Autorização de utilização de lotes rotulados em língua estrangeira | Flutiform - Suspensão pressurizada para inalação, 250 µg /dose + 10 µg /dose
Circular Informativa n.º 077/CD/100.20.200, de 28/07/2026
Portugal INFARMEDNewEurope & US health regulation, tracked.
Policy and regulatory updates from 75 official public sources across the EU, UK, Switzerland and the US. Updated several times a week.
Regulation
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Date
Infarmed divulga orientações sobre soluções digitais em saúde enquanto dispositivos médicos
Data : 29/07/2026
Portugal INFARMEDNewÚj szakmai ajánlás segíti a fekvőbeteg-ellátó intézmények felkészülését a hőhullámokra
A klímaváltozással járó extrém meleg egyre növekvő egészségügyi kockázatot jelent, amely az egészségügyi ellátó rendszert is jelentősen megterheli. A hőhullámok idején megemelkedik a sürgősségi esetek
Hungary NNGYKNewWest Nil Virus (WNV) - DeutschlandNeu
West Nil Virus (WNV) - Deutschland Neu Sicherheitsinformation | Blut & Gewebe | 30.07.2026 Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der deutschen Behörde mitgeteilt...
Austria BASGNewPMOS: how the new draft NICE guideline could transform diagnosis and care
In this episode we explore the draft NICE guideline for PMOS (formerly known as PCOS), out for public consultation until 11 August 2026. Podcasts 29 July 2026
UK NICENewDėl vaistinių preparatų tiekimo sutrikimo
Informuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTGuidance: Magnetic resonance imaging equipment in clinical use: safety guidelines
Relevant safety information for users of magnetic resonance imaging (MRI) equipment in clinical use.
UK MHRAThousands of patients to benefit from new daily pill for serious heart condition following co-ordinated MHRA and NICE decisions
Aficamten is recommended by NICE at the same time it was approved by the MHRA, thanks to improvements driven by closer working between the two organisations.
UK MHRAGuidance: London Region I MHRA Regulatory Sandbox: call for expressions of interest
Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.
UK MHRAΑνάκληση της παρτίδας 150426 του Καλλυντικού προϊόντος Lolota Professional nails UV& UV LED GEL POLISH 46
Αρ. πρωτ.: 97921 Ανάκληση της παρτίδας 150426 του Καλλυντικού προϊόντος Lolota Professional nails UV& UV LED GEL POLISH 46. Για
Greece EOFFood Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2027
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the F...
US Federal Register - FDA Guidance NoticesMedicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List
This document announces updates to the Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face Encounter and Written Order ...
US Federal Register - CMS RulesAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027
The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as ame...
US Federal Register - FDA Guidance NoticesFood Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspection...
US Federal Register - FDA Guidance NoticesOutsourcing Facility Fee Rates for Fiscal Year 2027
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing...
US Federal Register - FDA Guidance NoticesDCP (Latvija kā RMS) reģistrāciju procedūru laika rezervēšana uz atlikušajām vietām 2027.gadam tiks atvērta 2026. gada 4.augustā
30.07.2026. 2026. gada 4. augustā tiks atvērta pieteikšanās atlikušajām četrām vietām zāļu reģistrācijas pieteikumu izskatīšanai 2027. gadam DCP procedūrām (Latvija kā atsauces valsts (RMS)) – janvāris (1 vieta), jūli...
Latvia ZVA (State Agency of Medicines)Vydání stanoviska MDCG 2026-5 k přidělování UDI mezi výrobci a distributory
Zveřejnění dokumentu MDCG 2026-5 týkajícího se přidělování jedinečné identifikace prostředku (UDI) mezi výrobci a distributory
Czechia SUKLOprava Seznamu cen a úhrad LP k 1. 8. 2026
Státní ústav pro kontrolu léčiv v souladu s ustanovením § 39n odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění a o změně a doplnění některých souvisejících zákonů (dále jen „zákon“) zveřejňuje Seznam cen ...
Czechia SUKLDėl vaistinių preparatų registracijos pažymėjimų galiojimo panaikinimo
Informuojame, kad Valstybinės vaistų kontrolės tarnybos prie Lietuvos Respublikos sveikatos apsaugos ministerijos viršininko 2026 m. liepos 29 d. įsakymu panaikinamas vaistinių preparatų registracijos paž...
Lithuania VVKTΑνάκληση της παρτίδας V0281, του φαρμακευτικού προϊόντος FAMPRIDIN-NEURAXPHARM 10MG
Αρ. πρωτ.: 95909 Ανάκληση της παρτίδας V0281, του φαρμακευτικού προϊόντος FAMPRIDIN-NEURAXPHARM 10MG. Για να έχετε πρόσβαση στην απόφαση πατήστε εδώ.
Greece EOFField Safety Notices: 29 June to 03 July 2026
List of Field Safety Notices from 29 June to 03 July 2026
UK MHRAGuidance: Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
UK MHRAGuidance: Ambient voice technology-enabled products
Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
UK MHRADėl vaistinių preparatų tiekimo sutrikimo
Informuojame, kad laikinai sutriko šių vaistinių preparatų tiekimas Lietuvos Respublikos rinkai. NPAKID7 Vaistinio preparato pavadinimas Veiklioji medžiaga Stiprumas Farmacinė forma Kiekis pakuotėje Registruoto...
Lithuania VVKTOmezení předepisování a výdeje léčivých přípravků s tamoxifenem
Tamoxifen lze předepsat a vydat pouze v množství jednoho balení na jeden lékařský předpis, další balení lze pacientovi předepsat nejdříve po 21 kalendářních dnech od posledního předepsání.
Czechia SUKLMedical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in thi...
US Federal Register - FDA RulesProduct-Specific Guidances; Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other thin...
US Federal Register - FDA Guidance NoticesLa AEMPS valida un modelo de gobernanza y un plan de acción para facilitar la aplicación del reglamento sobre evaluación de tecnologías sanitarias
Generar PDF Fecha de publicación: 28 de julio de 2026 Categoría: la AEMPS Referencia: AEMPS, 19/2026 Esta hoja de ruta, enmarcada dentro del Instrumento de Apoyo Técnico de la CE, tiene como objetivo realizar una impl...
AEMPS (Spanish Medicine Agency)Field Safety Notices: 20 to 24 July 2026
List of Field Safety Notices from 20 to 24 July 2026.
UK MHRAΝέα ΣΥΦΑ 2ου Τριμήνου 2026 _ Τιμολόγηση Φαρμακευτικών Προϊόντων (τελ.ενημ. 30-7-2026)
Στα πλαίσια της διαδικασίας τιμολόγησης νέων φαρμακευτικών προϊόντων, παρακαλούνται οι κάτοχοι των αδειών κυκλοφορίας αυτών όπως υποβάλλουν από σήμερα Τρίτη
Greece EOF
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