Mutual Recognition Procedure (MRP)

 

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.
Mutual Recognition Procedure (MRP)
  • Offering support in mutual recognition procedure for drug registration.
  • Expertise in handling EU MRP.
  • Proven skills in EU Regulatory procedures.
Mutual Recognition Procedure (MRP)

Choose the Mutual Recognition Procedure for Drug Registration

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Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​