【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第8页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (a) the name, at least in Chinese, of the medicine; (b) the name of the wholesale dealer as specified in its wholesaler licence; (c) the batch number of the medicine; (d) a warning containing the Chinese text: "" or ""; and (e) (if the warning referred to in paragraph (d) is to be available in English also) a warning containing the English text: "Toxic Chinese Medicine". Cap 549F reg 24 Labelling of containers of Schedule 2 medicines by wholesale dealers Remarks: not yet in operation A wholesale dealer in Schedule 2 medicines shall ensure that a label attached to or printed on a container in which a Schedule 2 medicine is stored- (a) includes the name, at least in Chinese, of the medicine; and (b) has the name of the medicine being clearly and distinctly set out and not in any way obscured or obliterated. Cap 549F reg 25 Proprietary Chinese medicines to be labelled Remarks: not yet in operation For the purposes of section 143 of the Ordinance, no person shall sell or have in his possession for the purpose of selling any proprietary Chinese medicine unless the package of the medicine is labelled in a conspicuous position. Cap 549F reg 26 Labelling of proprietary Chinese medicines to be sold in Hong Kong Remarks: not yet in operation (1) A person who sells in Hong Kong or has in his possession for the purpose of selling in Hong Kong a proprietary Chinese medicine shall ensure that a label on a package of the medicine- (a) includes the particulars set out in subsection (2), (3) or (4), as the case may be; and (b) has the particulars being clearly and distinctly set out and not in any way obscured or obliterated.(2) Except as otherwise provided in subsections (3) and (4), a label on a package of a proprietary Chinese medicine to be sold in Hong Kong, whether being the outermost package to be sold or distributed to an ultimate user of the medicine or otherwise, shall include the following particulars, at least in Chinese- (a) the name of the medicine; (b) if- (i) the medicine is composed of less than 3 kinds of active ingredients, the name of each kind of active ingredient; or (ii) the medicine is composed of 3 or more kinds of active ingredients, the names of more than half of the total number of kinds of active ingredients;(c) the name of the country or territory in which the medicine is produced; (d) the registration number of the medicine as specified in its certificate of registration; (e) if the package- (i) is the outermost package, the name of the holder of the certificate of registration of the medicine as specified in the certificate; or (ii) is not the outermost package, either the particulars set out in paragraph (e)(i) or the name of the manufacturer who produces the medicine;(f) its packing specification; (g) its dosage and method of usage; (h) its expiry date; and (i) its batch number.(3) Except as otherwise provided in subsection (4), a label on a package of a proprietary Chinese medicine to be sold in Hong Kong, not being the outermost package to be sold or distributed to an ultimate user of the medicine, which- (a) is in the form of a strip pack, blister pack or similar article, shall include, at least in Chinese, the name of the medicine, the name of the holder of the certificate of registration of the medicine as specified in the certificate or the name of the manufacturer who produces the medicine, and the expiry date, packing specification and batch number of the medicine; (b) is in the form of an ampoule, vial or similar receptacle, with not more than 10 ml capacity or equivalent, shall include, at least in Chinese, the name of the medicine; or (c) contains a single dose in the form of a pill, shall include, at least in Chinese, the name of the medicine.(4) A label on a package of a proprietary Chinese medicine which is- (a) manufactured in the premises in respect of which a manufacturer licence is in force; (b) manufactured by or under the supervision of a responsible person in accordance with a prescription given by a registered or listed Chinese medicine practitioner; and (c) to be sold or distributed to the Chinese medicine practitioner,shall include the following particulars, at least in Chinese- (d) if the prescription is given to a patient under the direct care of the Chinese medicine practitioner, and the prescription indicates that the medicine is for internal application or both internal and external application- (i) the name and address of the Chinese medicine practitioner; (ii) the name and address of the manufacturer who produces the medicine; (iii) its batch number; (iv) the date on which it is produced; (v) its dose form; (vi) its packing specification; (vii) its expiry date; (viii) the name and quantity of each ingredient listed in the prescription; (ix) a statement containing the following Chinese text- (x) (if the statement referred to in subparagraph (ix) is to be available in English also) a statement containing the English text: "To be used only in accordance with the instructions of a Chinese medicine practitioner"; |
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