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!