Hong Kong Regulations

CHINESE MEDICINES REGULATION - SECT 2

Interpretation

In this Regulation, unless the context otherwise requires-

"batch number" (批次編號) means a series of numbers, letters or other
symbols, or a series consisting of a combination of numbers, letters and other
symbols, used-

   (a)  in the case of a Chinese herbal medicine supplied to a wholesale
        dealer in Chinese herbal medicines, for the purpose of identifying
        when and by whom the medicine is supplied to the dealer; or

   (b)  in the case of a proprietary Chinese medicine, for the purpose of
        identifying when and by whom the medicine is produced;

"excipient" (賦形劑), in relation to a proprietary Chinese medicine, means
a substance or compound that is used or intended to be used in the preparation
or production of the medicine but which is not an active ingredient of the
medicine;

"expiry date" (失效日期), in relation to a proprietary Chinese medicine,
means the expiry date of the medicine as determined by the manufacturer who
produces the medicine, being the date after which the medicine should not be
administered;

"ingredient" (成分), in relation to a proprietary Chinese medicine, means-

   (a)  its active ingredient; or

   (b)  its excipient;

"intermediate product" (中間產品) means a substance or compound generated
in the course of manufacture of a proprietary Chinese medicine and which is to
be used in further preparation or production process of the medicine;

"manufacturing process" (製造程序), in relation to a proprietary Chinese
medicine, means the preparation, production, packing or repacking process of
the medicine;

"packing material" (包裝物料), in relation to a proprietary Chinese
medicine, means a material used for packing or repacking the medicine;

"responsible person" (負責人)-

   (a)  in relation to the dispensing of Chinese herbal medicines, means a
        person responsible for the supervision of the dispensing or his
        deputies-

        (i)    as nominated in an application for a retailer licence under
               section 114(2)(b) of the Ordinance; or

        (ii)   as notified to the Medicines Board under section 145(2) of the
               Ordinance;

   (b)  in relation to the manufacture of proprietary Chinese medicines, means
        a person responsible for the supervision of the manufacture or his
        deputies-

        (i)    as nominated in an application for a manufacturer licence under
               section 132(1)(b) of the Ordinance; or

        (ii)   as notified to the Medicines Board under section 145(2) of the
               Ordinance;

"Schedule 1 medicine" (附表1藥材) means a Chinese herbal medicine
specified in Schedule 1 of the Ordinance;

"Schedule 2 medicine" (附表2藥材) means a Chinese herbal medicine
specified in Schedule 2 of the Ordinance;

"Vocational Training Council" (職業訓練局) means the Vocational Training 
Council established under section 4 of the Vocational Training Council 
Ordinance ( Cap 1130).

"batch number" (批次編號)

"excipient" (賦形劑)

"expiry date" (失效日期)

"ingredient" (成分)

"intermediate product" (中間產品)

"manufacturing process" (製造程序)

"packing material" (包裝物料)

"responsible person" (負責人)

"Schedule 1 medicine" (附表1藥材)

"Schedule 2 medicine" (附表2藥材)

"Vocational Training Council" (職業訓練局)