Pakistan's Drug Regulatory Authority (DRAP) has finalized its guidelines for imports and exports of therapeutic goods.
This document applies to the manufacturers, importers, institutions, and individuals, etc. that intend to import or export therapeutic goods for human and veterinary use.
This guidance document is aimed to provide requirements, procedures, and practices for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Products (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemical and Chinese products) and their raw materials.
These guidelines are meant to:
Elaborate on the requirements and documentation
Determine the eligibility;
The elaborate procedure adopted by DRAP for verification and port clearance
Describe the responsibilities of the entities involved
The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods.
These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.
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