PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Tuesday, 18 February 2020

Enforcement Activities

The MCAZ is concerned about the illicit importation, and illegal sale of medicines on the market, including medicines being sold on the street. The Authority regularly carries out blitzes in conjunction with the Zimbabwe Republic Police (ZRP), and works with the ZRP and National Prosecuting Authority in prosecuting perpetrators. The Authority carries out capacity building exercises which involve the training of other law enforcement agencies on a regular basis. The Authority also has a dedicated enforcement team which conducts inspections around the country. To date numerous arrests have been made of both licensed and unlicensed persons dealing in unregistered medicines and selling medicines from unapproved premises. Stakeholders are advised and encouraged to acquire medicines from licensed and approved premises.

Supervision inspections

Random checks are carried out to ensure that licensed premises are under the continuous personal supervision of licensed persons in line with legislative requirements. Supervision inspections are conducted randomly during the premises operating times. In the event the premises are found without the continuous personal supervision of a licensed supervisor, the premises shall be instructed to close by the inspectors. The premises will be authorized to open after confirmation of supervision and payment of re-inspection fees.

Hiring of locum Pharmacists-Link to Circular 3 of 2019

Investigative inspections

Investigations may be carried out as a result of non-compliances identified in the inspection process or using intelligence gathered by MCAZ, other agencies or volunteered by members of the public. Investigation activities are frequently conducted in conjunction with other agencies. The MCAZ has carried out investigations with the Zimbabwe Republic Police (ZRP) -CID Drugs squad. Once an investigation is concluded a report is completed and a copy may be furnished to the party (pharmacist/pharmacy owner) under investigation. The pharmacist/pharmacy owner is invited to submit their comments on the findings. The report and submissions (if provided) are considered by the Licensing and Enforcement Committee. Matters may be referred to ZRP for further action.

Routine Inspections

Our inspectorate endeavors to carry out comprehensive inspections of every pharmacy at least once every two years. The frequency of routine inspections is ideally the same although there may be instances when a pharmacy may be inspected once every year based on risk. The target may be difficult to reach because the number of premises that are inspected are on the increase. The MCAZ also inspects pharmaceutical manufacturers, wholesalers, industrial clinics, medical practitioners (both Veterinary and Human), veterinary medicine general dealers and public health institutions.

The concerns of the Authority regarding inspection findings: Link to Circular 20 of 2019

GMP Inspections

The LED is responsible for approval and assessment of new, licensed and approved manufacturing facilities for compliance   with current Good Manufacturing Practices (cGMP). The requirements are outlined in the GMP guideline: Link to GMP Inspections

Latest News

Medicines Information Bulletin - 2019

20 December 2019
Medicines Information Bulletin - 2019

Inside this issue: E-Reporting Tools Safety Notifications for Fluoroquinolones and Quinolones Antibiotics Notification of a potential risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) in patients treated...

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

  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...

Draft Guidelines For Comments Only: Guideline for Submitting Application for Variations to Registered Medicines

17 May 2019
Draft Guidelines For Comments Only: Guideline for Submitting Application for Variations to Registered Medicines

In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines. The update...

Careers @ MCAZ

30 October 2018

There are currently no vacancies...  

Fellowship in regulatory science for African Medicine Reviewers/Assessors

26 October 2018
Fellowship in regulatory science for African Medicine Reviewers/Assessors

  Background   The Medicines Control Authority of Zimbabwe (MCAZ) Regional Centre of Regulatory Excellence (ReCORE) in partnership with the European and Developing Countries Clinical Trials Partnership (EDCTP) is offering...

Quality Policy Statement

06 July 2018
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...

MCAZ Newsletter

10 May 2018
MCAZ Newsletter

In this issue: MCAZ turns 20 years Basics of reporting Side Effects of medicines Electronic Adverse Drug Reaction Reporting   For more information Please click here to download the Newsletter...

Medicines Information Bulletin - 2018

02 February 2018
Medicines Information Bulletin - 2018

Increased Reporting from the Targeted Spontaneous Reporting (TSR) Programme Click here to download the 2018 Drug Information Bulletin    

Press Statement on extension of submission of Complementary medicines applications

18 May 2017
Press Statement on extension of submission of Complementary medicines applications

Download Complementary  medicines applications extension - press statement

Zimbabwe National Pharmacovigilance Policy Handbook

12 April 2017
Zimbabwe National Pharmacovigilance Policy Handbook

The aims of the PV policy handbook are to firstly provide a framework for a national pharmacovigilance system in Zimbabwe. Secondly, to define the pharmacovigilance activities undertaken by the Pharmacovigilance...

Scholarship Programme Publicity

14 July 2016
 Scholarship Programme Publicity

The Medicines Control Authority of Zimbabwe (MCAZ) as a responsible corporate citizen runs a Scholarship Fund as part of its corporate social responsibility programmes.   Click here to download the...

Guidelines for Advertising and Promotion of Medicines

24 June 2016
Guidelines for Advertising and Promotion of Medicines

  The approved Guidelines for Advertising and Promotion of Medicines are now available.  Download the Guidelines for Advertising and Promotion of Medicines