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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:

 IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS

Guidelines for EU OCABR and OBPR

Document  Title

Last Web Update

In force from

 

Preface and Notes for use (Back to top)

25/01/22  x

Administrative Procedure (Back to top)

EU Administrative Procedure for Official Batch Release of Immunological Veterinary Medicinal Products in Application of Article 128 of Regulation (EU) 2019/6

01/06/2022

01/07/2022

Marketing Information Form (Back to top)

25/01/22

 28/01/22

Product Specific Guidelines for IVMPs eligible for OCABR (Back to top)

Aujeszky's Disease Vaccine (inactivated)

25/01/22

28/01/22

Aujeszky's Disease Vaccine (live)

 25/01/22

 28/01/22

Brucellosis Vaccine (brucella melitensis rev.1 strain and brucella abortus S19 strain) (Live)

25/01/22

28/01/22

Brucellin Preparations

25/01/22

28/01/22

Equine Influenza Vaccine (live)  25/01/22 28/01/22

Equine Influenza Vaccine (inactivated)

 25/01/22

28/01/22

Infectious Bovine Rhinotracheitis Vaccine (inactivated)

 25/01/22

 28/01/22

Infectious Bovine Rhinotracheitis Vaccine (live)

 25/01/22

28/01/22

Newcastle Disease Vaccine (inactivated) Oil Emulsion

 25/01/22

 28/01/22

Newcastle Disease Vaccine (live)

 25/01/22

28/01/22

Rabies Vaccine (inactivated)

 25/01/22

 28/01/22

Rabies Vaccine (live) 

 25/01/22

28/01/22

Swine Erysipelas Vaccine (live)

 25/01/22

28/01/22

Tuberculin Purified Protein Derivative (PPD), Avian

 25/01/22

 28/01/22

Tuberculin Purified Protein Derivative (PPD), Bovine

 25/01/22

28/01/22

Model Protocol Templates for OBPR and OCABR (Back to top)

Inactivated Bacterial Vaccines

 25/01/22

28/01/22

Live Bacterial Vaccines

 25/01/22

28/01/22

Inactivated Viral Vaccines

 25/01/22

28/01/22

Live Viral Vaccines

 25/01/22

28/01/22

Tuberculin PPD/Brucellin Preparations

 25/01/22

28/01/22

General Information (Back to top)

Change Request for Revision of Adopted Guidelines/Procedures for Batch Release (OCABR-Human Network, VBRN)

 25/01/22

x

 

RECENT UPDATES

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