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Translation timelines
Marketing authorisation


All registration procedures: NP, CP, DCP and MRP National procedure, centralised and decentralised procedures, mutual recognition procedure

LABELLING TRANSLATIONS FOR THE MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS


Summary of product characteristics (SmPC), package leaflets (PL), labels. As part of the marketing authorisation of a medicinal product within Europe, after successfully completing the application assessment within 5 calendar days (!), as part of the

  • Centralised procedure (CP) in all official EU languages
  • Decentralised procedure (DCP) or
  • Mutual recognition procedure (MRP) in all official languages of the Member States involved

 

certain documents must be submitted to the relevant authorities for assessment. This basically affects the documents for product information, that is, the SmPC, package leaflet and labels.

In light of the extremely tight deadline for submitting the documents in the national languages and the volume of texts to be translated, it is essential to translate the source texts into the national language documents during the application assessment. The 5-day deadline should be reserved for final modifications only.

mpü processes assure far-sighted planning of the translation process and timely delivery of correct and reviewed documents in the national languages.