Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines that describe the requirements for commercial imports and exports of therapeutic goods including finished products and active ingredients.
This document applies to the manufacturers, importers and individuals or organizations that intends to import or exports of human and veterinary therapeutic goods. These guidelines are intended to aid following :-
i. Importers and manufacturer of therapeutic goods;
ii. Health care professionals or investigators of clinical trials;
iii. Hospitals/Government institutions/ non-Government organizations/trust etc.
This guidance document is aimed at provision of an overview of the requirements, procedures and best practices for imports and exports in compliance with the legal and regulatory requirements for all therapeutic goods including finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials.
This document is intended to provide an outline of the requirements for importing and exporting therapeutic goods for commercial purposes, as well as for bringing therapeutic goods for hospital/intuitional use or personal uses.
These guidelines are meant to:-
Outline the requirements and documentation for import and export of therapeutic goods
Determine the eligibility; who can import or export therapeutic goods
Elaborate procedure adopted by DRAP for verification and port clearance
Describe the responsibilities of the entities involved in import and export
Check out this guidance for more detailed information.
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