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Appendix 1 Definitions of Words and Phrases Used in the Act And

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Appendix 1 Definitions of Words and Phrases Used in the Act And Appendix 1 Definitions of Words and Phrases Used in the Act and Subordinate Legislation The persons responsible for drafting a piece of legislation aim to achieve clarity and avoid ambiguity in the document. However, most words have shades of meaning and the interpretation of the statute or instrument becomes difficult for those who have to obey or enforce it, especially when such persons are not law­ yers. In the last analysis, it is a judge who has to decide whether a particular set of circumstances fall within or outside a given set of words, but this may be too late for the citizen who may have done utmost to keep within the law. It should, however, be pointed out that government departments and others who have a duty to enforce a piece of legislation are usually willing to advise members of the public as to its meaning and effects. In order to help those who have to obey or enforce the law an 'interpretation' section, regulation or rule containing a number of technical terms used in the document is often included. In the Medicines Act, sections 130,131 and 132 are devoted to this purpose. However, many other terms are defined in other sec­ tions and are sometimes less easy to locate. Furthermore, numerous statutory instruments also define various words and phrases and these definitions are not always identical with those used in the Act. To facilitate reference to these defi­ nitions, they have been collected together and printed alphabetically with the exception of 'medicinal product' and 'wholesale' and 'retail' sale which, in view of their importance, are treated separately. Where a definition has been taken from a statutory instrument, the reference number of the instrument is stated. 'ABBREVIATED ADVERTISEMENT' means an advertisement, other than a loose insert, in a professional publication which complies with the requirements imposed by regulation 5d of, and Schedule 2 to, these Regulations. (1978/1020) The requirements relate to size, specifically, the advertisement must not exceed 420 square centimetres in area. 'ACTIVE INGREDIENT' means any chemical or other substance specified in a product licence or animal test certificate and included in a medicated feed­ ing stuff for a medicinal purpose; (1973/1530) 257 258 THE LAW ON MEDICINES 'ADMINISTER' means administer to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering a substance or article is a reference to administering it either in its existing state or after it has been dissolved or dispersed in or diluted or mixed with, some other substance used as a vehicle. (section 130(9)) 'ADMINISTER' has the same meaning as in section 130(9) of the Act as modified by Article 2 of and paragraph 9 of Part II of Schedule 2 to, the Specified Articles and Substances Order; (1979/1759) Thus, administer may be construed as extending to include the application of such substances to contact lenses or blanks. 'ADVERTISEMENT' includes every form of advertising, whether in a publi­ cation, or by the display of any notice, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document, or by words inscribed on any article, or by the exhibition of a photograph or by a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement shall be construed accordingly; (section 92(1)) However, 'ADVERTISEMENT', does not include spoken words except: (I) words forming part of a sound recording or embodied in a sound­ track associated with a cinematograph film, and (2) words broadcast by way of sound broadcasting or television or transmitted to subscribers to a diffusion service. (section 92(2)) Furthermore, except as provided by section 95 of this Act,for the purposes of this Part of this Act neither of the following shall be taken to constitute the issue of an advertisement, that is to say - (a) the sale or supply, or offer or exposure for sale or supply of a medicinal product in a labelled container or package; (b) the supply, with a medicinal product of any description of a leaflet relating solely to medicinal products of that description. (section 92(3)) 'ADVERTISEMENT' has the same meaning as in section 92(1) and (2) of the Act; (1978/41) 'ADVERTISEMENT' has the same meaning as in section 92(1) and (2) of the Act but these Regulations shall only apply to advertisements which are issued for the purpose of inducing a doctor or dentist to prescribe, supply, administer, or procure the administration of medicinal products of a particular description; (1978/1020) This very restricted meaning of advertisement is intended to limit the application of the regulations to doctors and dentists and what they may prescribe on the NHS. 'AEROSOL' means a product which is dispersed from its container by a propellent gas or liquid; (1983/1212) 'AGRICULTURAL ANALYST' means an agricultural analyst appointed under section 67 of the Agriculture Act 1970 and includes a deputy agricultural analyst appointed for the same area; (1985/273) VOLUME 1: A COMPREHENSIVE GUIDE 259 '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 in or 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;(1984/1861) 'AGRICULTURE MINISTERS' means the Minister of Agriculture, Fisheries and Food, the Secretaries of State concerned with Agriculture in Scotland and in Wales and the Department of Agriculture for Northern Ireland; (section 1(1) as amended by 1975/1349; 1976/31 and 1978/272) 'AMPHOTERICIN B' is any antimicrobial substance or mixture of such substances produced by Streptomyces nodosus. The expression includes any salt or derivative, or salt of a derivative, of amphotericin B and any substance the chemical and biological properties of which are identical with or similar to those of amphotericin B but which is produced by other means; (197111200) 'AMPHOTERICINS' are antimicrobial substances or mixtures of such substan­ ces produced by Streptomyces nodosus; (197712131) 'ANALYSIS' includes microbiological assay but no other forms of biological assay, and 'analyse' has a corresponding meaning; (section 132) 'ANIMAL' includes any bird, fish or reptile; (section 132) In fact, it is intended to include insects and all other members of the animal kingdom. 'ANIMAL FEEDING STUFF' means any substance which is intended for use either by being fed to one or more animals or as an ingredient in the preparation of such a substance, not being in either case a medicinal product; (section 132) 'ANIMAL FEEDING STUFF' includes a complete feeding stuff, a feed supplement and a protein concentrate. (197311530, 1976/1726 and 1985/273) 'ANIMALS' means domestic animals of the bovine species, swine, sheep, goats, solipeds and poultry, and wild animals of these species and wild ruminants which have been raised on a holding; (1982/626) 'ANIMAL TEST CERTIFICATE' means a certificate issued certifying that, subject to the provisions of the certificate, the licensing authority have consented to the test in question and that certificate is for the time being in force and the test is to be carried out in accordance with that certificate; (section 32(2)b) 'ANTIGENS' are substances which on administration to a human being or an animal are capable of eliciting a specific immunological response; (197111198, 197111200, 197111309, and 197111326) 'ANTIMICROBIAL PROPERTIES' means the capacity to inhibit the growth of, or to destroy bacteria and other micro-organisms whether in-vitro or in-vivo; (1973/367) 'ANTISERA' are substances which consist wholly or partly of sera derived from animals which have been immunised against one or more micro-organ­ isms, viruses or other antigens; (197111198; 197111200; 197111309; 197111326) 260 THE LAW ON MEDICINES 'ANTITOXINS' are substances which consist wholly or partly of immuno­ globulins of antisera derived from animals which have been immunised against one or more toxins whether detoxified or not;(197111l98; 197111200; 197111309; 1971/1326) 'APPLICATION' means the request for the grant of a licence together with the particulars required by these regulations, but does not include a request to renew a licence; (19711974) 'APPLICAnON' means a request for the grant of a product licence (other than a product licence of right) or the issue of a clinical trial certificate or animal test certificate (other than a clinical trial certificate or animal test certificate issued under section 37(4) of the Act) but does not include a request to renew a product licence or a clinical trial certificate or animal test certi­ ficate; (1971/973) 'APPROPRIATE COMMITTEE' in this Act 'the appropriate committee', for the purposes of any provision of this Act under which a function falls to be performed, means such committee established under this section for pur­ poses which consist of or include any of those specified in subsection (3) of this section as the authority performing that function considers appropriate in the circumstances; (section 4(6)) 'APPROPRIATE CURRENT MONOGRAPH' in relation to a particular name, means- (a) the monograph (if any) headed
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