Applications for variations were traditionally considered in the individual countries. However, with the publication of a draft SADC guideline, draft SADC guideline on the collaborative assessment of post-registration variations, ZAZIBONA is ready to pilot the consideration of variations. The only variations that will be considered are those for products that were registered through the ZAZIBONA collaborative process.
Applicants can submit their applications for variations at national level, indicating they would want the variation considered through the collaborative process.
Renewals are currently not being considered under ZAZIBONA. Applications for renewals are considered in the individual countries, however, it is envisioned that in the near future, a guideline will be published enabling the assessment of renewals under ZAZIBONA.