Overview

With advance healthcare provisions in place, market forecast for pharmaceuticals in France predicts a continued demand. For a medicinal product / drug to be marketed in France, a manufacturer must obtain a Marketing Authorization (MA) from the Ministry of Health (MoH) of France. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:

  • Article 8(3) for New Chemical Entity (NCE)
  • Article 10 for generic, hybrid and similar biological medicinal products

Further, the MA Holder (MAH) has to meet all the requirements listed out by EU and European Economic Area (EEA) considering UK MHRA as a 3rd country after 30th March 2019.

The initial, post-approval and life cycle management (LCM) submissions in EU are specific and critical considering the procedural requirements. But as the most countries in EU, France also has national specific regulations pertaining to technical documentation, fees and language translations which may increase the process duration that may in turn lead to increased costs. Thus, opting for regional expertise is required.

Freyr, with a dedicated EU Regulatory team, assists clients in France with Regulatory guidance that span across product development, gap analysis of executed data and remediation plan in line with both, EU and France’s individual requirements along with professional assistance for post approval changes and life cycle management of the licenses for pharmaceutical and biological products. 

 

Freyr Expertise

  • Initial submissions (MAAs) via various procedures- National, Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP) for innovator, hybrid and generic products
  • Regulatory consultation and strategic support on submission roadmaps, submission procedures
  • Pre-submission administrative activities such as interaction with Health Authorities (HAs), slot booking for submissions, selection of the RMS and CMS, request to HA to work as RMS
  • Evaluation of the product and source data from R&D and manufacturing site (executed data) for the EU-specific Regulatory and submission requirements
  • Compilation and submission of the dossiers to HAs in eCTD format in line with France MoH requirements
  • Consultation during developments and manufacturing of the medicinal products
  • Initial submissions for APIs - ASMF/ CEP submissions
  • Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV) in EU
  • Post-approval changes submissions with strategies and compilation/ submission for: 
    • Marketing authorization holder (MAH) transfers
    • Post-approval quality change like-
      • Change in manufacturing site, addition/deletion of the site, Batch size change, changes in manufacturing changes, administrative and labeling changes
    • Monograph updates i.e. compliance to European pharmacopoeia
    • Changes in container closure system
    • Change in primary packaging material supplier
    • Shelf life extension/reduction
    • Addition of new supplier for active substance
    • Inclusion of additional source for starting material for drug substance
  • Impact analysis of Brexit and submission of the relevant changes to HA(s) like- change in Reference Member State (RMS), changes to MAH, addition/ replacement of the batch release and testing sites, changes to the QP, QPPV and Pharmacovigilance system master file (PSMF) (Article 57 notification)
  • Life cycle maintenance by submission of renewal applications
  • Support in handling France MoH’s deficiencies with Regulatory strategy and preparation and submission of the response