GF/B22/DP09
Approved by the Board on: 15 December 2010
Amendment to the Quality Assurance Policy for pharmaceutical products
The Board approves the amendment and restatement of the Quality Assurance Policy for Pharmaceutical Products as set out in Annex 1 to the report of the Market Dynamics and Commodities Ad-hoc Committee (MDC) to the Board (GF/B22/11, Revision 1) (the QA Policy).
The Board requests the Secretariat to explain to grant recipients in writing the implications of the termination of the Interim Exception and the changes to the eligibility criteria for the review of Finished Pharmaceutical Products by the Expert Review Panel (ERP) as specified in the QA Policy.
The Board requests the World Health Organisation (WHO) to consider evaluating products under the WHO Prequalification Programme in circumstances where the relevant product may only have a limited geographical relevance.
The Board confirms that, as requested by the Board at its Twenty-First Board Meeting (GF/B21/DP16), the MDC has reviewed the updated Expert Review Panel (ERP) process to deal with exceptional cases, and considers it to be satisfactory.