Den indbragte sag beror på, at Frankrig er af den opfattelse, at der for disse 2 batcher ikke er blevet påvist ækvivalens mellem referencevaccinebatchen i batchstyrketesten for erysipelas, som er godkendt i det oprindelige dossier, og den nye referencevaccinebatch, og at CVMP derfor må overveje, om markedsføringstilladelsen skal ændres, suspenderes eller inddrages.
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.