1. The normal pathway involves full dossier review to check for compliance in quality, safety, and efficacy of medicines.
  2. The Stringent Regulatory Agencies (SRA) registration procedure can be used to accelerate assessment of products already approved by globally recognized regulatory agencies; for example, the European Medicines Agency (EMA).

 WHO-prequalified products are not eligible for consideration under Zazibona, as most SADC countries participate in the WHO prequalification collaborative registration procedure.

Variations

Variations for products registered under the collaborative initiate are considered under the collaborative procedure:

Download Guideline here