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[Subsidiary]

L.N. 137/78.

Labelling by manufacturers. L.N. 137/78.

CAP. 138]

Pharmacy and Poisons Regulations

[1987 Ed.

(2) For the purposes of paragraph (1), "supervision" means the exercise by any of the persons referred to in paragraph (1) of control over the process of manufacture and of the persons engaged therein.

31. (1) Subject to paragraph (4), a manufacturer or authorized seller of poisons, supplying for distribution under regulation 29(2), shall label or cause to be labelled the container of each pharmaceuti- cal product, with the following particulars—

(a) the appropriate designation of--

(i) the substance or substances from which the phar- maceutical product was manufactured;

(ii) each of the active constituents of the product; or

(iii) each of the ingredients from which the product was compounded;

(b) in the case where the appropriate designation of each of the active constituents or ingredients of a product is given, the appropriate quantitative particulars of those constituents or ingredients;

(c) the name and address of the manufacturer; and

(d) the number of the certificate of drug/product registration or the provisional certificate of drug/product registration of the pharmaceutical product issued by the Board.

(2) For the purposes of paragraph(1)—–

(a) the expression “appropriate designation”, in relation to a

substance, constituent or ingredient, means--

(i) in the case of a poison included in the Poisons List, the name with which the container of the poison is for the time being required to be labelled in accordance with regulation 13;

(ii) in the case where a substance, constituent or ingredient is not a poison and is described in any of the monographs contained in the edition of the British Phar- macopoeia, the British Pharmaceutical Codex or the British Veterinary Codex which was last published before the date on which the article was sold or supplied, the des- cription set out at the head of that monograph; and

(iii) in any other case the accepted scientific name or the name descriptive of the true nature and origin of the substance, constituent or ingredient;

(b) the expression "appropriate quantitative particulars”, in relation to the active constituent or ingredient of a phar- maceutical product, means-

(i) the percentage or quantity of that constituent or ingredient contained in the pharmaceutical product sold or supplied; or

(ii) in the case of a pharmaceutical product which is in pill, capsule, tablet or similar article, either the percentage

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