eSubmission/PharmNet.Bund
Is there also a status "in process" for Type IA notifications?
As Type IA notifications are simple validation procedures, the procedure will normally be completed directly after validation so that no "in process" phase will exist.
In July 2013, many CMS variations received the status "End of procedure"; the final product information, however, is not yet published. Is this situation due to the amended regulation?
Due to the newly created link between the AMIS database with adjoining IT systems, data were automatically transferred into AMIS. This transfer triggered the status information. However, the formal closure of these procedures still has to be executed manually. Due to the large number of procedures this may lead to delays. Thus, the a.m. status information is not related to the amended regulation.
How shall texts be submitted after the end of the procedure?
In cases where variation applications also lead to changes in the product information (Package Leaflet and SmPC), the amended version of these texts has to be submitted immediately to the relevant national competent authority in accordance with Sections 11 (1a) and 11a (3) AMG.
For the submission of final texts the BfArM is planning to introduce a simplified electronic procedure via PharmNet.Bund. In the transitional phase, the submission should be made within 3 weeks after the end of procedure of the variation according to the conventions of the AMG Submission Ordinance. In this procedure, only clean versions have to be submitted as pdf-documents. The technical prerequisites as well as the fixed rules and format provisions according to the current information for the implementation of the AMG Submission Ordinance under www.bfarm.de have to be regarded. Please observe that the exact reference to the variation application is made as follows:
Example:
Table – Naming of metadata within attribut.txt
| New application: zulassung renewal: verlaengerung post-marketing approval: nachzulassung Note: procedure types as given above are also valid for the application of homeopathic medicinal products with indication | Variation: aenderung
| Product information release: freigabe |
Naming of attribut.txt for new applications for homeopathic medicinal products without indication: Registration: registrierung Post-marketing registration: nachregistrierung | ||
| pnr = pharmaceutical company number enr = submission number verf = procedure type as given above edat = tt.mm.jjjj (date of submission according to date of cover letter in paper submission) | pnr = pharmaceutical company number enr = submission number verf = aenderung aend = tt.mm.jjjj (date of submission according to date of cover letter in paper submission) | pnr = pharmaceutical company number enr = submission number verf = freigabe dat = tt.mm.jjjj (date of end of procedure according to status information by e-mail or date of end of procedure letter/decision) |
| Example attribut.txt: pnr = 0000000 enr = 1999023 verf = zulassung edat = 24.12.2006 | Example attribut.txt: | Example attribut.txt: |
Will a purely electronic submission for national or European Variations via the PharmNet.Bund portal together with an upload via CESP be possible for documents which do not comply with the requirements for eCTD or NeeS?
Basically, yes. However, the BfArM strongly recommends switching to the eCTD or NeeS formats, as only structured submissions like with eCTD ensure that the processing is as smooth and resource-sparing as possible.
Since 4 August 2013, the BfArM neither requires paper submissions nor digital signatures. However, the application form for variations states that the main signatory is mandatory. Likewise, the form for purely national variations provided via the PharmNet.Bund portal requires a signature. Does this mean, that these forms have to be printed, signed and submitted as a scanned document?
Provided the submission is made via the PharmNet.Bund and/or CESP portals, no signature is necessary on these forms. The authorisation procedure and the login data needed for this purpose which are part of the PharmNet.Bund and/or CESP portals are considered as adequate substitute for the signature. The BfArM therefore strongly recommends not submitting scanned application forms.
Is it possible to use the EU Electronic Application Forms (eAF) alternatively? Which signature is required in this case?
EU Electronic Application Forms can definitively be used as an alternative. In this case, the scanned signature will be accepted in any format, as the authorisation procedure which is part of the PharmNet.Bund and/or CESP portal is considered an adequate substitute for the signature. Here, the scanned signature ensures that data cannot be modified subsequently. Therefore, the Electronic Application Forms should not be submitted without the scanned signature.
For submissions made via the PharmNet.Bund portal, how can a CESP submission number for a variation already sent be amended, in case a new CESP upload including a new CESP submission number becomes necessary due to an incorrect initial CESP submission?
The PharmNet.Bund “Online Variation Submission” application offers the possibility of sending a request for correction. For this purpose you have to select the option “list sent notifications” from “Work list” under “Notification sent”. From this list you can choose the variation by clicking on “Correction request” and then “Continue”; the next step is to enter the reason: “correction of CESP submission number”. The command “Submit” then sends the request for correction to the BfArM which will usually be confirmed the next working day. After release of the data record you can select the variation by choosing “list sent notifications for correction”, perform the changes and resend the modified variation.
Further Information can be found in Chapters 6.7 and 6.8 of the German version of the manual: Handbuch "Elektronische Änderungsanzeigen"
Are variations required if the marketing authorisation dossier is reformatted into the eCTD format?
A variation is not required, if no changes to the content of the marketing authorisation dossier are necessary for reformatting into the eCTD format and if a corresponding confirmation is given.
Please also consider the FAQs concerning eSubmissions - Information on the electronic submission ("e-only") of follow-up applications.
If content modifications are required to implement the eCTD format, these modifications should be classified according to the variation guideline.