To ensure high quality and consistent Product Information (PI) of centrally authorised medicinal products in the Member States of the European Economic Area (EEA), a linguistic review of the PI in all 24 European languages, including Icelandic and Norwegian, is required following the Opinion of the Committee for Human Medicinal Products (CHMP) concerning new applications.
The duration of the procedure for evaluation of marketing authorisation applications (MAAs) by the European Medicine Agency (EMA) is 210 days, excluding any clock-stops for the Applicant to provide answers to questions from the Agency. At submission and during assessment of MAAs, only the English language of the PI is submitted and reviewed.
According to the linguistic review process, at the latest by Day 215, the Applicant should provide the EMA with the final English version of PI and relevant translations in 24 languages (along with the annexes and QRD Form 1, necessary for the check of the documentation).
Each translation will be subject to the Member States’ linguistic review and, at the latest, by Day 229 the response will be sent to the Applicant who will have to implement possible amendments and send the tracked and final texts to the EMA by Day 235.
Following the EMA’s confirmation of the translations, the PI will be sent to the European Standing Committee, which will take into account the legal and public health matters, for the final approval.
According to Regulatory Pharma Net experience in supporting Applicants during this procedure, it is crucial to maintain close contacts with Member States (particularly between Day 229 and Day 235), in order to promptly solve any issue that might be raised during the implementation of Member States’ linguistic comments in the requested 24 languages. So that the procedure can be finalized in due time, avoiding any delay of the EU Commission Decision.