INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalNew European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · PortugalINFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalJoint informative circular on the mandatory use of legally valid medical prescriptions for dispensing prescription medicines.
Portugal INFARMED · PortugalNew homogeneous groups added to Portugal's reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalEMA publishes guidance and template for Shortage Prevention Plans required of marketing authorisation holders for prescription medicines.
Portugal INFARMED · PortugalPortugal's INFARMED adds new homogeneous groups to the reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalPortugal's INFARMED announces the COMBINE programme has progressed to the second phase of its pilot project for coordinated evaluation of combined clinical trials.
Portugal INFARMED · PortugalInfarmed publishes 2025 and H1 2026 reports on medicinal cannabis licensing, supervision, inspection, export and use in Portugal.
Portugal INFARMED · PortugalVolume 30, issues 5 and 6 (May and June 2026) of the Pharmacovigilance Bulletin is now available.
Portugal INFARMED · PortugalCircular Informativa n.º 081/CD/100.20.200 de 30/07/2026
Portugal INFARMED · PortugalData : 23/07/2026
Portugal INFARMED · PortugalData : 27/07/2026
Portugal INFARMED · PortugalData : 18/07/2026
Portugal INFARMED · PortugalPortugal has authorised the first clinical trial under the European FAST-EU pilot project.
Portugal INFARMED · PortugalPortugal's INFARMED has approved public funding for Jakavi (ruxolitinib) following completion of the funding evaluation report.
Portugal INFARMED · PortugalElrexfio (elranatamab) approved for hospital use in relapsed/refractory multiple myeloma after three prior therapies; public evaluation report published.
Portugal INFARMED · PortugalAdcetris (brentuximab vedotin) approved for hospital use in combination with AVD for untreated CD30+ Hodgkin lymphoma stages III–IV; public evaluation report published.
Portugal INFARMED · PortugalRetsevmo (selpercatinib) authorised for hospital use; public evaluation reports published on Infomed.
Portugal INFARMED · PortugalPortugal's INFARMED has approved public funding for Rybrevant (amivantamab); assessment report now available.
Portugal INFARMED · PortugalINFARMED has granted a positive assessment for public funding of Briumvi (ublituximab); evaluation report now available.
Portugal INFARMED · PortugalPublic funding assessment report for Enhertu (trastuzumab deruxtecano) published; preliminary assessment requests approved.
Portugal INFARMED · PortugalINFARMED has granted a positive assessment for public funding of Trodelvy (sacituzumab govitecano).
Portugal INFARMED · PortugalCresemba (isavuconazole) approved for hospital use; public evaluation reports published on Infomed.
Portugal INFARMED · PortugalPortugal's INFARMED has approved public funding for Akeega (niraparib + abiraterone) following completion of the funding evaluation report.
Portugal INFARMED · PortugalINFARMED denied prior hospital funding assessment for Datroway (datopotamab deruxtecano) in HR-positive, HER2-negative advanced breast cancer.
Portugal INFARMED · PortugalINFARMED has approved prior assessment requests for Imfinzi (durvalumab) and published the public funding evaluation report.
Portugal INFARMED · PortugalINFARMED authorizes the use of Flutiform batches labeled in a foreign language.
Portugal INFARMED · PortugalRapibloc (landiolol hydrochloride) approved for hospital use in adults; public evaluation report published on Infomed.
Portugal INFARMED · PortugalProtart fixed-dose combination approved for reimbursement in Portugal for essential hypertension with primary hypercholesterolaemia or mixed dyslipidaemia in adequately controlled adults.
Portugal INFARMED · PortugalINFARMED approves public funding for Litfulo (ritlecitinib) in Portugal following evaluation.
Portugal INFARMED · PortugalPublic funding approval granted for Winrevair (sotatercept) following completion of the financing evaluation report.
Portugal INFARMED · PortugalPortugal INFARMED approved the prior assessment request for Rozlytrek (entrectinib) and made the public funding evaluation report available.
Portugal INFARMED · PortugalINFARMED authorizes use of Simedur 1000 mg + 50 mg modified-release tablet batches labeled in a foreign language.
Portugal INFARMED · PortugalINFARMED authorises the use of batches of Moviprep and macrogol combinations labelled in a foreign language.
Portugal INFARMED · PortugalApplicant withdrew request for public reimbursement funding of Quadrixam combination antihypertensive medicine.
Portugal INFARMED · PortugalINFARMED authorises the use of Movicol paediatric batches with foreign-language labelling.
Portugal INFARMED · Portugal