Following the European Commission report published in June 2021, it was confirmed that no capacity problems are foreseen for translations as of 2022 and, as result, the derogation for the Irish language (obligation to translate the opinion page and the product information annexes) will be finally lifted in January 2022.
This means that from January 2022 onwards every new MAA Human and Veterinary will have to include the annexes in the Irish language and decisions of the European Commission addressed to EU Member States, including the product information they contain, 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)
Irish will also be the authentic language of Commission decisions addressed to any MAH established in Ireland, unless they request a language waiver using an appropriate template, by which they request to use English as authentic language. The waiver will be valid for a period of 3 years from the date of notification and will be automatically renewed for further consecutive periods of 3 years, unless the companies or individuals decide to withdraw the waiver. The withdrawal of the waiver will take effect at the end of the three years period or three months after it has been notified, whatever is earlier. Marketing Authorisation holders should regularly review the corresponding information and update the waiver, as needed.
The concerned companies or individuals (in case of orphan designations) are requested to submit their waiver by 31 January 2022.
Regulatory Pharma Net team has successfully provided assistance in centralized procedures and is also available to support Irish companies with language waiver request and submission by advising on next steps to be fulfilled.