Introduction to Decentralized Procedure (DCP):
Templarpharma assists companies seeking authorization in multiple EU member states through the Decentralized Procedure (DCP). experts provides guidance on the regulatory framework and the submission requirements for the Decentralized Procedure (DCP). During this process, the applicant can choose any EU member state to act as the 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 experts at Templarpharma assist clients in selecting the most suitable RMS and provide guidance on the regulatory requirements for DCP. They also offer support in preparing the submission package and addressing any queries raised by the authorities during the evaluation process.
Role of Reference Member State (RMS):
Understand the importance of selecting the right Reference Member State (RMS) for a successful DCP submission. RMS plays a crucial role in coordinating the evaluation process, preparing the assessment report, and leading the overall communication with CMS. Templarpharma’s experts help clients in selecting the right RMS and provide support throughout the entire submission process.
Market Authorization Application (MAA) Submission in DCP:
Experts help clients in preparing and submitting MAA through DCP. The MAA submitted to the RMS includes the product information, clinical data, and quality data. Templarpharma provides guidance on the submission requirements and helps clients in preparing a comprehensive dossier to ensure a smooth submission process.
Review cycle for approval of MAA:
The review cycle for the approval of MAA in DCP is about two hundred and ten (210) days, including a thirty (30)-day national phase to translate the product information in the regional languages. Templarpharma ensures that clients are aware of the review timelines and provides support in addressing queries raised by the RMS and CMS during the evaluation process.
Assistance in Generic Medical Product Submissions:
Templarpharma provides in-house expertise in driving generic medical product submissions through DCP. With extensive knowledge of regulatory requirements and submission guidelines, Templarpharma’s experts help clients in preparing and submitting generic product dossiers to the relevant authorities. Templarpharma’s experts also provide assistance in addressing any queries raised by the authorities during the evaluation process.
Legal Representative Services:
As part of its DCP services, Templarpharma provides legal representative services to clients. The legal representative is responsible for communicating with the regulatory authorities on behalf of the client and ensuring compliance with the regulatory requirements. Templarpharma’s experts provide legal representative services and liaise with regional Health Authorities (HAs) for quick addressing of queries.
Support in Communication with Health Authorities:
team of experts who can provide support to clients during the Decentralized Procedure (DCP) process. The team is experienced in communicating with Health Authorities (HAs) and ensuring that clients are informed of all regulatory requirements. They can provide guidance on how to address any queries raised by the authorities during the DCP process. The team can also assist in preparing responses to queries and addressing any concerns raised during the evaluation process. Templarpharma’s goal is to help clients navigate the DCP process successfully and ensure that their medicinal products are approved for sale in the European Union.
Expertise in Decentralized Procedure:
- Legal representation for non-EEA medicinal product manufacturers as Marketing Authorization Holder (MAH).
- Regulatory consultation/strategic support during the product development stage.
- Support in selecting dissolution parameters/multimedia for test and Reference Medicinal Product (RMP).
- Preparation of Product Development Report along Decentralized Procedure.
- Designing specifications for finished product/API/In-process/Intermediates.
- Advice in selecting Regulatory submission procedure based on MAH’s requirements.
- Pre-submission administrative activities.
- Guidance on appointing a Qualified Person (QP) for quality and QPPV is provided.
- Support is provided for consultation of batch release testing site and batch control site testing.
- Regulatory assessment and gap analysis of source documents and registered dossier are conducted.
- Compiling, reviewing, finalizing, publishing, and submitting Marketing Authorization Application (MAA) to EU HAs.
- Regulatory strategy in responses to HA queries (RTQs).
- Assistance is provided in preparing responses to queries from Health Authorities (HAQs) along with the necessary supporting documents and data
- Evaluation of change controls and supporting documents.
- Preparation of variation submission strategy.
- assists in the preparation and submission of variations and renewal applications to the Market Authorization Application (MAA).
- They also track the progress of renewal submissions for MAA within the European Union.
- Follow-up with Regulatory agencies for MAA approval and Decentralized Procedure.
- Compliant with the latest regulatory guidelines and requirements.
- Ensures timely and efficient approval of medicinal products in the EU.