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OMCL BATCH RELEASE GUIDELINES

Official Control Authority Batch Release (OCABR) for Human Use &
Official Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) of Immunological Veterinary Medicinal Products (IVMPs)

Product Specific Guidelines for OCABR for Human Use

To download all 58 product specific guidelines and procedures OR an individual product specific guideline or procedure, simply click on the relevant link below.

To download ALL 58 Batch Release Guidelines & Procedures

To download a SPECIFIC Batch Release Guideline or Procedure

Product Specific Guidelines for OCABR for Veterinary Use

Product-Specific Technical Guidelines

The product specific technical procedures and guidelines, as well as the templates for submission of batch protocols by an marketing authorisation holder for OCABR/OBPR are available below to download.



Model Protocol Templates for Submission of Batch Protocols by an MA for OCABR/OBPR


Important Information


Further information and more detailed explanations on the use of procedures and guidelines can be found in the 'Preface and Note to Users for Procedures and Guidelines' below.


OCABR Procedure Preface & Note to Users - Human

OCABR Procedure Preface & Note to Users - Veterinary

Catalogues

Products & Services Catalogue 2008 (English/French)
Products & Services Catalogue 2008 (English/Spanish)
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