Submission via CESP
Submission via CESP
The Common European Submission Platform (CESP)
- permitselectronic submission of applications authorisations, permits, change notifications and other processes electronically in national, MRP / DCP or centralised procedures.
- is available within the EU to all applicants and marketing authorisation holders of human and veterinary medicinal products.
- replaces sending CDs or DVDs to the Paul-Ehrlich-Institut (PEI). CDs / DVDs can be requested only if problems occur with the submission via CESP.
Registration
http://cesp.hma.eu/Home
The portal offers information all about the use of CESP, including a registration form, FAQ, training videos and webinars. The company operates by means of the so-called "self-service model for user management": each company appoints its own administrator, who sets up access to CESP and supports the employees of this company.
Contact
Email: cesp@hma.eu
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Submission pursuant to AMG-EV
Submission pursuant to AMG-EV
The Statutory Regulation on the Submission of Documents in Procedures for the Admission and Extension of the Authorisation of Medicinal Products (AMG Submission Regulation [AMG-Einreichungsverordnung, AMG-EV]) regulates the electronic submission of documents pursuant to Section 2 AMG-EV including the procedure to be used. It does not affect the requirements for written submission and does not apply to funds within the meaning of Section 17c Tierseuchengesetz (Animal Diseases Act) (as from 01 May 2014 Section 11 TierGesG {Animal Health Act, Tiergesundheitsgesetz]).
Submission Process
Email: eSubmission@pei.de
For each application, please send a separate email, taking into account the content of the email. The applicant must be recognisable as the sender. Written documents should be sent to the Paul-Ehrlich-Institut (PEI) at the same time as the electronic version.
The receipt of your email is confirmed automatically. The acknowledgment of receipt does not indicate completeness or correctness of the documents sent by email.
If the drug dossier is already managed electronically (eCTD or NeeS), the dossier may also be submitted as so-called "Working Documents" along with the application. Then the separate submission according to AMG-EV will not be required.
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PEI-C Rebuild
PEI-C Rebuild
Electronic Submission of Applications for Batch Release
Batch release applications for the human and veterinary sectors can be submitted electronically via the portal PEI-C Rebuild integrated in PharmNet.Bund.de:
- Regular application
- Parallel Testing
- Packing and filling batches
- Parallel import
- Parallel trade in Europe
- Plasma pool certificate
- Test reports for plasma pools
- Recognition of an OMCL certificate
- Quantity extension
- Plasma certificate of origin
- Additional releases
- Renunciation of release
- Withdrawal of an application for batch release
About the Procedure
Pharmaceutical companies can use PEI-C Rebuild to submit batch release applications electronically. The electronic application contains all the documentation. Separate submission of paper applications or parts thereof is not required.
To be able to use PEI-C Rebuild as a pharmaceutical company, you need to register for the application. Afterwards, the electronic submission route is available. You can administer the creation and submission of your batch release requests yourself, and you have a dual control approach to support GMP compliant electronic filing. For the samples to be sent to the Paul-Ehrlich-Institut (PEI) there is the possibility to print a sample delivery note matching the electronic application.
The process has been in operation since April 2014. Experience shows that the system works consistently and safely. Due to the security requirements of the system, initial registration is not quite simple. However, the feedback of already registered companies clearly shows that the disadvantage caused by the workload is more than offset by the convenience of electronic submission and the associated benefits. Members of staff from the authorities are available for assistance.
Registration - Access - User Administration (Registrierung – Zugang – Benutzerverwaltung, RuBen)
In order to use PEI-C Rebuild, you need to register with the RuBen application. With RuBen, you can register your company as a user and then set up a self-managed user administration for your company.
The use of RuBen is documented in detail.
Please note: An authentication based on two factors (possession and knowledge) serves the secure registration and use of the application. Initial registration requires the transmission of an X.509 user certificate. In addition to the username and password you will receive after a successful registration, this is the second factor for authentication. For details, see the instructions for the Single Sign On.
You can obtain X.509 certificates through the trusted certification authority or distributor. A selection of possible reference, points can be found in the appendix to the single sign-on instructions. Further information can be obtained from the contact persons for PEI-C Rebuild at the following address: pei_cr_support@pei.de.
Submission of documents via the portal PEI-C Rebuild
After registering and logging in, you will reach the interface of the portal PEI-C-Rebuild. Here you can submit your applications for release in accordance with Section 32 of the German Medicines Act (AMG) for products which are subject to the obligation of official batch testing. A manual and other documents explain the use in detail.
Contacts
PEI-C Rebuild
Email: pei_cr_support@pei.de
RuBen
Phone: +49 221 4724 270
Email: helpdesk-technik@bfarm.de
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De-Mail Communication
De-Mail Communication
The Paul-Ehrlich-Institut (PEI) offers De-Mail as an additional means of communication. The security standards of De-Mail make it possible for applicants and pharmaceutical companies, in particular, to submit applications and documents with a requirement of written form electronically by De-Mail:
- The identity of the communication partners can be proved beyond doubt.
- Declarations of intent made using De-Mail are legally binding.
- The access of a De-Mail is verifiable.
- For example, a registered mail with acknowledgment of receipt can be electronically mapped.
Notifications and confirmation letters can also be sent by the PEI via this route. By publishing the De-Mail address, PEI has formally opened its De-Mail account:
pei@pei.de-mail.de
Requirements for use
- The recipient has a De-Mail account and ideally a standard De-Mail mail client.
- The recipient opened the De-Mail account with the PEI. To do this, please fill out the access opening form stating a functional e-mail address, sign the form, and return it o the PEI.
Legal remarks
An electronic document is legally effective upon receipt by the recipient. It is considered received if, in the ordinary course and under normal circumstances, the recipient can be expected to be aware of it.
We therefore ask you to inform us immediately about a failed transmission or a lack of readability. It should be ensured that any changes to the notified address details are reported to the PEI without delay. The declaration of access can be revoked or changed at any time by the applicant.
Contact
Unit PEI Gateway, Document Management
Phone: +49 (0) 6103 77 1300
Email: portal@pei.de
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HMA eSubmission Roadmap
HMA eSubmission Roadmap
As per 1 January 2019, all submissions for human medicines in Germany will be performed in eCTD and for veterinary medicines in VNeeS.
The BfArM and the PEI hereby expressly refer to the HMA eSubmission Roadmap, which stipulates, among other things, from what point in time only structured submission formats will be accepted. In addition to the technical and organisational requirements for the implementation of the eSubmission Roadmap, the two federal authorities are also determined to pave the way for an adapted legal basis for the electronic submission of applications as quickly as possible. BfArM and PEI also intend to implement the other milestones of the eSubmission Roadmap in an appropriate way.
Milestones
- 1st Quarter 2018 Electronic filing for all regulatory activities of Central Procedures (CP), Decentralised Procedure (DCP) and Mutual Recognition Procedures (MRP) in eCTD format
- 3rd quarter 2018 New applications for national eCTD format (human) and VNees format (veterinary)
- 1st quarter 2019 Electronic filing for all regulatory activities in eCTD format (Human) and VNeeS format (veterinary); desirable that the restricted part of ASMFs in eCTD format is also presented
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