Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure for a Human Medicinal Product" last Wednesday (03 April 2024), detailing how to submit a request for Ireland to act as the RMS in a DCP, providing valuable insights for pharmaceutical companies seeking regulatory approval for their products in multiple European Union (EU) member states.
Decentralised procedures allow pharmaceutical companies to apply for marketing authorisation for a medicinal product in multiple EU member states simultaneously. The RMS plays a central role in coordinating the assessment of the application and liaising with other member states involved in the procedure.
The guidance, states If an applicant wishes Ireland to serve as RMS, they are requested to submit their request to the CMDh as soon as possible, and not later than three months before the application is scheduled to be submitted. Requests should be made using the common RMS request form published on the CMDh website and sent to RMS@hpra.ie.
After the HPRA has reviewed all applications, successful applicants will be contacted by email to confirm that they are available to submit the dossier within the next two years (next available slot). To secure the DCP slot, the MAH will need to pay a non-refundable booking fee of €1,000.
Slots are allocated for specific active substance(s), dosage form(s), and submission time(s), so if any of those parameters need to be changed, a new request and booking deposit may be required. HPRA also operates a cancellation list for slots which become available at short notice.
By following the guidance, companies can navigate the RMS request process with confidence and ensure the timely and efficient assessment of their medicinal products in multiple member states.