【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第5页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (c) the name, address and telephone number of- (i) the person who sells or distributes the medicine to him; or (ii) the person to whom he sells or distributes the medicine, as the case may be; and(d) the reference number of the invoice or other document.(3) The licence holder shall also ensure that the invoice or other document evidencing the transaction is retained in the premises to which the licence relates for a period of not less than 2 years from the date of the transaction. Cap 549F reg 15 Particulars to be registered for proprietary Chinese medicines PART 5 REGISTRATION OF PROPRIETARY CHINESE MEDICINES For the purposes of section 121(1)(b) of the Ordinance, the following particulars are required to be registered for a proprietary Chinese medicine- (a) its Chinese and English name; (b) its dose form; (c) the name and quantity of each of its active ingredient; (d) the name and quantity of each of its excipient (if any); (e) its specification; (f) its indication (if any); (g) its dosage and method of usage; (h) each of its labels to be attached or printed on its package; (i) the package insert to be supplied for its sales inside Hong Kong; (j) each of the package inserts to be supplied for its sales outside Hong Kong (if any); (k) the name and address of each of its manufacturer; and (l) its function or pharmacological action. Cap 549F reg 16 General duties of holders of manufacturer licences PART 6 DUTIES OF HOLDERS OF MANUFACTURER LICENCES A holder of a manufacturer licence shall ensure that- (a) the premises to which the licence relates are maintained in sanitary condition; (b) where ingredients or packing materials, or both, used for manufacturing proprietary Chinese medicines are 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) the facilities (if any) for storing ingredients or packing materials, or both, as the case may be, 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) fittings and equipment suitable for use in the manufacturing process specified in the licence are provided in the premises; (f) the fittings and equipment used in the manufacturing process are maintained in good condition; (g) where intermediate products generated or proprietary Chinese medicines manufactured in the course of manufacture, or both, are 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;(h) the facilities (if any) for storing intermediate products or proprietary Chinese medicines, or both, are maintained in good condition; (i) 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;(j) where any ingredient is used in the manufacturing process, the ingredient is examined by a responsible person before it is used to ensure its identity and quality; (k) no manufacturing process is carried out in the premises otherwise than under the supervision of a responsible person; (l) adequate steps have been taken to prevent contamination of any ingredient or packing material used, any intermediate product generated or any proprietary Chinese medicine manufactured in the course of manufacture; (m) each batch of intermediate product generated or proprietary Chinese medicine manufactured in the course of manufacture, or both, is examined by a responsible person before it is sold or distributed by the holder of the licence to ensure its quality; (n) no proprietary Chinese medicine that he manufactures is sold or distributed by him after its expiry date; (o) each container or package of intermediate product generated or proprietary Chinese medicine manufactured in the course of manufacture is sufficiently stout to prevent leakage and contamination arising from the ordinary risks involved in handling the products or medicines, as the case may be; (p) no intermediate product generated or proprietary Chinese medicine manufactured in the course of manufacture is consigned for transport unless suitable arrangements have been made to prevent leakage and contamination arising from the ordinary risks involved in the delivery and transport of the product or medicine, as the case may be; (q) a system of control is set up and maintained, which will enable the rapid and, so far as practicable, complete recall of any intermediate product generated or proprietary Chinese medicine manufactured in the course of manufacture which has been sold or distributed in the event of the product or medicine, as the case may be, being found to be dangerous, injurious to health or unfit for human consumption; |
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