Decentralized Procedure - An Overview
The Decentralized Procedure (DCP) allows the applicant to submit their application to the Health Authority (HA) and seek authorization in multiple EU member states simultaneously. This procedure facilitates the harmonized evaluation and approval of medicinal products across the EU, ensuring a consistent and efficient Regulatory process. By utilizing the Decentralized Procedure EMA, applicants can streamline their authorization process in the complex Regulatory landscape of the EU.
If an applicant is not granted authorization by any of the European Union (EU) member states and is aiming for authorization in multiple EU member states, then they can approach the HA through the Decentralized Procedure (DCP). The applicant can request any one of the EU member states to act as Reference Member State (RMS) and submit the Market Authorization Application (MAA) to all the selected EU member states (RMS and Concerned Member States (CMS)). The review cycle for the MAA approval would be about two hundred and ten (210) days, including a thirty (30)-day national phase to translate the product information into the regional languages.
Freyr, with in-house expertise in generic medicinal product submissions through the Decentralized Procedure (DCP), assists manufacturers to streamline their DCP submissions. Freyr also extends legal representative services and liaises with regional HAs for quick addressing of queries.
Decentralized Procedure - Freyr Expertise
- Legal representation as Marketing Authorization Holder (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 the selection of dissolution parameters/multimedia/for the performance of dissolution for the test product and Reference Medicinal Product (RMP).
- Preparation of Product Development Report (discriminatory nature of media).
- Designing the specifications (Finished product/API/In-process/Intermediates).
- Advice in the selection of the 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 testing and batch control testing sites (if the applicants do not have their own sites in EEA).
- Regulatory assessment/gap analysis of source documents and registered dossier.
- Compiling, reviewing, finalizing, and publishing & submitting the Marketing Authorization Application (MAA) to the EU HAs.
- Regulatory strategy in the responses to HA queries (RTQs).
- Prepare responses to HA queries (HAQs) with supporting documents/data with the scientific rationale to avoid delay in approvals.
- Evaluation of change controls and supporting documents.
- Preparation of variation submission strategy.
- Compilation and submissions of variations and renewals to MAA.
- Track renewal submissions for MAA in the EU.
- Follow-up with Regulatory agencies for MAA approval.