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.

translations@bfarm.de

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.