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Drugs (Licensing, Registering and Advertising) Rules, 1976.

Country/Territory
Pakistan
Document type
Regulation
Date
1976 (2017)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Drugs Packaging/labelling Registration Authorization/permit Animal health Transport/storage Inspection Internal trade International trade
Geographical area
Asia, Asia and the Pacific, Indian Ocean, South Asian Seas, Southern Asia
Entry into force notes
These Rules enter into force immediately.
Abstract

These Rules, consisting of four Chapters completed by seven Schedules, establish Drugs (Licensing, Registering and Advertising) regulation. In exercise of the powers conferred by Section 41 of the Drugs Ordinance, 1976 (IV of 1976), the Federal Government makes the following rules. They establish that any licences to manufacture drugs shall be of the following types: (i) licence to manufacture by way of basic manufacture; (ii) licence to manufacture by way of semi-basic manufacture; (iii) licence to manufacture by way of formulation; (iv) licence to manufacture by way of repacking; and (v) licence to manufacture for experimental purposes. If drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. In addition, for licence to manufacture drugs and fee therefor they apply as follows: (1) An application for the grant or renewal of a licence shall be made to the Central Licensing Board addressed to its Secretary; (2) An application under sub-rule (1) shall be accompanied by the proper fee as specified in Schedule F; (3) If the application for renewal of the licence is made after the expiry of the period of the validity of the licence, it shall be treated as a fresh application for the grant of a licence; (4) A fee shall be paid for a duplicate copy of the licence if the original is damaged or lost.

Full text
English
Website
www.dra.gov.pk

References - Legislation

Implements

Drugs Act, 1976 (Act No. XXXI of 1976).

Legislation | Pakistan | 1976

Keyword: Food quality control/food safety, Residues, Pesticides, Public health, Internal trade, Packaging/labelling, Animal health, Drugs, Transport/storage, Inspection, Authorization/permit

Source: FAO, FAOLEX