Planning to submit a new DCP application in 2027?

The HPRA is accepting applications available to act as Reference Member State (RMS) for new Decentralised Procedure (DCP) applications in 2027.

Applicants planning to submit a DCP application with the HPRA as RMS in 2027, particularly for generic medicines and products for which there are limited alternatives available in Ireland, are encouraged to plan their submissions early. Further information is available on the new product applications page of the HPRA website, under the ‘Applying for a national product or DCP authorisations in Ireland – Slot booking’ section.

The HPRA operates a slot-based booking system for DCP applications, with applicants allocated a suitable submission slot in an agreed month. To request a preferred slot, applicants should complete the request form in full and submit it to RMS@hpra.ie.

The HPRA has experienced regulatory assessors and administrative staff supporting these procedures. A national scientific and regulatory advice process is also available for significant regulatory queries or requests for scientific advice that may need to be considered in advance of submission. Applicants should ensure that the relevant published guidance is consulted before submitting regulatory queries.

Availability for 2026 is now very limited. However, the HPRA is operating a cancellation list for high-quality applications that are ready for immediate submission should a slot become available.