Applying for a national product or DCP authorisation in Ireland – slot booking

News Category: Regulatory news

Date: 28/03/2024

The HPRA is transitioning towards a system of allocating slots (expected submission dates) for certain new product authorisations. This system will affect those applying through the national product authorisation and the Decentralised Procedure (DCP).

This new system aims to facilitate capacity planning for efficient assessment of these applications. This will also help maintain access for products on both the Irish and European markets.

Information on how to book a slot is available on our webpage on new product authorisations.

« Back