Submission of national translations in MR/DC procedures
What has to be considered when preparing national translations?
If the final English product information is based upon a CHMP referral or a centralised procedure, the corresponding German translation has to be used.
If parallel procedures are concluded with identical final English product information, identical German translations have to be submitted.
If considered necessary, BfArM may declare one translation binding.
What is the contact address for the submission of translations?
In what form should the national texts be submitted?
The national texts are to be inserted into the “Bescheidmaske”, which is made available on the BfArM homepage.
Submissions without a “Bescheidmaske” will be rejected unprocessed.
For each strength, a separate “Bescheidmaske” must be submitted in which the first pages (up to the signature) are completely filled in.
The text of the product information is only to be inserted in Annexes 1-3 of the “Bescheidmaske” for the lowest strength.
If a combined “Fachinformation” for several strengths is intended, sections 1, 2, 3, 4 (excipient warnings, if applicable) and 6 in Appendix 4 shall be completed for all strengths.
If the texts for different strengths of a medicinal product differ in terms of content (e.g. indication, dosage), a fully completed “Bescheidmaske” must be submitted for each strength.
In addition, the product information for all strengths / parallel processes must be submitted in Word format.
“Bescheidmaske” with instructions for filling in
Which language is to be used for submission of dossier and product information texts in MRP/DCP, if only German-speaking member states (DE/AT) are involved?
All guidance documents of the CMDh refer to the use of English dossiers and English product information texts. At the end of the procedure, the RMS has to provide the final English texts for SmPC, PL and Labelling. This is also necessary for the upload of the texts and the public assessment report in the MRI-PI. For this reason, English texts must be submitted and evaluated, both for procedures that are submitted only to German-speaking CMS and for procedures that are completed with only German-speaking CMS by withdrawing the applications in other CMS. The national phase for the evaluation of the German-language texts begins only after the conclusion of the procedure.
How do I implement BfArM comments?
If the “Bescheidmaske” commented upon by BfArM contains track-changes, these changes are accepted and the "Bescheidmaske" is drafted accordingly for all strengths / procedures.
When returning the drafts to BfArM, the applicant has to confirm, that all comments have been accepted and no further changes have been made.