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Alternative Medicines and Health Products (Enlistment) Rules, 2014.

Country/Territory
Pakistan
Document type
Regulation
Date
2014
Source
FAO, FAOLEX
Subject
Livestock, Food & nutrition
Keyword
Food additives Drugs Food quality control/food safety Institution Inspection Authorization/permit Animal health Legal proceedings/administrative proceedings Public health Classification/declassification
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

This Rules establish Alternative Medicines and Health Products (Enlistment) regulation. In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with prior approval of the Federal Government makes the following rules. They establish that the Authority shall enlist alternative medicine and health products, their manufacturers and importers subject to fulfillment of the criteria prescribed below. The following shall be eligible to apply for enlistment namely: a) manufacturers having manufacturing and quality control facilities; b) contract giver as prescribed in rule 6; c) importers authorized by the overseas principal manufacturer; and d) manufacturers holding manufacturing license under the Act may also apply for approval of dedicated sections for manufacturing of alternative medicines or health products and probiotics or food supplements to the Authority and thereafter become eligible to apply for enlistment. Application for enlistment shall be made to the Authority, addressed to the Director of Division of Health and OTC Products (non-drugs) in specific manner. The manufacturing and testing of alternative medicines and health products shall be conducted in accordance with specific criteria laid down in this edition of specified publication or as may be prescribed and approved by the Authority.

Full text
English
Website
www.dra.gov.pk

References - Legislation

Implements

Drug Regulatory Authority of Pakistan Act, 2012 (Act No. XXI or 2012).

Legislation | Pakistan | 2012

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

Source: FAO, FAOLEX