CRED SMPC 2024

17/09/2024

Example: Irish language derogation ending on 1 January 2022

Marketing authorisation and orphan designation holders established in the Republic of Ireland: Commission decisions to be communicated in Irish unless request a language waiver. For all new marketing authorisation applications, irrespective of where the applicant is established, (i.e. in Ireland or elsewhere), applicants will be required to submit the International Non-Proprietary Name (INN) translation in all official EU languages including the Irish language following a positive CHMP opinion adopted after 1 January 2022. In those cases where the Irish translation of the INN is not available, applicants can submit the English language INN.

Product-information requirements | European Medicines Agency (EMA) (europa.eu)

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Example: Anonymisation of annotated annexes

April 2021: EMA updated guidance to Marketing Authorisation Holders to ensure annotated (tracked) labelling is anonymised:

“Please be reminded that in accordance with Union data protection requirements, no personal data should be included in the annotated product information annexes. This applies to the English version as well as to all the other languages translation versions. Please submit annotated product information annexes in an anonymised format (i.e. names of the reviewers removed from the track-changes). If you do not wish to do so, please ensure that the individuals whose data is included consented to its sharing with EMA and its further sharing by EMA with third parties such as other marketing authorisation applicants, marketing authorisation holders and National Competent Authorities, as relevant. EMA expressly disclaims any liability or accountability for the presence of unnecessary personal data in the annotated product information annexes submitted by the marketing authorisation holder.”

• Impact to ongoing procedures – needed to ensure English and translations anonymised.

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