28.03.2022

The Medical Device Coordination Group (MDCG) has provided guidance on the appropriate surveillance regarding legacy devices

Some devices may still be placed on the EU markets under the Medical Devices Directives as so-called legacy devices.

28.03.2022

New talents to DRA’s diverse expert teams

Welcome to DRA Hanna Ridderheim, Solja Kalha, Elisa Saarnio ja Henna Torvi!

01.02.2022

A new innovation that makes placing  medicinal products on the market quicker and saves money

Press Release: A Finnish company is digitalising the process of writing marketing authorisation applications – the sections describing the medicinal product’s manufacturing and quality can be completed in half the time with the new DRA Variator® software. 

31.01.2022

It is a pleasure to introduce our new experts

Welcome Moona, Pauliina, Nina and Joona!

31.01.2022

The extension to the transition period of the IVD Regulation (EU) 2017/746 is now official

On 28th of January 2022, the European Commission published in the Official Journal of the European Union an amending regulation as regarding to the transitional provisions of the in vitro diagnostic medical device (IVD) regulation for certain IVD medi

28.01.2022

Application of the Veterinary Medicines Regulation to begin

The Veterinary Medicines Regulation (2019/6) will be applied as-is in all EU Member States from 28 January 2022. The Regulation will lead to changes in the pharmacovigilance, distribution and marketing of veterinary medicinal products, as well as applying for marketing authorisation and maintaining it.

17.12.2021

Gift to the sustainable future and green pharmacy

We made a donation to the sustainable pharmacy fund of the University of Helsinki and the new professorship. With this donation, we want to support the establishment of the world’s first professorship in sustainable development in pharmacy.

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.

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