Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 17

Other duties of holders of manufacturer licences-keeping of documents relating to acquisition of ingredients

(1) A holder of a manufacturer licence shall ensure that every transaction
whereby a batch of ingredient is acquired or received by him is evidenced by
an invoice or other document.

(2) The licence holder shall ensure that the invoice or other document
evidencing the transaction contains the following particulars in respect of
the transaction-

   (a)  the date of the transaction;

   (b)  the name and quantity of the batch of ingredient acquired or received
        by him;

   (c)  the name, address and telephone number of the person who sells or
        distributes the batch of ingredient to him; and

   (d)  the reference number of the invoice or other document.

(3) Subject to subsections (4) and (5), the licence holder shall also ensure
that 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-

   (a)  in the case where a batch of intermediate product is generated from
        the batch of ingredient, from the date of generation of the batch of
        product; or

   (b)  in the case where a batch of proprietary Chinese medicine is
        manufactured from the batch of ingredient, from the expiry date of the
        batch of medicine.

(4) Where 2 or more batches of intermediate product or proprietary Chinese
medicine are generated or manufactured, as the case may be, from the batch of
ingredient and they have different dates of generation or expiry dates, as the
case may be, the invoice or other document shall be retained until the expiry
of 2 years from the latest of such dates of generation or expiry dates, as the
case may be.

(5) Where a batch of intermediate product is generated and a batch of
proprietary Chinese medicine is manufactured from the batch of ingredient, the
invoice or other document shall be retained until the expiry of 2 years from
the latter of the dates referred to in subsection

(3)(a) or (b).