【法规名称】
【法规编号】 82241 什么是编号？
【正 文】
第11页 CAP 138A PHARMACY AND POISONS REGULATIONS
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[接上页] (1C) It shall be a defence to a charge against any person for contravening paragraph (1) if the person proves that he did not know and could not with reasonable diligence have discovered that the product or substance was not registered with the Board. (L.N. 366 of 1995) (2) Application for the initial registration of a pharmaceutical product or substance shall be made in the form prescribed in the Eighth Schedule and shall be accompanied by the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 6) (2A) In considering an application for registration of a pharmaceutical product which contains as active ingredients any Chinese herbal medicines or proprietary Chinese medicines as defined in section 2 of the Chinese Medicine Ordinance (Cap 549) or other materials of herbal, animal or mineral origin customarily used by the Chinese for medicinal purpose, the Board shall seek advice from the Chinese Medicines Board established under the Chinese Medicine Ordinance (Cap 549). (47 of 1999 s. 175) (3) The particulars to be registered shall- (a) in the case of a product or substance, be- (i) its name; (ii) its specifications; (iii) its label; (iv) its package insert, if any; (v) the name and address of the manufacturer; and (vi) the name and address of the applicant;(b) in the case of a product, further be- (i) its dose form; (ii) the quantity or quantities of the dose form contained in its unit package or unit packages; (iii) the name and quantity of all its active ingredients; (iv) the name and quantity of all its excipients; and (v) its proposed indication, dosage and route of administration. (L.N. 366 of 1995)(3A) For the purposes of paragraph (3)- "active ingredient" (有效成分) means an ingredient of the product which is not an excipient; "excipient" (赋形剂) means an ingredient of the product which does not contribute to its pharmacological action or which so contributes only by regulating the release of an active ingredient; "label" (标签) means any statement forming part of or affixed to the container or package of the product or substance; "package insert" (装附页) means any leaflet, notification or other document supplied with the container or package of the product or substance, but does not include a label. (L.N. 366 of 1995) (4) Representative specimen sales packs of the product or representative samples of the substance shall be made available for inspection by the Committee. In the case of products not yet marketed the Committee may accept prototypes of the packs and proposed wordings of the labels on the understanding that these will be replaced by actual sale packs not later than 6 months after registration of the product or substance. (5) The Committee may issue to an applicant a registration certificate in the form prescribed in the Eighth Schedule valid for a period of 5 years from the date of registration on payment of the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 7) (6) The Committee shall advise the applicant whether the pharmaceutical product or substance appears in the Poisons List and if so, under which classification. (7) A registration certificate issued under paragraph (5) shall be renewable on payment of the fee prescribed in the Ninth Schedule. (8) The Committee may deregister a pharmaceutical product or substance if it considers it to be in the public interest to do so. (8A) Where the Committee refuses to register or deregisters a pharmaceutical product or substance it shall forward to the applicant or permit holder, as the case may be, a notice of refusal or of deregistration and shall state in such notice its reasons for refusal to register or for deregistration. (L.N. 137 of 1978) (9) 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) (10) (Repealed L.N. 369 of 1980) (11) (Repealed L.N. 366 of 1995) (L.N. 137 of 1978; L.N. 369 of 1980) Cap 138A reg 36A Application for approval to change the registered particulars of a registered product or substance (1) In this regulation- "person responsible for registering a registered product or substance" (负责将注册制品或物质注册的人) means a person who, in relation to the product or substance, belongs to any one of the classes of person described in regulation 36(1)(a), (b) or (c). (2) The person responsible for registering a registered product or substance may apply in writing to the Committee for approval to change any of the registrable particulars of the product or substance except the particulars referred to in regulation 36(3)(a)(i) and (b)(i) and (iii). (3) A person responsible for registering a registered product or substance who proposes to change the particulars referred to in regulation 36(3)(a)(i) or (b)(i) or (iii) may apply under regulation 36 for registering, as a separate product or substance, as the case may be, the product or substance with the particulars changed as proposed. |
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