Application for Batch Release

Guidelines

General guidelines are in place for the official batch testing of immunological veterinary medicinal products:

• The OCABR guideline (Official Control Authority Batch Release) applies to experimental testing-based batch testing.
• The OBPR guideline (Official Batch Protocol Review) applies to protocol review by a control laboratory.

The Paul-Ehrlich-Institut (PEI) follows these guidelines when issuing a decision on the batch release.

How to Submit an Application

Documents should be submitted via the PharmNet.Bund application portal:

PEI-C Rebuild: Electronic submission of batch release applications

Submission of Test Samples

The number of test samples required for submission can be found in the table below.

Testing type	Volume	Number of samples required
OCABR	< 100 ml	10*
	100 - 500 ml	5*
	> 500 ml	5*
OBPR	< 100 ml	6
	100 - 500 ml	Live attenuated bacterial and fungal vaccines: 6 Other: 3
	> 500 ml	Live attenuated bacterial and fungal vaccines: 6 Other: 2

* The number of samples required may vary depending on the product.

Please send the test samples by post to the address below.

Costs

The fees to be paid for official batch testing can be found in the Special Fee Ordinance of the Federal Ministry of Food and Agriculture (BMELBGebV, section 15, subsection 2).

Contact

Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
Section VET 3 Product Testing Immunological Veterinary Medicinal Products
Paul-Ehrlich-Str. 51-59
63225 Langen
GERMANY

Email: veterinaermedizin@pei.de

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