- European Commission publishes updated guidance for duplicate marketing authorisations
- Updated guidance
- Implication of the updated guidance
Life Sciences analysis: Jackie Mulryne and Alexander Roussanov, partners, and Eftychia Sideri, associate, at Arnold & Porter Kaye Scholer, discuss the European Commission’s updated version of the 2011 Note on the handling of duplicate marketing authorisation applications for medicinal products (the 2011 Note). Following a long period of consultation and exchange with stakeholders and representatives from the EU Member States, the Commission has sought to clarify the conditions under which applications for duplicate marketing authorisations will be assessed. This article discusses the relevant changes, as well as the implications for the industry.
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