Denne batch og de foregående må derfor godkendes som værende i overensstemmelse med betingelserne for markedsføringstilladelserne for begge produkter.
During assessment of a Type II variation for changing the mouse potency test to comply with the revised Ph. Eur monograph for erysipelas vaccines, vaccine batch 8500 was accepted as being a reference vaccine and therefore this batch and those prior to it have to be accepted as being compliant with the conditions of the Marketing Authorisations for both products.