The Medicines (Medicated Animal Feeding Stuffs) Regulations 1989

Registration of persons incorporating medicinal products in animal feeding stuffs

6.—(1) The registrar and the Department shall each keep for the purposes of these Regulations a Register–

(a) Part A of which shall be a list of persons entitled in the course of businesses carried on by them, to incorporate medicinal products in animal feeding stuffs on premises in respect of which their names are entered in that Part of the Register, and to sell or supply animal feeding stuffs in which medicinal products have been incorporated; and

(b) Part B of which shall be a list of persons as being persons entitled, in the course of businesses carried on by them, to incorporate medicinal products in animal feeding stuffs on premises in respect of which their names are entered in that Part of the Register at a rate of at least 2 kilograms per tonne, and to sell or supply animal feeding stuffs in which medicinal products have been so incorporated.

(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 operating 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 B (as the case may be) 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 on 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 B (as the case may be) 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 that he 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 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–

(a) in respect of the entry of the name of any person in respect of any premises–

(i) in Part A of the Register a fee of £150 for each premises;

(ii) in Part B of the Register a fee of £50 for each premises;

(b) in respect of the retention of the name of any person in respect of any premises–

(i) in Part A of the Register a fee of £150 for each premises;

(ii) in Part B of the Register a fee of £50 for each premises;

(c) in respect of the restoration of the name of any person in respect of any premises–

(i) to Part A of the Register a fee of £270 for each premises;

(ii) to Part B of the Register a fee of £95 for each premises.

(7) The registrar or the Department shall refuse to enter in the Register the name of any person in respect of any premises unless–

(a) that person–

(i) has paid to the registrar or the Department (as the case may be) the fee specified in paragraph (6)(a)(i) above for the entry of his name in Part A of the Register, and

(ii) has given an undertaking in writing to the registrar or the Department (as the case may be) that he will comply with the provisions of the Code of Practice for Category A Registered Manufacturers of Medicated Animal Feeding Stuffs published by the Ministry of Agriculture, Fisheries and Food on 18th December 1987; or

(b) that person–

(i) has paid to the registrar or the Department (as the case may be) the fee specified in paragraph (6)(a)(ii) above for the entry of his name in Part B of the Register, and

(ii) has given an undertaking in writing to the registrar or the Department (as the case may be) that he will comply with the provisions of the Code of Practice for Category B Registered Manufacturers of Medicated Animal Feeding Stuffs published by the Ministry of Agriculture, Fisheries and Food on 18th December 1987.

(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 (as the case may be), that person cannot demonstrate that the standards required by the Code of Practice referred to in paragraph (7)(a)(ii) or (7)(b)(ii) above as appropriate are met.

(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 observe 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 furnish to the Minister on or before 1st November each year an up to date copy of the Register and at monthly intervals thereafter any amendments to the Register.