Q&As

Are there any requirements to monitor medicines once they have been authorised and placed on the market?

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Published on LexisPSL on 04/01/2018

The following Life Sciences Q&A provides comprehensive and up to date legal information covering:

  • Are there any requirements to monitor medicines once they have been authorised and placed on the market?

Are there any requirements to monitor medicines once they have been authorised and placed on the market?

All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored so as to make sure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures are taken. This monitoring is called pharmacovigilance. Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines.

Pharmacovigilance activities include:

  1. collecting and managing data on the safety of medicines

  2. looking at the data to detect ‘signals’ (any new or changing safety issue)

  3. evaluating the data and making decisions

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