The Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992

Title and commencement

1.  This Order may be cited as the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) Order 1992 and shall come into force on 30th January 1992.

Interpretation and revocation

2.—(1) In this Order, unless the context otherwise requires—

“the Act” means the Medicines Act 1968;

“agricultural requisites” means things used in the cultivation of the soil or in the keeping of animals for the production of food or as game, and equipment used for the collection of produce from animals kept for the production of food and things used for the maintenance of such equipment, and includes any protective clothing but does not include any other kind of human apparel;

“the Department of Agriculture” means the Department of Agriculture for Northern Ireland;

“the Department of Health (N.I.)” means the Department of Health and Social Services for Northern Ireland;

“final medicated feeding stuff” means any substance, not being a medicinal product, which is for use wholly or mainly by being fed to one or more animals for a medicinal purpose, or for purposes that include that purpose, without further processing;

“fish farmer” means—

(a)

a person carrying on a business of fish farming or shellfish farming which is registered in a register kept by the Minister or the Secretary of State (as the case may be) pursuant to the Registration of Fish Farming and Shellfish Farming Businesses Order 1985(1), or

(b)

a person to whom a licence has been granted by the Department of Agriculture under section 11 of the Fisheries Act (Northern Ireland) 1966(2);

“intermediate feed” means a medicated feeding stuff sold, supplied or imported for use wholly or mainly as an ingredient in the preparation of a substance which is to be fed to one or more animals for a medicinal purpose or for purposes that include that purpose, with or without further processing;

“the Minister” means the Minister of Agriculture, Fisheries and Food;

“placing on the market” means the holding for sale or disposal in any other form whatever to third parties, whether or not for consideration, and actual sale or disposal;

“prescription only medicine” means a medicinal product falling within a description or class for the time being specified for the purposes of section 58 of the Act in an Order made under that section(3);

“qualifying business” means a business involving in whole or in part the retail sale of agricultural requisites;

“the Register of Manufacturers” means the register of persons entitled to incorporate medicinal products in animal feeding stuffs kept respectively by the Department of Agriculture, and the registrar under regulation 3(1) of the Medicines (Medicated Animal Feeding Stuffs) Regulations 1992(4);

“the Register of Merchants” means the register of merchants in veterinary drugs or intermediate feed kept respectively by the Society and the Department of Health (N.I.), under articles 5(1) and 8(1) of this Order;

“saddlery business” means a business involving in whole or in part the retail sale of saddlery requisites;

“saddlery requisites” means products and equipment used in the keeping of horses or ponies and things used for the maintenance of such equipment, and includes any human apparel used in the keeping of horses or ponies;

“self-service methods” means any method of sale which allows a purchaser to help himself on or before payment;

“sell by retail” includes offer or expose for sale by retail and supply in circumstances corresponding to retail sale, and cognate expressions shall be construed accordingly;

“the Society” means the Royal Pharmaceutical Society of Great Britain;

“a specially authorised person” means, in relation to a veterinary drug—

(a)

a person specially authorised, by virtue of a direction of the licensing authority under article 3(1) of the Medicines (Exemptions from Licences) (Special and Transitional Cases) Order 1971(5), to assemble that drug otherwise than in accordance with a manufacturer’s licence; or

(b)

a person specially authorised by the product licence in respect of that drug to sell the drug under the alternative product name specified in the licence;

“veterinary drug” includes a veterinary drug in respect of which a product licence is granted, after the date of coming into force of this Order, containing a provision to the effect that it may be sold by retail only in accordance with a prescription by an appropriate practitioner or by a person referred to in article 3(1), 6(1), 9(1), 11(1) or 13(1) of this Order;

“veterinary drug not on a general sale list” means a veterinary drug which is not of a description or falling within a class, specified in an Order under section 51 of the Act which is for the time being in force(6) ;

“wholesale dealer” means a person for the time being carrying on a business wholly or mainly comprising the sale or supply in bulk of veterinary drugs.

(2) Unless the context otherwise requires, any reference in this Order to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number.

(3) The Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) (No.2) Order 1989(7) , the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) (No. 2) (Amendment) Order 1990(8) and the Medicines (Veterinary Drugs) (Pharmacy and Merchants' List) (No. 2) (Amendment No. 2) Order 1990(9) are hereby revoked.

Exemptions for merchants in veterinary drugs

3.—(1) The restrictions imposed by section 52 of the Act (restrictions on sale or supply of medicinal products not on a general sale list) shall not apply to the sale by retail of any veterinary drug not on a general sale list by the holder of the product licence in respect of that veterinary drug, by a specially authorised person or by a person entered in the Register of Merchants as a Category 1 merchant, if that veterinary drug is specified in the second column of Schedule 1 and the conditions contained in paragraph (2) below and article 4 are complied with.

