In order to increase the transparency and predictability of DCP applications with DE=RMS for applicants, the BfArM is changing its submission modalities as of 01.03.2024 and is setting up reliable time slots.

Before submitting a DCP application, the slot request form should be completed in full and sent to slotrequest-DCP@bfarm.de .

Applicants will receive a reply within 3 weeks stating the best possible submission month (time slot). This offer should be confirmed within one week.

Please take note of the following information:

• If the offered time slot is not confirmed within one week, the slot will be considered free again.
• Failure to keep the agreed slot without prior agreement will result in the loss of the slot and the need to submit a new slot request.
• A one-off postponement of up to one month on the part of the applicant will be accepted. Postponements beyond this will be treated as a new slot allocation.
• The postponement or withdrawal of the agreed slot should be communicated at least 2 months before the date.
• If the medicinal product for the confirmed slot changes significantly (e.g. due to a change in the active substance), a new slot should be applied for.

• Art. 10a applications (so-called "well-established use") require a high administrative processing effort. Longer processing times are also required if bioequivalence studies have to be requested. See also:

  NtA Chapter 1, section 5.4:

  "…The well-established medicinal use legal basis is to be used only in cases where all aspects of the safety and efficacy are demonstrated by reference to published scientific literature. It would derive that it should not be considered as an alternative to other legal basis such as Article 10 of Directive 2001/83/EC. The adequacy of the bibliographic evidence has to be assessed on a case by case basis in the understanding that applications under Article 10a does not lower the requirements of safety and efficacy that must be met."

Notes on applying for a processing number (Eingangsnummer) and procedure number (DCP number)

Before assigning a procedure number, it is necessary to apply for a so-called “Eingangsnummer” (ENR) for each strength by contacting antragseingang@bfarm.de approximately 4 weeks before submission.

Please then send an overview of the proposed names together with the corresponding ENR to slotrequest-DCP@bfarm.de , and we will inform you of the procedure number.