【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
CAP 549F CHINESE MEDICINES REGULATION
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(Cap 549, section 161(5)) [The Regulation (other than sections 12, 15, 22 to 28, 31 and 33 to 38 and Schedules 2 and 3)］ 30 April 2003 L.N. 54 of 2003 Sections 15 and 38 and Schedule 3 ［19 December 2003 L.N. 229 of 2003] (L.N. 160 of 2002) Cap 549F reg 1 Commencement PART 1 PRELIMINARY This Regulation shall come into operation on a day to be appointed by the Secretary for Health, Welfare and Food by notice published in the Gazette. Cap 549F reg 2 Interpretation In this Regulation, unless the context otherwise requires- "batch number" (批次编号) means a series of numbers, letters or other symbols, or a series consisting of a combination of numbers, letters and other symbols, used- (a) in the case of a Chinese herbal medicine supplied to a wholesale dealer in Chinese herbal medicines, for the purpose of identifying when and by whom the medicine is supplied to the dealer; or (b) in the case of a proprietary Chinese medicine, for the purpose of identifying when and by whom the medicine is produced;"excipient" (赋形剂), in relation to a proprietary Chinese medicine, means a substance or compound that is used or intended to be used in the preparation or production of the medicine but which is not an active ingredient of the medicine; "expiry date" (失效日期), in relation to a proprietary Chinese medicine, means the expiry date of the medicine as determined by the manufacturer who produces the medicine, being the date after which the medicine should not be administered; "ingredient" (成分), in relation to a proprietary Chinese medicine, means- (a) its active ingredient; or (b) its excipient;"intermediate product" (中间产品) means a substance or compound generated in the course of manufacture of a proprietary Chinese medicine and which is to be used in further preparation or production process of the medicine; "manufacturing process" (制造程序), in relation to a proprietary Chinese medicine, means the preparation, production, packing or repacking process of the medicine; "packing material" (包装物料), in relation to a proprietary Chinese medicine, means a material used for packing or repacking the medicine; "responsible person" (负责人)- (a) in relation to the dispensing of Chinese herbal medicines, means a person responsible for the supervision of the dispensing or his deputies- (i) as nominated in an application for a retailer licence under section 114(2)(b) of the Ordinance; or (ii) as notified to the Medicines Board under section 145(2) of the Ordinance;(b) in relation to the manufacture of proprietary Chinese medicines, means a person responsible for the supervision of the manufacture or his deputies- (i) as nominated in an application for a manufacturer licence under section 132(1)(b) of the Ordinance; or (ii) as notified to the Medicines Board under section 145(2) of the Ordinance;"Schedule 1 medicine" (附表1药材) means a Chinese herbal medicine specified in Schedule 1 of the Ordinance; "Schedule 2 medicine" (附表2药材) means a Chinese herbal medicine specified in Schedule 2 of the Ordinance; "Vocational Training Council" (职业训练局) means the Vocational Training Council established under section 4 of the Vocational Training Council Ordinance (Cap 1130). Cap 549F reg 3 Licensing requirements in respect of applications made under section 114 of the Ordinance PART 2 LICENSING REQUIREMENTS IN RESPECT OF APPLICATIONS FOR RETAILER, WHOLESALER AND MANUFACTURER LICENCES For the purposes of section 114(3) of the Ordinance, the following are the prescribed licensing requirements in respect of an application for a retailer licence- (a) the premises to which the application relates are in sanitary condition; (b) (i) adequate space; and (ii) adequate and suitable facilities, for storing Chinese herbal medicines are provided in the premises;(c) where any Schedule 1 medicine is to be stored in the same premises with any Schedule 2 medicine or material of herbal, animal or mineral origin customarily used by the Chinese for medicinal purpose, arrangements are made so that the Schedule 1 medicine can be stored effectively separated from the Schedule 2 medicine or material; (d) where Chinese herbal medicines are to be dispensed in the premises- (i) adequate space; and (ii) adequate and suitable facilities, for dispensing the medicines are provided in the premises;(e) the premises are in all other respects suitable for carrying on a business in the retail of Chinese herbal medicines; and (f) each responsible person nominated in the application complies with the minimum requirements regarding knowledge and experience as set out in section 1 of Schedule 1. Cap 549F reg 4 Licensing requirements in respect of applications made under section 115 of the Ordinance For the purposes of section 115(3) of the Ordinance, the following are the prescribed licensing requirements in respect of an application for a wholesaler licence in Chinese herbal medicines- |
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