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In order to obtain an authorisation under this scheme the applicant must demonstrate:
– That the product is a homeopathic product that conforms with the principles and characteristics of homeopathy as practised in the State;
– That the indication sought is appropriate;
– That any such indication is suitable for use without the intervention of a registered medical practitioner for diagnosis, or for prescription or for the monitoring of treatment;
– That the efficacy of the product is based on evidence that the particular class of product has been in use in the State as a homeopathic treatment for the indication sought and;
– That the safety of the product has been established as set down in the relevant regulations.

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Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems with the view to early detection of unknown adverse reactions and interactions, increase in frequency of known adverse reactions and identification of risk factors and possible mechanisms underlying adverse reactions. Medicines have significant benefits to our lives and lead to significant
reduction in morbidity and mortality.

This guideline describes the following points;

  • Structure and flow of information coordination
  • Some Tools for Pharmacovigilance
  • ADR Monitoring within the Pharmacovigilance System
  • Roles and Responsibilities
  • Training, Roll-out and Capacity Building

 

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No medicinal product can be provided for free or against payment without receiving a Marketing Authorization from the Ministry of Health after the committee consultation. This Marketing Authorization is issued for a 5 years period and renewable for a 5 years period. This requirement results from the act n°85-91 of 22nd November 1985, regulating the manufacture and the registration of medicinal products intended for human use in Tunisia.

This guideline describes the following points;

  • Registration Procedure
  • ANNEXE 1: Application Letter
  • Annexe II: Application Form
  • ANNEX III: Summary of Product Characteristics
  • Annexe IV: Particulars to Appear on the Outer Pack and on the Immediate Packaging
  • Annexe V: Minimum Particulars to Figure on Blisters or Strips
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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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The Food and Drug Regulations set forth regulatory requirements for manufacturers to report ADRs and to report
unusual failure in the efficacy of new drugs to Health Canada. Within the context of the GVP inspection program, MAH
and importers are subject to GVP inspections as their name appears on the label and as such may receive ADRs.

This guide covers the following drugs marketed in Canada for human use which are subject to GVP inspections:

  •  pharmaceuticals,
  • biologics, including biotechnology products, vaccines and fractionated blood products,
  • medical gases, and
  • radiopharmaceuticals.

This guide does not currently apply to:

  • hard surface disinfectants,
  • veterinary products,
  • natural health products, and
  • whole blood and blood components.
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