Board Decisions

GF/B25/EDP19


Approved by the Board on:
26 April 2012


Exception to the Quality Assurance Policy for Pharmaceutical Products for the Procurement of Ritonavir 100mg in Cuba

The Board refers to the Quality Assurance Policy for Pharmaceutical Products (the “QA Policy”) (as last approved and amended in GF/B22/DP9), and the requirement set forth therein that Global Fund grant funds may only be used to purchase Finished Pharmaceutical Products which comply with the QA Policy.

The Board grants an exception to the quality standards set forth in the QA Policy such that sufficient quantities of ritonavir 100mg may be procured under existing Global Fund grants in Cuba to avoid a treatment disruption.

This exception is valid until a source of ritonavir 100mg that is compliant with the quality standards of the QA Policy is available for the Global Fund Cuba programs, and if such a source becomes available and a procurement of ritonavir 100mg can be made from that source in time to avoid a treatment disruption in Cuba, that procurement should be made and this exception should not be applied.

The Secretariat shall take appropriate measures to minimize and address any quality risks associated with the procurement authorized by this decision, including:

  1. Requiring that, at a minimum, the manufacturing site of the ritonavir 100mg procured must, at the time of the procurement, be in compliance with Good Manufacturing Practices as verified by the WHO Prequalification Programme, a Stringent Drug Regulatory Authority, or a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme; and
  2. Applying the notification/confirmation and systematic quality control testing as described in paragraphs 9 and 31 of the QA Policy to such procurement.

  • Related Decision Points: