Human OCABR Guidelines
Read more on:
- Official Control Authority Batch Release (OCABR) for Human Biologicals: Vaccines, blood and plasma derivatives.
- Questions and answers on OCABR
- NEW: OCABR guidelines for Pandemic COVID-19 vaccines
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 MEDICINESGuidelines for EU Official Control Authority Batch Release |
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Document Title |
Last Web Update |
In force from |
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User Guidance (Back to top) | |||||
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 | |||
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EU Administrative Procedure for Official Control Authority Batch Release |
08/06/22 |
01/07/22 |
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01/08/14 |
01/07/10 |
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Medicinal Products Derived From Human Blood and Human Plasma – Product Specific Guidelines (Back to top) |
|
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Clotting Factor Concentrates, Plasma Inhibitor Concentrates and Fibrin Sealants |
26/07/22 |
01/09/22 |
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01/08/14 |
01/01/12 |
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02/08/23 |
01/09/23 |
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Human Plasma (pooled and treated for virus inactivation) formerly Solvent-Detergent (SD) Plasma |
25/11/14 |
01/01/15 |
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25/11/14 |
01/01/15 |
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Immunological Products Consisting of Vaccines - Product Specific Guidelines (Back to top) |
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Anthrax Vaccine (adsorbed) | 28/02/19 | 01/04/19 | |||
06/03/18 |
01/04/18 |
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01/08/14 |
01/01/12 |
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Cholera Vaccine (Oral, Live) | 15/06/20 | 15/07/20 | |||
16/03/23 |
27/03/23 |
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01/08/14 |
01/01/12 |
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Diphtheria, Tetanus and Hepatitis B (rDNA) Combined Vaccine (adsorbed) |
09/05/23 |
obsolete |
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Diphtheria, Tetanus and Pertussis (Acellular Component) Combined Vaccine (adsorbed) |
13/12/19 |
01/01/20 |
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Diphtheria, Tetanus and Pertussis (Whole Cell) Combined Vaccine (adsorbed) |
03/12/20 |
01/01/21 |
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Diphtheria, Tetanus and Poliomyelitis (Inactivated) Combined Vaccine (adsorbed) |
01/08/14 |
01/01/12 |
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13/12/19 |
01/01/20 |
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Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (adsorbed) |
09/05/23 |
obsolete |
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13/12/19 |
01/01/20 | ||||
13/12/19 |
01/01/20 |
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13/12/19 |
01/01/20 |
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11/01/23 |
20/01/23 |
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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 |
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03/12/20 | 01/01/21 | ||||
Hepatitis A (Inactivated) and Hepatitis B (rDNA) Combined Vaccine (Adsorbed) |
11/01/23 |
20/01/23 |
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Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (adsorbed) |
11/12/18 |
01/01/19 |
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13/12/19 |
01/01/20 |
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07/08/20 |
31/08/20 |
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11/12/18 |
01/01/19 |
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11/01/23 |
20/01/23 |
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11/01/23 |
20/01/23 |
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03/12/20 | 01/01/21 | ||||
Influenza (rDNA) Vaccine | 14/12/21 | 21/01/22 | |||
15/06/20 |
01/07/20 |
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Influenza Vaccine (Surface Antigen, Inactivated) Produced in Cell Culture | 15/06/20 | 01/07/20 | |||
15/06/20 | 01/07/20 | ||||
13/12/19 |
01/01/20 |
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Live Attenuated Influenza Vaccine | 15/06/20 | 01/07/20 | |||
15/06/20 | 01/07/20 | ||||
11/12/18 |
01/01/19 |
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Measles Vaccine |
15/06/20 |
obsolete |
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Meningococcal B Vaccine (Adsorbed) |
11/01/23 |
20/01/23 |
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11/12/18 |
01/01/19 |
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03/12/20 | 01/01/21 | ||||
08/03/22 | 21/03/22 | ||||
Mumps Vaccine |
15/06/20 | obsolete | |||
03/12/15 |
01/01/16 |
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13/12/19 |
01/01/20 |
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11/12/18 |
01/01/19 |
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15/06/20 | 01/07/20 | ||||
15/06/20 | 01/07/20 | ||||
21/02/17 |
01/04/17 |
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09/05/23 | 01/06/23 | ||||
NEW: Respiratory Syncytial Virus (rDNA) Vaccine | 06/10/23 | 20/10/23 | |||
14/12/21 | 21/01/22 | ||||
Rubella Vaccine |
15/06/20 | obsolete | |||
15/06/20 | 01/07/20 | ||||
13/12/19 |
01/01/20 |
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01/08/14 |
01/01/12 |
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Vaccine Containing Vaccinia Virus Produced In Cell Culture (Smallpox Vaccine) |
15/06/20 | 01/07/20 | |||
15/06/20 | 01/07/20 | ||||
Varicella (rDNA) Vaccine | 11/01/23 | 20/01/23 | |||
06/10/20 |
01/11/20 |
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15/12/16 |
01/02/17 |
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Article 58 EU Official Control Authority Batch Compliance Testing of Hexaxim (Sanofi Pasteur) |
27/11/13 |
obsolete |
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Article 58 EU Official Control Authority Batch Compliance Testing of Mosquirix (GSK), Malaria Vaccine | 11/01/23 | 20/01/23 | |||
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.
New Guideline (in force from 20 October 2023)
Respiratory Syncytial Virus (rDNA) Vaccine
Revised Guideline (in force from 1 September 2023)
Human Immunoglobulin
Revised Guideline (in force from 25 August 2023)
COVID-19 pandemic vaccine (Recombinant Protein)
Revised Guideline (in force from 1 June 2023)
Rabies vaccine
Obsolete Guidelines (from 1 June 2023)
Diphtheria, Tetanus, and Hepatitis B (rDNA) Combined Vaccine (adsorbed)
Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Combined Vaccine (adsorbed)
Revised Guideline (in force from 27 March 2023)
Dengue vaccine
Revised Guidelines (in force from 20 January 2023)
Vaccine guidelines revised for purity testing on monovalent bulks of recombinant protein vaccines in addition to other modifications (8 guidelines)
New Guideline (in force from 15 December 2022)
COVID-19 pandemic vaccine, Inactivated (full guideline)
- Annex III of EU Administrative Procedure for Official Control Authority Batch Release: Human OCABR contact list (17/10/2023)
- Administrative Procedure for European OMCL Certification of Compliance of Batches under Article 58 (10/12/2012)
- OCABR Human Biologicals Flowchart (revised December 2010)
- "The EU/EAA Network for Official Control Authority Batch Release of Biologicals for Human Use", The Regulatory Affairs Journal, June 2002