Q&As

Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no adverse reaction? If so, how?

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Published on LexisPSL on 17/10/2017

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

  • Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no adverse reaction? If so, how?

Does a marketing authorisation holder (MAH) of a medicinal product need to collect information on individual cases of ‘off-label’ use if there is no adverse reaction? If so, how?

Article 23(2) of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code requires the marketing authorisation holder (MAH) to report to the competent authorities ‘any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned’, including ‘data on the use of the medicinal product where such use is outside the terms of the marketing authorisation’ (ie off-label use).

Chapter V.B.8.5.4 of Good Pharmacovigilance Practice

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