1987 Ed.]
Pharmacy and Poisons Regulations
[CAP. 138
A 23
[Subsidiary]
(a) by the manufacturer, if the pharmaceutical product or substance is manufactured in Hong Kong,
(b) by the importer, if the pharmaceutical product or substance is manufactured outside Hong Kong; or
(c) by the local branch, subsidiary, representative, agent or distributor of an overseas manufacturer.
(1A) Nothing in paragraph (1) shall apply in the case of possession or use where the pharmaceutical product or substance-
(a) has been imported into Hong Kong-
(i) to be exported outside Hong Kong;
(ii) by a pharmaceutical manufacturer for the purpose of manufacture or the compounding of pharmaceutical preparations;
(iii) for the purpose of treatment by a registered medical practitioner or a registered dentist, of a particular patient or, for the purpose of treatment by a duly qualified veterinary surgeon of a particular animal; or
(b) has been manufactured in Hong Kong to be exported outside Hong Kong.
(2) Application for the initial registration of a pharmaceutical product or substance shall be made in the form prescribed in the Eighth Schedule and shall be accompanied by the fee prescribed in the Ninth Schedule.
(3) The particulars to be registered shall include--
(a) the trivial, proprietary or approved name of the product or substance;
(b) the chemical name in the case of a substance which has no trivial, proprietary or approved name;
(c) details of the composition in the case of a product;
(d) the name and address of the manufacturer;
(e) the name and address of the person who applies for registration; and
(f) the quantity or quantities of the dose form contained in a unit package or unit packages in the case of a product.
(4) Representative specimen sales packs of the product or representative samples of the substance shall be made available for inspection by the Committee. In the case of products not yet marketed the Committee may accept prototypes of the packs and proposed wordings of the labels on the understanding that these will be replaced by actual sale packs not later than 6 months after registration of the product or substance.
(5) The Committee may issue to an applicant a registration certificate in the form prescribed in the Eighth Schedule valid for a period of 5 years from the date of registration on payment of the fee prescribed in the Ninth Schedule.
L.N. 85/87.
Eighth Schedule, Form 6. Ninth Schedule.
L.N. 137/78.
L.N. 137/78.
Eighth Schedule. Form 7. L.N. 137/78.
Ninth Schedule.