【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第12页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] (4) In dealing with an application under paragraph (2)- (a) the Committee shall take into consideration the safety, efficacy and quality of the pharmaceutical product or substance with its particulars changed as proposed, and in considering such safety and efficacy, the Committee shall observe the requirements of regulation 37(2); and (b) regulation 37(3) shall apply to such application as if it were an application for initial registration of the pharmaceutical product or substance with the particulars changed as proposed.(5) The Committee shall advise the applicant in writing whether the change is approved, and where the Committee refuses to approve a change it shall state its reasons for such refusal. (6) Where the change is approved, it shall be approved to take effect from a certain date, and the following provisions shall apply- (a) as from that date, and without limiting the generality of regulation 36(1B), the product or substance having as its registrable particulars the registered particulars which are to be changed (hereinafter referred to as the "product or substance to be replaced") shall not be regarded as registered with the Board; (b) the applicant shall, prior to that date, recall or cause to be recalled any product or substance to be replaced which may still be in the possession of any person to whom he supplied the product or substance; (c) where the product or substance to be replaced is to be recalled, the applicant shall, as soon as reasonably possible, replace or cause to be replaced such product or substance with the product or substance having the particulars changed as approved, or make such alternative arrangements as are agreed with the person to whom he supplied the product or substance.(7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 366 of 1995) Cap 138A reg 36B Clinical trials and medicinal tests (1) For the purpose of conducting a clinical trial on human beings or a medicinal test on animals application shall be made in writing to the Committee and shall be accompanied by the fee prescribed in the Ninth Schedule. (2) A sample of the product or substance and a copy of the protocol for the trial or test shall accompany the application. (3) The Committee may issue a clinical trial certificate or medicinal test certificate in the form prescribed in the Eighth Schedule valid for a period not exceeding 2 years on payments of the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 12) (4) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (L.N. 137 of 1978; L.N. 360 of 1980) Cap 138A reg 36C Definition of "pharmaceutical product" and "substance" for the purposes of this Part For the purposes of this Part "pharmaceutical product" (药剂制品) and "substance" (物质) have the meaning assigned to "pharmaceutical product" and "medicine" in the Ordinance. (L.N. 137 of 1978) Cap 138A reg 36D Duplicate certificates (1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued. (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 certificate issued under this regulation the fee prescribed in respect thereof in the Ninth Schedule. (L.N. 369 of 1980) Cap 138A reg 37 Factors relevant to determination of application for registration (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 proposed 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 pharmaceutical 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. |
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