Friday, 03 February 2023

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

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

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...

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...