(2) No veterinary drug described in paragraph (1) above shall be sold by retail except to a person whom the seller knows, or has reasonable cause to believe, to be a person who has animals under his control for the purposes of, and in the course of carrying on, a business, either as his sole business activity or as a part of his business activities.

(3) The restrictions imposed by section 52 of the Act shall not apply to the sale by retail of any veterinary drug not on a general sale list and not being a prescription only medicine by the holder of the product licence in respect of that veterinary drug, by a specially authorised person or by a person entered in the Register of Merchants as a Category 1 merchant, if—

(a) that veterinary drug—

(i) is a veterinary drug specified in Schedule 2, and

(ii) is intended for incorporation in animal feeding stuffs at a rate below 2 kilograms per tonne of the final medicated feeding stuff, are complied with; or

(b) that veterinary drug—

(i) is a veterinary drug specified in Schedule 2, and

(ii) is intended for incorporation in animal feeding stuffs at a rate of at least 2 kilograms per tonne of the final medicated feeding stuff, are complied with.

(4) No veterinary drug described in paragraph (3) (a) above shall be soldby retail except—

(a) to a person whose name is entered in Part A of the Register of Manufacturers, or

(b) to a fish farmer.

(5) No veterinary drug described in paragraph (3) (b) above shall be sold by retail except—

(a) to a person whose name is entered in Part A or Part B of the Register of Manufacturers, or

(b) to a fish farmer.

Further conditions for exemption under article 3

4.—(1) No veterinary drug described in article 3(1) or (3) (a) or (b) shall be sold by retail except—

(a) in the container in which it was made up for sale by the manufacturer or, as the case may be, the assembler of the drug,

(b) in a container which has not been opened since the drug was made up for sale in it, and

(c) on premises which are occupied by, and under the control of, the seller at the time of sale and which are capable of being closed so as to exclude the public, on the premises of the seller, condition (c) above shall not apply to the subsequent delivery of that drug to that person.

(2) No veterinary drug described in article 3(1) or (3) (a) or (b) shall be sold by retail by self-service methods.

(3) In respect of any sale by retail of any veterinary drug described in article 3(1) or (3) (a) or (b) the seller shall make a record of the sale containing particulars of—

(a) the date on which the veterinary drug was sold,

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the veterinary drug sold, and

(c) the name and address of the person to whom the veterinary drug was sold, date of the sale.

(4) No person shall, in the course of a qualifying business carried on by him, sell by retail any veterinary drug described in article 3(1) or (3) (a) or (b) unless his name is entered in the Register of Merchants as a Category 1 merchant in respect of each premises on which the drug is sold or stored.

(5) In paragraph (1) (c) above “premises” includes a stall of a permanent nature situated at a market or an agricultural showground.

Register of Merchants for the purposes of article 4(4)

5.—(1) For the purposes of article 4(4) the Society and the Department of Health (N.I.) shall each continue to keep a register of persons as being persons entitled, in the course of qualifying businesses carried on by them, to sell by retail on premises in respect of which their names are entered in the register, any veterinary drug described in article 3(1) or (3) (a) or (b) free from the restrictions imposed by section 52 of the Act, if and so long as the conditions contained in articles 3 and 4 are complied with.

(2) Details of premises used for the storage of any veterinary drug described in article 3(1) or (3) (a) or (b) at a different postal address from that of premises used to sell by retail such drug shall be recorded in a register kept under paragraph (1) above.

(3) Where a person who, whilst carrying on a qualifying business elsewhere than in Northern Ireland, makes an application in writing to the Society for his name to be entered in the Society’s Register of Merchants in respect of any premises on which any veterinary drug described in article 3(1) or (3) (a) or (b) is to be sold or stored by him in the course of that qualifying business, the Society shall, subject to paragraphs (8) and (9) below, enter his name in that Register in respect of those premises.

(4) Where a person who, whilst carrying on a qualifying business in Northern Ireland, makes an application in writing to the Department of Health (N.I.) for his name to be entered in the Department of Health’s (N.I.) Register of Merchants in respect of any premises on which any veterinary drug described in article 3(1) or (3) (a) or (b) is to be sold or stored by him in the course of that qualifying business, the Department of Health (N.I.) shall, subject to paragraphs (8) and (9) below, enter his name in that Register in respect of those premises.

(5) Subject to paragraphs (10) and (12) below, a person whose name is entered in the Register of Merchants in respect of any premises shall, in order to retain his name in that 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 January in any such year make an application in writing to the Society or the Department of Health (N.I.) (as the case may be) for his name to be retained in the Register of Merchants in respect of those premises.

