3.—(1) Subject to paragraph (2), the standard provisions for licences (including provisional licences) to be granted under Part II of the Act shall be the following:| (a) | for product licences, those provisions set out in the First Schedule; | | (b) | for import licences, those provisions set out in the Second Schedule; | | (c) | for wholesale dealer’s licences, those provisions set out in the Third Schedule; and | | (d) | for manufacturer’s licences, those provisions set out in the Fourth Schedule. |
(2) The standard provisions for import licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be as follows:| (a) | those provisions set out in the Second Schedule except paragraphs 8, 9(2) and 11; | | (b) | the provision that the holder of the licence shall seek the prior approval of the licensing authority to deal with any medicinal product under his licence, and he shall, within such time as the licensing authority may specify, provide such information and documents as may be required by the licensing authority; | | (c) | the provision that the holder of the licence shall not import, sell or supply any medicinal product to which the licence relates unless —| (i) | the approval of the licensing authority to deal with that medicinal product under his licence continues to be valid at the time of the import, sale or supply, as the case may be, of the medicinal product; and | | (ii) | he complies with any written law applicable to the import, sale or supply, as the case may be, of the medicinal product; and |
| | (d) | the provision that the holder of the licence shall not sell or supply any medicinal product to which the licence relates unless he has submitted to the licensing authority the following documents within 2 months of the import of the consignment of the medicinal product —| (i) | a declaration of the absence of any poison as defined in the Poisons Act (Cap. 234) and any synthetic active substance in the medicinal product; | | (ii) | test results on the content of Arsenic, Copper, Lead and Mercury in the medicinal product; | | (iii) | where the medicinal product is for oral consumption, test results on the content of Escherichia coli, Salmonella, Staphylococcus aureus, *the total yeast and mould count, and *the total aerobic microbial count per gram or millilitre of the medicinal product (*not necessary if the medicinal product contains any active substance which is derived from plants, animals or a combination thereof and which has been produced by fermentation processes); and | | (iv) | where the medicinal product is for external application, test results on the content of Pseudomonas aeruginosa, Staphylococcus aureus, *the total yeast and mould count, and *the total aerobic microbial count per gram or millilitre of the medicinal product (*not necessary if the medicinal product contains any active substance which is derived from plants, animals or a combination thereof and which has been produced by fermentation processes). [S 621/2003 wef 01/01/2004] |
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| (3) The standard provisions for wholesale dealer’s licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be those provisions set out in the Third Schedule except that paragraph 6 thereof shall read as if the words “or by the holder of the product licence” in the second line have been deleted. |
(4) The standard provisions for manufacturer’s licences to be granted under Part II of the Act in respect of Chinese proprietary medicines shall be —| (a) | those provisions set out in the Fourth Schedule, except that —| (i) | paragraph 4 thereof shall read as if the words “under the relevant product licences” at the end thereof have been deleted; and | | (ii) | paragraph 12 thereof shall read as if the words “, except so far as the conditions of the relevant medicinal product licence may otherwise provide,” in the third and fourth lines have been deleted; |
| | (b) | the provision that the holder of the licence shall seek the prior approval of the licensing authority to deal with any medicinal product under his licence, and he shall, within such time as the licensing authority may specify, provide such information and documents as may be required by the licensing authority; | | (c) | the provision that the holder of the licence shall not manufacture, assemble, sell or supply any medicinal product to which the licence relates unless —| (i) | the approval of the licensing authority to deal with that medicinal product under his licence continues to be valid at the time of the manufacture, assembly, sale or supply, as the case may be, of the medicinal product; and | | (ii) | he complies with any written law applicable to the manufacture, assembly, sale or supply, as the case may be, of the medicinal product; and |
| | (d) | the provision that the holder of the licence shall inform the licensing authority of any decision to cease the manufacture or assembly of the medicinal product to which the licence relates and shall state the reason for that decision. |
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