Reply To: In-use stability testing single unit dose injectable

[Wei Wang]

#25501

Does anyone know how to do a repeat challenge for multi-dose injectable products for claiming in-use period of more than 28 days ?

EMA guidance explicitly doesn’t state on how to execute the repeat challenge.

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-use-stability-testing-veterinary-medicinal-products-excluding-immunological-veterinary-medicinal-products_en.pdf