02.06.2021

Our Health Technology expertise is increasing further

Tiina Riihimäki, PhD (Medical Technology), has been appointed as Health Technology Team Leader at DRA.

02.06.2021

Electronic product information – where are we at?

When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is.

25.05.2021

Zero day MRP/RUP in Iceland

IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).

18.05.2021

Cycling Day 2021 – doing good for the benefit of young people’s mental health

The charitable exercise day will take place on 19 May.

10.05.2021

CMDh: Dexamethasone for the treatment of COVID-19

CMDh has published a summary RMP for medicinal products containing dexamethasone for the treatment of COVID-19.

03.05.2021

Download a guide on the certification and licencing of Life Science products

The guide describe the essential regulatory requirements in Finland and in the EU.

12.04.2021

It is a pleasure to introduce our new experts

Welcome Malena, Adele, Carita, Santtu-Matti, Jussi, Katri and Miika!

07.04.2021

The Swedish Medicines Agency (MPA) is proposing increases in fees

On March 2, 2021, the MPA has proposed to the Swedish government an increase in fees for control of medicinal products as of January 1, 2022. The reason for the increases is mentioned e.g. increase in operating costs.

07.04.2021

Guideline on Nordic Packages and Q&A document updated

The Nordic Co-operation Group has updated the Guideline on common Nordic packaging materials and the Q&A document. Four new questions have been added to the Q&A document. Some of the existing questions/answers have also been updated.

01.04.2021

EU Digital Application Dataset Integration (DADI) – new eAF formats

A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU.

17.03.2021

EMA Medical terms simplifier

EMA has published Medical terms simplifier – a list of plain-language descriptions of medical terms commonly used in information about medicines.

15.02.2021

Monitoring the adverse reactions of COVID-19 vaccines

On January 27, 2021, Fimea opened a website for adverse reaction reports for coronavirus vaccines. The page is updated more than once a week by the number and severity of adverse reaction reports.

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