PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Tuesday, 17 October 2017
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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

Drug Information Bulletin

07 June 2017
Drug Information Bulletin

Increased Reporting from the Targeted Spontaneous Reporting (TSR) Programme Click here to download 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...

2nd Bioavailability/ Bioequivalence Training Course ,24 October - 11 November 2016

15 September 2016
2nd Bioavailability/ Bioequivalence Training Course ,24 October - 11 November 2016

The MCAZ offers training services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia. The course is...

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...

Draft Guidelines for Advertising and Promotion of Medicines

24 June 2016
Draft Guidelines for Advertising and Promotion of Medicines

  These guidelines are under review and comments are welcome.  Download Draft Guidelines for Advertising and Promotion of Medicines  

Complementary Medicine Regulation

19 April 2016
Complementary Medicine Regulation

The Medicines Control Authority of Zimbabwe is responsible for the evaluation of safety, efficacy and quality and registration of complementary medicines destined for use in Zimbabwe. Please see the documents...

TAX COMPLIANCE

25 February 2016
TAX COMPLIANCE

  Click here for more information on implementation of VAT Click here for Tax Clearance Certificate (ITF263)  

SADCAS Accreditation for Chemistry and Medical Devices Laboratories.

06 January 2016
SADCAS Accreditation for Chemistry and Medical Devices Laboratories.

The MCAZ Chemistry and Medical Devices laboratories are now accredited to the ISO/IEC 17025 standard through the Southern African Development Community Accreditation Service (SADCAS). The Chemistry laboratory is accredited for...

ZAZIBONA Collaborative Medicines Registration Process

06 January 2016
ZAZIBONA Collaborative Medicines Registration Process

  The ZAZIBONA process is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, and Zimbabwe. These are four neighbouring countries in Southern Africa which have a...