(6) Subject to paragraphs (11) and (12) below, a person whose name is removed from the Register of Merchants in respect of any premises by reason only that he failed either to make proper application for the retention of his name in that Register pursuant to paragraph (5) above or to pay the fee due in respect of the retention of his name in that Register pursuant to paragraph (10) below may, in order to restore his name to that Register in respect of those premises, make an application to the Society or the Department of Health (N.I.) (as the case may be) for his name to be restored to the Register of Merchants in respect of those premises.

(7) There shall be paid to the Society or the Department of Health (N.I.)—

(a) in respect of the entry in the Register of Merchants of the name of any person in respect of any premises on which any veterinary drug described in article 3(1) or (3) (a) or (b) is to be sold or stored a fee of £198 for each such premises;

(b) in respect of the retention in the Register of Merchants of the name of any person in respect of any premises on which any veterinary drug described in article 3(1) or (3) (a) or (b) is to be sold or stored a fee of £124 for each such premises;

(c) in respect of the restoration to the Register of Merchants of the name of any person in respect of any premises on which any veterinary drug described in article 3(1) or (3) (a) or (b) is to be sold or stored a fee of £174 for each such premises.

(8) The Society or the Department of Health (N.I.) shall refuse to enterin its respective Register of Merchants the name of any person in respect of any premises unless that person—

(a) has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (a) above for the entry of his name in that Register; and

(b) has given to the Society or the Department of Health (N.I.) (as the case may be) an undertaking in writing that he will comply with the provisions of the Code of Practice for Distributors (Category 1 Agricultural Merchants) Registered for the Sale, Supply and Storage of Licensed Animal Medicines and Medicated Animal Feeding stuffs dated December 1991, and published by the Ministry of Agriculture, Fisheries and Food (being a Code relating to the sale or supply of the veterinary drugs described in article 3(1) or (3) (a) or (b)).

(9) The Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to enter in its respective Register of Merchants the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be), the premises are unsuitable for the storage or safekeeping of any veterinary drug described in article 3(1) or (3) (a) or (b).

(10) The Society or the Department of Health (N.I.) shall refuse to retain in its respective Register of Merchants 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 Society or the Department of Health (N.I.) (as the case may be) on or before 31st January in that year the fee specified in paragraph (7) (b) above for the retention of his name in that Register.

(11) The Society or the Department of Health (N.I.) shall refuse to restore to its respective Register of Merchants the name of any person in respect of any premises unless that person, having made proper application pursuant to paragraph (6) above, has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (c) above for the restoration of his name to that Register.

(12) The Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to retain in or to restore to, or may remove from its respective Register of Merchants the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be)—

(a) that person has failed to observe any of the provisions of the Code of Practice referred to in paragraph (8) (b) above; or

(b) the conditions under which any veterinary drug described in article 3(1) or (3) (a) or (b) is sold by retail on those premises or under which it is stored on those premises (whether immediately prior to retail sale or not) are unsuitable for that purpose.

(13) In respect of any premises the Society or the Department of Health (N.I.) may remove from its respective Register of Merchants the name of any person entered in it, at the request of that person.

(14) The registrar and the Department shall each furnish to the Minister, on or before 1st April 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 March in the year in questionand, 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.

Exemptions for merchants in intermediate feed

6.—(1) The restrictions imposed by section 52 of the Act (restrictions on sale or supply of medicinal products not on a general sale list) shall not apply to the placing on the market of any intermediate feed by the holder of a product licence in respect of that intermediate feed, by a specially authorised person or by a person entered in the Register of Merchants as a Category 1 or 2 merchant unless that intermediate feed has been manufactured in accordance with these Regulations pursuant to Council Directive 90/167/EEC(10) (laying down the conditions governing the preparation, placing on the market and use of medicated feeding stuffs in the Community) and then only if that intermediate feed contains a veterinary drug specified in the second column of either Schedule 2 or Schedule 3 and the conditions contained in paragraphs (2) and (6) below and article 7 are complied with.

(2) No intermediate feed described in paragraph (1) above shall be placed on the market or sold by retail except to a person whom the seller knows, or has reasonable cause to believe, to be a person who has animals under his control for the purposes of, and in the course of carrying on, a business, either as his sole business activity or as part of his business activities.

(3) The restrictions imposed by section 52 of the Act shall not apply to the placing on the market of intermediate feed by a person who is entered in the Register of Merchants as a Category 1 or Category 2 merchant, if—

(a) that intermediate feed—

(i) contains a veterinary drug specified in Schedule 2 or 3, and

(ii) is intended for incorporation in animal feeding stuffs at a rate below 2 kilograms per tonne of the final medicated feeding stuff, are complied with; or

(b) that the intermediate feed—

(i) contains a veterinary drug specified in either Schedule 2 or Schedule 3, and

(ii) is intended for incorporation in animal feeding stuffs at a rate of at least 2 kilograms per tonne of the final medicated feeding stuff, are complied with.

