【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第2页 CAP 549F CHINESE MEDICINES REGULATION
|
[接上页] (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; and (d) the premises are in all other respects suitable for carrying on a business in the wholesale of Chinese herbal medicines. Cap 549F reg 5 Licensing requirements in respect of applications made under section 132 of the Ordinance For the purposes of section 132(2) of the Ordinance, the following are the prescribed licensing requirements in respect of an application for a manufacturer licence- (a) the premises to which the application relates are in sanitary condition; (b) where ingredients or packing materials, or both, used for manufacturing proprietary Chinese medicines are to be stored in the premises- (i) adequate space; and (ii) adequate and suitable facilities, for storing the ingredients or packing materials, or both, as the case may be, 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) fittings and equipment suitable for use in the manufacturing process specified in the application are provided in the premises; (e) where intermediate products generated or proprietary Chinese medicines manufactured in the course of manufacture, or both, are to be stored in the premises- (i) adequate space; and (ii) adequate and suitable facilities, for storing the products or medicines, or both, as the case may be, are provided in the premises;(f) the humidity, lighting, temperature and ventilation of the part of the premises provided for- (i) storing ingredients or packing materials; (ii) manufacturing proprietary Chinese medicines; or (iii) storing intermediate products or proprietary Chinese medicines, are suitable for their respective purposes;(g) the premises are in all other respects suitable for carrying on a business in the manufacture of proprietary Chinese medicines; and (h) each responsible person nominated in the application complies with the minimum requirements regarding knowledge and experience as set out in section 2 of Schedule 1. Cap 549F reg 6 Licensing requirements in respect of applications made under section 135 of the Ordinance For the purposes of section 135(2) of the Ordinance, the following are the prescribed licensing requirements in respect of an application for a wholesaler licence in proprietary Chinese medicines- (a) the premises to which the application relates are in sanitary condition; (b) (i) adequate space; and (ii) adequate and suitable facilities, for storing proprietary Chinese medicines are provided in the premises; and(c) the premises are in all other respects suitable for carrying on a business in the wholesale of proprietary Chinese medicines. Cap 549F reg 7 General duties of holders of retailer licences PART 3 DUTIES OF HOLDERS OF RETAILER LICENCES A holder of a retailer licence shall ensure that- (a) the premises to which the licence relates are maintained in sanitary condition; (b) (i) adequate space; and (ii) adequate and suitable facilities, for storing Chinese herbal medicines are provided in the premises;(c) the facilities for storing Chinese herbal medicines are maintained in good condition; (d) where any Schedule 1 medicine is 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, the Schedule 1 medicine is stored effectively separated from the Schedule 2 medicine or material; (e) where Chinese herbal medicines are dispensed in the premises- (i) adequate space; and (ii) adequate and suitable facilities, for dispensing the medicines are provided in the premises;(f) the facilities (if any) for dispensing Chinese herbal medicines are maintained in good condition; (g) each type of Chinese herbal medicine stored in the premises is stored in a separate container; (h) each container referred to in paragraph (g)- (i) has the name of the medicine stored in it being printed or affixed in a conspicuous position; (ii) has the name of the medicine stored in it being clearly and distinctly set out and not in any way obscured or obliterated; and (iii) is sufficiently stout to prevent leakage and contamination arising from the ordinary risks involved in handling the medicine stored in it;(i) no Chinese herbal medicine in his possession is dispensed to any person otherwise than under the supervision of a responsible person; |
- 此法规有错误，我来纠正。请点击在此 提交错误内容或者您纠正的内容！