The Medicines and Healthcare products Regulatory Agency (MHRA) has launched an online Eligibility Checker tool to help applicants determine whether their Marketing Authorisation Application (MAA) is suitable for the International Recognition Procedure (IRP) and to identify which route (A or B) to follow, before submitting an IRP application. The new IRP itself becomes operational in six weeks’ time, on 1 January 2024.
The IRP is a new streamlined procedure for granting marketing authorisations for medicines that have already been approved by a trusted regulatory agency, such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), or Health Canada. The IRP is designed to reduce the time and cost of bringing new medicines to the UK market, while ensuring that patients continue to have access to high-quality medicines.
The Eligibility Checker tool is a simple and easy-to-use online tool that applicants can use to answer a series of questions about their medicine. The tool will then provide advice on whether the medicine is eligible for the IRP and which route to follow.
How to Use the Eligibility Checker Tool
To use the Eligibility Checker tool, applicants will need to provide the following information:
- The name of the medicine
- The active substance(s) in the medicine
- The strength(s) of the medicine
- The intended use(s) of the medicine
- The reference regulatory agency (RRA) that has approved the medicine
- The date of approval by the RRA
Once the applicant has provided this information, the Eligibility Checker tool will provide advice on whether the medicine is eligible for the IRP and which route to follow.