Market Authorization Holder (MAH) who already has authorization for a medicinal product in a member state of the 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 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 considered as the Concerned Member States (CMSs). After the submission of the MAA to all the 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, an MRP is assigned a review cycle of ninety (90) days followed by a thirty (30)-day national phase to translate the product information in the regional languages.
After completion of the first 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 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 a 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 compilation, technical review, finalization, and publishing of support documents related to submission.
- Legal representation as an MAH for the medicinal products manufacturers who do not have establishments in the European Economic Area (EEA).
- Regulatory consultation/strategic support during the development stage of the medicinal products.
- Support in the selection of dissolution parameters/multimedia/for 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 for appointment/consultation of Qualified Person (QP) for quality and Qualified Person for Pharmacovigilance (QPPV) (if applicant’s office is not in the EEA and they do not have their own QP and QPPV).
- Advice for consultation of batch release testing site and batch control site testing (if the applicants do not have their own sites in EEA).
- Regulatory assessment/gap-analysis of source documents/registered dossier.
- Compiling, technical reviewing, finalizing, publishing, and submission of the MAA to the EU HAs.
- Regulatory strategy in the response to HA queries (RTQs).
- Response to HA queries (HAQs) with supporting documents/data with scientific rationale to avoid 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.