United Kingdom (UK), has one of the world’s best healthcare policies, thus attracting renowned pharmaceutical players from across the globe. Medicinal products must be marketed in the country only after registering the product and obtaining an approval from Medicines and Healthcare Products Regulatory Agency (MHRA). 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  
    • Article 10(1) Generic Application
    • Article 10(3) Hybrid Application
    • Article 10(4) Similar Biological Application
    • Article 10a of Directive 2001/83/EC for well-established use supported by bibliographic literature
    • Article 10b of Directive 2001/83/EC for new fixed combination of active substances in a medicinal product
    • Article 10c of Directive 2001/83/EC for informed consent application

With the Brexit expected to come into effect from March 30, 2019, massive Regulatory changes are anticipated impacting the submissions and approvals of MAAs. Regulatory pathways, strategies for submissions and all criteria may require meticulous planning. With an exclusive delivery center in the UK, Freyr keeps a thorough track of Regulatory changes and enable manufacturers to make informed choices for compliant market entry. 

Freyr Expertise

Freyr can help the license holders for the following services applicable for both nationally and mutually approved licenses:

  • Regulatory support as Marketing Authorization Holder (MAH) and local representative in UK for nationally approved procedures
  • Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) in UK and EU member countries before and post-Brexit
  • Submission through Mutual Recognition Procedures for nationally approved products (by MHRA) including the administrative and CMC activities
  • Support in the preparation and submission of the updated labels as per the EU requirements
  • Change control evaluation and preparation of variation submission strategy
  • Support in review, compilation and submission of the variations for addition, replacement and/or deletion batch release, batch testing sites
  • National submissions for transfer of the marketing authorization.
  • Strategic support from Regulatory perspective for the planned Marketing Authorization Applications (MAAs) including the gap analysis, compilation and submission of the application
  • Provide Regulatory response strategy, preparation and submission of response to MHRA queries on time to avoid delay in approval