Tunisia

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 CTD format and in French or English language with some parts in French and / or Arabic.

The authority governing the registration of medicines: the DPM (Directorate of Pharmacy and Medicine) whose website: http://www.dpm.tn/

The registration of medicines in Tunisia requires an appointment, upon acceptance of the deposit the assessment is made by the DPM (Directorate of Pharmacy and Drug) 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:

• email : info@arema-international.com