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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 August 2017)

 

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)

 01/08/17  x

Administrative Procedures (Back to top)

EU Administrative Procedure for a Harmonised Application of Article 81 for Official Batch Protocol Review of Immunological Veterinary Medicinal Products

 01/09/14

 01/01/13

EU Administrative Procedure for Application of Article 82 for Official Control Authority Batch Release of Immunological Veterinary Medicinal Products

 01/08/17  01/09/17

Marketing Information Form (Back to top)

 01/09/14

 01/01/11

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

Aujeszky's Disease Vaccine (inactivated)

 01/09/14

 01/01/13

Aujeszky's Disease Vaccine (live)

 01/09/14

 01/01/13

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

 01/09/14

 01/01/13

Brucellin Preparations

 01/09/14

 01/01/13

Equine Influenza Vaccine (live)  05/05/15 01/06/15

Equine Influenza Vaccine (inactivated)

 01/09/14

 01/01/13

Infectious Bovine Rhinotracheitis Vaccine (inactivated)

 01/09/14

 01/01/13

Infectious Bovine Rhinotracheitis Vaccine (live)

 01/09/14

 01/01/13

Newcastle Disease Vaccine (inactivated) Oil Emulsion

 01/09/14

 01/01/13

Newcastle Disease Vaccine (live)

 05/05/15

 01/06/15

Rabies Vaccine (inactivated)

 01/09/14

 01/01/13

Rabies Vaccine (live) 

 01/09/14

 01/01/14

Swine Erysipelas Vaccine (live)

 01/08/17

 01/01/15

Tuberculin Purified Protein Derivative (PPD), Avian

 01/08/17

 01/01/15

Tuberculin Purified Protein Derivative (PPD), Bovine

 01/08/17

 01/01/15

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

Inactivated Bacterial Vaccines

 01/09/14

 01/04/07

Live Bacterial Vaccines

 01/09/14

 01/04/07

Inactivated Viral Vaccines

 01/09/14

 01/04/07

Live Viral Vaccines

 21/11/14

 01/01/15

Tuberculin PPD/Brucellin Preparations

 01/09/14

 01/04/07

General Information (Back to top)

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

 10/12/12

 x

 

NB. All guidelines were updated on 21/11/14 for editorial changes to the cover page. The content of the guidelines has not changed.

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