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Major 3Rs achievement for Official Control Authority Batch Release of human vaccines

11 December 2018
Strasbourg, France

In line with the removal of the abnormal toxicity test (ATT) from the European Pharmacopoeia (Supplement 9.6), the 21 product-specific guidelines for Official Control Authority Batch Release (OCABR) of vaccines for human use that contained references to the ATT in the manufacturer’s protocol section (Section 3) have been revised to delete the test.

This represents complete removal of the ATT from all OCABR guidelines. The revised guidelines come into force on 01 January 2019. The following guidelines are affected: Cell Cultured Influenza Vaccine (Surface Antigen, Inactivated), Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (adsorbed), Hepatitis A (Inactivated) and Typhoid Polysaccharide Combined Vaccine (Adsorbed) for Mix-At-Use Format Products, Hepatitis A Vaccine (Inactivated, Adsorbed), Hepatitis A (Virosomal) Vaccine, Hepatitis B (rDNA) Vaccine, Human Papillomavirus (rDNA) Vaccine, Influenza Vaccine (Surface Antigen, Inactivated, Virosome), Measles, Mumps and/or Rubella Component Combined Vaccine, Measles, Mumps, Rubella and Varicella Combined Vaccine, Measles Vaccine, Mumps Vaccine, Meningococcal Polysaccharide Vaccine, Monovalent or Multivalent Meningococcal Conjugate Vaccine, Pneumococcal Polysaccharide Vaccine, Poliomyelitis Vaccine (Inactivated), Rubella Vaccine, Typhoid Polysaccharide Vaccine, Vaccine Containing Vaccinia Virus Produced in Cell Culture (Smallpox Vaccine), Varicella Vaccine and Shingles Vaccine and Yellow Fever Vaccine.

More detail on all OCABR guidelines

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