【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第6页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (r) a control sample of each batch of intermediate product (if any) generated in the course of manufacture which has been sold is retained, under suitable conditions of storage, in the premises from the date on which the batch of product is generated until the expiry of 2 years from the date of the last transaction in the batch of product; and (s) a control sample of each batch of proprietary Chinese medicine (if any) manufactured in the course of manufacture is retained, under suitable conditions of storage, in the premises from the date of the manufacture until the expiry of 2 years from the expiry date of the batch of medicine. Cap 549F reg 17 Other duties of holders of manufacturer licences-keeping of documents relating to acquisition of ingredients (1) A holder of a manufacturer licence shall ensure that every transaction whereby a batch of ingredient is acquired or received 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 batch of ingredient acquired or received by him; (c) the name, address and telephone number of the person who sells or distributes the batch of ingredient to him; and (d) the reference number of the invoice or other document.(3) Subject to subsections (4) and (5), 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 from the date of the transaction until the expiry of 2 years- (a) in the case where a batch of intermediate product is generated from the batch of ingredient, from the date of generation of the batch of product; or (b) in the case where a batch of proprietary Chinese medicine is manufactured from the batch of ingredient, from the expiry date of the batch of medicine.(4) Where 2 or more batches of intermediate product or proprietary Chinese medicine are generated or manufactured, as the case may be, from the batch of ingredient and they have different dates of generation or expiry dates, as the case may be, the invoice or other document shall be retained until the expiry of 2 years from the latest of such dates of generation or expiry dates, as the case may be. (5) Where a batch of intermediate product is generated and a batch of proprietary Chinese medicine is manufactured from the batch of ingredient, the invoice or other document shall be retained until the expiry of 2 years from the latter of the dates referred to in subsection (3)(a) or (b). Cap 549F reg 18 Other duties of holders of manufacturer licences-keeping of manufacturing records (1) A holder of a manufacturer licence shall ensure that the following particulars in respect of each manufacturing process of a proprietary Chinese medicine carried out by him are recorded- (a) the name of the intermediate product generated or proprietary Chinese medicine manufactured from the manufacturing process, or both, as the case may be; (b) the quantity of the batch of product or medicine, or both, as the case may be; (c) the expiry date and batch number of the batch of medicine (applicable only where a proprietary Chinese medicine is manufactured from the manufacturing process); (d) the name and quantity of each ingredient or packing material used in the manufacturing process; (e) a description of each manufacturing method used; and (f) the date on which the manufacturing process- (i) begins; and (ii) is completed.(2) The licence holder shall also ensure that- (a) the particulars mentioned in subsection (1) (other than those referred to in subsection (1)(b) and (f)(ii)) are recorded within 72 hours after the manufacturing process begins; (b) the particulars mentioned in subsection(1)(b) and (f)(ii) are recorded within 72 hours after the manufacturing process is completed; and (c) subject to subsection (3), 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 record relates to a batch of intermediate product, from the date of the last transaction in the batch of product or the date when the batch of product is used up by the licence holder, whichever is later; or (ii) in the case where the record relates to a batch of proprietary Chinese medicine, from the expiry date of the batch of medicine.(3) Where the record prepared pursuant to subsection (1) relates to a batch of intermediate product and proprietary Chinese medicine, the record shall be retained until the expiry of 2 years from the latter of the dates referred to in subsection (2)(c)(i) or (ii). Cap 549F reg 19 Other duties of holders of manufacturer licences-keeping of transaction records (1) A holder of a manufacturer licence shall ensure that the following particulars in respect of every transaction whereby a batch of intermediate product generated or a batch of proprietary Chinese medicine manufactured in the course of manufacture is sold or distributed by him are recorded- |
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