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Agenzia Italiana del Farmaco
AIFA guideline for scientific opinion on ancillary medicinal substances incorporated in medical device - AIFA guideline for scientific opinion on ancillary medicinal substances incorporated in medical device
AIFA guideline for scientific opinion on ancillary medicinal substances incorporated in medical device
AIFA publishes the guideline addressed to Notified Bodies who wish to consult the Italian Medicines Agency and submit a request for consultation on a medicinal substance with an ancillary function contained in a class III medical device.
This guideline aims to provide interested parties with appropriate information on the procedural aspects as well as the format and data requirements to facilitate the consultation procedure.
Published on: 15 March 2024
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