Ireland's HPRA Requirements for National Marketing Authorisation Applications and Decentralised Procedures
- Sharan Murugan
- 8 minutes ago
- 3 min read
Obtaining marketing authorisation for medicinal products in Ireland requires careful planning and early engagement with the Health Products Regulatory Authority (HPRA). To support efficient assessment and resource management, the HPRA has established guidance for companies seeking to submit new national marketing authorisation applications and for applicants requesting Ireland to act as the Reference Member State (RMS) in a Decentralised Procedure (DCP).
The guidance documents outline the processes for requesting submission slots, the timelines that applicants should follow, and the allocation procedures used by the HPRA. Together, these requirements help improve regulatory planning, facilitate efficient dossier assessments, and ensure that applicants can access the appropriate regulatory pathways for their products.
The HPRA has introduced a system for allocating submission slots for new national marketing authorisation applications. These applications relate to products seeking approval through a purely national procedure that will result in a marketing authorisation valid only in Ireland.
The slot allocation system is designed to support effective capacity planning and ensure efficient assessment of national applications. It also helps maintain a dedicated regulatory pathway for products that are particularly relevant to the Irish market. Applicants are encouraged to plan submissions well in advance and engage with the HPRA at an early stage of the process.
Submission Requirements
Companies wishing to submit a new national application should submit a request to the HPRA as early as possible and no later than two months before their preferred submission date.
Requests should be submitted via the standard request form and include a justification explaining the product's relevance to the Irish market. Complete and accurate information is important for facilitating the review and allocation of submission slots.
Slot Allocation Process
All requests are reviewed by the HPRA before a decision is made regarding slot availability. Successful applicants are offered a specific submission period within the next available six-month planning window.
To secure the allocated slot, applicants are required to pay a non-refundable booking fee. This fee is subsequently offset against the full application fee once the marketing authorisation application is submitted.
In addition to national applications, the HPRA actively supports participation in Decentralised Procedures and welcomes requests for Ireland to act as the Reference Member State. The RMS plays a key role in coordinating the scientific assessment and communication activities during a decentralised procedure involving multiple Member States. Early planning is therefore essential to ensure that appropriate resources and assessment timelines can be allocated.
Requesting Ireland to Act as RMS
Applicants wishing for Ireland to act as RMS should submit their request as early as possible and no later than three months before the planned dossier submission date.
Requests should be completed using the common RMS request form and submitted to the HPRA. All sections of the request form should be completed to allow the authority to evaluate the proposed procedure and determine slot availability.
Allocation of DCP Slots
Following review of the request, successful applicants are notified of the next available submission slot within the HPRA planning schedule. The authority allocates slots within a two-year planning window to facilitate effective management of decentralised procedures.
As with national applications, a non-refundable booking fee is required to reserve the allocated slot. This fee is later deducted from the overall application fee when the dossier is submitted.
Applicants should note that allocated slots are linked to specific active substances, dosage forms, and agreed submission timelines. Significant changes to these parameters may require submission of a new request and potentially a new booking fee.
Repeat Use Decentralised Procedures
The guidance also addresses repeated use of decentralised procedures. These procedures allow additional concerned Member States to be included after completion of the original decentralised procedure.
Requests for repeat use can be submitted directly to the HPRA at any stage. Following receipt of the request, the authority will provide further information regarding the process and applicable requirements.
For applicants seeking access to the Irish market, understanding these requirements is essential for successful regulatory planning. Whether pursuing a national authorisation route or requesting Ireland to act as Reference Member State in a decentralised procedure, early preparation and adherence to HPRA expectations can support a more predictable and efficient approval process.