Overview

Denmark is highly regarded for its thriving pharmaceutical market. All medicinal products to be marketed in the country must be approved by the Danish Medicines Agency before marketing them 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 Market Authorization Holder (MAH) has to meet all the requirements listed out by the European Union (EU) and European Economic Area (EEA) considering the UK as a 3rd country post March 30, 2019. 

The procedural requirements of submissions in the EU and unique regional requirements may add to the Regulatory procedural complexities in addition to finding a dependable local representative. Moreover, the Brexit might impact in unprecedent manners and applicants may have to gear up for updated regulations.

Freyr, with a strong foothold in handling submissions to the European Medicines Agency (EMA) and Danish Medicines Agency guides applicants throughout the Regulatory process and also extends legal representation services to manage all Regulatory proceedings right from strategy to submissions to lifecycle management such as post-approval activities such as HA query response, variation submissions and license renewals. 

 

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, and 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 as per the Danish Medicines Agency 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 the 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 Danish Medicines Agency’s deficiencies with Regulatory strategy and preparation and submission of the response