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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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