【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第4页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (A) the name and quantity of each type of material (including the Chinese herbal medicine or mixture of Chinese herbal medicines to be processed) used in the processing; (B) the name and quantity of the processed medicine or mixture; (C) the name or a description of the processing method; (D) the date of the completion of the processing; (E) the result of the examination referred to in subparagraph (iii); and (F) the name of the person who supervises the processing;(v) the particulars mentioned in subparagraph (iv) are recorded within 72 hours after the completion of the processing; and (vi) the record prepared pursuant to subparagraph (iv) is retained in the premises to which the licence relates for a period of not less than 2 years from the date of the completion of the processing;(h) no Chinese herbal 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 (i) a system of control is set up and maintained, which will enable the rapid and, so far as practicable, complete recall of any Chinese herbal 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 12 Additional duties of holders of wholesaler licences in Chinese herbal medicines in respect of Schedule 1 medicines-selling restrictions Remarks: not yet in operation A holder of a wholesaler licence in Chinese herbal medicines in respect of Schedule 1 medicines may sell or distribute a Schedule 1 medicine only to the following categories of persons or entities- (a) a holder of a wholesaler licence in Chinese herbal medicines in respect of Schedule 1 medicines; (b) a holder of a retailer licence in respect of Schedule 1 medicines; (c) a holder of a manufacturer licence; (d) a registered Chinese medicine practitioner; (e) a person or an institution exempted under section 158(1) of the Ordinance requiring the medicine for the purpose of education or scientific research; (f) a Government department or public officer requiring the medicine for the purpose of public service; (g) a purchaser outside Hong Kong; (h) a hospital or clinic managed or controlled by the Hospital Authority established under section 3(1) of the Hospital Authority Ordinance (Cap 113); or (i) a hospital within the meaning of the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap 165). Cap 549F reg 13 Additional duties of holders of wholesaler licences in Chinese herbal medicines in respect of Schedule 1 medicines-keeping of records (1) A holder of a wholesaler licence in Chinese herbal medicines in respect of Schedule 1 medicines shall ensure that the following particulars in respect of every transaction whereby a Schedule 1 medicine is acquired, received, sold or distributed by him are recorded- (a) the date of the transaction; (b) the nature of the transaction; (c) the name and quantity of the medicine acquired, received, sold or distributed, as the case may be; (d) 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;(e) the reference number of the invoice or other document evidencing the transaction; and (f) the balance of the medicine remaining in his possession after the completion of 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 for a period of not less than 2 years from the date of the transaction.(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 subsection (1)(a) to (e); and (b) 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 14 Additional duties of holders of wholesaler licences in Chinese herbal medicines in respect of Schedule 2 medicines-keeping of records (1) A holder of a wholesaler licence in Chinese herbal medicines in respect of Schedule 2 medicines shall ensure that every transaction whereby a Schedule 2 medicine is acquired, received, 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, sold or distributed, as the case may be; |
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