PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Thursday, 28 October 2021

Red Blood Cells Picture.

 The draft Blood and Blood Components Regulations are now available

Please note that this is a DRAFT  that has been uploaded to obtain comments from stakeholders before the regulations are finalised. Kindly submit your comments to This email address is being protected from spambots. You need JavaScript enabled to view it. on or before Monday the 26th of July, 2020.

Download the regulations using the following link

 

This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat or
cure COVID-19.

 

Medical Product Alert N°3/2020 Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19

SADC Pic.

 

Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization of product information and labelling requirements within the region has been outstanding. Harmonizing regulatory standards to create one regional market and mutual recognition is one of the strategies included in the draft Strategy on Regional Manufacturing of Essential Medicines and Health Commodities (2016-2020), which supports the pharmaceutical component in the SADC Industrialization Strategy and Roadmap 2015 – 2063. Moreover, this supports the priority areas of creating an enabling regulatory environment and strengthening medicines regulatory capacity in the approved SADC Pharmaceutical Business Plan 2015 – 2019.
 
Taking into account the need for stakeholder engagement in drafting regulatory guidelines, a workshop with industry and regulators was held as the initial step in developing a regional guideline on product information and labelling. This engagement resulted in drafting instructions for the product information and labelling guideline that were approved by the regulators forum. Subsequently, these drafting instructions were utilized for formulating the guidelines presented in this document. Please Click the following links to download the Guidelines and Table for Comments.

SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING

SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING: TABLE FOR COMMENTS

Draft SADC Variations Guidelines are now available 

Click the following links to download the guidelines and the comments sheet

The Quality Policy of the Medicines Control Authority of Zimbabwe (MCAZ) is to ensure the provision of accurate and timeous services, continuously meet requirements of our customers and guarantee patient safety as stated in the Medicines and Allied Substances Control Act (Chapter 15:03). This enables the Authority to be an effective medicines regulator in Zimbabwe and a leading regulatory authority in the world. MCAZ is committed to protecting the public and animal health by ensuring that accessible medicines, allied substances and medical devices are safe, effective and of good quality. This is achieved by carrying out activities in accordance with the relevant procedures and specifications.

Click here to view Quality Policy Statement

 

Latest News

MCAZ Reliance Policy

16 August 2021
MCAZ Reliance Policy

The Medicines Control Authority of Zimbabwe (MCAZ) is the statutory body responsible for protecting public and animal health by ensuring that all medicines, devices, allied substances, and other health commodities...

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Code Of Ethics

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Quality Policy Statement

20 April 2021
Quality Policy Statement

The Quality Policy of the Medicines Control Authority of Zimbabwe (MCAZ) is to ensure the provision of accurate and timeous services, continuously meet requirements of our customers and guarantee patient...

Covid-19 Vaccine Applications Submission Guidance

12 January 2021
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Guidance on submission of covid-19 vaccine applications for emergency use authorisation and registration have been published. Click  MCAZ COVID-19 VACCINE GUIDANCE-VERSION 11 download the guideline.

2019 Customer Complaints Trends Analysis

29 October 2020
2019 Customer Complaints Trends Analysis

  In order to improve service delivery to our valued customers, MCAZ collects information on Customer Complaints.   To download the 2019 Customer Complaints Trends Analysis Click here 

MCAZ Covid-19 Health and Safety Guidelines

29 September 2020
MCAZ Covid-19 Health and Safety Guidelines

The Medicines Control Authority of Zimbabwe (MCAZ) Covid-19 Health and Safety Guidelines applies to MCAZ staff with the intention of preventing workplace infections, protecting lives, and promoting employee health for...

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

26 June 2020
Draft Medicines and Allied Substances Control (Blood and Blood Components) Regulations

 The draft Blood and Blood Components Regulations are now available Please note that this is a DRAFT  that has been uploaded to obtain comments from stakeholders before the regulations are...

Medical Product Alert ; Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19

06 April 2020
Medical Product Alert ; Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19

  This Medical Product Alert warns consumers, healthcare professionals, and health authorities against a growing number of falsified medical products that claim to prevent, detect, treat orcure COVID-19.   Medical...

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

SADC Guideline on Product Information and Labeling

10 July 2019
SADC Guideline on Product Information and Labeling

  Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization...