DRA continues to grow and we are proud to introduce our new team of experts. Welcome Henna Juvonen, Elsi Tuominen, Militsa Kukko, Roosa Bäck, Pia Mustakangas, Jasmin Pyrhönen ja Vilhelmiina Peltoniemi.
Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.
The latest application form version has been published on 1 October 2021 and the use of the form and OMS information is mandatory from 1 November 2021.
The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic.
The document provides practical examples of devices, including applicable rules and classifications.
The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.
His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.
We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.
The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.
The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland.
To guide registration activities, EU-Commission has released a Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorized representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR in June.
These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.