Overview

If a market authorization applicant is not granted authorization by any of the European Union (EU) member states, and is aiming for procuring authorization in multiple selected EU member states, then they can approach the Health Authority (HA) through 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 selected EU member states (RMS and concerned member states [CMS]). The review cycle for the approval of MAA would be about 210 days, including a 30-day national phase to translate the product information in regional language.

Freyr with in-house expertise of driving generic medical product submissions through DCP, assists manufacturers to streamline submissions. Freyr also extends legal representative services and liaises with regional Health Authorities (HAs) which in turn will be helpful for quick addressing of queries.

 

Freyr Expertise

  • Legal representation as marketing authorization holder (MAH) for the medicinal product 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 the 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 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 and registered dossier
  • Compiling, reviewing, finalizing, publishing and submission of marketing authorization application (MAA) to EU HAs
  • Regulatory strategy in the response to HA queries (RTQs)
  • Prepare 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
  • Track of renewal submissions for MAA in EU
  • Follow-up with Regulatory agencies for MAA approval