Last Updated on October 16, 2023
DRAP is responsible for ensuring that therapeutic goods approved and available in market for the people of Pakistan must meet the prescribed standards of quality, safety and efficacy. DRAP has a regulatory oversight on import and export of all types of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws.
DRAP denies the entry of therapeutic good that does not comply to the regulatory requirements to prevent the infiltration of any substandard and suspected falsified product into the supply chain system.
Commercial Import and Export
Manufacturers and Importers of therapeutic goods who has valid registration/ marketing authorization of their products with DRAP can import 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, bio-chemic and Chinese products) and their raw materials for their respective products with the approval from DRAP.
In order to facilitate the therapeutic goods’ industry for ease of doing business and provision of conducive environment for compliance to regulatory requirement, DRAP has introduced electronic application management system online import and export system (OIES) which enable applicants and regulators to communicate electronically for management of import and export related information and processing of applications related to permission for import and export of therapeutic goods.
Applications for the import and export of authorized therapeutic goods are reviewed and approved by Import and Export Section of QA< Division. DRAP has issued a guideline to assist the applicants on the regulatory mechanism and procedures to be followed for Import and Export of therapeutic goods.
The application process flows for applications under this category are provided below:
Import procedures
Drug Import License (D.I.L) :-
Application for grant of Drug Import License shall be submitted by applicant on online portal with requisite documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 05 days |
Import Clearance Certificate of Finished Drugs :-
Application for grant of NOC for Import of Finished Drugs for commercial purpose shall be submitted by applicant on online portal with mandatory documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 05 days |
Import Clearance Certificate of Raw Material :-
Application for grant of clearance certificate for Import of raw material or packaging material (other than finished drugs) shall be submitted by applicant on online portal with requisite documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 05 days |
Export procedure
Drug Export License (D.E.L) :-
Application for grant of Drug Export License shall be submitted by applicant on online portal with mandatory documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 05 days |
Export NOC of Finished Drugs :-
Application for grant of NOC for Export of Finished Drugs for commercial purpose shall be submitted by applicant on online portal with supporting documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 02 days |
Export NOC of Raw Material :-
Application for grant of NOC for Export of raw material/ packaging material (other than finished drugs) shall be submitted by applicant on online portal with supporting documents. The application process flow is being provided for illustrative purpose.
Process Timeline | 02 days |