(4) No intermediate feed described in paragraph (3) (a) above shall beplaced on the market or sold by retail except—

(a) to a person whose name is entered in Part A of the Register of Manufacturers, or

(b) to a fish farmer.

(5) No intermediate feed described in paragraph (3) (b) above shall be placed on the market or sold by retail except—

(a) to a person whose name is entered in Part A or Part B of the Register of Manufacturers, or

(b) to a fish farmer.

(6) No intermediate feed which contains a prescription only veterinary drug specified in Schedule 3 shall be placed on the market or sold by retail to any person (except as provided for in article 9(6) (a)) except on production by him of a veterinary written direction.

Further conditions for exemption under article 6

7.—(1) No intermediate feed described in article 6 shall be placed on the market except—

(a) in the container in which it was made up for sale by the manufacturer or, as the case may be, the assembler of the feed,

(b) in a container which has not been opened since the feed was made up for sale in it and,

(c) on premises which are occupied by, and under the control of, the seller at the time of sale and which are capable of being closed so as to exclude the public, feed on the premises of the seller, condition (c) above shall not apply to the subsequent delivery of that feed to that person.

(2) No intermediate feed described in article 6 shall be sold by retail by self-service methods.

(3) In respect of any sale by retail of any intermediate feed described in article 6 the seller shall make a record of the sale containing particulars of—

(a) the date on which the intermediate feed was sold,

(b) the name, identification and quantity of the intermediate feed sold, and

(c) the name and address of the person to whom the intermediate feed was sold, date of the sale.

(4) No person shall, in the course of a qualifying business carried on by him, place on the market or sell by retail any intermediate feed described in article 6 unless his name is entered in the Register of Merchants in respect of each premises on which the intermediate feed is sold or stored or he is already entered as a Category 1 or Category 2 merchant in the Register of Merchants kept pursuant to article 5(1).

(5) In paragraph (1) (c) above “premises” includes a stall of a permanent nature situated at a market or an agricultural showground.

Register of Merchants for the purposes of article 7(4)

8.—(1) For the purposes of article 7(4) the Society and the Department of Health (N.I.) shall each continue to keep a register of persons as being persons entitled, in the course of a qualifying business carried on bythem, to place on the market or sell by retail on premises in respect of which their names are entered in the register, any intermediate feed described in article 6 free from the restrictions imposed by section 52 of the Act, if and so long as the conditions contained in articles 6 and 7 are complied with.

(2) Details of premises used for the storage of any intermediate feed described in article 6 at a different postal address from that of premises used to place on the market or sell by retail such intermediate feed shall be recorded in a register kept under paragraph (1) above.

(3) Where a person who, whilst carrying on a qualifying business elsewhere than in Northern Ireland, makes an application in writing to the Society for his name to be entered in the Society’s Register of Merchants in respect of any premises on which any intermediate feed described in article 6 is to be sold or stored by him in the course of that qualifying business, the Society shall, subject to paragraphs (8) and (9) below, enter his name in that Register in respect of those premises.

(4) Where a person who, whilst carrying on a qualifying business in Northern Ireland, makes an application in writing to the Department of health (N.I.) for his name to be entered in the Department of Health’s (N.I.) Register of Merchants in respect of any premises on which any intermediate feed described in article 6 is to be sold or stored by him in the course of that qualifying business, the Department of Health (N.I.) shall, subject to paragraphs (8) and (9) below, enter his name in that Register in respect of those premises.

(5) Subject to paragraphs (10) and (12) below, a person whose name is entered in the Register of Merchants in respect of any premises shall, in order to retain his name in that 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 January in any such year make an application in writing to the Society or the Department of health (N.I.) (as the case may be) for his name to be retained in the Register of Merchants in respect of those premises.

(6) Subject to paragraphs (11) and (12) below, a person whose name is removed from the Register of Merchants in respect of any premises by reason only that he failed either to make proper application for the retention of his name in that Register pursuant to paragraph (5) above or to pay the fee due in respect of retention of his name in that Register pursuant to paragraph (10) below may, in order to restore his name to that Register in respect of those premises, make an application to the Society or the Department of Health (N.I.) (as the case may be) for his name to be restored to the Register of Merchants in respect of those premises.

