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EMA confirms that access to clinical study reports for preparation of Health Technology Dossiers will be permitted within the new EMA Disclosure Policy

April 2015

Focus on Regulation - Hogan Lovells Blog

According to the minutes of a meeting between the European Medicines Agency (“EMA”) and the European Network for Health Technology Assessment (“EUnetHTA”) held on 9 December 2014, the EMA has clarified that pharmaceutical companies may use clinical data made available as part of the EMA’s new Disclosure Policy as part of a Health Technology Assessment (“HTA”) dossier. The EMA further stated that this use would not be considered a breach of the Terms of Use governing such disclosure.

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