Overview

Pharmaceutical market in Germany has displayed a continued growth over the years. As a prominent member of European Union (EU), Germany requires a Market Authorization (MA) granted by the country’s Ministry of Health (MoH) to market and distribute medicinal products locally. 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.

Apart from the EU’s centralized regulations, Germany has its own national specific requirements for technical documentation, fees and language that might require the market entrants to put in extra efforts for successful compliance.

Freyr with an exclusive delivery center in Germany assists manufacturers with the updated Regulatory intelligence and helps aligning with the requirements in a cost-effective manner. With proven expertise in handling end-to-end Regulatory process concerning submissions, we also cater post-approval services including renewals, changes in manufacturing site, labeling and other frequent dossier updates.

 

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 Germany MoH’s deficiencies with Regulatory strategy and preparation and submission of the response