CRED ERP 25

5. Managing the Procedure: MRP

Selection of RMS and MA As a National Procedure is specific to each Member State, this can differ widely in the approach and process. Therefore, MRP must be used with caution ensuring that CMS approval process, methods, or criteria would meet expectations of the MRP. This depends on the MS Competent Authority’s experience with clinical, marketing, post market, and labelling of medicinal products. Selection of the Reference Member State must be made by the applicant. This RMS should be acceptable to MRP process with good relationship with the applicant and a positive approach. In many cases, if a National Procedure or DCP was initially used, the selection of the RMS State should be the lead used previously. Preparing Product Dossier The applicant must harmonise the already approved national Summary of Product Characteristics (SmPC). This can be achieved through coordinated national variation procedure or through Article 30 stated in Directive 2001/83/EC.

The application must include: •

Assessment report (drafted by Reference Member State) • SmPC • PIL • Labelling

Three Stage Process MRP is a three-stage process though most applicants should hopefully experience a two-stage process: 1) MA approved in Reference Member State, 2) MRP process, and 3) CMDh referral and even arbitration at CHMP if not accepted (if required). As the MA is approved in the RMS, the procedure starts with preparation of an assessment report. The assessment report is then sent to the CMS with the SmPC, PIL, and labelling, along with the dossier by the applicant. The validation of the application is similar to the DCP a 14 days period within CMSs can raised validation issues. The procedure is started once the validation phase is ended.. Comments are then made on the assessment report with the remainder of the MRP procedure being applied. Further reading: https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma/mrp/rup.html https://www.hma.eu/human-medicines/cmdh/procedural-guidance/application-for-ma.html https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap2_2007-02_en.pdf