Translations of SmPC/PL and label documents in MRP and CP.

We will coordinate translations for you during your marketing authorisation projects. As soon as you have submitted your English drafts during the marketing authorisation procedure, we will start coordinating the translation and create pre-translations in the languages of all EU Member States After the final English version has been approved by the competent authority, we will adjust these pre-translations to the latest changes within three working days. We will help you to remain within your five-day deadline. We will readily support you in your submissions to the national authorities and will take over handling any feedback relating to translations within the deadline allowed for adaptation.

Apart from compliance with your deadlines, we also pay attention to the following:

  • Use of the appropriate QRD templates for CP or MRP/DCP
  • Compliance with MedDRA and EDQM terminology
  • Correct rendering of standardised wording, such as excipient information, doping warnings or the Blue Box
  • EMA formatting requirements
  • Maintenance of readability in accordance with your readability compliance studies

We are also happy to coordinate the typesetting of your package leaflests and labels with our external experts via LangCorNET.

Our team is ready to advise you at all times. It is best if you contact us at the start of your procedure so that we can plan the respective language services in a time manner and put together the ideal translation team for you.