Q&As

Is there a requirement to report or notify the authorities of any incidence of falsified medicines?

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Published on LexisPSL on 08/11/2017

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

  • Is there a requirement to report or notify the authorities of any incidence of falsified medicines?

Directive 2011/62/EU (Falsified Medicines Directive) which amends Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes specific rules in respect of ‘falsified medicinal products’ which are defined as:

‘any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder

(c) its history, including the records and documents re

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