Tuesday, 15 October 2019
The Medicines and Allied Substances Control Act (MASCA)[15:03] and the Medicines and Allied Substances Control Regulations (MASCR) SI 150 of 1991 requires that all medicines be registered, after scientific scrutiny of quality, safety and efficacy data, before they are allowed to be used on the Zimbabwean public and/or animals. The Evaluations and Registration (EVR) Division is responsible for the evaluation of both human and veterinary pharmaceutical and biological (vaccines) products. The EVR Division reviews safety, quality and efficacy of medicines in accordance with the requirements of MASCA [15:03], MASCR SI 150 of 1991, the MCAZ Registration Guidelines, Registration Committee policies and approved internal procedures (SOPs) which are in accordance with the MCAZ Quality Management System (QMS). The technical elements in the MCAZ Registration Guideline are based on Southern African Development Community (SADC) Registration Guidelines, WHO norms and standards or equivalent. For sophisticated novel dosage forms and other new products, the EVR Division borrows concepts from WHO, ICH, USFDA, EMA and other leading regulatory agencies, as appropriate.
Approval of Registration of Medicines
The Registration Committee or the Veterinary Committee registers medicines that have met all the technical & legal requirements i.e. evaluation of dossier, analysis of samples and GMP compliance.
These successful applications will be issued with registration certificates and published in the MCAZ medicines register.
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