Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 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

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-

   (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.