New European regulations updating rules for medical devices enter into force
New European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · Portugal
Source
Portugal INFARMED
Regulation
Category
Type · Breadth
Date
INFARMED guidance on digital health solutions as medical devices
INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalFrequently Asked Questions on SiNATS Review: First Answers Now Available
INFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalReference Pricing System: Addition of new homogeneous groups (Q3 2026)
New homogeneous groups added to Portugal's reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalDispensing of prescription medicines: mandatory use of legally valid medical prescription
Joint informative circular on the mandatory use of legally valid medical prescriptions for dispensing prescription medicines.
Portugal INFARMED · PortugalEuropean guidance for implementation of Shortage Prevention Plans
EMA publishes guidance and template for Shortage Prevention Plans required of marketing authorisation holders for prescription medicines.
Portugal INFARMED · PortugalReference Pricing System: Addition of new homogeneous groups (Q3 2026)
Portugal's INFARMED adds new homogeneous groups to the reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalInfarmed updates medicinal cannabis sector activity data
Infarmed publishes 2025 and H1 2026 reports on medicinal cannabis licensing, supervision, inspection, export and use in Portugal.
Portugal INFARMED · PortugalInfarmed publishes July 2026 performance indicators
O Infarmed disponibiliza indicadores relativos aomês de julho, destacando algumas atividades que contribuem para garantir aos cidadãos a qualidade, segurança e eficácia dos medicamentos e produtos de saúde, bem como a...
Portugal INFARMED · PortugalNew edition of the Pharmacovigilance Bulletin
Volume 30, issues 5 and 6 (May and June 2026) of the Pharmacovigilance Bulletin is now available.
Portugal INFARMED · PortugalCOMBINE Programme advances to second phase of coordinated assessment pilot project for combined clinical trials
Portugal'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 · PortugalUpdate of lists under the Regulation on control of medicine transactions for export (August 2026)
Circular Informativa n.º 081/CD/100.20.200 de 30/07/2026
Portugal INFARMED · PortugalInfarmed and partners strengthen strategy for medicine availability following annual review
Data : 23/07/2026
Portugal INFARMED · PortugalInfarmed receives Ukrainian delegation and strengthens international cooperation in medicines regulation
Data : 27/07/2026
Portugal INFARMED · PortugalMedicines and heat: Essential care to ensure their safety and efficacy
Data : 18/07/2026
Portugal INFARMED · PortugalPortugal authorises first clinical trial in European FAST-EU pilot project
Portugal has authorised the first clinical trial under the European FAST-EU pilot project.
Portugal INFARMED · PortugalPiasky (Crovalimab) – Public funding evaluation report available; preliminary assessment request approved
INFARMED has approved the preliminary assessment request for Piasky (Crovalimab) and published the public funding evaluation report.
Portugal INFARMED · PortugalTryngolza (Olezarsen) – Public funding evaluation report available; preliminary assessment request approved
INFARMED has approved the preliminary assessment request for Tryngolza (Olezarsen) and published the public funding evaluation report.
Portugal INFARMED · PortugalJakavi (ruxolitinib) – Public funding evaluation report available; approval granted
Portugal's INFARMED has approved public funding for Jakavi (ruxolitinib) following completion of the funding evaluation report.
Portugal INFARMED · PortugalElrexfio (elranatamab) – Public funding evaluation report available; approval granted
INFARMED has approved public funding for elranatamab (Elrexfio) following completion of the funding evaluation report.
Portugal INFARMED · PortugalAdcetris (brentuximab vedotin) – Public funding evaluation report available
Adcetris (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) – Public funding evaluation reports available
Retsevmo (selpercatinib) authorised for hospital use; public evaluation reports published on Infomed.
Portugal INFARMED · PortugalRybrevant (amivantamab) – Public funding evaluation report available; approval granted
Rybrevant (amivantamab) approved for hospital use in specified indications; public evaluation report published.
Portugal INFARMED · PortugalBriumvi (Ublituximab) – Public funding evaluation report available; positive assessment decision
INFARMED has granted a positive assessment for public funding of Briumvi (ublituximab); evaluation report now available.
