Tunisia

The primary regulatory authority for health products in Tunisia is the Direction de la Pharmacie et du Médicament (DPM), operating under the Ministry of Health. The DPM is responsible for the registration, control, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. The overarching legal framework is established by Law No. 85-91 of 1985 on pharmaceutical organization, as amended, along with subsequent ministerial decrees and circulars that govern product classification, registration requirements, and market authorization procedures. All health products intended for commercialization in Tunisia must obtain a marketing authorization (autorisation de mise sur le marché, AMM) prior to market entry, with the DPM conducting technical and administrative review of submitted dossiers.

Submission dossiers for pharmaceuticals are generally required to follow the Common Technical Document (CTD) format, and the DPM may accept technical data packages referencing approvals from stringent regulatory authorities such as the EMA or FDA as supportive evidence, though full local review is still conducted. A local representative or registered importer established in Tunisia is mandatory for foreign manufacturers seeking product registration. Medical devices are subject to a separate registration track, with classification aligned broadly to risk-based principles, though the regulatory framework for devices and in vitro diagnostics remains less codified than the pharmaceutical pathway. Tunisia has pursued reforms to modernize its regulatory system, including efforts to streamline the AMM process, improve transparency, and align more closely with international standards. The country is also an active participant in regional harmonization initiatives under the African Medicines Regulatory Harmonization (AMRH) program.

Public procurement of health products in Tunisia is centralized through the Pharmacie Centrale de Tunisie (PCT), a state-owned entity operating under the Ministry of Health that serves as the exclusive procurement and distribution body for pharmaceuticals, medical devices, and diagnostics destined for public health facilities. The PCT conducts periodic national tenders (appels d'offres) governed by the national public procurement law (Decree No. 2014-1039 and subsequent amendments), which require open competitive bidding and compliance with technical and administrative specifications. Regional health directorates and public hospitals are supplied through the PCT's distribution network, meaning that access to the public market is effectively gated through PCT tender participation. Suppliers must be registered with the PCT and meet local regulatory requirements, including valid AMM where applicable, prior to tender eligibility.

The private health sector in Tunisia operates through a parallel distribution system involving licensed importers, wholesalers, and private pharmacy chains, representing a significant and growing share of total health expenditure. Private procurement follows commercial contracting norms and is less subject to centralized tender requirements, offering a more accessible entry point for some product categories. Donor-funded procurement channels play a supplementary role in Tunisia, with organizations such as UNICEF, the Global Fund, and bilateral development partners historically supporting procurement of specific health commodities including HIV and tuberculosis medicines, vaccines, and reproductive health supplies, often utilizing international procurement mechanisms and pre-qualified supplier lists. Tunisia does not currently maintain an explicit local manufacturing preference policy in public tenders, but there is growing government interest in strengthening domestic pharmaceutical production capacity as part of broader industrial and health sovereignty strategies, which may influence future procurement policy.