Harmonisation with VICH Guidelines 41 and 44 and deletion of the TABST, adopted at the 142nd Session of the European Pharmacopoeia Commission (April 2012)
What has changed and why:
Following their publication in Pharmeuropa 23.1, around 80 vaccine-specific monographs, the general monograph Vaccines for veterinary use (0062) and 2 general chapters (5.2.6. Evaluation of safety of veterinary vaccines and immunosera and 5.2.9. Evaluation of safety of each batch of immunosera for veterinary use) were adopted at the 142nd Session of the European Pharmacopoeia (Ph. Eur.) Commission and published in Supplement 7.7. The main improvements were:
- a new format for the monographs to avoid unnecessary repetitions;
- harmonisation with VICH Guidelines 41 (test for reversion to virulence) and 44 (developmental safety tests), which came into force in 2008 and 2009 respectively, and, as a consequence, the deletion of the target animal batch safety test (TABST) from the Ph. Eur. (however, a statement was introduced allowing for the performance of a TABST under particular circumstances, e.g. significant changes to the manufacturing process, reports of unexpected adverse reactions observed in the field, or reports that final batches do not comply with the data initially provided during licensing).