【法规名称】
【法规编号】 81875 什么是编号？
【正 文】
第10页 CAP 549F CHINESE MEDICINES REGULATION
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[接上页] Cap 549F reg 31 Offences and penalties Remarks: not yet in operation PART 11 OFFENCES AND PENALTIES A person who contravenes a provision of this Regulation set out in column 1 of Schedule 2 commits an offence and is liable on conviction to the penalty set out opposite that provision in columns 2 and 3 of that Schedule. Cap 549F reg 32 Exemptions for applications for retailer licences PART 12 EXEMPTIONS Section 114(2)(b) of the Ordinance shall not apply in respect of an application for a retailer licence if the application states that no Chinese herbal medicine is to be dispensed in the premises to which the application relates. Cap 549F reg 33 Exemptions for persons or institutions concerned with education or scientific research Remarks: not yet in operation The Medicines Board may exempt, with or without conditions or restrictions, a person or institution concerned with education or scientific research from the application of sections 143 and 144 of the Ordinance if the proprietary Chinese medicine in question is required for the purpose of education or scientific research. Cap 549F reg 34 Exemptions for proprietary Chinese medicines imported for re-export and conducting clinical trials or medicinal tests Remarks: not yet in operation Sections 143 and 144 of the Ordinance shall not apply in respect of a proprietary Chinese medicine which is- (a) imported by a wholesaler in proprietary Chinese medicines for the purpose of re-exporting by the same wholesaler; or (b) imported by a holder of a valid certificate for clinical trial and medicinal test issued under section 129 of the Ordinance and to be used for the purpose of the clinical trial or medicinal test to which the certificate relates. Cap 549F reg 35 Exemptions for proprietary Chinese medicines manufactured in Hong Kong and to be exported Remarks: not yet in operation Section 144 of the Ordinance shall not apply in the case where a person is in possession of a proprietary Chinese medicine manufactured in Hong Kong for the purpose of exporting the medicine. Cap 549F reg 36 Exemptions for proprietary Chinese medicines compounded by Chinese medicine practitioners or in accordance with prescriptions given by Chinese medicine practitioners Remarks: not yet in operation Sections 143 and 144 of the Ordinance shall not apply in respect of a proprietary Chinese medicine which is- (a) compounded by or under the supervision of a registered or listed Chinese medicine practitioner at the premises where he practises if, and only if, such proprietary Chinese medicine is being used for the purpose of administering or supplying to a patient under his direct care; or (b) individually prepared or compounded- (i) by a responsible person; or (ii) under the supervision of such person, at the premises in respect of which a retailer licence is in force and in accordance with a prescription given by a registered or listed Chinese medicine practitioner. Cap 549F reg 37 Exemptions for proprietary Chinese medicine manufactured in accordance with prescriptions given by Chinese medicine practitioners and to be administered or supplied to their patients Remarks: not yet in operation (1) Sections 119 and 144 of the Ordinance shall not apply in respect of a proprietary Chinese medicine if- (a) the medicine is manufactured- (i) in the premises in respect of which a manufacturer licence is in force; and (ii) by or under the supervision of a responsible person in accordance with a prescription given by a registered or listed Chinese medicine practitioner;(b) the medicine is- (i) for internal application or both internal and external application, and the medicine is to be administered or supplied to the patient to whom the prescription is given and who is under the direct care of the Chinese medicine practitioner; or (ii) for external application only, and the medicine is to be administered or supplied to a patient or patients under the direct care of the Chinese medicine practitioner; and(c) the Medicines Board has received from the manufacturer, at least 1 working day before the day on which the manufacturing process of the medicine begins, a written notification including the particulars set out in subsection (2) and being accompanied by an undertaking referred to in subsection (3).(2) A notification referred to in subsection (1)(c) shall include- (a) the quantity of the medicine to be manufactured; (b) the names and quantities of each ingredient listed in the prescription; (c) its dose form; (d) the name and address of the registered or listed Chinese medicines practitioner; and (e) the date on which the Chinese medicine practitioner entrusts the manufacturer to manufacture the proprietary Chinese medicine.(3) A notification referred to in subsection (1)(c) shall be accompanied by a written undertaking given by the registered or listed Chinese medicine practitioner to the manufacturer, stating that the medicine will only be administered or supplied to- |
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