The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce that, effective August 15, 2024, we have successfully transitioned from the Online Import Export System (OIES) to the Pakistan Single Window (PSW) for processing applications related to the clearance of commercial imports of raw materials and finished drug products at Karachi Seaport and Airport customs stations.
Pakistan Single Window (PSW) is an electronic portal enabling cross-border trade using standardized information and documents through a single entry point for all import, export, and transit-related regulatory requirements. The information is transmitted electronically, and individual data elements for clearance and regulatory approvals need only be submitted once. Authorized users who have completed the subscription process can access the PSW to perform cross-border procedures, including online payment/fees.
Key Highlights of the Transition:
- Single Declaration Release: DRAP officers are now electronically issuing Release Orders through a Single Declaration (SD) system, streamlining the import/export process for pharmaceutical products.
- Trade Automation: The new system allows for 24/7 electronic submission of cross-border trade applications, including online payment of fees and controlled data processing by authorized users.
- Single Entry Point: Users can now submit standardized information and documents just once, simplifying the application process.
- Clear Visibility and Application Tracking: The PSW system provides clear visibility of actions on applications, eliminating the need for physical visits for application follow-ups. It also allows for electronic calls on documents for any shortcomings.
DRAP Operations at PSW Include:
- Entity Registration: Onboarding of existing Drug Manufacturing Licenses (DMLs), product registrations, and importers with existing drug sale licenses.
- Raw Materials & Finished Drugs: Processing of drug import licenses (Form 5), clearance certificates for the import of raw materials, finished drugs, and controlled drugs.
- Clinical Trials, Tests & Analysis: Issuance of drug import licenses for test analysis (Form 6) and clearance certificates for the import of drugs/medicines for clinical trials.
- Hospital/Institutional Use & Donations: Import permits for unregistered/unavailable drugs and clearance certificates for donation medicines.
Additional Information:
- DRAP Notification: DRAP has issued a notification regarding this transition to ensure all stakeholders are informed and prepared for the new process.
- PSW User Manual: PSW has issued a comprehensive user manual to guide users through the new system, ensuring a smooth and efficient transition.
For further assistance, please contact us at 021-111-111-779 or email support∂psw.gov.pk.