The Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988

Interpretation

2.—(1) In these Regulations, unless the context otherwise requires—

“the Act” means the Medicines Act 1968;

“active ingredient”, in relation to a medicated feeding stuff, means any chemical or other substance specified in a product licence, veterinary written direction or animal test certificate and included in a medicated feeding stuff for a medicinal purpose;

“appropriate non-proprietary name”, in relation to a medicinal product, excepted medicated feeding stuff or ingredient, means—

(a)

where the medicinal product, excepted medicated feeding stuff or ingredient is described in a monograph in a specified publication, any name, or abbreviation of such name, at the head of that monograph or, in the case of the European Pharmacopoeia, an approved synonym or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that specified publication, or

(b)

where the medicinal product, excepted medicated feeding stuff or ingredient is not described in a monograph in a specified publication but has an approved name, such approved name, or

(c)

where the medicinal product, excepted medicated feeding stuff or ingredient is not described in a monograph in a specified publication and does not have an approved name, but has an international non-proprietary name, such international non-proprietary name, or

(d)

where the medicinal product, excepted medicated feeding stuff or ingredient is not described in a monograph in a specified publication and does not have an approved name or an international non-proprietary name, the accepted scientific name or any other name descriptive of the true nature of the medicinal product, excepted medicated feeding stuff or ingredient;

“approved name” means the name which appears in the current edition (as defined in section 103(5) of the Act) of the list prepared and published under section 100 of the Act as in force at the time of sale or supply of the medicinal product, excepted medicated feeding stuff or ingredient by the person who has labelled the container of the medicinal product, excepted medicated feeding stuff or ingredient;

“approved synonym” has the same meaning as in section 65(8) of the Act;

“container”, in relation to a medicinal product or medicated feeding stuff, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;

“data sheet” means a document relating to medicinal products or excepted medicated feeding stuffs of a particular description, which is prepared by or on behalf of the holder of a product licence which is applicable to medicinal products or excepted medicated feeding stuffs of that description and which—

(a)

complies with such requirements as to dimensions and form, as to the particulars to be contained in it, and as to the manner (whether in respect of type, size, colour or disposition of lettering or otherwise) in which any such particulars are to be so contained, as may be prescribed for the purposes of section 96(6) of the Act, and

(b)

does not contain any information relating to medicinal products or excepted medicated feeding stuffs of that description except the particulars so prescribed;

“dosage unit” means that quantity of the medicinal product or excepted medicated feeding stuff which is used as the unit by reference to which the dose of the medicinal product or excepted medicated feeding stuff is measured;

“excepted medicated feeding stuff” means a medicated feeding stuff in respect of which a product licence or animal test certificate has been granted;

“expiry date” means the date after which, or the month and year after the end of which, the medicinal product or excepted medicated feeding stuff should not be used, or the date before which, or the month and year before the beginning of which, the medicinal product or excepted medicated feeding stuff should be used;

“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;

“foreign or international compendium of standards” means the national pharmacopoeia or similar compendium of a foreign country published on or before 6th June 1988 or the Specifications for the Quality Control of Pharmaceutical Preparations published by the World Health Organisation on or before 6th June 1988;

“intermediate medicated feeding stuff” means any substance, not being a medicinal product, which is 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;

“international non-proprietary name” means a name which has been selected by the World Health Organisation as a recommended international non-proprietary name and in respect of which the Director-General of the World Health Organisation has given notice to that effect in the World Health Organisation Chronicle on or before 6th June 1988;

“medicated feeding stuff” means an intermediate medicated feeding stuff or a final medicated feeding stuff;

“medicinal product” means—

(a)

any medicinal product in respect of which there is a product licence relating to the incorporation of that product in an animal feeding stuff,

(b)

any medicinal product in respect of which there is no product licence but which is intended by virtue of a veterinary written direction or animal test certificate for incorporation in an animal feeding stuff, or

(c)

a substance specified in the Medicines (Control of Substances for Manu-facture) Order 1971(1) or the Medicines (Control of Substances for Manufacture) Order 1985(2) which in either case is intended to be incorporated in any animal feeding stuff,

but does not include any herbal remedy to which the provisions of section 12(2) of the Act are applicable;

“package”, in relation to any medicinal products or medicated feeding stuffs, means any box, packet or other article in which one or more containers of the products or feeding stuffs are or are to be enclosed, and, where any such box, packet or other article is or is to be itself enclosed in one or more other boxes, packets or other articles, includes each of the boxes, packets or articles in question;

“person responsible for the composition of the medicinal product or excepted medicated feeding stuff” means a person who in the course of a business carried on by him—

(a)

procures the manufacture of the product or medicated feeding stuff to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product or medicated feeding stuff ordered, whether those particulars amount to a complete specification or not, or

(b)

manufactures the product or medicated feeding stuff otherwise than in pursuance of an order which fulfils the conditions specified in paragraph (a) above;

“prescription only medicine” means a medicinal product or excepted medicated feeding stuff 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;

“proprietary designation” means a word or words used in connection with the sale or supply of medicinal products or excepted medicated feeding stuffs for the purpose of indicating that they are the goods of a particular person by virtue of manufacture, selection, certification, dealing or offering for sale or supply;

“quantity” means, where the quantity is not the exact quantity, the quantity which is as near to the exact quantity as is reasonably practicable or which differs from the exact quantity only to such extent as is reasonably necessary in the circumstances having regard to the nature of the medicinal product, excepted medicated feeding stuff or ingredient in question;

“specified publication” has the same meaning as in section 103(1) of the Act;

“standard withdrawal period” in relation to an animal or product of a kind referred to in the first column of Schedule 1 means the withdrawal period set out in the second column of that Schedule opposite that reference;

“veterinary written direction” means a written direction which is given by a veterinary surgeon or a veterinary practitioner and which complies with such requirements as may be specified in regulations under section 40 of the Act(3);

“withdrawal period” means the period from cessation of medication of an animal with a medicated feeding stuff to slaughter of that animal for human consumption or to the taking of products derived from such an animal for human consumption.

(2) Any reference in these Regulations to a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

(1)

S.I. 1971/1200.

(2)

S.I. 1985/1403.

(3)

Section 40 was substituted by the Animal Health and Welfare Act 1984 (c. 40), section 13(1).