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null Should Fimea be notified within 7 or 15 days of a serious unexpected adverse event, which, in the opinion of the sponsor or researcher only, is attributable to the medicinal product?

Should Fimea be notified within 7 or 15 days of a serious unexpected adverse event, which, in the opinion of the sponsor or researcher only, is attributable to the medicinal product?

Yes. Adverese events attributable to medicines are considered an adverse effect.

 

10 Nov 2015