BfArM has joined CESP, an HMA initiative aiming to establish a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the EEA.

After 5 August 2013 there is no need to submit any documents on paper.

Please observe the BfArM’s general rules for the acceptance of electronic-only submissions (here):

eSubmissions via CESP will be accepted for

• submissions structured according to eCTD or NeeS specifications and tested for technical validity in case of
  o Marketing Authorisation Applications (MAA)
  o variations (Please observe specific advice)

  o purely national variations ("Änderungsanzeigen") according to Section 29 AMG (Please observe specific advice)
  o renewals
  for decentralised procedures (DCP), mutual recognition procedures (MRP) or purely national procedures except for draft response documents submitted for pre-assessment by the RMS.

• educational material (for further details please click here (German only)
• PSURs (for further details please click here) (German only)
• ASMF (according to eCTD or NeeS specifications and tested for technical validity)

Not accepted via CESP

• draft response documents submitted for pre-assessment when Germany is acting as RMS cannot be accepted via CESP. These should be submitted directly to the case manager via e-mail or EudraLink.

In general, the applicant/Marketing Authorisation Holder will not receive the information that a submission not acceptable via CESP is ignored.

Note: In case of variations, we highly recommend using our national portal for online variation submissions (here) for the generation of the application and structured data. Large documentations should be submitted via CESP prior to using the variation portal. The CESP delivery number is required as an entry.

The following information is required when filing via CESP or when creating the CESP delivery file:

• MRP/DCP :

  1. Procedure number in ‚Delivery File Step 1‘:
     Please enter the complete EU procedure number including all procedure type qualifiers and sequence numbers (e.g. for a type II variation DE/H/1234/001/II/002 instead of only DE/H/1234/001)
     If the submission applies to more than one pharmaceutical strength or form you may indicate this by using a minus in the strength counter of the procedure number (e.g. DE/H/01234/001-003/II/002). Out-of-range strengths may be separated by semicola without blanks (e.g. DE/H/1234/001-003;006;008/II/002).
     If the submission applies to multiple products by way of exception, please enter the product numbers in the respective counter using a minus or a semicolon. (e.g. DE/H/1234-1236;2345/001-003/DC)
     All preceding zeros should be stated: 0123 instead of 123; 006 instead of 6 or 06
  2. Agency Ref No(s) in ‘Delivery File Step 1’:
     DE being RMS: Please enter the 7-digit ENR for the product (e.g.: 2123456, in case of a post-approval procedure the MA number (ZNR) may be used instead (e.g. 4321.00.01)).
     If the submission applies to more than one product you may enter a range of ENRs by using a minus. Individual ENRs may be separated by a semicolon without blanks (e.g. 2123456-2123460;2187654).
     DE is CMS: information as requested by the RMS should be filled in here.
  3. Product(s) in ‘Delivery File Step 2’:
     DE being RMS or CMS: Please enter the 7-digit ENR and the product name (e.g.: 2123456,oneProduct). In case of a post-approval procedure the MA number (ZNR) may be used instead (e.g. 4321.00.01).
     If the submission applies to more than one pharmaceutical strength or form you may enter a range of ENRs by using a minus. Individual ENRs may be separated by a semicolon without blanks (e.g. 2123456-2123460;2187654).
     You may enter multiple lines of MA numbers and product names for the same agency.

Stating the eCTD sequence number as a comment would be appreciated. For specific types of submissions (e.g. educational material) further information may be required in the CESP comment field as indicated on the respective BfArM page.

• National Procedures

  1. Procedure number in ‚Delivery File Step 1‘:
     all procedures except for variations: Please enter the 7-digit ENR for the product (e.g. 2123456; in case of a post-approval procedure the MA-number (ZNR) may be used instead (e.g. 4321.00.01)
     If the submission applies to more than one product you may enter a range of ENRs by including a minus; individual ENRs or ZNRs may be separated by a semicolon without blanks (e.g. 2123456-2123460;2187654).
     For variations please enter the national variation number (e.g. IA-S-2112345-20130711-001). If you do not have the variation number, the above applies.
  2. Agency Ref No(s) in ‘Delivery File Step 1’:
     The same information as above can be given again.
  3. Product(s) in ‘Delivery File Step 2’:
     Please enter the 7-digit ENR and the product name (e.g. 2123456,oneProduct). In case of a post-approval procedure the MA-number (ZNR) may be used instead (e.g. 4321.00.01).
     If the submission applies to more than one product you may enter a range of ENRs by including a minus; individual ENRs or ZNRs may be separated by a semicolon without blanks (e.g. 2123456-2123460;2187654).
     If the submission applies to more than one pharmaceutical strength or form you may enter a range of ENRs by using a minus. Individual ENRs may be separated by a semicolon without blanks (e.g. 2123456-2123460;2187654).
     You may enter multiple lines of MA numbers and product names for the same agency.

You will find detailed information on how to use CESP in the ‘training’ area once you have logged in.