Mutual Recognition Procedure (MRP) - Overview
A Market Authorization Holder (MAH) who already has authorization for a medicinal product in the European Union (EU) member state can choose Mutual Recognition Procedure (MRP) to procure authorization in multiple EU member states.
In this case, the EU member state that has granted the authorization for the medicinal product acts as a Reference Member State (RMS), and the other EU member states to which the Marketing Authorization Application (MAA) is to be submitted for the same medicinal product, shall be the Concerned Member States (CMSs). After the submission of the MAA to all the EU member states (RMS & CMS), the assessment report of the RMS acts as the basis for the other member states to grant authorization by all CMSs. As per the EU directive, a Mutual Recognition Procedure (MRP) is assigned a review cycle of ninety (90) days followed by a thirty (30)-day national phase to translate the product information into the regional languages.
After the first Mutual Recognition Procedure (MRP), the applicant may use it multiple times to obtain market authorizations in other member states by Repeat Use Procedure (RUP). It is applicable for use only between RMS and a new CMS. Being prepared for Mutual Recognition Procedure (MRP) prerequisites can be challenging. There could be validation issues due to non-compliance with the latest regulations. Lack of preparation can cause further delays in the process, which may affect the cycle.
Freyr, with vast Regulatory experience, assists manufacturers with information on submission requirements related to Article 10(1), apart from handling pre-submission administrative activities. Freyr’s Regulatory experts support manufacturers in the compilation, technical review, finalization, and publishing of support documents related to the submission.
Mutual Recognition Procedure (MRP)
- Legal representation as a MAH for medicinal product manufacturers who do not have establishments in the European Economic Area (EEA).
- Regulatory consultation/strategic support during the development stage of medicinal products.
- Support in selecting dissolution parameters/multimedia/for the performance of dissolution for test product and Reference Medicinal Product (RMP).
- Preparation of Product Development Report (discriminatory nature of media).
- Designing specifications (finished product/API/in-process/intermediates).
- Advice in the selection of Regulatory submission procedure based on the MAH’s requirements.
- Pre-submission administrative activities.
- Advice in the appointment/consultation of a Qualified Person (QP) for quality and a Qualified Person for Pharmacovigilance (QPPV) (if the applicant’s office is not in the EEA and they do not have their own QP and QPPV).
- Advice in batch release site and batch control site testing (if the applicants do not have their sites in EEA).
- Regulatory assessment/gap analysis of source documents/registered dossier.
- Compiling, technical reviewing, finalizing, publishing, and filing the MAA submission to the EU HAs.
- Regulatory strategy in response to HA queries (RTQs).
- Response to HA queries (HAQs) with supporting documents/data with the scientific rationale to avoid a delay in approval.
- Evaluation of change controls and supporting documents.
- Preparation of variation submission strategy.
- Compilation and submissions of variations and renewals to MAA.
- Tracking renewal submissions for MAA in the EU.
- Follow-up with Regulatory agencies for the approval of the MAA.
- Offering support in mutual recognition procedure for drug registration.
- Expertise in handling EU MRP.
- Proven skills in EU Regulatory procedures.
