Tunisia

In Tunisia, the primary regulatory authority responsible for health products, including pharmaceuticals, medical devices, diagnostics, and related technologies, is the Direction de la Pharmacie et du Médicament (DPM), operating under the Ministry of Health. The legal framework is anchored in Law No. 85-91 of 1985 on the organization of pharmaceutical professions and trade, as subsequently amended, alongside a series of ministerial decrees governing the registration, importation, pricing, and distribution of health products. The DPM oversees the marketing authorization (visa de mise sur le marché) process, which requires applicants to submit a comprehensive technical dossier demonstrating safety, efficacy, and quality before any product may be commercialized or procured within the public system. An inter-ministerial commission convened by the DPM evaluates submissions, and products must obtain a formal registration certificate prior to public tender eligibility.

Applications are generally expected to follow the Common Technical Document (CTD) format for pharmaceuticals, and dossier requirements for medical devices and diagnostics are increasingly aligned with international standards, including references to CE marking and ISO certifications as supporting evidence. A local representative or a registered Tunisian importer/agent is mandatory for foreign manufacturers, as the DPM requires an in-country point of accountability for post-market surveillance and regulatory correspondence. Tunisia has engaged in ongoing reform efforts under its National Health Strategy, including digitization of dossier submission processes and participation in regional regulatory harmonization initiatives coordinated through the African Medicines Regulatory Harmonization (AMRH) program. Pricing for pharmaceuticals is strictly controlled by the DPM in coordination with the Ministry of Trade, and any price revision requires a separate administrative procedure.

Public procurement of health products in Tunisia is centrally coordinated through the Pharmacie Centrale de Tunisie (PCT), a state-owned wholesale entity that serves as the primary purchasing and distribution body for pharmaceuticals, medical devices, and diagnostics destined for public health facilities. The PCT conducts national open tenders governed by Decree No. 2014-1039 on public procurement, which mandates competitive bidding, transparency, and compliance with technical specifications approved by the Ministry of Health. The Ministry of Health defines the national essential medicines list and the medical device needs schedule, which form the basis of PCT tender packages. Regional health directorates (Directions Régionales de la Santé) may initiate supplementary procurement for locally managed facilities, but large-volume and strategic commodity purchasing remains centralized through the PCT. Public hospitals and university hospital centers (CHUs) may also conduct limited direct procurement for specialized or high-value equipment under delegated authority.

The private sector in Tunisia operates through a network of licensed pharmaceutical wholesalers and importers, with products distributed to private clinics, pharmacies, and diagnostic laboratories outside the PCT framework. Private channel pricing and purchasing are subject to DPM-approved price ceilings for regulated products. Tunisia benefits from selective donor-funded procurement channels, particularly for public health program commodities: the Global Fund supports procurement of HIV, tuberculosis, and malaria-related diagnostics and medicines, while UNICEF and WHO provide technical and occasional supply support for immunization and maternal and child health programs. The government has historically favored local manufacturing through preferential pricing policies and import substitution incentives, and the national pharmaceutical industry, represented by the Groupement Interprofessionnel des Médicaments (GIPAM), benefits from a protected domestic pricing structure that encourages local production of generic medicines and, increasingly, medical consumables.