GMP FAQs

ZAZIBONA does not register products but provides a recommendation for implementation by the countries. The products are registered in the respective member countries. The process of dossier assessment takes up to 12 months from when an application is submitted to when a recommendation is made. The time to registration is subject to the fulfilment of country specific requirements by the applicant and may vary however a target of not more than 90 days has been set.

No. It is currently not possible to submit applications centrally to ZAZIBONA. To be eligible for the ZAZIBONA collaborative process an application should have been lodged with at least to two (2) ZAZIBONA participating countries in line with national requirements.

The application cost varies with participating country requirements since the applicant is required to submit separate applications and pay the applicable fees to each member state that they intend to market their products.  

No. Variations are currently not being considered under ZaZiBoNa. Applications for variations are considered in the individual countries.

Products used in the treatment of the following conditions; HIV/AIDS, tuberculosis, malaria, acute respiratory infections, diarrhoea, diabetes, pneumonia, cardiovascular, cancer, obstetrics, gastroenteritis and colic, reproductive health products and products included in the list of United Nations Commission for Life-Saving Commodities for Women and Children Final UN Commission Report_14sept2012.pdf (unfpa.org)