An application for the registration of a medicine shall be submitted to the Director-General in Common Technical Document (CTD) form and accompanied by the prescribed fee payable in respect of an application for the registration of a medicine. A complete application consists of a product dossier, samples and application fees. A completed screening checklist should also be submitted as evidence that the applicant checked completeness of the dossier before submission. The screening checklist is included as Annex II of the MCAZ CTD Registration Guidelines. Annex IV of the MCAZ CTD Registration Guidelines states the quantities of sample(s) required at submission. The CTD Registration Guidelines, fee schedule and the statutes are available on MCAZ website www.mcaz.co.zw.
MCAZ reviews applications for registration of medicines and there are various possible outcomes depending on the sufficiency of provided documentation for the medicine. When the documentation in the submission is grossly deficient or the medicine contains undesirable ingredients or it is not in the public interest to register the medicine, the Authority can refuse registration of the product. When the information provided is critically deficient such that the safety, efficacy and quality of the product cannot be immediately ascertained, the Authority can intend to refuse the product.
When the applicant has managed to address critical issues with regard to the safety, efficacy and quality of the medicines, within a defined window period of 60 days, the product can be conditionally approved or the Authority can intend to register the product subject to the applicant addressing any minor outstanding issues within the window period. When the Authority is satisfied that the medicine is safe, efficacious and of good quality, it is approved and a marketing authorisation (registration certificate) will be issued. This means that the product can be distributed in Zimbabwe and can be used by the general public.