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;
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