Portugal INFARMED · PortugalEnhertu (trastuzumab deruxtecano) – Public funding assessment report available; approval of preliminary assessment requests
Public funding assessment report for Enhertu (trastuzumab deruxtecano) published; preliminary assessment requests approved.
Portugal INFARMED · PortugalTrodelvy (sacituzumab govitecano) – Public funding evaluation report available; positive assessment decision
INFARMED has granted a positive assessment for public funding of Trodelvy (sacituzumab govitecano).
Portugal INFARMED · PortugalCresemba (isavuconazole): public funding evaluation reports available; approval of prior evaluation requests
Cresemba (isavuconazole) approved for hospital use; public evaluation reports published on Infomed.
Portugal INFARMED · PortugalAkeega (niraparib + abiraterone): public funding assessment report available; approval granted
Portugal's INFARMED has approved public funding for Akeega (niraparib + abiraterone) following completion of the funding evaluation report.
Portugal INFARMED · PortugalDatroway (Datopotamab deruxtecano) — Public funding evaluation report available; prior assessment request denied
INFARMED denied prior hospital funding assessment for Datroway (datopotamab deruxtecano) in HR-positive, HER2-negative advanced breast cancer.
Portugal INFARMED · PortugalImfinzi (Durvalumab): Public funding evaluation report available; approval of prior assessment requests
INFARMED has approved prior assessment requests for Imfinzi (durvalumab) and published the public funding evaluation report.
Portugal INFARMED · PortugalRapibloc (Landiolol hydrochloride) – Public funding evaluation report available; prior assessment request approved
Rapibloc (landiolol hydrochloride) approved for hospital use in adults; public evaluation report published on Infomed.
Portugal INFARMED · PortugalProtart (Rosuvastatin + Amlodipine + Ramipril) — reimbursement authorisation granted
Protart fixed-dose combination approved for reimbursement in Portugal for essential hypertension with primary hypercholesterolaemia or mixed dyslipidaemia in adequately controlled adults.
Portugal INFARMED · PortugalAuthorization for use of batches labeled in foreign language | Flutiform - Pressurized inhalation suspension, 250 µg/dose + 10 µg/dose
INFARMED authorizes the use of Flutiform batches labeled in a foreign language.
Portugal INFARMED · PortugalLitfulo (Ritlecitinib) – Public funding evaluation report available – Approval
INFARMED approves public funding for Litfulo (ritlecitinib) in Portugal following evaluation.
Portugal INFARMED · PortugalWinrevair (sotatercept) – Public funding assessment report available – Approved
Public funding approval granted for Winrevair (sotatercept) following completion of the financing evaluation report.
Portugal INFARMED · PortugalRozlytrek (Entrectinib) – Public funding evaluation report available; approval of prior assessment request
Portugal INFARMED approved the prior assessment request for Rozlytrek (entrectinib) and made the public funding evaluation report available.
Portugal INFARMED · PortugalAuthorization for use of batches labeled in foreign language: Simedur, 1000 mg + 50 mg, modified-release tablet
INFARMED authorizes use of Simedur 1000 mg + 50 mg modified-release tablet batches labeled in a foreign language.
Portugal INFARMED · PortugalAuthorisation for use of batches labelled in foreign language: Moviprep, Macrogol and other combinations (powder for oral solution)
INFARMED authorises the use of batches of Moviprep and macrogol combinations labelled in a foreign language.
Portugal INFARMED · PortugalQuadrixam (Perindopril + Indapamida + Amlodipina + Bisoprolol) – Withdrawal of reimbursement request
Applicant withdrew request for public reimbursement funding of Quadrixam fixed-dose combination antihypertensive.
Portugal INFARMED · PortugalAuthorisation for use of batches labelled in foreign language: Movicol paediatric (Macrogol + Sodium bicarbonate + Potassium chloride + Sodium chloride, powder for oral solution)
INFARMED authorises the use of Movicol paediatric batches with foreign-language labelling.
Portugal INFARMED · Portugal
Showing 43 of 43 tracked updates
Health-tech only