【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第10页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] Cap 138A reg 35 Records to be kept by manufacturers (1) A manufacturer shall maintain adequate records in respect of each pharmaceutical product prepared by him, showing- (a) the quantities of all substances used in the manufacture of the product; (b) the quantity of the product manufactured; (c) the name and the address of the person to whom the pharmaceutical product was sold or supplied; (d) the nature and results of tests made on each lot or batch of raw or bulk materials used in the product; (e) the nature and results of tests made on each batch of finished product; (f) any complaints received relating to the product and the action taken thereon by him; and (g) the nature and result of any tests made on the samples retained. (L.N. 228 of 1975)(2) The records required to be maintained by paragraph (1) shall be completed within 72 hours from the time the process or test was carried out or the transaction took place. (L.N. 137 of 1978) Cap 138A reg 35A Interpretation (Part VIII) PART VIII REGISTRATION OF PHARMACEUTICAL PRODUCTS AND SUBSTANCES In this Part, unless the context otherwise requires- "additional particulars" (附加详情), in relation to a pharmaceutical product or substance registered before the commencement date, means those registrable particulars of the product or substance not referred to in the repealed regulation 36(3); "commencement date" (生效日期) means the commencement date* of section 4 of the Pharmacy and Poisons (Amendment) (No. 2) Regulation 1995 (L.N. 366 of 1995); "registered particulars" (注册详情) means- (a) in relation to a pharmaceutical product or substance registered before the commencement date- (i) such of its particulars as are registered under the repealed regulation 36(3); and (ii) its additional particulars as contained in or ascertainable from the application form, the relevant literature and supporting documents (if any) submitted to the Committee for the purpose of the registration of the product or substance, or as contained in or ascertainable from the specimen sales packs or samples (or prototypes of the packs and proposed wordings of the labels) made available for inspection by the Committee for the purpose of the registration of the product or substance;(b) in relation to a pharmaceutical product or substance registered on or after the commencement date, its registrable particulars as registered under regulation 36(3), orin either case, where from time to time any subsequent approval has been given by the Board or the Committee to change any of the registrable particulars of the product or substance as from a certain date, then as from that date, its said particulars changed in accordance with such approval;"registered product or substance" (注册制品或物质) means any pharmaceutical product or substance which is the subject of a valid registration certificate issued under regulation 36(5); "registrable particulars" (须注册详情), in relation to a pharmaceutical substance, means the particulars referred to in regulation 36(3)(a), and, in relation to a pharmaceutical product, means all of the particulars referred to in regulation 36(3)(a) and (b); "repealed regulation 36(3)" (已废除的第36(3)条) means the regulation 36(3) which was in force immediately before the commencement date. (L.N. 366 of 1995)________________________________________________________________________________ Note: * Section 4 of the L.N. 366 of 1995 commenced operation on 28 July 1995. Cap 138A reg 36 Registration of pharmaceutical products and substances (1) Subject to paragraphs (1A), (1B) and (1C), no person shall sell, offer for sale or distribute or possess for the purposes of sale, distribution or other use any pharmaceutical product or substance unless the product or substance is registered with the Board- (L.N. 85 of 1987; L.N. 366 of 1995) (a) by the manufacturer, if the pharmaceutical product or substance is manufactured in Hong Kong; (b) by the importer, if the pharmaceutical product or substance is manufactured outside Hong Kong; or (c) by the local branch, subsidiary, representative, agent or distributor of a manufacturer outside Hong Kong. (L.N. 137 of 1978; 23 of 1998 s. 2)(1A) Nothing in paragraph (1) shall apply in the case of possession or use where the pharmaceutical product or substance- (a) has been imported into Hong Kong- (i) to be exported outside Hong Kong; (ii) by a pharmaceutical manufacturer for the purpose of manufacture or the compounding of pharmaceutical preparations; (iii) for the purpose of treatment by a registered medical practitioner or a registered dentist, of a particular patient or, for the purpose of treatment by a registered veterinary surgeon of a particular animal; or (L.N. 614 of 1997)(b) has been manufactured in Hong Kong to be exported outside Hong Kong. (L.N. 85 of 1987)(1B) For the avoidance of any doubt, a pharmaceutical product or substance is registered with the Board, for the purposes of paragraph (1), if and only if its registrable particulars are those which correspond exactly with the registered particulars of a registered product or substance. (L.N. 366 of 1995) |
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