The initiative conducts product-based inspections to support product registration, generally facilities are inspected within 6 months from the time of initial dossier review. However, it should be noted that ZaZiBoNa inspections are scheduled quarterly with 3-4 facilities being considered in each inspection schedule.
Read MoreAs a manufacturer or applicant, you will receive a List of Queries after the initial review of your product. If the outstanding issues to be addressed include confirmation of GMP compliance through a site GMP inspection or a GMP Desk Review you need to contact the Joint Inspections Coordinator on SMutyavaviri@mcaz.co.zw and gmp@mcaz.co.zw. Correspondence on
Read MoreThe inspection fees are as follows; FACILITY TYPE FEE (US$) Envisaged inspection days 1 Non-Sterile plant (<3 dosage forms i.e. tablets & capsules and one other)) 8,000 3 2 Sterile and special plant* (NB: plant with svp and powders treated as 2 different plants) 10,000 3 3 Plant with 3 dosage forms
Read MoreYes, a dossier should have been submitted for an applicant to be eligible for a ZaZiBoNa inspection. This is because ZaZiBoNa GMP inspections are done to support product registration.
Read MoreA ZaZiBoNa GMP inspection is conducted to support product registration. A manufacturer to be considered for an inspection should have submitted dossiers for product registration in any two of the Active ZaZiBoNa countries. Currently product-based inspections are conducted. Any two of the ZaZiBoNa countries and a third observing country will come for the onsite inspection.
Read MoreThe ZaZiBoNa project implementing agency is the Medicines Control Authority of Zimbabwe (MCAZ). Their address is; 106 Baines Avenue Harare Zimbabwe All general correspondences are directed to the Director General-MCAZ, email address, mcaz@mcaz.co.zw; Products evaluations and registration are directed to the Joint Assessments Coordinator, Mr F. Masekela on the following email address: fmasekela@mcaz.co.zw; GMP specific
Read MoreThe SADC Member States are involved at differing levels. Active Member States (Countries that can apply a registration and inspection system by virtue of having in place national requirements and processes. They participate in product evaluation and manufacturing site inspection in accordance with agreed standards). These are: Botswana Democratic Republic of Congo Malawi Mozambique Namibia
Read MoreZaZiBoNa is the collaborative medicines registration initiative for the 16 SADC Member States. ZaZiBoNa was established in 2013 by four countries, Zambia, Zimbabwe, Botswana and Namibia. Although the initiative has expanded beyond these four countries, the name ZaZiBoNa has been maintained because of its special meaning in Nyanja, one of the local Zambian languages: “look
Read MoreProducts 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)
Read MoreNo. Variations are currently not being considered under ZaZiBoNa. Applications for variations are considered in the individual countries.
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