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Product Specific Guidelines for Official Control Authority Batch Release (OCABR) of Human Biological Medicinal Products & OCABR/Official Batch Protocol Review (OBPR) of Immunological Veterinary Medicinal Products (IVMPs)
Product Specific Guidelines for OCABR of Human Biological Medicinal Products
To download all 60 product specific guidelines and procedures, click HERE.
For individual procedures and product specific guidelines, click here
Product Specific Guidelines/Model Protocol Templates for OCABR/OBPR of IVMPs
Product-Specific Technical Guidelines
To download individual product specific guidelines, click on your preferred link below.
- Aujeszky's Disease Vaccine (inactivated) (2007)
- Aujeszky's Disease Vaccine (live) (2007)
- Brucellosis Vaccine (brucella melitensis rev.1 strain and brucella abortus S19 strain) (Live) (2007)
- Brucellin Preparations (2007)
- Equine Influenza Vaccine (inactivated) (2007)
- Infectious Bovine Rhinotracheitis Vaccine (inactivated) (2007)
- Infectious Bovine Rhinotracheitis Vaccine (live) (2007)
- Newcastle Disease Vaccine (inactivated) Oil Emulsion (2007)
- Newcastle Disease Vaccine (live) (2007)
- Rabies Vaccine (inactivated) (revised in January 2012)
- Rabies Vaccine for Foxes (live) (2007)
- Swine Erysipelas Vaccine (inactivated) (2007)
- Swine Erysipelas Vaccine (live) (2007)
- Tuberculin Purified Protein Derivative (PPD), Avian (2007)
- Tuberculin Purified Protein Derivative (PPD), Bovine (2007)
To download a model protocol template for the submission of batch protocols, click on your preferred link below.
- Inactivated Bacterial Vaccines
- Live Bacterial Vaccines
- Inactivated Viral Vaccines
- Live Viral Vaccines
- Tuberculin PPD/Brucellin Preparations
Product specific guidelines
Further information and more detailed explanations on the use of product specific guidelines can be found in the documents below.
NEW OCABR Procedure Preface & Note to Users - Human (Revised December 2011)
REVISED OCABR/OBPR Procedure Preface & Note to Users - Veterinary (Revised January 2012)
Important Information
For information about Official Control Authority Batch Release (OCABR) of human biological medicinal products, go to the Human Biologicals (OCABR) section. For information about Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) of Immunological Veterinary Medicinal Products (IVMPs), go to the Veterinary Biologicals (OCABR/OBPR) section.
Catalogue
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