【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第13页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] (3) In dealing with an application by an importer the Committee shall also take into consideration in particular the methods, standards and conditions of manufacture of the pharmaceutical product or substance in respect of which application is made and may, if it thinks fit, require the production by the applicant of one or both of the following- (a) an undertaking, given by the manufacturer of any such products or substances, to permit the premises where they are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the Committee; (b) a declaration, given by or on behalf of the manufacturer of any such products or substances, that, in relation to the manufacture of these products any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.(4) The Committee shall make arrangements for the separate processing of an application for the registration of a new pharmaceutical product or new substance so that its registration shall not be unduly delayed. (L.N. 137 of 1978) (5) For the purposes of paragraph (4) "new pharmaceutical product" (新药剂制品) and "new substance" (新物质) mean a medicine containing an active ingredient, or a substance, having a chemical formula which has not previously been marketed or registered in Hong Kong under some other name or description. (L.N. 137 of 1978; L.N. 235 of 1996) (L.N. 369 of 1980) Cap 138A reg 37A Application for registration under section 28A PART VIIIA REGISTRATION OF IMPORTERS AND EXPORTERS (1) Any application for registration under section 28A as an importer or exporter of pharmaceutical products shall be made to the Committee in Form 13 in the Eighth Schedule and shall be accompanied by the fee specified in the Ninth Schedule. (2) The Committee may require any applicant under this regulation to furnish such information and to permit such inspection of premises and storage facilities used by the applicant for the purposes of his business as the Committee may specify by notice to the applicant. (3) The Committee may grant or refuse any application under this regulation as the Committee may deem fit. (4) The Committee shall furnish any person whose application is granted with a certificate in Form 14 in the Eighth Schedule. (5) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (Part VIIIA added L.N. 369 of 1980) Cap 138A reg 38 Disclosure of composition of medicines PART IX SALE OF MEDICINES (1) Subject to these regulations, no person shall- (a) sell any article consisting of or comprising a substance recommended as a medicine; or (b) supply any such article as a sample for the purpose of inducing persons to buy the substances of which it consists or which it comprises,unless- (i) the article is labelled as required under regulation 31; or (ii) the particulars specified under regulation 31(1) are printed so as to be clearly legible in English or Chinese on the article or a label affixed thereto. (L.N. 137 of 1978)(2) Nothing in this regulation shall apply to any article- (a) made up and supplied for the use of a particular person, being an article prescribed by reference to the needs of that person; or (b) consisting wholly of either- (i) a product resulting solely from the pharmaceutical treatment of natural products as referred to by the Chinese Herbal Materia Medica; (ii) a mixture the sole ingredients of which are two or more of such products; or (iii) a natural mineral water or an artificial imitation thereof.(3) For the purposes of this regulation- "advertisement" (广告) includes any notice, circular, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound; "proprietary designation" (所有人称号), in relation to the sale of an article consisting of or comprising a substance recommended as a medicine, means words used or proposed to be u |
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