RegulatoryGuideline · final

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

🇬🇧 MHRA · Fri 06 Nov 2026

The regulator's first list covers products whose global marketing authorisations began between 2014 and 2021, with further additions and periodic updates promised.

The Medicines and Healthcare products Regulatory Agency (MHRA) published on 6 November 2026 a list of UK reference medicinal products (RMPs), showing when data protection and marketing exclusivity expire for each. The list is available as a CSV file of about 330 KB, alongside explanatory notes that the agency asks users to read before consulting it.

The initial publication covers products whose global marketing authorisation (GMA) started between 1 January 2014 and 31 December 2021. The MHRA says the list will be extended in due course and updated periodically to reflect new information.

Under the Human Medicines Regulations 2012, an RMP is a product granted a UK marketing authorisation under regulation 49(1)(a), in accordance with regulation 50. Additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions belong to the same GMA as the initial authorisation.

RMPs can be cited in applications for generic, biosimilar or hybrid products, but the regulations provide intellectual property protection in the form of data protection and marketing exclusivity. The initial data protection period is eight years from authorisation of the RMP, followed by a further two years of marketing exclusivity. Specific rules apply to orphan medicinal products, and the agency points readers to its guidance on types of application and on orphan medicines.

Queries can be sent to RIS.NA@MHRA.gov.uk with 'Data and market protection' in the subject line.

What it means for your team

  • Generic, biosimilar and hybrid developers can use the list to check expiry dates for RMPs authorised in 2014-2021, but should read the explanatory notes first.
  • Originator companies may wish to compare the published dates with their own records and raise any queries with the MHRA through the dedicated mailbox.
  • The list is not yet complete: products with a GMA starting outside 2014-2021 are not covered, and the MHRA plans extensions and periodic updates, so teams should monitor the page.
  • Orphan products are subject to specific rules, so teams should consult the MHRA's orphan guidance as well.

Official guideline text: MHRA ↗

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

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