The Ministry of Health, through the Directorate of Medicine and Pharmacy (DMP), is the authority in-charge of medicine regulations in Tunisia. The authority decides on the creation and closure of pharmacies, laboratories and drug stores and ensure their inspection, controls the production and quality of drugs, their import, movement and nomenclature of the prices of pharmaceuticals, biological and similar products, controls the consumption of narcotic drugs, psychotropic substances and poisonous substances and screening for the use of doping.

The DMP manages the registration procedures for medicines for human and veterinary use and delivers marketing authorizations for imported and locally produced medicines. It also deals with MA follow-up (renewal, cancellation, handover and modification), in accordance with the regulations in force.

The Directorate of pharmaceutical inspection is in-charge of ensuring the application of laws and texts organizing pharmaceutical professions as well as pharmaceutical products for human and veterinary use. It performs the various necessary inspections, assessments and survey operations in order to guarantee the final quality of the prescribed medicine.

Tunisia is part of the Arab Maghreb Union. Therefore, Tunisia is likely to benefit from the region’s medicine regulation harmonization, through the union’s website - https://maghrebarabe.org/. Locally, Tunisia depend on their MoH website for dissemination of information regarding pharmaceutical policies. The website contains information on public health structures, legal and regulatory information and more details about the pharmaceutical industry in Tunisia.