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Collaborative procedure between the World Health ...
Collaborative procedure between the World Health organization Prequalification of Medicines Programme (WHO/PQP) and national medicines regulatory authorities (NMRAs) in the assessment and accelerated national registration of WHO prequalified pharmaceutical products and vaccines Revision 1, draft for comments 1. Definitions 2. Background information 3. Principles of collaboration 4. Steps in the collaboration for national registration of a pharmaceutical product or a vaccine 5. Collaboration mechanisms for post-prequalification and/or post- registration variations 6. Withdrawals, suspensions or delistings of prequalified pharmaceutical products or vaccines and national deregistrations Appendix 1: NMRA participation agreement and undertaking for NMRA focal point(s).
1 Collaborative procedure between the World Health Organization Prequalification of Medicines Programme (WHO/PQP) and national medicines regulatory authorities (NMRAs) in the assessment and
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