12.10.2021

DRA welcomes new professionals

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.

11.10.2021

Swedish SPC approved for less than 50% of human medicinal products

Fimea reminds marketing authorisation and registration holders of the requirement to submit a Swedish Summary of Product characteristics by 9 February 2022.

11.10.2021

The use of EMA’s Organisation Management Services (OMS) data is extended

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.

11.10.2021

The validity of GMP and GDP certificates are extended until the end of 2022.

The European Commission, EMA and the European medicines regulatory network has updated the activities to ensure the availability of medicines during COVID-19 pandemic.

06.10.2021

MDCG has released guidance for classification of medical devices

The document provides practical examples of devices, including applicable rules and classifications.

06.10.2021

The device and certification module of EUDAMED is now open for registration and searches!

The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.

07.09.2021

DRA’s organisation is developing – Jussi Rysä has been appointed Unit Head

His responsibilities in DRA’s operations are Market Access, Marketing Compliance and Medical Services, Pharmacovigilance and Language and Communications Services.

03.09.2021

DRA joins effort to establish the world’s first professorship in sustainable development in pharmacy in Finland

We want to promote actions that can effectively reduce environmental impact of pharmaceutical manufacturing and the different stages of medicinal product’s life cycle.

25.08.2021

MDCG has released guidance for performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVD) 

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. 

25.08.2021

The Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices 

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. 

29.06.2021

Guidance published by EU-commission on obligations and related rules for the registration in EUDAMED

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.

29.06.2021

SWIXIT – Effects on the current status of the EU-Switzerland mutual recognition agreement (MRA) for medical devices markets

These should be noted by Swiss medical device manufacturers and legal manufacturer with Swiss Notified body or Swiss-based Authorized Representative.

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