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[接上页] (a) (in the case where the medicine is for internal application or both internal and external application) the patient to whom the prescription is given and who is under his direct care; or (b) (in the case where the medicine is for external application only) a patient or patients under his direct care. Cap 549F reg 38 Certificate of sale of proprietary Chinese medicine PART 13 FORMS A certificate issued under section 130(1) of the Ordinance shall be in the form prescribed in Schedule 3. Cap 549F reg 39 Manufacturer licence A licence issued under section 132(2) of the Ordinance shall be in the form prescribed in Schedule 4. Cap 549F reg 40 Certificate for manufacturer A certificate issued under section 133 of the Ordinance shall be in the form prescribed in Schedule 5. Cap 549F Sched 1 MINIMUM REQUIREMENTS REGARDING KNOWLEDGE AND EXPERIENCE OF RESPONSIBLE PERSONS [sections 3 & 5] 1. A responsible person nominated under section 114(2)(b) of the Ordinance shall- (a) (i) hold a bachelor's degree in Chinese medicine awarded by a university in Hong Kong; or (ii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i), and have 6 months' practical experience in dispensing Chinese herbal medicines in Hong Kong;(b) (i) hold a diploma in Chinese medicines awarded by a university in Hong Kong; (ii) hold a diploma in Chinese medicines awarded by the Vocational Training Council; or (iii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i) or (ii), and have 1 year's practical experience in dispensing Chinese herbal medicines in Hong Kong;(c) in the case where he is a registered or listed Chinese medicine practitioner, have 6 months' practical experience in dispensing Chinese herbal medicines in Hong Kong; (d) in the case where he is a pharmacist registered under the Pharmacy and Poisons Ordinance (Cap 138)- (i) hold a postgraduate certificate in Chinese medicines awarded by a university in Hong Kong; or (ii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i), and have 1 year's practical experience in dispensing Chinese herbal medicines in Hong Kong;(e) (i) hold a certificate in Chinese medicines awarded by a university in Hong Kong on completion of a 120 hour course; (ii) hold a certificate in Chinese medicines awarded by the Vocational Training Council on completion of a 120 hour course; or (iii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i) or (ii), and have 3 years' practical experience in dispensing Chinese herbal medicines in Hong Kong; or(f) have 5 years' practical experience in dispensing Chinese herbal medicines in Hong Kong.2. A responsible person nominated under section 132(1)(b) of the Ordinance shall- (a) (i) hold a bachelor's degree in Chinese medicine awarded by a university in Hong Kong; or (ii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i), and have 6 months' practical experience in manufacturing proprietary Chinese medicines in Hong Kong;(b) (i) hold a diploma in Chinese medicines awarded by a university in Hong Kong; (ii) hold a diploma in Chinese medicines awarded by the Vocational Training Council; or (iii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i) or (ii), and have 1 year's practical experience in manufacturing proprietary Chinese medicines in Hong Kong;(c) in the case where he is a registered or listed Chinese medicine practitioner, have 6 months' practical experience in manufacturing proprietary Chinese medicines in Hong Kong; (d) in the case where he is a pharmacist registered under the Pharmacy and Poisons Ordinance (Cap 138)- (i) hold a postgraduate certificate in Chinese medicines awarded by a university in Hong Kong; or (ii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i), and have 6 months' practical experience in manufacturing proprietary Chinese medicines in Hong Kong;(e) (i) hold a certificate in Chinese medicines awarded by a university in Hong Kong on completion of a 120 hour course; (ii) hold a certificate in Chinese medicines awarded by the Vocational Training Council on completion of a 120 hour course; or (iii) have a qualification which, in the opinion of the Medicines Board, is equivalent to that mentioned in subparagraph (i) or (ii), and have 3 years' practical experience in manufacturing proprietary Chinese medicines in Hong Kong; or(f) have 5 years' practical experience in manufacturing proprietary Chinese medicines in Hong Kong. Cap 549F Sched 2 OFFENCES AND PENALTIES Remarks: not yet in operation [section 31] Column 1 Section Column 2 Fine Column 3 |