Hong Kong Regulations

PHARMACY AND POISONS REGULATIONS - REGULATION 29

Licensing of manufacturers

PART VII

MANUFACTURERS

(1) Subject to paragraph (2), no person shall manufacture any pharmaceutical
product on any premises unless he is the holder of a licence to manufacture
pharmaceutical products on those premises.

(2) Paragraph (1) and regulations 33 and 35 shall not apply to an authorized
seller of poisons, who in the course of his retail business, manufactures any
pharmaceutical product at any premises registered by him under the Ordinance
in quantities which in the opinion of the Board, are consistent with the scope
of his business and the nature of the product.

(3) The Committee may issue a licence to manufacture pharmaceutical products
in such form as it may prescribe on payment of the fee prescribed in the Ninth
Schedule.

(4) The Committee may revoke the licence or suspend it for such period as it
thinks fit, if, in its opinion, the licensee has failed to comply with the
conditions subject to which the licence was issued or with any of these
regulations.

(5) For the purpose of certifying that a manufacturer is licensed under this
regulation, the Committee, subject to any conditions it may impose and to the
payment of the fee prescribed in the Ninth Schedule, may issue to the
manufacturer-

   (a)  a certificate for manufacture; or

   (b)  an interim-certificate for manufacture, in the forms prescribed in the
        Eighth Schedule. (See Eighth Schedule Forms 3 & 4) (L.N. 137 of 1978)

(6) For the purpose of exporting pharmaceutical products manufactured by a
manufacturer licensed under this regulation, the  Committee may, subject to
any conditions it may impose and to the payment of the fee prescribed in the
Ninth Schedule, issue to the manufacturer-

   (a)  a free sale certificate of pharmaceutical product; or

   (b)  a certificate of pharmaceutical product, in the forms prescribed in
        the Eighth Schedule. (see Eighth Schedule, Forms 5 & 5A) (L.N. 449 of
        1991)

(7) Any person aggrieved by a decision of the Committee under this regulation
may, in the prescribed manner, appeal to the Tribunal against that decision.
(L.N. 369 of 1980) (L.N. 369 of 1980)