Transcription of European Medicines Agency post-authorisation procedural ...
{{id}} {{{paragraph}}}
Example: quiz answers
European Medicines Agency post-authorisation procedural ...
20 December 2021. EMEA-H-19984/03 Rev. 96. Human Medicines Evaluation Division European Medicines Agency post - authorisation procedural advice for users of the centralised procedure Important information regarding ending of Irish language derogation As of 1st January 2022, a derogation expires concerning the status of Irish as a working language of the EU Institutions. This means that Irish will be the authentic language of Commission decisions on marketing authorisations, including the product information they contain, addressed to any marketing authorisation holder established in Ireland, unless they request a language waiver. This will also apply to post - authorisation decisions of the European Commission addressed to EU Member States, including the product information they contain, which will be translated into Irish together with the other official EU languages, for the following procedures: Referrals, Periodic safety update reports (PSURs), post - authorisation safety studies (PASS)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure EMEA-H-19984/03 Page 2/299 . Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication.
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: