Overview

Despite a moderate growth value, consistent demand for medicinal products has made Ireland a viable market for drug and biological products. Before marketing medicinal products in the country, manufacturers must obtain an approval from the Health Products Regulatory Authority (HPRA) of Ireland by submitting a Marketing Authorization Application (MAA). 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 the European Union (EU) and European Economic Area (EEA) considering the UK as a 3rd country post March 30, 2019. 

In attempt to adapt to global Regulatory changes, the HPRA is implementing dynamic actions amending its regulations which may require Regulatory tracking from applicants to ensure continued compliance.

To assist manufacturers, navigate those changes effectively, Freyr provides effective Regulatory Intelligence for informed compliance best practices and market entry with assured Regulatory support throughout strategy, submissions and life cycle management.

 

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 in line with Health Products Regulatory Authority (HPRA) of Ireland 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 the HPRA’s deficiencies with Regulatory strategy and preparation and submission of the response