(7) There shall be paid to the Society or the Department of Health (N.I.)—

(a) in respect of the entry in the Register of Merchants of the name of any person in respect of any premises on which any intermediate feed described in article 6 is to be sold or stored a fee of £115 for each such premises;

(b) in respect of the retention in the Register of Merchants of the name of any person in respect of any premises on which any intermediate feed described in article 6 is to be sold or stored a fee of £72 for each such premises;

(c) in respect of the restoration to the Register of Merchants of the name of any person in respect of any premises on which any intermediate feed described in article 6 is to be sold or stored a fee of £101 for each such premises.

(8) The Society or the Department of Health (N.I.) shall refuse to enter in its respective Register of Merchants the name of any person in respect of any premises unless that person—

(a) has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (a) above for the entry of his name in that Register; and

(b) has given the Society or the Department of Health (N.I.) (as the case may be) an undertaking in writing that he will comply with the provisions of the Code of Practice for Distributors (Category 2 Agricultural Merchants) Registered for the Sale, Supply and Storage of Medicated Animal Feeding stuffs dated December 1991, and published by the Ministry of Agriculture, Fisheries and Food (being a Code relating tothe sale or supply of intermediate feed containing the veterinary drugs described in article 6).

(9) The Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to enter in its respective Register of Merchants the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be), the premises are unsuitable for the storage or safekeeping of any intermediate feed described in article 6.

(10) The Society or the Department of Health (N.I.) shall refuse to retain in its respective Register of Merchants 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 Society or the Department of Health (N.I.) (as the case may be) on or before 31st January in that year the fee specified in paragraph (7) (b) above for the retention of his name in that Register.

(11) The Society or the Department of Health (N.I.) shall refuse to restore to its respective Register of Merchants the name of any person in respect of any premises unless that person, having made proper application pursuant to paragraph (6) above, has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (c) above for the restoration of his name to that Register.

(12) The Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to retain in or to restore to, or may remove from its respective Register of Merchants the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be)—

(a) that person has failed to observe any of the provisions of the Code of Practice referred to in paragraph (8) (b) above; or

(b) the conditions under which any intermediate feed described inarticle 6 is sold by retail on those premises or under which it is stored on those premises (whether immediately prior to retail sale or not) are unsuitable for that purpose.

(13) In respect of any premises the Society or the Department of Health (N.I.) may remove from its respective Register of Merchants the name of any person entered in it, at the request of that person.

Exemptions in respect of (a) veterinary drugs to be incorporated in animal feeding stuffs and (b) intermediate feed

9.—(1) The restrictions imposed by section 52 of the Act shall not apply to the placing on the market of any veterinary drug not on a general sale list nor of any intermediate feed by—

(a) the holder of the product licence in respect the reof;

(b) the holder of a product licence in respect of an intermediate feed containing or consisting of a veterinary drug;

(c) a specially authorised person;

(d) a person whose name is entered in the Register of Merchants as a Category 1 merchant; or, in the case of an intermediate feed, a person whose name is entered in the Register of Merchants as a Category 1 or Category 2 merchant;

(e) a person whose name is entered in Part A of the Register of Manufacturers; or

(f) wholesale dealer,

(i) is or contains a veterinary drug specified in Schedule 2 or, in the case of an intermediate feed, specified in either Schedule 2 or Schedule 3, and

(ii) is intended for incorporation in animal feeding stuffs at a rate below 2 kilograms per tonne of the final medicated feeding stuff, are complied with.

(2) No veterinary drug nor intermediate feed described in paragraph (1) above shall be placed on the market by any of the persons—

(a) specified in paragraph (1) (a) to (d), or, in the case of an intermediate feed, specified in paragraph (1) (e), except to a personwhose name is entered in Part A of the Register of Manufacturers or to a fish farmer;

(b) specified in paragraph (1) (e) or (f), except to a person whose name is entered in Part A of the Register of Manufacturers and who the seller knows, or has reasonable cause to believe, to be a person who does not have animals under his control for the purposes of, or in the course of carrying on, a business, either as his sole business activity or as part of his business activities, except for research or education purposes only.

(3) The restrictions imposed by section 52 of the Act shall not apply to the placing on the market of any veterinary drug not on a general sale list nor of any intermediate feed by—

(a) the holder of the product licence in respect the reof;

(b) the holder of a product licence in respect of an intermediate feed containing or consisting of a veterinary drug;

(c) a specially authorised person;

(d) a person whose name is entered in the Register of Merchants as a Category 1 merchant; or, in the case of an intermediate feed, a person whose name is entered in the Register of Merchants as a Category 1 or Category 2 merchant;

(e) a person whose name is entered in Part A of the Register of Manufacturers; or

(f) wholesale dealer,

(i) is or contains a veterinary drug specified in Schedule 2 or, in the case of an intermediate feed, specified in either Schedule 2 or Schedule 3, and

(ii) is intended for incorporation in animal feeding stuffs at a rate of at least 2 kilograms per tonne of the final medicated feeding stuff, are complied with.

