PEI-C Rebuild - electronic submission of applications for batch release applications
Applications for the batch release of human and veterinary medicinal products can be submitted electronically using the PEI-C Rebuild Portal which is integrated in the webpage PharmNet.Bund.de. This facilitates the work for all parties involved in the application procedure.
- Information on the application procedure
- Registration – access – user administration (RuBen)
- Submission of the application documents using the PEI-C Rebuild Portal
- Types of applications
- Contact and support
- Link to the batch release portal
Information on the application procedure
Pharmaceutical companies can submit their applications for batch release electronically using PEI-C Rebuild. The electronic application contains the entire documentation. A separate submission of your batch release application or parts thereof in paper form is not required.
To use PEI-C Rebuild as pharmaceutical company, you will be required to register. The electronic method of submission will then be available to you. You will be able to handle the administration of the preparation and submission of your batch release applications by yourself. In addition, a system of counter-checking will be available to you as an aid for GMP compliant electronic submissions. The electronic submission procedure also offers you the possibility to print a delivery slip for the samples to be sent to the Paul-Ehrlich-Institut (PEI).
This procedure has been in the production phase since April 2014. Experience has shown that the system functions safely and steadily in all its components. Because of the security requirements, first-time registration is a bit complicated. However, the feedback given by previously registered companies very clearly shows that the workload involved in this is more than offset by the subsequent ease that the electronic submission offers and the advantages related to this. A support team from the Paul-Ehrlich-Institut is available to provide help.
Registration – access – user administration (RuBen)
A registration procedure is required to use PEI-C Rebuild. This is done by means of the RuBen software. It is used to register your company as user. Then you can set up a user administration system for your company which you will manage all by yourself.
RuBen contains the following documents:
- Single Sign On – Digital certificate for authentification
- User administration – Administration and self-administration of users
- Conditions of use – User self-administration
Please note: For secure registration and use of the application, an authentication procedure is required which consists of two factors (possession and knowledge). The transmission of an X.509 user certificate is required at first-time registration. In addition to the username and the password, which you will receive after successful registration, this is the second factor of authentication. For more details please refer to the instructions for the single sign-on.
X.509 certificates are available from the certification office or a distributor of your choice. The annex of the instructions for the single sign-on contains a selection of possible distributors. You can also contact the support staff for PEI-C Rebuild for further information by following this link: email@example.com.
Submission of the application documents using the PEI-C Rebuild Portal
After registration and sign-on, you will see the screen of the PEI-C-Rebuild Portal. Here, you can submit all applications for a batch release pursuant to Section 32 of the German Medicines Act (Arzneimittelgesetz, AMG) for products subject to official batch release testing. The use is explained in detail in the user guide and other documents which you will find in the portal. Below, you will find a list of these documents:
User Guide PEI-C Rebuild
General conditions of use PEI-C Rebuild
Presentation of introduction to the portal PEI-C Rebuild
XSD-Scheme definition file for application in XML-Format.
Additional Information is also offered by DIMDI on the portal’s homepage.
Types of applications
The following types of applications can be submitted using the portal:
- Regular application
- Parallel testing
- Packaging and filling batches
- Parallel import
- Parallel trade in Europe
- Plasma pool certificate
- Test report for plasma pools
- Acceptance of an OMCL certificate
- Extensions with regard to quantities
- Certificate of origin of plasma
- Additional releases
- Renunciation of release
Withdrawal of an application for batch release
Contact and support
Our support team will help you if you have any questions about the use of PEI-C Rebuild or RuBen, or if you have problems with your authentification.