EMA confirms that access to clinical study reports for preparation of Health Technology Dossiers will be permitted within the new EMA Disclosure Policy
- use the clinical data to support an application for a marketing authorisation and any extensions or variations thereof for a medicinal product anywhere in the world;
- share the user’s username, password or other account details with a third party or otherwise provide a third party with access to the user’s account;
- make any unfair commercial use of the clinical data.
Similar conditions are imposed on users of the clinical data for the academic and other non-commercial research purposes referred to in Annex 2 to the Disclosure Policy. Any failure by the user to comply with these conditions would result in the revocation of the users' right to access and use the clinical data.
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