(4) No veterinary drug nor intermediate feed described in paragraph (3) above shall be placed on the market by any of the persons—

(a) specified in paragraph (3) (a) to (d), or, in the case of an intermediate feed, specified in paragraph (3) (e), except to a person whose name is entered in Part A or Part B of the Register of Manufacturers or to a fish farmer;

(b) specified in paragraph (3) (e) or (f), except to a person whose nameis entered in Part A of the Register of Manufacturers and who the seller knows, or has reasonable cause to believe, to be a person who does not have animals under his control for the purposes of, or in the course of carrying on, a business, either as his sole business activity or as part of his business activities, except for research or educational purposes only.

(5) The restrictions imposed by section 52 of the Act shall not apply to the placing on the market of any veterinary drug not on a general sale list nor of any intermediate feed by—

(a) the holder of the product licence in respect thereof,

(b) the holder of a product licence in respect of an intermediate feed containing or consisting of such a veterinary drug,

(c) a specially authorised person,

(d) a person whose name is entered in Part A of the Register of Manufacturers and who does not have animals under his control for the purposes of, or in the course of carrying on, a business, either as his sole business activity or as part of his business activities, except for research or educational purposes, or

(e) a wholesale dealer, veterinary drug specified in Schedule 3 and the conditions contained inparagraph (6) below and article 10 are complied with.

(6) No veterinary drug nor any intermediate feed described in paragraph (5) above shall be placed on the market or sold by retail except—

(a) to a person whose name is entered in Part A of the Register of Manufacturers and whom the seller knows, or has reasonable cause to believe, to be a person who does not have animals under his control for the purposes of, or in the course of carrying on, a business, either as his sole business activity or as part of his business activities, except for research or educational purposes only, or

(b) to a person—

(i) whose name is entered in Part A of the Register of Manufacturers and whom the seller knows, or has reasonable cause to believe, to be a person who has animals under his control for the purposes of, and in the course of carrying on, a business, either as his sole business activity or as part of his business activities but not for research oreducational purposes only, or

(ii) whose name is entered in Part B of the Register of Manufacturers and that veterinary drug or intermediate feed is intended for incorporation in animal feeding stuffs at a rate of at least 2 kilograms per tonne of the final medicated feeding stuff, or

(iii) who is a fish farmer,

Further conditions for exemption under article 9

10.—(1) No veterinary drug nor intermediate feed such as is described inarticle 9(1), (3) or (5) shall be sold by retail by self-service methods.

(2) In respect of any placing on the market of any veterinary drug described in article 9(1), (3) or (5) the seller shall make a record of the sale containing particulars of—

(a) the date on which the veterinary drug was sold,

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the veterinary drug sold, and the name, identification and quantity of the intermediate feed sold, and

(c) the name and address of the person to whom the veterinary drug or intermediate feed was sold, date of the sale.

(3) No person, other than a person whose name is entered in Part A of the Register of Manufacturers shall, in the course of a business carried on by him, place on the market or sell by retail any veterinary drug or intermediate feed such as is described in article 9(1), (3) or (5) unless—

(a) before making any such sale he, or a previous owner of the business, has notified the Society, or in the case of a business carried on in Northern Ireland, the Department of Health (N.I.), as appropriate, of the relevant particulars; and

(b) every twelve months after the first notification, whether made by him or by a previous owner, he notifies the Society or the Department of Health (N.I.), as appropriate, of the relevant particulars; and

(c) he notifies the Society or the Department of Health (N.I.), as appropriate, of any change in the relevant particulars which has occurred since the last notification the reof as soon after such change occurs as is reasonably practicable.

(4) In paragraph (3) above “the relevant particulars”, in relation to a business, means the name of the business and the address, or, where appropriate, the location of every premises on which, during the course of the carrying on of that business, veterinary drugs described in article 9(1), (3) or (5) are being, or are during the next twelve months to be, sold or stored.

Exemptions for merchants in horse wormers

11.—(1) The restrictictions imposed by section 52 of the Act shall not apply to the sale by retail of any veterinary drug not on a general sale list by the holder of the product licence in respect of that veterinary drug, by a specially authorised person or by a person who is for the time being carrying on a qualifying business or a saddlery business if—

(a) that veterinary drug is specified in the second column of Schedule 4, and

(b) the conditions contained in this article are complied with.

