Dáil Éireann Debate, Tuesday - 19 May 2026
1231. Deputy Barry Ward asked the Minister for Health if she will set out the mechanism and timeframe of reference for the HPRA to approve the use of a particular pharmaceutical; and if she will make a statement on the matter. [37707/26]
Amharc ar fhreagraWith respect to marketing authorisations of medicinal products, the HPRA (Health Products Regulatory Authority) operates in accordance with EU pharmaceutical legislation (primarily EU Directive 2001/83/EC) and national legislation (Medicinal Products (Control of placing on the Market) Regulations 2007). While the process mechanism and timelines depend on the authorisation route (national, decentralised, mutual recognition, or centralised), the core assessment steps and timelines are broadly consistent.
Prior to submitting a marketing authorisation application (MAA), the applicant/company determines the appropriate regulatory route, between:
• National procedure, for approval in Ireland only,
• Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP), for approval in multiple EU member states, or
• Centralised Procedure via European Medicines Agency (EMA), for pan-EU approval.
For certain products, applicants are required to apply via the centralised procedure (e.g. innovative, biotechnology-derived, advanced therapy medicinal products, orphan medicinal products, new active substances for specific therapeutic areas).
Assessment timelines can vary depending on the type of procedure and aspects such as the quality and completeness of the dossier, the complexity of the product (e.g. novel biologics versus established generics), and number of review cycles (issues / questions raised). However, typical assessment process and timelines for MAA range from 12 to 24 months, in line with established national and EU protocol. For medicines considered to be of major interest for public health (for example those that target a condition for which there is no treatment option and that have the potential to address an unmet clinical need), the standard assessment timeline via the centralised procedure may be reduced by up to 60 days.
