【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第9页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] (xi) a statement containing the following Chinese text- (xii) (if the statement referred to in subparagraph (xi) is to be available in English also) a statement containing the English text: "To be supplied to a Chinese medicine practitioner solely for the purpose of administering or supplying to the patient to whom the prescription of this medicine is given and who is under his direct care";(e) if the medicine is to be administered or supplied to a patient or patients under the direct care of the Chinese medicine practitioner, and the prescription indicates that the medicine is for external application only- (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"; (xi) a statement containing the following Chinese text- (xii) (if the statement referred to in subparagraph (xi) is to be available in English also) a statement containing the English text: "To be supplied to a Chinese medicine practitioner solely for the purpose of administering or supplying to a patient or patients under his direct care"; (xiii) a statement containing the Chinese text: "只供外用"; and (xiv) (if the statement referred to in subparagraph (xiii) is to be available in English also) a statement containing the English text: "For external application only". Cap 549F reg 27 Labelling of proprietary Chinese medicines to be exported Remarks: not yet in operation A person who exports or has in his possession for the purpose of exporting a proprietary Chinese medicine manufactured in Hong Kong shall ensure that a label on the outermost package of the medicine likely to be sold or distributed to an ultimate user of the medicine- (a) includes the following particulars- (i) the name of the medicine; (ii) the name of the holder of the certificate of registration of the medicine as specified in the certificate; and (iii) the registration number of the medicine as specified in its certificate of registration; and(b) has the particulars being clearly and distinctly set out and not in any way obscured or obliterated. Cap 549F reg 28 Requirements for package inserts Remarks: not yet in operation PART 9 REQUIREMENTS FOR PACKAGE INSERTS (1) For the purposes of section 144 of the Ordinance, no person shall sell in Hong Kong or have in his possession for the purpose of selling in Hong Kong any proprietary Chinese medicine without a package insert which- (a) includes the particulars set out in subsection (2); and (b) has the particulars being clearly and distinctly set out and not in any way obscured or obliterated.(2) A package insert of a proprietary Chinese medicine to be sold in Hong Kong shall include, at least in Chinese, the following particulars in respect of the medicine- (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 and its quantity; 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 and their respective quantities;(c) either 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; (d) its dosage and method of usage; (e) its functions or pharmacological action; (f) its indications (if any); (g) its contra-indications (if any); (h) its side-effects (if any); (i) its toxic effects (if any); (j) the precautions to be taken regarding its use (if any); (k) its storage instructions; and (l) its packing specification. Cap 549F reg 29 Duration of licences PART 10 DURATION OF LICENCES AND CERTIFICATES (1) A licence issued under section 114(3), 115(3), 132(2) or 135(2) of the Ordinance shall be for a period of 2 years. (2) A licence renewed under section 116(3) or 136(3) of the Ordinance shall be for a period of 2 years or for such shorter period as considered appropriate by the Medicines Board. Cap 549F reg 30 Duration of certificates (1) A certificate issued under section 121(2) of the Ordinance shall be for a period of 5 years. (2) A certificate renewed under section 123(3) of the Ordinance shall be for a period of 5 years or for such shorter period as considered appropriate by the Medicines Board. (3) A certificate issued under section 133 of the Ordinance shall be for a period of 2 years or for such shorter period as considered appropriate by the Medicines Board. |
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