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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

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)

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)

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)

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
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

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)

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)

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