1987 Ed.]
Pharmacy and Poisons Regulations
[CAP. 138
A 19
[Subsidiary]
PART VII
MANUFACTURERS
29. (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.
(6) For the purpose of exporting pharmaceutical products manufactured by a manufacturer licensed under this regulation, the Committee may issue a free sale certificate in the form prescribed in the Eighth Schedule subject to such conditions as the Committee may impose and upon payment of the fee prescribed in the Ninth Schedule.
(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.
30. (1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by or under the supervision of—
(a) a registered pharmacist;
(b) a Fellow or Associate of the Royal Institute of Chemistry;
or
(c) a person having such other qualifications or sufficient experience as may be approved by the Board.
Licensing of manufacturers. L.N. 369/80.
Ninth Schedule.
Ninth Schedule.
Eighth Schedule, Forms 3 & 4. L.N. 137/78.
Eighth Schedule, Form 5.
L.N. 369/80.
Manufacture to be under supervision of a registered pharmacist.