PXL/HO/Cir-052/2025-26                                                                                                     Date: 06.08.2025

Hyderabad

Dear Sir/Madam,

Subject: Mandatory Implementation of Pre-shipment Document Verification, Inspection, Testing and CRIA Requirement for Pharmaceutical Exports to Zambia

We wish to inform our members that the Zambia Medicines Regulatory Authority (ZAMRA) has officially communicated the implementation of a mandatory requirement for pre-shipment document verification, physical inspection, quality control testing, and the issuance of a Clean Report of Inspection and Analysis (CRIA) for all pharmaceutical consignments being exported to Zambia.

This regulation is being implemented to curb the entry of substandard and falsified medicines into the Zambian market and applies to all pharmaceutical products exported from India.

Key Highlights:

• The new requirement will be effective from 1st October 2025.
• All shipments with Bill of Lading dated on or after 1st October 2025must be accompanied by a CRIA.
• The CRIA will be required for customs clearance at Zambian ports of entry.
• Quntrol Laboratories Private Limitedhas been designated by ZAMRA as the authorized agency to carry out the verification, inspection, testing, and CRIA issuance in India.

Exporters are requested to ensure strict compliance with this requirement to avoid any clearance issues at the Zambian border. Please find the Guidelines for Exporters attached for your reference.

We request all member companies exporting formulations to Zambia to take note and act accordingly.

Thanking you,

With Regards

Raja Bhanu

Director General