Veterinary Medicines Zazibona
The Veterinary Medicines Zazibona Collaborative Procedure for Veterinary Medicinal Products (VMP) is a Southern African Development Community (SADC) initiative. It focuses on joint assessment of dossiers and Good Manufacturing Practices inspections of manufacturers by the active SADC Member States (MS) through the collaborative initiative. This initiative is leveraging on the efforts and success of the Zazibona Collaborative Procedure, a similar SADC harmonization initiative for joint assessment of human medicine applications and inspection of human medicine facilities and the success of other regional collaborative initiatives e.g., the EAC, WAEMU/UEMOA. The active SADC MS include Botswana, South Africa, Tanzania, Zambia and Zimbabwe. Namibia and Malawi are observers and any other SADC MS willing to participate in the Veterinary Medicines Zazibona Collaborative Procedure are free to express interest as they may also benefit from this procedure. The Veterinary Medicines Zazibona Collaborative Procedure aims to facilitate:
- Reduction of timelines for registration of VMPs
- efficient utilisation of available regional resources, and
- ensure the availability of safe, efficacious, and good quality veterinary medicines within the region, thus improving animal health and public health.
The procedure is facilitated by the United Kingdom Veterinary Medicines Directorate (UK-VMD) through the Bill and Melinda Gates Foundation (BMGF). The initiative is at its pilot phase, and the focus is to pilot the joint assessments of pharmaceutical VMP dossiers. Members of the Veterinary Pharmaceutical Industry interested in participating in the pilot SADC VMP joint assessment procedure should comply with the following requirements:
- Call for Expression of Interest (click here)
- Letter of access of Proprietary Information (click here)
- Intention to submit application form (click here)
- Common application form (click here)
- SADC (draft) Technical Guidelines on Registration of Veterinary Pharmaceuticals (click here)
- QOS (Quality Overall Summary) – assessment template for quality section (click here)
- BTIF (Bioequivalence Trial Information Form) – assessment template for Bioequivalence section.