Market Access in Portugal: A Practical Guide

This guide brings together what a pharmaceutical or medical device company needs to know to bring a health technology to patients in Portugal: who assesses it, what evidence is expected, how early access works, and how the national process connects with the EU Joint Clinical Assessment.

1. Who decides: INFARMED and SiNATS

Public funding of health technologies in Portugal is decided within the National Health Technology Assessment System (SiNATS), coordinated by INFARMED, the national medicines and health products authority. A new SiNATS regime was established by Decree-Law no. 118/2026, of 17 June, in force since 1 July 2026. It covers medicines, medical devices, in vitro diagnostics, digital technologies and other health technologies. Procedures already pending continue under the previous rules.

Read more: HTA in Portugal and what changes with the new SiNATS.

2. What evidence is expected

• Relative clinical effectiveness against the comparators used in Portugal, usually built on a systematic literature review.
• Indirect comparisons when there is no head-to-head trial against the relevant comparator. See indirect treatment comparisons in HTA.
• Economic evaluation, usually a cost-effectiveness or cost-utility analysis. Try our QALY and ICER calculator.
• Budget impact for the National Health Service. See budget impact analysis in Portugal and how it differs from cost-effectiveness analysis.

Before preparing a submission, an evidence gap analysis shows what is missing and what can still be generated in time.

3. Early access before the funding decision

Patients with no satisfactory alternative can be treated before the funding decision through the Early Access Programme (PAP) and the Exceptional Use Authorisation (AUE). Under INFARMED Deliberation no. 80/CD/2017, the company requests the PAP from INFARMED and the hospital requests an AUE for each patient. As a rule, medicines in a PAP are supplied free of charge to the National Health Service, within the time limits set in the rules. See our analysis of every INFARMED decision on early access since 2017.

4. The European layer: Joint Clinical Assessment

Under the EU HTA Regulation, new medicines in scope go through a Joint Clinical Assessment (JCA) at EU level, based on PICOs requested by the member states. The national assessment in Portugal then builds on that report for the economic and funding decision. Read what the EU Joint Clinical Assessment is.

5. A practical sequence

1. Map the likely PICOs and comparators for Portugal and for the JCA.
2. Run the systematic review and the evidence gap analysis.
3. Plan the indirect comparisons and the economic and budget impact models.
4. Decide on early access and its cost for the launch.
5. Prepare the submission and the value messages for INFARMED.

Terms used in this guide are defined in our HTA and HEOR glossary. For support at any step, see our HTA and market access services and how we provided integrated support for the HTA process and financing in Portugal.