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When medicines, vaccines or medical device products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to recall and all related information must be reported to the Medicines Control Authority of Zimbabwe (MCAZ).

The Medicines Control Authority of Zimbabwe Medicines Products Recall Guidelines is intended to ensure that in the event of a necessary recall, the recall operations are effectively and efficiently carried out by the manufacturer, importer, distributor or certificate holder of a pharmaceutical product (hereafter known as the applicant) in order to safeguard public health.

This guideline describes the following points;

  1. Introduction and Definitions
  2. Stages of Recall Procedure
  3. Assessment of Recall
  4. Communication to Public
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These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food or drug to which they refer.

This guideline describes the following points;

  • Administration
  • Foods
  • Drugs
  • Vitamins, Minerals and Amino Acids
  • Cyclamate Sweeteners
  • Controlled Drugs
  • Restricted Drugs
  • Reasonable Daily Intake for Various Foods

 

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This guidance describes section 3 and Schedule A as they relate to drugs (pharmaceuticals, biologics and NHPs), food, cosmetics and medical devices. The current list of Schedule A diseases are found in the Food and Drugs Act and is appended here for convenience as are some of the other relevant statutory provisions referenced in this document (Appendix A).

this guideline describes the following points;

  • Guidance For Implementation
  • APPENDIX A – Statutory Provisions
  • APPENDIX B – Definitions
  • APPENDIX C – Data Requirements for Market Authorization
  • APPENDIX D – Schedule A / Section 3 Flowchart
  • APPENDIX E – Schedule A Synonyms
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This guidance document applies to all health products as defined by the Food and Drugs Act and its Regulations. This includes Human Drugs; Natural Health Products; Medical Devices; Veterinary Drugs; Blood and Blood Components for Transfusion; Human Cells, Tissues and Organs for Transplantation; and Semen for Assisted Conception.

This guidance document only addresses the requirements under the Food and Drugs Act and its Regulations for health products. Some health products may also have additional restrictions placed on them by other Acts and Legislation, such as the Controlled Drugs and Substances Act and its Regulations. Where two different restrictions/requirements exist, such as the quantity allowed for importation, the most restrictive or prescriptive will take precedence.

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This policy outlines the Inspectorate’s position with respect to the importation to Canada and the exportation
from Canada of health products.

This policy applies to all health products as defined by the Food and Drugs Act and its Regulations. This includes Human Drugs; Natural Health Products; Medical Devices; Veterinary Drugs; Blood and Blood Components for Transfusion; Human Cells, Tissues and Organs for Transplantation; and Semen for Assisted Conception.

This policy only addresses the requirements under the Food and Drugs Act and its Regulations for health products. Some health products may also have additional restrictions placed on them by other Acts and Legislation, such as the Controlled Drugs and Substances Act and its Regulations. Where two different restrictions/requirements exist, such as the quantity allowed for importation, the most restrictive or prescriptive will take precedence.

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These guidelines apply to you if you have a medical device establishment licence (MDEL) and you are a:

  • class I medical device manufacturer
  • the importer (Class I–IV medical devices)
  • distributor (Class I–IV medical devices)

You may also be inspected if you do not have an establishment licence but you are subject to the Act and Regulations. This includes:
 class I device manufacturer who imports or distributes their medical device through someone who has an establishment licence
 company or person subject to one of the following sections in the Regulations:
o Part 2 – “Custom‐made devices and medical devices to be imported or sold for special access”
o Part 3 – “Medical devices for investigational testing involving human subjects”
 class II, III or IV manufacturer (including private‐label manufacturer) who has a medical device licence

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This document is applicable to any situation of noncompliance with the requirements of the MDR or a section
of the Act applicable to medical devices.

Where noncompliance with the requirements of the Act or the MDR is identified, the Inspectorate shall ensure that appropriate actions are taken by the company to address the noncompliance, based on the risk to health. If appropriate actions are not taken to comply with the requirements, the company shall be subject to enforcement action.

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A Manufacturer’s Certificate to Cover Export of Medical Devices is issued for medical devices that are legally for sale in Canada, which are intended for export to a foreign country and are currently licensed for use in Canada. The issuance of an MCE is not a regulatory requirement but rather a service to manufacturers provided by the Health Products and Food Branch Inspectorate (HPFBI), Health Canada. It cannot be issued for medical devices manufactured solely for the purpose of export of medical devices exempted under section 37 of the Food and Drugs Act.

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This document provides guidance on all aspects of MDELs mandated by Part 1 of the Regulations. This document also provides a reference to guidance on preparing for a regulatory inspection conducted by the Inspectorate. Distributors located outside of Canada and selling in Canada are subject to the same regulations. In addition, this document includes a section that provides guidance on how to calculate and pay fees and the fee remission process.

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