Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 11

General duties of holders of wholesaler licences in Chinese herbal medicines

PART 4

DUTIES OF HOLDERS OF WHOLESALER LICENCES IN CHINESE HERBAL MEDICINES

A holder of a wholesaler licence in Chinese herbal medicines shall ensure
that-

   (a)  the premises to which the licence relates are maintained in sanitary
        condition;

   (b)  (i) adequate space; and

        (ii)   adequate and suitable facilities, for storing Chinese herbal
               medicines are provided in the premises;

   (c)  the facilities for storing Chinese herbal medicines are maintained in
        good condition;

   (d)  where any Schedule 1 medicine is stored in the same premises with any
        Schedule 2 medicine or material of herbal, animal or mineral origin
        customarily used by the Chinese for medicinal purpose, the Schedule 
        1 medicine is stored effectively separated from the
        Schedule 2 medicine or material;

   (e)  each type of Chinese herbal medicine stored in the premises is stored
        in a separate container;

   (f)  each container referred to in paragraph (e) is sufficiently stout to
        prevent leakage and contamination arising from the ordinary risks
        involved in handling the Chinese herbal medicine stored in it;

   (g)  where any Chinese herbal medicine or mixture of Chinese herbal
        medicines is processed in the premises-

        (i)    equipment and facilities suitable for processing are provided
               in the premises;

        (ii)   the equipment and facilities for processing are maintained in
               good condition;

        (iii)  the processed medicine or mixture is examined by the licence
               holder to ensure its quality before it is offered for sale or
               supplied to or used by any other person;

        (iv)   the following particulars in relation to each processing are
               recorded- (A) the name and quantity of each type of material
               (including the Chinese herbal medicine or mixture of Chinese
               herbal medicines to be processed) used in the processing; (B)
               the name and quantity of the processed medicine or mixture; (C)
               the name or a description of the processing method; (D) the
               date of the completion of the processing; (E) the result of the
               examination referred to in subparagraph

        (iii)  ; and (F) the name of the person who supervises the processing;

        (v)    the particulars mentioned in subparagraph (iv) are recorded
               within 72 hours after the completion of the processing; and

        (vi)   the record prepared pursuant to subparagraph (iv) is retained
               in the premises to which the licence relates for a period of
               not less than 2 years from the date of the completion of the
               processing;

   (h)  no Chinese herbal medicine in his possession is consigned for
        transport unless suitable arrangements have been made to prevent
        leakage and contamination arising from the ordinary risks involved in
        the delivery and transport of the medicine; and

   (i)  a system of control is set up and maintained, which will enable the
        rapid and, so far as practicable, complete recall of any Chinese
        herbal medicine sold or distributed by him in the event of the
        medicine being found to be dangerous, injurious to health or unfit for
        human consumption.