Overview

If an applicant aims to procure a marketing authorization (MA) in a chosen European Union (EU) member state, it is required to submit market authorization application (MAA) to the respective state’s competent authority through National Procedure (NP).

The competent authority is responsible for reviewing and granting MA. Most of the Health Authorities (HAs) require 210 days for review and approval of MAA, however it may vary slightly from HA to HA of different member states followed by national phase for translation activities.

If an MA is granted by competent authority of EU member state and the applicant would like to register the medicinal product in any other EU member state, MA holder can file the same MAA to required state (which will be referred to as concern member state [CMS]) and the member state who authorized the MAA shall be considered as reference member state (RMS).

With an expertise in dealing with Article 10(1) submissions to HAs in EU, Freyr extends end-to-end submissions support by all procedures including National Procedure (NP). Further, Freyr supports manufacturers in appointing Qualified Person (QP) for quality and QP for Pharmacovigilance (QPPV) in respective member states to validate quality and organize post-market surveillance. 

 

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 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 applicants don’t have their own site in EEA)
  • Regulatory assessment / gap analysis of source documents / already registered dossier for their Regulatory adequacy
  • Compiling, technical 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 the approval of the MAA