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Apply for batch release of tuberculins as veterinary medicinal products

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6Plus)

Service Description

Would you like to market tuberculins approved in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute (PEI).

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

  • Tuberculins
  • sera
  • vaccines
  • immunomodulators

How are the tuberculins tested?

The PEI first reviews your submitted documentation on the batch (Official Batch Protocol Review, OBPR). For certain tuberculins, this is followed by an experimental batch review of the batches you have submitted (test samples).

Whether the PEI only reviews your documentation or also carries out an experimental batch review is decided after a risk assessment based on the EU administrative procedure for the batch review of immunological veterinary medicinal products in accordance with Article 128 of Regulation (EU) 2019/6. Among other things, the following are taken into account

  • the potential risks of the product for human and animal health
  • the requirements for the control of animal diseases
  • the product characteristics of the tuberculin
  • the risk-benefit assessment

The risk assessment of the competent authority is based on the European guidelines for batch testing (Official Control Authority Batch Release, OCABR Guidelines).

If your batch meets the criteria laid down in the marketing authorization for your medicinal product, you will receive a national release notice 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?

Levy: 120,00 - 210,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmelbgebv/index.html
for an examination procedure with document-based examination

Levy: 1310,00 - 2710,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmelbgebv/index.html
for a test procedure with experimental testing, in particular due to extensive tests and multiple tests

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
Appeal
  • Contradiction
    • Further information on how to lodge an objection can be found in the notification of your application.
  • Appeal to the administrative court
Applications / forms

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.

Author

Paul-Ehrlich-Institut (PEI)


Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Teaser

Would you like to market tuberculins approved in Germany as veterinary medicinal products? Then you must apply for a batch release from the Paul Ehrlich Institute (PEI).

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?

Levy: 120,00 - 210,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmelbgebv/index.html
for an examination procedure with document-based examination

Levy: 1310,00 - 2710,00 EUR
Payment in advance: no
https://www.gesetze-im-internet.de/bmelbgebv/index.html
for a test procedure with experimental testing, in particular due to extensive tests and multiple tests

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

Appeal

  • Contradiction
    • Further information on how to lodge an objection can be found in the notification of your application.
  • Appeal to the administrative court

Applications / forms

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.

Author

Paul-Ehrlich-Institut (PEI)


Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

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