Service Finder
Apply for batch release of immunomodulators as veterinary medicinal products
Service Description
Before you can make an immunological veterinary medicinal product batch available for the German market, it must be tested and approved. State batch testing for immunological veterinary medicinal products is carried out by the Paul Ehrlich Institute (PEI). If you would like to have an in-vitro diagnostic product approved and a batch released, you must submit a separate application to the Friedrich-Loeffler-Institut (FLI).
Immunological veterinary medicinal products that require batch release include
- Immunomodulators
- sera
- vaccines
- Tuberculins
How are the immunomodulators checked?
The PEI reviews your submitted batch documentation (Official Batch Protocol Review, OBPR) on the basis of the EU administrative procedure for batch verification of immunological veterinary medicinal products in accordance with Article 128 of Regulation (EU) 2019/6.
If your batch meets the criteria specified in the marketing authorization for your medicinal product, you will receive a national release decision and/or an EU certificate, if requested, by post from the PEI or you can retrieve both in PEI-C Rebuild.
What European standards are there?
Batch testing is regulated uniformly in the member states of the European Union (EU) and in Norway, Liechtenstein, Iceland and Switzerland. It is carried out according to the rules of the Official Medicines Control Laboratories (OMCL).
These laboratories have joined together to form a network under the direction of the European Directorate for the Quality of Medicines (EDQM). The Paul-Ehrlich-Institut (PEI) is represented in the OMCL network as a state control laboratory.
If your batch has already been released by a laboratory in the OMCL network, it will be recognized and therefore also released more quickly in Germany. If you would like to distribute your batches from Germany to other countries in the OMCL network, you can apply for an EU certificate from the PEI for this purpose.
Process flow
You can apply for batch release online or by post and, in exceptional cases, by e-mail.
Online application:
-
Call up the online service PEI-C Rebuild
- In order to use PEI-C Rebuild, you need to register using the RuBen application.
- With RuBen you register your company and can then set up a self-managed user administration for your company.
- Create your application for PEIC Rebuild and submit it online with all the required documents.
- Send your test samples to the Paul Ehrlich Institute by post.
- After successful verification by the PEI, you will receive the national release notice and/or an EU certificate, if requested, by post or you can retrieve both in PEI-C Rebuild.
Requirements
Immunological veterinary medicinal products may only be placed on the market or used in Germany if they have been authorized by the PEI or the European Union.
The batches you send us must meet the criteria specified in the marketing authorization of the veterinary medicinal product with regard to
- quality,
- safety and
- efficacy.
Which documents are required?
- Application for batch release
- Manufacturing and test records
- Test samples of the manufactured batches
If the batch was released in another member state of the European Union (EU):
- Certificate of release (EU certificate) in addition to the above-mentioned documents
What are the fees?
Emission: 120,00 - 210,00 EURPayment in advance: Nohttps://www.gesetze-im-internet.de/bmelbgebv/index.htmlfor an examination procedure with document-based examination
What deadlines do I have to pay attention to?
The national release decision has a period of validity, i.e. it is valid until the end of the batch's period of usability.
Processing duration
If only a document-based batch inspection is required, you will receive notification of the batch release and/or the EU certificate no later than 15 working days after receipt of the batch documentation.
You will receive the release faster if the batch has already been tested in the OMCL network and the release is recognized in Germany. In this case, you will receive notification of the batch release from the PEI no later than 7 working days after receipt of the batch.
Legal basis
Applications / forms
-
Contradiction
- Further information on how to lodge an objection can be found in the notification of your application.
- Appeal to the administrative court
Appeal
Forms available: No
Written form required: Yes
Informal application possible: Yes
Personal appearance necessary: No
What else should I know?
You can have your veterinary medicinal product tested by the PEI in parallel to your own testing as a pharmaceutical company in order to speed up the release procedure.
Further Information
- Information from the Paul-Ehrlich-Institut (PEI) on veterinary batch testing
- Information from the PEI on immunological veterinary medicinal products
- Information on the OMCL network on the website of the European Directorate for the Quality of Medicines (EDQM)
- Information on batch documentation verification (OBPR) and experimental batch verification (OCABR) on the EDQM website
- Information on the guidelines for experimental batch testing (OCABR) on the EDQM website
- Information on batch documentation on the EDQM website
- Manual for the online platform PEI-C Rebuild
- Questions and answers on RuBen user registration on the website of the Federal Institute for Drugs and Medical Devices (BfArM)
Author
Paul-Ehrlich-Institut (PEI)
Forwarding service: Deep link to the original portal
The text was automatically translated based on the German content.
Technically approved by
Federal Ministry of Food and Agriculture (BMEL)
Professionally released on
08.11.2022
Source: Zuständigkeitsfinder Thüringen (Linie6PLus)
Start your request directly online:
Competent Authority
Paul-Ehrlich-Institut (PEI), PEI-C Rebuild
Further Authorities
Address
63225 Langen (Hessen)