Updated EMA and EUnetHTA advice on parallel consultation

The European Network for Health Technology Assessment (EUnetHTA) was initially set up in 2017 to enable a simplified procedure for obtaining joint scientific advice from the European Medicines Agency (EMA) and Health Technology Assessment (HTA) bodies.

A guidance document was created to advise stakeholders on the aims and scope of this parallel consultation procedure. Additionally, the document contains a section on the process of submitting a request for parallel consultation. This section has been updated in the latest revision to the guidance document.

Previously, applicants who received a notification of pre-selection by the EUnetHTA after the Open Call were required to simultaneously notify the EMA Scientific Advice and EUnetHTA Early Dialogue (ED) Secretariats via a Letter of Intent. However, based on the latest guidance, applicants are required to submit an application via the IRIS platform. Due to this, information on responses to the applicant from the EMA/EUnetHTA ED Secretariats has been omitted from the latest guidance as this now all takes place within the IRIS platform.

The guidance on the timelines for submission deadlines and organisation of face-to-face meetings remains the same.

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