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Guidance notes on collecting adverse events, product complaints and special reporting situations during market research

Guidance notes on collecting adverse events, product complaints and special reporting situations during market research

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Guidance for market research agencies and marketing authorisation holders when collecting and forwarding information about an adverse event (AE), product complaint (PC) or special reporting situation (SRS) that comes up during a market research project when the company commissioning the research is a marketing authorisation holder or holder of a certificate of conformity of a medical device.

Last modified: 23 May 2024

Last reviewed: 23 May 2024