PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Wednesday, 30 September 2020

Evaluations

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.

 

Registration

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.

Latest News

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Draft Medicines and Allied Substances Control (Blood and Blood Components) Regulations

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Draft SADC Variations Guidelines

20 March 2020

Draft SADC Variations Guidelines are now available  Click the following links to download the guidelines and the comments sheet Draft SADC Variations Guidelines Draft SADC Variations Guidelines Comments Sheet

Code of Ethics

22 August 2019
Code of Ethics

  In pursuit of promoting high ethical standards, the Authority has formulated a Code of Ethics for its employees and members of the Authority .The Authority believes that high ethical...

SADC Guideline on Product Information and Labeling

10 July 2019
SADC Guideline on Product Information and Labeling

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Careers @ MCAZ

30 October 2018

JOB ADVERTISEMENT:  DIRECTOR-GENERAL, GRADE F2  The Medicines Control Authority of Zimbabwe (MCAZ) is inviting applications from suitably qualified, honest, self-motivated and experienced applicants for the following vacant position: Director-General X...