S.L. 31.18 Art. 15Information by manufacturer and by importer. 

(1) Any person who manufactures or imports any drug or any pharmaceutical preparation shall, within eight days of any manufacture or importation, give notice thereof to the

Superintendent giving details as to the contents and dosage form of such drug or pharmaceutical preparation: Provided that when a person has complied once with the provisions of this sub-regulation in respect of a particular drug or pharmaceutical preparation, he shall not be bound to comply herewith in respect of any other manufacture or importation of the same drug or pharmaceutical preparation having the same trade name and made up of the same contents and dosage form.

(2) The Superintendent may at any time request the manufacturer or importer of any drug or pharmaceutical preparation, as the case may be, to give such information as the Superintendent may require in respect of such drug or pharmaceutical preparation and the said manufacturer or importer, as the case may be, shall comply with such request within fifteen days.

(3) The Superintendent may -

(a) prohibit the importation of any drug unless such drug is accompanied by -

(i) a certificate, acceptable to the Superintendent, from the competent government authority in the country of origin, stating that the drug has been manufactured by a firm duly authorised to produce such drug for sale in the same country, and that the quality control facilities at the firm are satisfactory; and

(ii) a certificate, acceptable to the Superintendent, stating that the drug complies with the standard referred to in the British Pharmacopea or in the British Pharmaceutical Codex or with other standards acceptable to the Superintendent, or, where no such standard exists in respect of such drug, a certificate, similarly acceptable, of analysis of such drug;

(b) suspend or prohibit the distribution, supply, sale or keeping or offering for sale, of any drug already imported, until the certificates referred to in sub-paragraphs (i) and (ii) of paragraph (a) of this sub-regulation are produced: Provided that no such suspension or prohibition shall take effect before the expiry of one month from the date of the demand of such certificates by the said Superintendent.

(4) The Superintendent may withdraw or cause to be withdrawn from the market any drug or pharmaceutical preparation if, because of adverse reactions or of other information relating to ill effects, manufacturing practices or other technical or scientific information, such withdrawal is in his opinion indicated in the interest of the health of patients.

(5) For the purposes of this regulation, "drug" includes any medicinal preparation for internal or external use, whether or not listed or specified in the First or Second Schedule to these Regulations.