1964_PHARMACY_AND_POISONS_REGULATIONS — Page 25

1987 Ed.]

Pharmacy and Poisons Regulations

[CAP. 138

A 25

[Subsidiary]

(2) A duplicate certificate issued under this regulation shall be certified in such manner as the Committee may determine.

(3) There shall be payable in respect of any duplicate certifi- cate issued under this regulation the fee prescribed in respect thereof in the Ninth Schedule.

37. (1) In dealing with an application for initial registration of a pharmaceutical product or substance the Committee shall in particular take into consideration-

(a) the safety of the pharmaceutical product or substance to

which the application relates;

(b) the efficacy of the pharmaceutical product or substance for the purposes for which the product or substance is pro- posed to be administered; and

(c) the quality of the pharmaceutical product or substance according to the specification and the method or proposed method of manufacture of the product or substance, and the provisions proposed for securing that the product or substance as sold or supplied will be of that quality.

(2) In taking into consideration the efficacy for a particular purpose of a pharmaceutical product or substance to which such an application relates, the Committee shall leave out of account any question whether a pharmaceutical product or substance of another description would or might be equally or more efficacious for that purpose:

Provided that nothing in the paragraph shall be construed as requiring the Committee, in considering the safety of a phar- maceutical product or substance of a particular description, in relation to a purpose for which it is proposed to be administered, to leave out of account any question whether a pharmaceutical product or substance of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.

(3) In dealing with an application by an importer the Commit- tee shall also take into consideration in particular the methods, standards and conditions of manufacture of the pharmaceutical product or substance in respect of which application is made and may, if it thinks fit, require the production by the applicant of one or both of the following-

(a) an undertaking, given by the manufacturer of any such products or substances, to permit the premises where they are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the Committee;

(b) a declaration, given by or on behalf of the manufacturer of any such products or substances, that, in relation to the manufacture of these products any requirements imposed

Ninth Schedule.

Factors relevant to determination of application for registration. L.N. 369/80.

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