Mutual Recognition Procedure, MRP, MAA Submissions, MAH, EU

Freyr supports Mutual Recognition Procedure (MRP)/Repeat Use Procedure (RUP) to procure authorization of medicinal products in multiple EU member states (CMS & RMS) & helps in compilation, technical review, finalization and publishing for MAA Submissions as per EU regulations.

Market authorization holder (MAH) who already has authorization for medicinal product in a member state of European Union (EU) can choose Mutual Recognition Procedure (MRP) in order to procure authorization in multiple EU member states.

In this case, the EU member state, which has granted the authorization for the medicinal product, acts as reference member state (RMS) and other EU member states to which the marketing authorization application (MAA) to be submitted for same medicinal product shall be considered as concerned member states (CMS). After MAA submission to all EU member states (RMS & CMS), the assessment report of RMS acts as the basis for other member states to grant the authorization by all CMSs. As per the EU directive, MRP is assigned a review cycle of 90 days followed by 30-day national phase to translate the product information in regional language.

After completion of first MRP, the applicant may use the MRP multiple times to obtain market authorization by other member states by Repeat Use Procedure (RUP). It is applicable for use only between RMS and a new CMS. Being prepared for MRP prerequisites can be challenging. There could be validation issues due to non-compliance with latest regulations. Lack of preparation can cause further delays in process which in turn may affect the cycle.

Know more at Freyr Page - Mutual Recognition Procedure (MRP)/Repeat Use Procedure (RUP)

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