Strategic Regulatory Partner for Success in United Kingdom

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

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Greetings from
Freyr United Kingdom

Growing consumer demand for moderate availability of new healthcare technology makes United Kingdom (UK), a lucrative market for pharmaceuticals, medical devices and biotech manufacturers. Medicines and Health products Regulatory Agency (MHRA) oversees / regulates respective Regulatory activities in the region. With different types of procedures to be chosen (Centralised Procedure [CP], National Procedure [NP], Decentralised Procedure [DCP] and Mutual Recognition Procedure [MRP]), the Regulatory regime in the UK might stand a challenging aspect to deal with to obtain necessary market authorizations.

Freyr with an exclusive operational center in UK, assists foreign manufacturers with localized Regulatory Affairs and operational support for required Regulatory procedures. Freyr’s end-to-end Regulatory affairs consulting for UK region span across:

Industries We Serve in United Kingdom

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:

Post-Brexit, the UK is still altering and adding its regulations for medical devices. The regulations to be followed in the country are bifurcated geographically – Great Britain (GB) and Northern Ireland (NI). Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority that looks after medical device. Northern Ireland is required to comply with European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746. Non-UK manufacturers must appoint a UK Responsible Person (UK RP) to help them comply with these regulations and ensure a successful UK Medical Device Registration process.

The United Kingdom (UK) has officially left the European Union (EU), and the transition period for Brexit ended on December 31, 2020. Hence, from January 01, 2021, manufacturers and importers must abide by the New Cosmetics Regulation in the UK and the existing EU Cosmetics Regulation in all remaining EU countries.

The Food Standards Agency (FSA) is responsible for food safety and hygiene across the United Kingdom (UK). Due to Brexit, the UK became the third country on December 31, 2020, and published a batch of technical guidance documents for businesses on the implications of its exit from the European Union (EU). Now, in the post-Brexit era, a Food Business Operator (FBO) UK, who is the responsible operator, must be identified, and the address should be mentioned on the label of food products.

Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets. After Brexit, the UK has framed a separate individual set of chemical/product legislation, which is an amended version of the EU’s existing legislation. In the UK, disinfectant products are classified as biocides in a similar way as in Europe. After Brexit, the UK framed its own disinfectant regulation like Europe, which is referred to as GB BPR. Biocides under the GB BPR are categorized in the same way as in Europe as Group I Disinfectants having below PT types.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations (MAA)
  • End-to-end operational support
  • Regulatory submission guidance and preparation
  • 510(k) Submissions
  • GLP, GCP
  • Pharmacovigilance
  • Safety Reports
  • CE marking
  • Patient Information Leaflet (PIL) and Summary of Product Characteristics services
  • Regulatory Labeling
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with UK MHRA
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Our Location in United Kingdom

9 Greyfriars Road,
Reading, RG1 1NU, UK