Guidelines for EU OCABR for IVMPs
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The Guidelines for EU Official Control Authority Batch Release and EU Official Batch Protocol Review are available only on the EDQM website. The website contains the most up to date versions as listed below.
Download the entire package of procedures and guidelines (updated June 2022)
The following table contains access to all documents by clicking on the guideline's name:
- Preface and notes for use
- Administrative Procedure for OCABR / OBPR According to Article 128
- Marketing Information Form
- Products Specific Guidelines for Immunological Veterinary Medicinal Products
- Model Protocol Templates for OBPR and OCABR
- General Information
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IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS Guidelines for EU OCABR and OBPR |
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Document Title |
Last Web Update |
In force from
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| 25/01/22 | x | |
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01/06/2022 |
01/07/2022 |
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25/01/22 |
28/01/22 |
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Product Specific Guidelines for IVMPs eligible for OCABR (Back to top) |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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Brucellosis Vaccine (brucella melitensis rev.1 strain and brucella abortus S19 strain) (Live) |
25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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| Equine Influenza Vaccine (live) | 25/01/22 | 28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
28/01/22 |
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25/01/22 |
x |
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- Annex IV to the Procedure for the Application of Article 128: VBRN Contact List (updated 05/07/2024)
- List of OMCLs able to provide OCABR certificates (updated 10/07/2024)
- Decision Flowchart for Control Authorities for the Control of IVMPs
- Benefits of official batch control and surveillance for immunological VMPs. Jungbäck et. al. Regulatory Rapporteur, Vol 13, No 4, April 2016
Revised Procedure (in force from 1 July 2022)
New combined format for the Administrative Procedure for Batch Release of IVMPs in Application of Article 128 of Regulation (EU) 2019/6 replacing the formerly separate procedures for OBPR and OCABR
Revised: All Guidelines and model protocol templates (in force from 28 January 2022)
Revised Procedure (in force from 28 January 2022)
EU Administrative Procedure for Application of Official Control Authority Batch Release of Immunological Veterinary Medicinal Products According to Article 128
EU Administrative Procedure for Application of Official Batch Protocol Review of Immunological Veterinary Medicinal Products According to Article 128
