Medicines can only be imported after registration and obtaining of a “Marketing Authorization”.
The marketing authorization is valid for a period of 5 years.
Other health products are governed by a special procedure of “authorization for consumption”
Medicines market in Tunisia:
The drug market in Tunisia represents nearly 1 billion dollars, with about 47% of imports (under the monopoly of the Central Pharmacy of Tunisia) and 53% as local production.
Arema offers you the possibility to carry out a market study and field surveys according to your needs
Registration of Medicines in Tunisia:
Tunisia’s drug registration standards are inspired from European standards, ICH guidelines with a national drug registration guideline.
The registration file must be in eCTD format and in French or English language with some parts in French and / or Arabic.
The authority governing the registration of medicines: The National Agency for Medicines and Health Products (ANMPS)
The registration of medicines in Tunisia is is handled through the ANMPS platform , upon acceptance of the deposit the assessment is made by the ANMPS (The National Agency for Medicines and Health Products) and the LNCM (National Laboratory for Drug Control). It requires 2 to 3 years for registration of the drug in Tunisia.
AREMA offers you a total assistance for the registration of your medicines in Tunisia
We provide regulatory services from the regulatory intelligence, preparation and translation of your dossier, the deposit, follow-up and registration of your various products until the establishment of pharmacovigilance system post-marketing monitoring and marketing authorization maintenance.