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MHRA publishes list of UK reference medicines with data and market exclusivity expiry dates

🇬🇧 MHRA · Fri 06 Nov 2026

The regulator's new standard covers products whose global marketing authorisations began between 2014 and 2021, with an explanatory note and a downloadable CSV file.

The Medicines and Healthcare products Regulatory Agency (MHRA) published on 6 November 2026 a standard setting out periods of data and market exclusivity for UK reference medicinal products. It lists products that started a global marketing authorisation between 1 January 2014 and 31 December 2021, with the dates on which data protection and marketing exclusivity expire.

Under the Human Medicines Regulations 2012, a reference medicinal product is one granted a UK marketing authorisation under regulation 49(1)(a), in line with regulation 50. Additional strengths, pharmaceutical forms, routes of administration, presentations, variations and extensions granted under that regulation, or included in the initial authorisation, belong to the same global marketing authorisation.

Reference products can be cited in applications for generic, biosimilar or hybrid medicines, but the rules provide for protection periods. The initial data protection period is eight years from authorisation of the reference product, followed by a further two years of marketing exclusivity. Separate, specific rules apply to orphan medicinal products, and the MHRA points readers to its guidance on types of application and on orphan medicines.

The list is available as a CSV file of 330 KB, with HTML explanatory notes that the agency asks users to read before consulting the data. The MHRA says the initial publication will be extended in due course and updated periodically to reflect new information. Queries can be sent to the agency's RIS.NA mailbox with 'Data and market protection' in the subject line.

What it means for your team

  • Generic, biosimilar and hybrid developers can check the published dates when planning UK applications and launch timing, after reading the explanatory notes.
  • Marketing authorisation holders of reference products from 2014 to 2021 should verify that their entries are correct and contact the MHRA about any queries.
  • Products authorised outside the 2014–2021 window are not yet covered, so teams should not assume the list is complete. The MHRA says it will be extended and updated.
  • Orphan products follow specific rules, so teams should consult the MHRA's orphan guidance alongside the list.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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