(2) No veterinary drug described in paragraph (1) (a) above shall be sold by retail except—

(a) in the container in which it was made up for sale by the manufacturer or, as the case may be, the assembler of the drug,

(b) in a container which has not been opened since the drug was made up for sale in it,

(c) on premises which are occupied by, and under the control of, the seller at the time of sale and which are capable of being closed so as to exclude the public, and

(d) to a person whom the seller knows, or has reasonable cause to believe, to be a person who has in his charge horses or ponies, drug on the premises of the seller, condition (c) above shall not apply to the subsequent delivery of that drug to that person.

(3) No veterinary drug described in paragraph (1) (a) above shall be sold by retail by self-service methods.

(4) In respect of any sale by retail of any veterinary drug described in paragraph (1) (a) above the seller shall make a record of the sale containing particulars of—

(a) the date on which the veterinary drug was sold, and

(b) the name, quantity and, except where it is apparent from the name, the pharmaceutical form and strength of the veterinary drug sold, of the sale.

(5) No person shall, in the course of a qualifying business or a saddlery business carried on by him, sell by retail any veterinary drug described in paragraph (1) (a) above unless his name is entered in the register kept by the Society or the Department of Health (N.I.) under article 12(1) in respect of each premises on which the drug is sold or stored.

(6) In paragraph (2) (c) above “premises” includes a stall of a permanent nature situated at a market or agricultural showground.

Register for the purposes of article 11(5)

12.—(1) For the purposes of article 11(5), the Society and the Department of Health (N.I.) shall each continue to keep a register of persons as being persons entitled, in the course of qualifying businesses or saddlery businesses carried on by the m, to sell by retail on premises in respect of which their names are entered in the register, any veterinary drug described in article 11(1) (a) free from the restrictions imposed by section 52 of the Act, if and so long as the conditions contained in article 11 are complied with.

(2) Details of premises used for the storage of any veterinary drug described in article 11(1) (a) at a different postal address from that of premises used to sell by retail such drug shall be recorded in a register kept under paragraph (1) above.

(3) Where a person who, whilst carrying on a qualifying business or a saddlery business elsewhere than in Northern Ireland, makes anapplication in writing to the Society for his name to be entered in the register kept by the Society under paragraph (1) above in respect of any premises on which any veterinary drug described in article 11(1) (a) isto be sold or stored by him in the course of that qualifying business or saddlery business, the Society shall, subject to paragraphs (8) and (9) below, enter his name in that register in respect of those premises.

(4) Where a person who, whilst carrying on a qualifying business or a saddlery business in Northern Ireland, makes an application in writing to the Department of Health (N.I.) for his name to be entered in the register kept by the Department of Health (N.I.) under paragraph (1) above in respect of any premises on which any veterinary drug described in article 11(1) (a) is to be sold or stored by him in the course of that qualifying business or saddlery business, the Department of Health (N.I.) shall, subject to paragraphs (8) and (9) below, enter his name in that register in respect of those premises.

(5) Subject to paragraphs (10) and (12) below, a person whose name is entered in the register kept by the Society or the Department of Health (N.I.) under paragraph (1) above 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 was first entered in it, in the month of January in any such year make an application in writing to the Society or the Department of Health (N.I.) (as the case may be) for his name to be retained in that register in respect of those premises.

(6) Subject to paragraphs (11) and (12) below, a person whose name is removed from the register kept by the Society or the Department of Health (N.I.) under paragraph (1) above 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 (5) above or to pay the fee due in respect of the retention of his name in the register pursuant to paragraph (10) below may, in order to restore his name to the register in respect of those premises, make an application in writing to the Society or the Department of Health (N.I.) (as the case may be) for his name to be restored to the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) in respect of those premises.

(7) There shall be paid to the Society or the Department of Health (N.I.)—

(a) in respect of the entry in the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above of the name of any person in respect of any premises on which any veterinary drug described in article 11(1) (a) is to be sold or stored a fee of £99 for each such premises;

(b) in respect of the retention in the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above of the name of any person in respect of any premises on which any veterinary drug described in article 11(1) (a) is to be sold or stored a fee of £62 for each such premises;

(c) in respect of the restoration to the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above of the name of any person in respect of any premises on which any veterinary drug described in article 11(1) (a) is to be sold or stored a fee of £87 for each such premises;whose name is for the time being entered in, or in the course of beingrestored to, the Register of Merchants in respect of those premises asbeing a person entitled to sell or store the reon, during the course of a qualifying business carried on by him, any veterinary drug described in article 3(1) or (3) (a) or (b).

(8) The Society or the Department of Health (N.I.) shall refuse to enterin the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above the name of any person in respect of any premises unless that person—

(a) has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (a) above for the entry of his name in the register; and

(b) has given to the Society or the Department of Health (N.I.) (as the case may be) an undertaking in writing that he will comply with the provisions of the Code of Practice for Saddlers Selling or Supplying Horse Wormers dated December 1991 and published by the Ministry of Agriculture, Fisheries and Food (being a Code relating to the sale or supply of the veterinary drugs described in article 11(1) (a)).

