Market Authorization Holder (MAH)
Templarpharma can guide the MAH through the Mutual Recognition Procedure (MRP) if they already have authorization for a medicinal product in one EU member state and want to obtain authorization in other member states. Templarpharma can assist in identifying the Reference Member State (RMS) and the Concerned Member States (CMSs) where the Marketing Authorization Application (MAA) needs to be submitted.
RMS including Concerned Member States
Templarpharma can advise the MAH on the RMS and CMSs selection for the MAA submission. The RMS will be responsible for coordinating the assessment of the MAA while the CMSs will rely on the RMS’s assessment report to grant the marketing authorization. TemplarPharma can help with the communication and coordination between the RMS and CMSs.
Assessment report of RMS
Templarpharma can assist the MAH in understanding the importance of the assessment report of the RMS. Which will serve as the basis for granting the authorization by other CMSs. Templarpharma’s experts can help the MAH in addressing the RMS’s concerns to obtain a favorable assessment report.
Review cycle of 90 days
Templarpharma can help the MAH in preparing the MAA dossier in compliance with the EU regulations. Which ensure a smooth review cycle of 90 days. Templarpharma can also help in addressing any concerns or queries from the RMS and CMSs during the review cycle to avoid any delay in the process.
Repeat Use Procedure (RUP) for MRP
Templarpharma can guide the MAH on using the assessment report obtained from the first MRP for Repeat Use Procedure (RUP) to obtain authorization in other member states. Templarpharma can also assist in identifying the new CMS and ensuring compliance with the regulatory requirements for the RUP submission.
Validation issues
Templarpharma’s experts can help the MAH in ensuring the MAA dossier is in compliance with the latest regulations to avoid any validation issues that may cause delay in the process. Templarpharma can also assist in addressing any non-compliance issues during the pre-submission phase to avoid rejection of the MAA.
Regulatory support for MRP
Templarpharma can support the MAH in all stages of the MRP submission, including compilation, technical review, finalization, and publishing of support documents. Templarpharma’s team of regulatory experts can ensure a successful submission by providing accurate and timely support.
Templarpharma Expertise in Mutual Recognition Procedure
- Provision of legal representation as an MAH for non-EEA medicinal product manufacturers.
- Regulatory consultation and strategic support during product development stage.
- Support for selection of dissolution parameters/multimedia for test product and RMP.
- Preparation of Product Development Report with discriminatory media nature.
- Designing of specifications for finished product/API/in-process/intermediates.
- Advice on selection of Regulatory submission procedure based on MAH requirements.
- Pre-submission administrative activities with Mutual Recognition Procedure.
- Advice on appointment/consultation of QP for quality and QPPV for Pharmacovigilance.
- Guidance provided for consulting batch release and control testing sites.
- Evaluation and analysis of regulatory compliance of source documents and registered dossier.
- Compiling, technical reviewing, finalizing, publishing, and submission of MAA to EU HAs.
- Regulatory strategy for response to HA queries (RTQs).
- Response to HA queries (HAQs) with supporting documents and scientific rationale.
- Evaluation of change controls and supporting documents.
- Preparation of variation submission strategy.
- Compilation and submission of variations and renewals to MAA.
- Monitoring and tracking the renewal submissions for Market Authorization Application (MAA) across the European Union (EU).
- Follow-up with Regulatory agencies for approval of MAA and MRP.
- Technical support for responding to deficiencies in the MAA.
- Assistance in the preparation and submission of periodic safety update reports.
- Providing regulatory assistance during inspections and audits
- Support in preparation and submission of clinical trial applications.
- Guidance on regulatory requirements for marketing of orphan drugs and pediatric products.
- Regulatory support for post-authorization activities like renewals, extensions, and variations.
- Assistance in the preparation and submission of Risk Management Plans (RMPs).
- Provision of regulatory support in the registration of Medical Devices.
- Technical support for establishment of GMP compliant manufacturing facilities.
- Assistance in the preparation and submission of Summary of Product Characteristics (SPCs).
- Advice on regulatory requirements for advertising and promotional materials.
- Provision of regulatory support for import/export of medicinal products.