinary drug which is exempted under article 3 (exemptions from licences and certificates in respect of medicinal tests on animals) of the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986[13], unless
(2) The requirement for his name to be entered in the Register, specified in paragraph (1) (a) (i) or (ii) above, shall not apply
(3) Any person who exports medicated animal feeding stuff, shall keep, for a period of at least 2 years from the date of export, a record of
(4) No person shall, in the course of a business carried on by him, incorporate in an animal feeding stuff a combination of prescription only medicinal products except in accordance with a veterinary written direction and then only where in the opinion of either a veterinary surgeon or a veterinary practitioner there is no effective licensed medicinal product for the disease to be treated or for the species concerned. (5) A person who, in the course of a business carried on by him, incorporates in an animal feeding stuff any medicinal product in accordance with a veterinary written direction, shall ensure that
5. Where, in pursuance of regulation 4, a person would not be entitled to incorporate in an animal feeding stuff a medicinal product but for his name being entered in the Register, he shall not, in the course of a business carried on by him, store that animal feeding stuff in which that medicinal product has been incorporated by him otherwise than on the premises in respect of which his name is entered in the Register.
6.(1) No person shall, in the course of a business carried on by him, place on the market any animal feeding stuff in which a medicinal product, not being a prescription only medicine, has been incorporated unless the medicinal product was incorporated in accordance with regulation 4. (2) No person shall, in the course of a business carried on by him, import any animal feeding stuff in which a medicinal product, not being a prescription only medicine, has been incorporated unless there is a valid product licence or animal test certificate relating to the incorporation of that medicinal product (whether held by him or another person), and the medicinal product was incorporated as mentioned in regulation 4(1)(a). (3) Subject to paragraph (4) below, no person shall, in the course of a business carried on by him, place on the market any animal feeding stuff in which a prescription only medicine has been incorporated unless
(4) Paragraph (3)(b) above shall not apply where any animal feeding stuff in which a prescription only medicine has been incorporated as mentioned in regulation 4(1) (a) is sold or supplied to a person
(5) No person shall, in the course of a business carried on by him, import any animal feeding stuff in which a prescription only medicine has been incorporated unless it has been manufactured in accordance with the provisions of Council Directive 90/167/EEC and then only if there is a valid product licence or animal test certificate relating to the incorporation of that medicinal product (whether held by him or another person) and the animal feeding stuff is placed on the market or imported in accordance with a veterinary written direction. (6) No person shall import from a Member State any animal feeding stuff in which a medicinal product has been incorporated unless that feeding stuff
(7) Any person who intends to export to a Member State any animal feeding stuff in which a medicinal product has been incorporated shall (if so required by the member State of destination) in the case of a person carrying on a business elsewhere than in Northern Ireland make an application in writing to the Society and in the case of a person carying on a business in Northern Ireland make an application in writing to the Department, and in either case not less than 72 hours before the date of exportation and upon payment of the appropriate fee, for a certificate corresponding in form to that set out in Schedule 1.
7. A veterinary written direction given for the purposes of regulation 4 or 6 shall be
8.(1) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated unless on or before 1st April 1992 he has applied for registration and his name is
(2) No person shall, in the course of a business carried on by him, place on the market or sell or supply any final medicated feeding stuff in which a medicinal product has been incorporated except to a person
(3) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated except
(4) No final medicated feeding stuff in which a medicinal product has been incorporated shall be sold by retail by self-service methods. (5) In respect of the placing on the market of any final medicated feeding stuff in which a medicinal product has been incorporated the seller shall make a record of the sale containing particulars of
(6) No person shall, in the course of a business carried on by him, place on the market any final medicated feeding stuff in which a medicinal product has been incorporated unless that feeding stuff has been manufactured in accordance with the provisions of these Regulations pursuant to Council Directive 90/167/EEC. (7) In paragraph (1) above, "premises" includes a stall of a permanent nature situated at a market or an agricultural showground.
9. No person shall use any medicated animal feeding stuff in which a prescription only medicine has been incorporated unless it has be enmanufactured in accordance with the provisions of these Regulations pursuant to Council Directive 90/167/EEC.
10. Where medicated feeding stuffs are made up for sale in packages or containers, no person shall, in the course of a business carried on by him, place on the market such a package or container unless it is sealed in such a way that, when the package or container is opened, the closure or seal is damaged and the package or container cannot be re-used.
11. Where medicated feeding stuffs are administered to animals whose meat, flesh, of fal or products are intended for human consumption, the stock farmer or holder of the animals concerned shall ensure that treated animals are not slaughtered in order to be offered for human consumption before the end of the withdrawal period and that products obtained from a treated animal before the end of such a withdrawal period are not disposed of with a view to their being offered for human consumption.
12.(1) To the extent that these Regulations are made under the European Community Act 1972, the provisions of the Medicines Act 1968 mentioned in paragraph (2) below shall apply as if they were made under this Act. (2) The provisions of the said Act of 1968 referred to in paragraph (1) above are those of sections 108 to 114 and section 119 (which relate to enforcement and matters connected herewith).
13.(1) Any person who contravenes any provision of regulations 4, 5, 6, 8, 9 or 11 of these Regulations shall be guilty of an offence and
(2) Any person who contravenes any provision of regulation 10 of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.
14.(1) Any person who, in the course of a business carried on by him, places on the market, imports or incorporates a medicinal product of any description in an animal feeding stuff in accordance with a forged veterinary written direction, shall not be guilty of an offence under these Regulations if, having exercised all due diligence, he believes on reasonable grounds that the veterinary written direction is genuine.
Notes: [1] 1968 c. 67; section 40 was substituted by the Animal Health and Welfare Act 1984 (c. 40), section 13(1); "the Agriculture Ministers" referred to in section 40 is defined in section 1(1)(b) of the Medicines Act 1968 (c. 67) (see also the following footnote). back [2] In the case of the Secretary of State concerned with agriculture in Wales by virtue of S.I. 1978/272 and in the case of the Department of Agriculture for Northern Ireland by virtue of the Northern Ireland Constitution Act 1973 (c. 36), section 40 and Schedule 5, and the Northern Ireland Act 1974 (c. 28), section 1(3) and Schedule 1, paragraph 2(1)(b). back [4] 1972 c. 68; for the purposes of these Regulations, section 2 is subject to Schedule 2 to that Act and is to be read, as regards England and Wales, with section 32(7) and (9) of the Magistrates' Courts Act 1980 (c. 43), and S.I. 1984/447, as regards Scotland, with section 289B(4) and (6) of the Criminal Procedure (Scotland) Act 1975 (c. 21), as inserted by paragraph 5 of Schedule 11 to the Criminal Law Act 1977 (c. 45) and amended by section 55(2) of the Criminal Justice Act 1982 (c. 48) and S.I. 1984/526, as regards Northern Ireland, with S.I. 1984/703 (N.I.3) and S.R. (N.I.) 1984 No. 253. back [8] 1966 c. 17 (N.I.); amended by S.I. 1991/1466. back [9] Section 130 was amended by the Animal Health and Welfare Act 1984 (c. 40), section 13(2). back [10] The current order is S.I. 1991/1392, amended by S.I. 1991/2568. back [13] S.I. 1986/1180; amended by S.I. 1991/633. back |
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