Insights
The MRP Day 0 Procedure and the New CMDh Guidance: Addressing Drug Shortages in Small Markets
In recent years, drug shortages have become a growing concern in many European countries, especially in small markets. These markets, often characterized by limited population sizes or lower commercial appeal, tend to face significant challenges in maintaining a steady supply of essential medicines. Factors such as production issues, delays in drug registration, and commercial decisions contribute to these shortages. In response, the European Union has implemented regulatory measures to streamline access to medicines while ensuring their safety and efficacy. One such measure is the Mutual Recognition Procedure (MRP) Day 0.
The Mutual Recognition Procedure (MRP) Day 0 allows a marketing authorization granted in one EU member state to be recognized by others. This procedure allows harmonization between the Reference Member State (RMS) and Concerned Member States (CMS).
The new CMDh guidance “Procedural Advice on Zero day MR procedure”, issued in April 2024 provides more clarity on this procedure and helps the applicants in understanding the steps to be performed in order to prepare the submission package. Some key points are summarised below:
- The RMS and the CMS must accept to participate in the procedure before the application is submitted. The Applicant must guarantee that the product will be placed on the market in the MS.
- More CMSs could participate in the same procedure in case the requirements are the same for both countries.
- The dossier to be submitted should be in eCTD format, for dossier not in eCTD format the applicant should liaise with the CMS and follow national guidance.
- The CMS agrees to accept the assessment of the RMS without any comments or questions. This kind of procedure is finalized once the application has been accepted by the RMS and CMS. The zero-day procedure is concluded on the same day it starts.
Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on the preparation and submission of MRP day 0 procedure.