【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第7页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (a) the date of the transaction; (b) the name and quantity of the batch of product or medicine sold or distributed, as the case may be; (c) the name, address and telephone number of the person to whom he sells or distributes the batch of product or medicine, as the case may be; (d) the batch number of the batch of medicine (applicable only where the transaction relates to a proprietary Chinese medicine); and (e) the reference number of the invoice or other document evidencing the transaction.(2) The licence holder shall ensure that- (a) the particulars mentioned in subsection (1) are recorded within 72 hours after the completion of the transaction; and (b) the record prepared pursuant to subsection (1) is retained in the premises to which the licence relates from the date of preparation of the record until the expiry of 2 years- (i) in the case where the transaction relates to a batch of intermediate product, from the date of the transaction; or (ii) in the case where the transaction relates to a batch of proprietary Chinese medicine, from the expiry date of the batch of medicine.(3) The licence holder shall also ensure that- (a) every transaction mentioned in subsection (1) is evidenced by an invoice or other document which contains the particulars mentioned in that subsection; and (b) the invoice or other document evidencing the transaction is retained in the premises to which the licence relates from the date of the transaction until the expiry of 2 years from the dates referred to in subsection (2)(b)(i) or (ii), as the case may be. Cap 549F reg 20 General duties of holders of wholesaler licences in proprietary Chinese medicines PART 7 DUTIES OF HOLDERS OF WHOLESALER LICENCES IN PROPRIETARY CHINESE MEDICINES A holder of a wholesaler licence in proprietary Chinese medicines 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 proprietary Chinese medicines are provided in the premises;(c) the facilities for storing proprietary Chinese medicines are maintained in good condition; (d) no proprietary Chinese medicine in his possession is sold or distributed after its expiry date; (e) all proprietary Chinese medicines sold or distributed by him are packed using materials that are sufficiently stout to prevent leakage and contamination arising from the ordinary risks involved in handling the medicine; (f) no proprietary Chinese medicine in his possession 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 medicine; and (g) a system of control is set up and maintained, which will enable the rapid and, so far as practicable, complete recall of any proprietary Chinese medicine sold or distributed by him in the event of the medicine being found to be dangerous, injurious to health or unfit for human consumption. Cap 549F reg 21 Other duties of wholesalers in proprietary Chinese medicines-keeping of transaction records (1) A holder of a wholesaler licence in proprietary Chinese medicines shall ensure that every transaction whereby a proprietary Chinese medicine is acquired, received, exported, sold or distributed by him is evidenced by an invoice or other document. (2) The licence holder shall ensure that the invoice or other document evidencing the transaction contains the following particulars in respect of the transaction- (a) the date of the transaction; (b) the name and quantity of the medicine acquired, received, exported, sold or distributed, as the case may be; (c) the name, address and telephone number of- (i) the person who imports, sells or distributes the medicine to him; or (ii) the person to whom he exports, 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 22 Chinese herbal medicines to be labelled Remarks: not yet in operation PART 8 REQUIREMENTS REGARDING LABELLING OF CONTAINERS AND PACKAGES For the purposes of section 142 of the Ordinance, a wholesale dealer in Chinese herbal medicines shall attach to or print on each container of Chinese herbal medicine a label in a conspicuous position, or cause a label to be so attached or printed. Cap 549F reg 23 Labelling of containers of Schedule 1 medicines by wholesale dealers Remarks: not yet in operation (1) A wholesale dealer in Schedule 1 medicines shall ensure that a label attached to or printed on a container in which a Schedule 1 medicine is stored- (a) includes the particulars set out in subsection (2); and (b) has the particulars being clearly and distinctly set out and not in any way obscured or obliterated.(2) A label referred to in subsection (1) shall include the following particulars in respect of the medicine stored in the container- |
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