March 31, 2022

From 1st January 2022, Irish is at the same level as the EU´s other official 23 languages. This means that European Commission decisions addressed to Member States adopted after 1st January, e.g. certain referrals, PSUR single assessment (PSUSA) procedures or assessment of non-interventional post-authorisation safety studies (PASS) will also be translated into Irish.

Furthermore, EMA will engage with marketing authorisation and orphan designation holders established in Ireland regarding whether they will require Commission decisions to be communicated to them in Irish or whether they would like to request a language waiver.

Would you like to know more about what a marketing authorisation holder should do to request a language waiver?

Asphalion, together with our partner Dora Wirth Languages (language solutions provider to leading Life Science organisations) are at your disposal to help navigate this new requirement and to translate all required documentation into Irish.

Contact us for further information!




Search News & Events

  • Filter by category


Related news and events

EVENT | Medicines for Europe annual conference

Asphalion’s Managing Director, Núria Romero, and Lidia Cánovas, Key Accounts Director will be joining the Medicines for Europe annual conference in Malta next week. The

NEW | MHRA announces new recognition routes

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners.
The new recognition routes open additional options for the MHRA to bring cutting-edge medicines faster to UK patients by leveraging the expertise and decision-making of trusted regulatory partners.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting