Starting 1 January 2024, the IRP replaces the EC Decision Reliance Procedure (ECDRP) and incorporates the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP). This change streamlines the approval process for medicinal products, relying on the expertise of trusted Reference Regulators (RRs) and as such uses global regulatory expertise to benefit UK patients and ensuring quicker access to essential medicines.
Key Points of the IRP are among others:
Transition: ECDRP and MRDCRP submissions received before 1 January 2024 will follow existing practices. For ECDRP, a CHMP positive opinion (not necessarily the EC Decision) must be received by 31 December 2023. Products within the scope of the EU Centralised Procedure can only be authorized in Great Britain until 1 January 2025 (by the time the Windsor Framework is implemented in Northern Ireland).
Eligibility: IRP is available for products already authorized by MHRA’s specified RRs. A CHMP positive opinion or MRDC positive end of procedure outcome counts as RR authorization.
Product Definition: The product must have the same qualitative and quantitative composition, pharmaceutical form, and belong to the same company/group or licensees.
The following application types are eligible for the IRP:
New Active Substances
Generic Applications
Hybrid Applications
Biosimilar Applications
New Fixed Combination Products
Also conditional and exceptional circumstances MAAs (or international equivalents) can support IRP applications as well as post-authorisation procedures like variations, line-extensions and renewals.
On the other side, traditional herbal products, homeopathic registrations and bibliographic applications are excluded from this procedure. Emergency approvals and cancelled authorizations are neither eligible.
There are two procedures, Recognition A and Recognition B:
Recognition A has a 60-day timetable for approvals granted within the past 2 years, with consistent manufacturing processes.
Recognition B has a 110-day timetable for approvals within the last 10 years or exceptional cases, accommodating more complex scenarios.
Trusted RRs are at the moment Australia, Canada, Switzerland, Singapore, Japan, USA and the EU/EEA.
If you want to learn more about the possibilities to register your product to the UK via this route, please let us know and contact us via Contact form.
