PXL/HO/Cir-031/2025-26                                                                                                     Date: 28.06.2025

Hyderabad

Subject:Implementation of Pre-Shipment Inspection (PSI) for Exports to Botswana – Effective 1st July 2025

Dear Members,

The Council has received official communication from the Botswana Medicines Regulatory Authority (BoMRA) regarding the implementation of Pre-Shipment Inspection (PSI) for specific categories of medicine consignments exported to Botswana, effective 1st July 2025.

The PSI requirement applies to:

1. Medicines exempted from registrationand
2. Products manufactured at identified facilities, as classified by BoMRA.

To facilitate this process, BoMRA has appointed Quntrol Laboratories Private Limited as the designated agency responsible for:

• Inspection and testing of consignments,
• Certification of compliance with applicable regulatory standards, and
• Issuance of a Certificate of Regulatory Inspection and Approval (CRIA) for eligible shipments.

Key Compliance Requirements for Exporters:

• Exporters must obtain the CRIA from Quntrol Laboratories before goods are cleared at Botswana ports of entry.
• Presentation of a valid CRIA will be a mandatory condition for consignment clearance.
• Non-compliance may result in denial of entry or further regulatory consequences.

Please refer to the attached guidelines shared by BOMRA in this regard. Members are advised to initiate timely coordination with Quntrol Laboratories and ensure compliance with the new pre-shipment requirements to avoid any disruptions in exports to Botswana. For any further clarifications, members may please write to dgdesk@pharmexcil.com& regulatory@pharmexcil.com. 

We appreciate your cooperation in adhering to these updated regulations.

Warm Regards,

Raja Bhanu

Director General

Enclosed: PSI Notifications

                BoMRA Guidelines