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.
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 Marketing Authorization Holder (MAH) for the medicinal products manufacturers, who do not have establishments in European Economic Area (EEA)
- Regulatory consultation/strategic support during the development stage of the medicinal products
- Support in 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 office is not in EEA and they don’t have their own QP and QPPV)
- Advice for consultation of batch release testing site and batch control site testing (if applicant don’t have their own sites in EEA)
- Regulatory assessment/gap analysis of source documents/registered dossier
- Compiling, technical reviewing, finalizing, publishing and submission of Marketing Authorization Application (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