Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 18

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

(1) A holder of a manufacturer licence shall ensure that the following
particulars in respect of each manufacturing process of a proprietary Chinese
medicine carried out by him are recorded-

   (a)  the name of the intermediate product generated or proprietary Chinese
        medicine manufactured from the manufacturing process, or both, as the
        case may be;

   (b)  the quantity of the batch of product or medicine, or both, as the case
        may be;

   (c)  the expiry date and batch number of the batch of medicine

(applicable only where a proprietary Chinese medicine is manufactured from the
manufacturing process);

   (d)  the name and quantity of each ingredient or packing material used in
        the manufacturing process;

   (e)  a description of each manufacturing method used; and

   (f)  the date on which the manufacturing process-

        (i)    begins; and

        (ii)   is completed.

(2) The licence holder shall also ensure that-

   (a)  the particulars mentioned in subsection (1) (other than those referred
        to in subsection (1)(b) and (f)(ii)) are recorded within 72 hours
        after the manufacturing process begins;

   (b)  the particulars mentioned in subsection(1)(b) and (f)(ii) are recorded
        within 72 hours after the manufacturing process is completed; and

   (c)  subject to subsection (3), 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 record relates to a batch of
               intermediate  product, from the date of the last transaction in
               the batch of product or the date when the batch of product is
               used up by the licence holder, whichever is later; or

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

(3) Where the record prepared pursuant to subsection (1) relates to a batch of
intermediate product and proprietary Chinese medicine, the record shall be
retained until the expiry of 2 years from the latter of the dates referred to
in subsection (2)(c)(i) or (ii).