(9) the Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to enter in the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be), the premises are unsuitable for the storage or safekeeping of any veterinary drug described in article 11(1) (a).

(10) The Society or the Department of Health (N.I.) shall refuse to retain in the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above 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 Society or the Department of Health (N.I.) (as the case may be) on or before 31st January in that year the fee specified in paragraph (7) (b) above for the retention of his name in the register.

(11) The Society or the Department of Health (N.I.) shall refuse to restore to the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above the name of any person in respect of any premises unless that person, having made proper application pursuant to paragraph (6) above, has paid to the Society or the Department of Health (N.I.) (as the case may be) the fee specified in paragraph (7) (c) above for the restoration of his name to the register.

(12) The Society, with the approval of the Minister, or the Department of Health (N.I.), with the approval of the Department of Agriculture, may refuse to retain in or to restore to, or may remove from, the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above the name of any person in respect of any premises if, in the opinion of the Society or the Department of Health (N.I.) (as the case may be)—

(a) that person has failed to observe any of the provisions of the Code of Practice referred to in paragraph (8) (b) above; or

(b) the conditions under which any veterinary drug described in article 11(1) (a) is sold by retail on those premises or under which it is stored on those premises (whether immediately prior to retail sale or not) are unsuitable for that purpose.

(13) In respect of any premises the Society or the Department of Health (N.I.) may remove from the register kept by the Society or the Department of Health (N.I.) (as the case may be) under paragraph (1) above the name of any person entered in it, at the request of that person.

Exemptions for pharmacists

13.—(1) The restrictions imposed by section 52(c) of the Act shall not apply to the retail sale of a veterinary drug described in article 3(1) or (3) (a) or (b) where the transaction is carried out in a registered pharmacy by a person acting on behalf of a pharmacist.

(2) The restrictions imposed by section 52 of the Act shall not apply to the supply in circumstances corresponding to retail sale of a veterinary drug such as is described in article 9(1), (3) or (5) by a pharmacist, or his agent, to the person to whom the pharmacist has, in accordance with the provisions of the said section 52, sold the drug by retail.

Exemptions in cases involving another’s default

14.—(1) The restrictions imposed by section 52 of the Act shall not apply to the sale by retail, in compliance with the conditions in articles 3(2),(4) or (5), 4, 6(2), (4) or (5) of a veterinary drug or intermediate feed by a person for the time being carrying on a qualifying business, which drug or intermediate feed that person, having exercised all due diligence, on reasonable grounds believes to be a veterinary drug or intermediate feed described in article 3(1) or (3) (a) or (b) or 6 but which, due to the act or default of another person, is not such a veterinary drug, or intermediate feed.

(2) The restrictions imposed by section 52 of the Act shall not apply to the sale by retail, in compliance with the conditions contained inarticles 9(2) to (6), of a veterinary drug or intermediate feed by a person for the time being carrying on a business described in article 9(1), which drug or intermediate feed that person, having exercised all due diligence, on reasonable grounds believes to be a veterinary drug orintermediate feed described in article 9(1), but which, due to the actor default of another person, is not such a veterinary drug or intermediate feed.

(3) The restrictions imposed by section 52 of the Act shall not apply to the sale by retail, in compliance with the conditions contained in articles 11(2) to (5) and 12, of a veterinary drug by a person for the time being carrying on a qualifying business or a saddlery business, which drug that person, having exercised all due diligence, on reasonable grounds believes to be a veterinary drug described in article 11(1) (a), but which, due to the act or default of another person is not such a veterinary drug.

Defences

15.  Any person who, in the course of a business carried on by him, places on the market or sells by retail, offers or exposes for sale by retail, or supplies in circumstances corresponding to retail sale, any intermediate feed in accordance with a forged veterinary written direction, shall not be guilty of an offence under this Order if, having exercised all due diligence, he believes on reasonable grounds that the veterinary written direction is genuine.

Signed by authority of the Secretary of State for Health

Virginia Bottomley

Minister of State,

Department of Health

6th January 1992

Strathclyde

Parliamentary Under Secretary of State, Scottish Office

8th January 1992

David Hunt

Secretary of State for Wales

8th January 1992

In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 9th January 1992.

L.S.

John Selwyn Gummer

Minister of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 6th day of January 1992.

L.S.

F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 7th day of January 1992.

L.S.

W. J. Hodges

Permanent Secretary

We consent.

Sydney Chapman

Thomas Sackville

Two of the Lords Commissioners of Her Majesty’s Treasury

7th January 1992