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Revised: Human vaccines guidelines with aP components

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European network of OMCLs
Human Biologicals (OCABR)
Vaccines
News
09 April 2018
Strasbourg, France

Revised guidelines on vaccinesThe human Official Control Authority Batch Release (OCABR) Network has adopted revisions to 9 human vaccine guidelines for vaccines containing acellular pertussis components. The update removes the requirement for the Official Medicines Control Laboratories (OMCLs) to perform the histamine sensitisation test in mice as part of OCABR.  These revisions to the OMCL tests are a positive step for 3Rs and are in line with the goal of the OCABR Network to continuously review OCABR testing needs for their added value.  Revisions are also proposed to the related Ph. Eur. monographs which have been published in Pharmeuropa 30.02, (April 2018) for public consultation.

The revised OCABR guidelines will enter into force on 15 April 2018.

 

The revised guidelines for vaccines

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

 

Access the full list of Human OCABR Guidelines

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