WHO Technical Report Series, No. 981 - World Health Organization

Annex 4
Collaborative procedure between the World Health
Organization Prequalification of Medicines Programme
and national medicines regulatory authorities in the
assessment and accelerated national registration of
WHO‐prequalified pharmaceutical products
1. Definitions 156
2. Background information 156
3. Principles of collaboration 158
4. Steps in the collaboration for national registration of a
pharmaceutical product 163
5. Collaboration mechanisms for post-registration variations 168
6. Withdrawals, suspensions or delistings of prequalified pharmaceutical
products and national deregistrations 169
Appendix 1. NMRA participation agreement and undertaking for NMRA focal point(s) 170
Appendix 2. Consent of WHO prequalification holder for WHO to share information with
NMRA confidentially under the Procedure 179
Appendix 3. Expression of interest to NMRA for the assessment and accelerated national
registration, acceptance by NMRA and notification of procedure outcomes 181
Appendix 4. Report on post-registration actions in respect of a product registered under
the Procedure 187
155