Regulatory Affairs

HPRA scientific advice, marketing authorisations, clinical trial applications, and lifecycle management for the Irish market. We prepare the dossier, submit to the HPRA, and manage the authority interaction through assessment and approval.

For our full regulatory support across all markets, see Regulatory Strategy & Operations.

HPRA Scientific Advice

The HPRA offers national scientific and regulatory advice on quality, nonclinical, clinical, and regulatory questions at any stage before or after authorisation. Two tracks are available: standard (briefing documents 30 days before the meeting, 90-minute meeting, written response within 30 days) and swift (briefing documents within 7 days of acceptance).

For centralised procedures where Ireland is CHMP rapporteur or co-rapporteur, the HPRA offers pre-submission meetings at no charge. The HPRA also proactively encourages scientific advice where it anticipates assessment difficulties.

What we do:
  • Assess whether HPRA national scientific advice is the right route for your product and development stage
  • Draft the briefing document and formulate questions that get actionable answers from the HPRA
  • Prepare your team for the meeting, including anticipated HPRA questions
  • Attend and support during the meeting
  • Interpret the HPRA written response and update the regulatory strategy accordingly

Marketing Authorisations

The HPRA participates routinely as a Concerned Member State in decentralised procedures and can act as Reference Member State. The HPRA operates slot allocation for national and DCP applications where the HPRA will be acting as RMS and requires justification of relevance to the Irish market when requesting a slot. For well-established use applications (Article 10a), the HPRA strongly recommends national scientific advice before or alongside the slot request.

What we do:
  • Advise on procedure selection and prepare HPRA slot requests for national applications
  • Prepare and submit DCP and MRP applications with HPRA as RMS or CMS
  • Manage the HPRA assessment process, including responses to questions and coordination with other member states
  • Handle national MA applications directly to the HPRA
  • Manage post-approval variations, renewals, and lifecycle activities for Irish marketing authorisations

Clinical Trial Applications

Ireland participates in the EU Clinical Trials Information System (CTIS). The HPRA handles Part II (national) assessments for clinical trials conducted in Ireland. Ethics approval is managed separately through the National Office for Research Ethics Committees (NREC).

What we do:
  • Prepare Ireland-specific Part II documentation for CTIS submissions
  • Manage HPRA Part II assessment interactions and responses
  • Coordinate ethics submissions to NREC
  • Support multi-country CTA strategies where Ireland is a participating member state
  • Handle substantial modifications and ongoing CTIS lifecycle activities for Ireland

Lifecycle Management

What we do:
  • Classify and prepare variations for Irish marketing authorisations (Type IA, IB, II)
  • Coordinate multi-country variation submissions where Ireland is an affected member state
  • Manage renewal submissions to the HPRA
  • Implement safety-related product information updates across the Irish market
  • Track HPRA-specific implementation timelines and national deadlines

Related Ireland pages: Quality & Compliance | QP Services | RP Services | EU Market Entry

Planning an HPRA Submission?

Tell us about your product and we will outline the best regulatory route.

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Frequently Asked Questions

For Clinical Trial Applications, can you manage ethics approval as well as CTIS submissions?

We manage the HPRA's Part II assessment for clinical trials conducted in Ireland and coordinate the related ethics submission to NREC, so both strands are covered even though they're handled by separate bodies.

What's the difference between the standard and swift HPRA scientific advice tracks?

The standard track requires briefing documents 30 days ahead of a 90-minute meeting, with a written response within 30 days. The swift track compresses that timeline, with briefing documents due within 7 days of acceptance. We can help you assess which is the right fit given your development stage and how urgent the question is.

Can you submit if Ireland isn't the reference member state?

Yes. The HPRA routinely acts as a Concerned Member State in decentralised procedures as well as Reference Member State, and we manage the HPRA assessment process either way, including responses to questions and coordination with other member states involved.

Do you manage variations and renewals, or just the initial submission?

Both. Beyond preparing and submitting the original marketing authorisation or clinical trial application, we manage post-approval variations, renewals, and broader lifecycle activity for as long as the product is on the Irish market.