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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.

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

05/03/24

01/04/24

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
Chikungunya Virus (live attenuated) Vaccine 15/07/24 01/08/24

Cholera Vaccine (Oral, Inactivated)

12/12/23

  01/01/24
Cholera Vaccine (Oral, Live) 15/06/20 15/07/20
COVID-19 Vaccine (inactivated) 15/01/24 01/02/24
COVID-19 Vaccine (mRNA)

 
17/01/24*
 01/02/24
COVID-19 Vaccine (non-replicating adenovirus vectored) 15/01/24 01/02/24
COVID-19 Vaccine (recombinant protein) 15/01/24 01/02/24

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)

06/05/24

01/06/24

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

16/12/24

obsolete

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

 18/11/24 01/12/24

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)

15/01/24

01/02/24

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 (mRNA) Vaccine 17/09/24 01/10/24
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.

* Replaces the web version published on 15/01/24 after an editorial correction

Recent updates

Obsolete Guideline (from 1 January 2025)

Hepatitis A (Virosomal) Vaccine

Revised Guideline (in force from 1 December 2024)

Monovalent or Multivalent Meningococcal Conjugate Vaccine

New Guideline (in force from 1 October 2024)

Respiratory Syncytial Virus (mRNA) Vaccine

New Guideline (in force from 1 August 2024)

Chikungunya Virus (live attenuated) Vaccine

Revised Guideline (in force from 1 June 2024)

Diphtheria, Tetanus, Pertussis (Acellular Component), Poliomyelitis (Inactivated), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Combined Vaccine (adsorbed)

Revised Procedure (in force from 1 April 2024)

EU Administrative Procedure for Official Control Authority Batch Release

Revised Guidelines (in force from 1 February 2024)

COVID-19 vaccine guidelines revised to transform them from pandemic to regular guidelines

Pertussis Vaccine (Acellular Component, Adsorbed)

Revised Guidelines (in force from 1 January 2024)

COVID-19 pandemic vaccine (mRNA)

Cholera Vaccine (Oral, Inactivated)

additional information
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