The Medicines (Medicated Animal Feeding Stuffs) Regulations 1992

Register of Manufacturers of animal feeding stuffs

3.—(1) For the purposes of these Regulations the registrar and the Department shall each continue to keep a Register—

(a) Part A of which shall be a list of persons entitled in the course of a business carried on by them—

(i) to incorporate medicinal products in any animal feeding stuff on premises in respect of which their names are entered in that Part of the Register, and to place on the market animal feeding stuffs in which medicinal products have been incorporated by them;

(ii) to store on premises in respect of which their names are entered in that Part of the Register any animal feeding stuff in which medicinal products have been incorporated by them; and

(b) Part B of which shall be a list of persons as being persons entitled, in the course of a business carried on by them—

(i) to incorporate medicinal products in any animal feeding stuff 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 place on the market animal feeding stuffs in which medicinal products have been so incorporated by them;

(ii) to store on premises in respect of which their names are entered in that Part of the Register any animal feeding stuff in which medicinal products have been incorporated by them.

(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—

(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 in December 1991; 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 in December 1991.

(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.