Portugal

INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) is the primary regulatory authority in Portugal responsible for the evaluation, authorization, regulation, and surveillance of medicines, medical devices, diagnostics, and health technologies. Portugal operates within the European Union regulatory framework, meaning that pharmaceuticals are governed primarily by EU Regulation No 726/2004 for centralized procedures and Directive 2001/83/EC for national and decentralized procedures, while medical devices are regulated under EU MDR 2017/745 and EU IVDR 2017/746. Marketing authorizations for medicines may be obtained via the EMA centralized procedure (directly valid across all EU member states), the mutual recognition procedure (MRP), the decentralized procedure (DCP), or a purely national procedure administered by INFARMED for products not covered by mandatory centralized routes. Digital health solutions and software as a medical device (SaMD) are classified and regulated under MDR 2017/745, with INFARMED acting as the national competent authority for conformity oversight.

For national marketing authorization submissions, applicants must submit a Common Technical Document (CTD) dossier in line with ICH standards, which is the accepted format across EU member states including Portugal. A local EU-based qualified person for pharmacovigilance (QPPV) and an EU-registered marketing authorization holder are mandatory requirements; non-EU companies must appoint an EU-established legal representative. Medical devices bearing CE marking under MDR/IVDR are generally market-ready without additional national approval, though registration in the EUDAMED database is required. INFARMED has been active in implementing the EU Joint Clinical Assessment (JCA) framework introduced under EU Regulation 2021/2282 on Health Technology Assessment (HTA), which came into full effect for oncology and advanced therapy medicinal products (ATMPs) in January 2025, streamlining joint scientific evaluation across member states while national relative effectiveness and pricing decisions remain at Portugal's discretion. Recent reforms have emphasized expedited pathways for orphan medicines, ATMPs, and digital therapeutics, aligned with the EU Pharmaceutical Strategy for Europe launched in 2020.

Public procurement in Portugal is centralized through the Servico Nacional de Saude (SNS), the national health service operating under the Ministerio da Saude. The primary procurement body for health products is SPMS (Servicos Partilhados do Ministerio da Saude, E.P.E.), which manages centralized purchasing agreements, framework contracts, and public tenders on behalf of NHS hospitals, primary care centers, and regional health administrations (Administracoes Regionais de Saude, ARS) covering the five mainland regions as well as the autonomous regions of Azores and Madeira. Public tenders are governed by the Codigo dos Contratos Publicos (CCP, Decree-Law No. 18/2008, as amended) and must comply with EU public procurement directives (2014/24/EU and 2014/25/EU). Medicines subject to reimbursement must obtain a positive HTA and pricing decision from INFARMED before entering the SNS reimbursement list (Formulario Nacional de Medicamentos), and pricing negotiations follow the comparator-based reference pricing system benchmarked against a basket of EU member states. Medical devices and diagnostics procured for public facilities must comply with CE marking requirements and are typically acquired through SPMS framework agreements or individual hospital tenders published on the BASE portal (base.gov.pt).

The private healthcare sector in Portugal is significant and growing, encompassing large hospital groups such as Luz Saude, Hospital da CUF, and others, which procure health products independently through direct commercial agreements with manufacturers and distributors, outside the SPMS centralized framework. Private procurement is market-driven with pricing negotiated bilaterally, and private insurers play an increasing role in shaping formulary access. Portugal does not receive substantial volumes of donor-funded health product procurement through channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi, as it is a high-income EU member state. However, Portuguese public health institutions participate in joint EU procurement initiatives, notably the EU Joint Procurement Agreement (JPA) coordinated by the European Commission for pandemic-related countermeasures, vaccines, and emergency health products. No formal local manufacturing preference policies are currently enforced in procurement, though EU strategic autonomy initiatives and the European Health Emergency Preparedness and Response Authority (HERA) are increasingly encouraging domestic and intra-EU production capacity as a policy priority.