Human OCABR Guidelines

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The Guidelines for EU Official Control Authority Batch Release are now available only on the EDQM website. The website contains the most up to date versions as listed below.

To download the entire package of procedures and guidelines listed below click here.

The following table contains access to all documents by clicking on the guideline's name.

User Guidance
OCABR Administrative Procedures
Medicinal Products Derived From Human Blood and Human Plasma – Product Specific Guidelines
Immunological Products Consisting of Vaccines - Product Specific Guidelines
Other related Procedures
General Information

HUMAN BIOLOGICAL MEDICINES Guidelines for EU Official Control Authority Batch Release
Document Title	Last Web Update		In force from
User Guidance (Back to top)
Preface and Notes for Use	22/09/17		x
Explanatory Note on Correct Application of Section 3.2 of Product Specific Guidelines for Official Control Authority Batch Release	30/06/15		01/08/15
OCABR Administrative Procedures (Back to top)
EU Administrative Procedure for Official Control Authority Batch Release	08/06/22		01/07/22
Procedure for Official Control Authority Batch Release of Centrally Authorised Immunological Medicinal Products for Human Use and Medicinal Products Derived From Human Blood and Plasma	01/08/14		01/07/10
Medicinal Products Derived From Human Blood and Human Plasma – Product Specific Guidelines (Back to top)
Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants	26/07/22		01/09/22
Human Albumin	01/08/14		01/01/12
Human Immunoglobulin	02/08/23		01/09/23
Human Plasma (pooled and treated for virus inactivation) formerly Solvent-Detergent (SD) Plasma	25/11/14		01/01/15
Protocol for Approval of Plasma Pools	25/11/14		01/01/15
Immunological Products Consisting of Vaccines - Product Specific Guidelines (Back to top)
Anthrax Vaccine (adsorbed)	28/02/19	01/04/19
BCG Vaccine	06/03/18	01/04/18
Cholera Vaccine (Oral, Inactivated)	01/08/14	01/01/12
Cholera Vaccine (Oral, Live)	15/06/20	15/07/20
Dengue Vaccine	16/03/23	27/03/23
Diphtheria and Tetanus Vaccine (adsorbed)	01/08/14	01/01/12
Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (adsorbed)	09/05/23	obsolete
Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (adsorbed)	13/12/19	01/01/20
Diphtheria, Tetanus and Pertussis (Whole Cell) Combined Vaccine (adsorbed)	03/12/20	01/01/21
Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)	01/08/14	01/01/12
Diphtheria, Tetanus, Pertussis (Acellular Component) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)	13/12/19	01/01/20
Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (adsorbed)	09/05/23	obsolete
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Liquid Combined Vaccine	13/12/19	01/01/20
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)	13/12/19	01/01/20
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)	13/12/19	01/01/20
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined Vaccine (adsorbed)	11/01/23	20/01/23
Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) with separate Haemophilus Type B Conjugate, Combined Vaccine (adsorbed)	11/01/23	20/01/23
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis (Inactivated) Combined Vaccine (adsorbed)	27/05/21	obsolete
Diphtheria, Tetanus, Pertussis (Whole Cell), Poliomyelitis (Inactivated) with separate Haemophilus Type B Conjugate Combined Vaccine (adsorbed)	27/05/21	obsolete
