TUNISIA
The Republic of Tunisia is a member state of the Arab Maghreb Union (UMA). Its capital is Tunis. The official language is Arabic.
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 requires an appointment, upon acceptance of the deposit the assessment is made by the ANMPS (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.
In order to initiate any collaboration or for any consultation you can contact us by: