Zero Day MR Procedure

11 apr. 2024
Zero Day MR Procedure

Last month, the CMDh published new procedural guidance on the so-called “Zero Day MR Procedure”. This is a procedure which has been in use in the EU for a few years already, mainly by the smaller Member States (MS), but is not very well-known. Briefly said, the Zero Day MR Procedure can be described as an “administrative” version of the commonly used Repeat Use procedures (RUP) or Mutual Recognition Procedure (MRP) with a shortened timetable. This procedure can be initiated by either the Marketing Authorisation Holder (MAH) or by the MS. However, it can only be used in exceptional circumstances to mitigate shortages or issues with access to critical medicines.

This procedure is applicable when a MS was not included in the original or subsequent waves of a Decentralized or Mutual Recognition Procedure, or when a MS requires access to a crucial medicinal product solely authorized in another MS.

Before an applicant proceeds with the submission of the Zero Day MR Procedure, there are a few prerequisites to take into consideration. 

For a Member State to participate in the procedure, it must agree to this before the application is submitted. Additionally, a MS can initiate contact with the MAH to propose this procedure for a certain product. The Reference Member State's (RMS) acceptance is also necessary before application submission. The MAH should discuss relevant marketing authorization aspects with the Concerned Member State (CMS) before application submission, e.g. product name, additional risk minimisation measures, if any, orphan status, etc.

It is allowed to have more than one CMS participating in the procedure; however, they should agree to the same common requirements. 

Furthermore, there are some commitments the CMS needs to make before the start of the procedure, including acceptance of existing RMS Assessment Reports and adherence to PSUR submission timelines.

But most of all, the applicant must commit to market the medicinal product in the MS. The timelines to place the product on the market should be agreed between the applicant and the CMS.

The submission itself consists of a fully updated Module 1 and common versions of the currently approved Product Information (PI) in Word format. The cover letter should confirm agreement for a Zero Day MR procedure.

Once the application has been submitted to the respective authority, the usual 14-day validation period applies for the CMS. As soon as the CMS positively validates the procedure in CTS, the RMS starts and ends the procedure on the same day. 

After this, only the national phase in the CMS follows, where national translations of the PI (and mock-ups where applicable) are to be submitted. In addition to this and also generally speaking, applicants should always check the national guidelines for completeness. 

In case you need help with figuring out national guidelines or need assistance with the Zero Day MR procedure, please reach out to us via our Contact form.

Zero Day MR Procedure