Ebola Virus Vaccine (AD26 Vectored Component of 2-Component Heterologous Vaccine)	20/01/21	08/02/21
Ebola Virus Vaccine (MVA-BN-FILO Vectored Component of 2-Component Heterologous Vaccine)	20/01/21	08/02/21
Ebola Vaccine (VSV Vectored Single Component Vaccine)	07/08/20	31/08/20
Haemophilus Type B Conjugate and Meningococcal C Conjugate Combined Vaccine	27/01/21	22/02/21
Haemophilus Type B Conjugate Vaccine	03/12/20	01/01/21
Hepatitis A (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed)	11/01/23	20/01/23
Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (adsorbed)	11/12/18	01/01/19
Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-At-Use Format Products	13/12/19	01/01/20
Hepatitis A Vaccine (Inactivated, Adsorbed)	07/08/20	31/08/20
Hepatitis A (Virosomal) Vaccine	11/12/18	01/01/19
Hepatitis B (rDNA) Vaccine	11/01/23	20/01/23
Human Papillomavirus (rDNA) Vaccine	11/01/23	20/01/23
Influenza Vaccine	03/12/20	01/01/21
Influenza (rDNA) Vaccine	14/12/21	21/01/22
Influenza Vaccine (Surface Antigen, Inactivated, Virosome)	15/06/20	01/07/20
Influenza Vaccine (Surface Antigen, Inactivated) Produced in Cell Culture	15/06/20	01/07/20
Japanese Encephalitis Vaccine (Inactivated)	15/06/20	01/07/20
Leptospirosis (Inactivated) Vaccine	13/12/19	01/01/20
Live Attenuated Influenza Vaccine	15/06/20	01/07/20
Measles, Mumps, and/or Rubella Component Combined Vaccine	15/06/20	01/07/20
Measles, Mumps, Rubella and Varicella Combined Vaccine	11/12/18	01/01/19
Measles Vaccine	15/06/20	obsolete
Meningococcal B Vaccine (Adsorbed)	11/01/23	20/01/23
Meningococcal Polysaccharide Vaccine	11/12/18	01/01/19
Monovalent or Multivalent Meningococcal Conjugate Vaccine	03/12/20	01/01/21
Multivalent Pneumococcal Polysaccharide Conjugate Vaccine	08/03/22	21/03/22
Mumps Vaccine	15/06/20	obsolete
Pandemic Influenza Vaccine	03/12/15	01/01/16
Pertussis Vaccine (Acellular Component, Adsorbed)	13/12/19	01/01/20
Pneumococcal Polysaccharide Vaccine	11/12/18	01/01/19
Poliomyelitis Vaccine (Inactivated)	15/06/20	01/07/20
Poliomyelitis Vaccine (Oral) (OPV) – Monovalent Bulk	15/06/20	01/07/20
Poliomyelitis Vaccine (Oral) (OPV)	21/02/17	01/04/17
Rabies Vaccine	09/05/23	01/06/23
NEW: Respiratory Syncytial Virus (rDNA) Vaccine	06/10/23	20/10/23
Rotavirus Vaccine	14/12/21	21/01/22
Rubella Vaccine	15/06/20	obsolete
Tick-Borne Encephalitis (TBE) Vaccine	15/06/20	01/07/20
Typhoid Polysaccharide Vaccine	13/12/19	01/01/20
Typhoid Vaccine (Live -Strain Ty21a, Oral)	01/08/14	01/01/12
Vaccine Containing Vaccinia Virus Produced In Cell Culture (Smallpox Vaccine)	15/06/20	01/07/20
Varicella Vaccine and Shingles Vaccine	15/06/20	01/07/20
Varicella (rDNA) Vaccine	11/01/23	20/01/23
Yellow Fever Vaccine	06/10/20	01/11/20
Other Related Procedures (Back to top)
Administrative Procedure for European Official Medicines Control Laboratory Certification of Compliance of Batches under Article 58	15/12/16	01/02/17
Article 58 EU Official Control Authority Batch Compliance Testing of Hexaxim (Sanofi Pasteur)	27/11/13	obsolete
Article 58 EU Official Control Authority Batch Compliance Testing of Mosquirix (GSK), Malaria Vaccine	11/01/23	20/01/23
General Information (Back to top)
Change Request for Revision of Adopted Guidelines/Procedures for Batch Release (OCABR-Human Network, VBRN)	02/07/18	x

NB. All guidelines were updated on 01/08/14 for editorial changes to the cover page. The content of the guidelines was not changed during this update.