Tunisia is a north African country. The drug market in Tunisia represents nearly 1 billion dollars, with about 47% of imports (under the monopoly of the government through Central Pharmacy of Tunisia) and 53% as local production.
Tunisia’s drug registration standards are approaching European standards with a national drug registration guideline.
The registration file must be in CTD format and in French or English language with some parts in French and / or Arabic.
The authority governing the registration of medicines in Tunisia are: The National Agency for Medicines and Health Products (ANMPS)
Medicine registration in Tunisia requires an appointment through a local and legal representative, upon acceptance of the deposit the assessment is made by the ANMPS and the LNCM (National Laboratory of Drug Control). It requires 2 to 3 years for registration of the drug in Tunisia.
Medical devices , food supplements and cosmetics are under another specific procedure of AMC (Autorization for consumption).
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