【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第8页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] (e) a reference to the invoice or other documents supporting the transaction; (f) the name of the poison or pharmaceutical product, as the case may be, and the unit of quantity; (g) the balance of the poison remaining in his possession after the transaction. (L.N. 137 of 1978)(3) For each poison in Part I of the Poisons List there shall be a separate entry in the records and all transactions involving that poison shall be entered in a part of the records reserved for that poison. (4) Unless the Committee approves another system of recording, all records of transactions involving poisons in Part I of the Poisons List shall be made in the form prescribed in the Eighth Schedule. (See Eighth Schedule, Form 2) (5) Every transaction to which these regulations relate shall be recorded within 72 hours after the time it took place. (6) Records of sales or supplies maintained under this regulation shall be supported by documents signed by the purchaser. (7) In the case of an export transaction the holder of a wholesale poisons licence or a licence to manufacture pharmaceutical products shall retain all shipping and other documents supporting the transaction. (L.N. 137 of 1978) (8) A holder of a wholesale poisons licence or a wholesale dealer in medicines not containing poisons shall set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978) Cap 138A reg 29 Licensing of manufacturers PART VII MANUFACTURERS (1) Subject to paragraph (2), no person shall manufacture any pharmaceutical product on any premises unless he is the holder of a licence to manufacture pharmaceutical products on those premises. (2) Paragraph (1) and regulations 33 and 35 shall not apply to an authorized seller of poisons, who in the course of his retail business, manufactures any pharmaceutical product at any premises registered by him under the Ordinance in quantities which in the opinion of the Board, are consistent with the scope of his business and the nature of the product. (3) The Committee may issue a licence to manufacture pharmaceutical products in such form as it may prescribe on payment of the fee prescribed in the Ninth Schedule. (4) The Committee may revoke the licence or suspend it for such period as it thinks fit, if, in its opinion, the licensee has failed to comply with the conditions subject to which the licence was issued or with any of these regulations. (5) For the purpose of certifying that a manufacturer is licensed under this regulation, the Committee, subject to any conditions it may impose and to the payment of the fee prescribed in the Ninth Schedule, may issue to the manufacturer- (a) a certificate for manufacture; or (b) an interim-certificate for manufacture,in the forms prescribed in the Eighth Schedule. (See Eighth Schedule Forms 3 & 4) (L.N. 137 of 1978) (6) For the purpose of exporting pharmaceutical products manufactured by a manufacturer licensed under this regulation, the Committee may, subject to any conditions it may impose and to the payment of the fee prescribed in the Ninth Schedule, issue to the manufacturer- (a) a free sale certificate of pharmaceutical product; or (b) a certificate of pharmaceutical product,in the forms prescribed in the Eighth Schedule. (see Eighth Schedule, Forms 5 & 5A) (L.N. 449 of 1991) (7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (L.N. 369 of 1980) Cap 138A reg 30 Manufacture to be under supervision of a registered pharmacist (1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by or under the supervision of- (a) a registered pharmacist; (b) a Fellow or Associate of the Royal Institute of Chemistry; or (c) a person having such other qualifications or sufficient experience as may be approved by the Board.(2) For the purposes of paragraph (1), "supervision" (监督) means the exercise by any of the persons referred to in paragraph (1) of control over the process of manufacture and of the persons engaged therein. (L.N. 137 of 1978) Cap 138A reg 31 Labelling by manufacturers (1) Subject to paragraph (4), a manufacturer or authorized seller of poisons, supplying for distribution under regulation 29(2), shall label or cause to be labelled the container of each pharmaceutical product, with the following particulars- (a) the appropriate designation of- (i) the substance or substances from which the pharmaceutical product was manufactured; (ii) each of the active constituents of the product; or (iii) each of the ingredients from which the product was compounded;(b) in the case where the appropriate designation of each of the active constituents or ingredients of a product is given, the appropriate quantitative particulars of those constituents or ingredients; |
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