Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 19

Other duties of holders of manufacturer licences-keeping of transaction records

(1) A holder of a manufacturer licence shall ensure that the following
particulars in respect of every transaction whereby a batch of
intermediate product generated or a batch of proprietary Chinese medicine
manufactured in the course of manufacture is sold or distributed by him are
recorded-

   (a)  the date of the transaction;

   (b)  the name and quantity of the batch of product or medicine sold or
        distributed, as the case may be;

   (c)  the name, address and telephone number of the person to whom he sells
        or distributes the batch of product or medicine, as the case may be;

   (d)  the batch number of the batch of medicine (applicable only where the
        transaction relates to a proprietary Chinese medicine); and

   (e)  the reference number of the invoice or other document evidencing the
        transaction.

(2) The licence holder shall ensure that-

   (a)  the particulars mentioned in subsection (1) are recorded within 72
        hours after the completion of the transaction; and

   (b)  the record prepared pursuant to subsection (1) is retained in the
        premises to which the licence relates from the date of preparation of
        the record until the expiry of 2 years-

        (i)    in the case where the transaction relates to a batch of
               intermediate product, from the date of the transaction; or

        (ii)   in the case where the transaction relates to a batch of
               proprietary Chinese medicine, from the expiry date of the batch
               of medicine.

(3) The licence holder shall also ensure that-

   (a)  every transaction mentioned in subsection (1) is evidenced by an
        invoice or other document which contains the particulars mentioned in
        that subsection; and

   (b)  the invoice or other document evidencing the transaction is retained
        in the premises to which the licence relates from the date of the
        transaction until the expiry of 2 years from the dates referred to in
        subsection (2)(b)(i) or (ii), as the case may be.