Call for Expression of Interest and Dossier submissions
The Veterinary Medicines Zazibona: the SADC VMP Collaborative Procedure would like interested applicants to submit Expression of Interest (EoI) and submit dossiers for review for the second pilot phase of the SADC VMP joint assessment procedure.
The SADC VMP joint assessment procedure provides a platform for joint assessment of VMP applications for registration and Good Manufacturing Practices (GMP) of manufacturers of VMPs by the National Medicines Regulatory Authorities (NMRAs) of actively participating of SADC MS namely Botswana, South Africa, Tanzania, Zambia and Zimbabwe. Namibia and Malawi are observers and other SADC MS willing to participate may also benefit from this procedure. The SADC VMP collaborative initiative shall make efficient use of the limited resources to ensure timely access to good quality, safe and efficacious veterinary medicines to the end users in the SADC region, while at the same time building regulatory capacity of the participating NMRAs. The Initiative is earmarked to aid reduction in the workload in participating member states by avoiding duplication of assessment efforts, improve / increase mutual trust and confidence in the regulatory capacities of all collaborating members states, thus facilitating successful recognition and reliance procedures, provide a platform for training and capacity building in other regulatory fields; and possibly reduce registration timelines. In return, Industry will have access to a wider market for distribution of their VMPs that would have gone through this collaborative initiative.
Inclusion and exclusion criteria for the SADC VMP Collaborative Procedure
The SADC VMP Collaborative Procedure will consider EoIs from Manufacturers or Applicants willing to participate in this VMP registration collaborative initiative. The Applicants should submit applications for registration of VMPs that are used in the treatment or prevention of the following diseases identified by various Status of Animal Health in SADC Region Bulletins,
1. Rabies,
2. Lumpy Skin Disease,
3. Heartwater,
4. Fowl Pox,
5. Blackleg,
6. Brucellosis,
7. Anaplasmosis,
8. African Swine Fever,
9. Theileriosis,
10. Peste Des Petis Ruminants,
11. Newcastle Disease,
12. Contagious Bovine Pleuropneumonia,
13. African Horse Sickness,
14. Foot rot,
15. Babesiosis,
16. Contagious Pustular Dermatitis,
17. Rift Velley Fever.
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