Periods of Data and Market Exclusivity for UK Reference Medicinal Products
UK reference medicinal products authorised in the period 2014 – 2021 and their associated dates of expiry of data protection, marketing exclusivity.
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Medicines marketed in the UK are governed by the Human Medicines Regulations 2012 (HMRs).
The HMRs provide for the concept of a reference medicinal product (RMP); this is a medicinal product which has been granted a UK marketing authorisation under regulation 49(1)(a) in accordance with the provisions of regulation 50 (“the initial marketing authorisation”). Any additional strengths, pharmaceutical forms, administration routes, presentations, variations and extensions in relation to which a UK marketing authorisation is granted under that regulation or which are included in the initial UK marketing authorisation, belong to the same “global marketing authorisation” (GMA).
Reference medicinal products can be referred to in applications submitted for generic, biosimilar or hybrid products, but the regulations provide for periods of intellectual property protection for these products in terms of data protection and marketing exclusivity. The initial data protection period is 8 years from authorisation of the RMP and the marketing exclusivity period is a further 2 years.
In addition, there are specific rules that apply to orphan medicinal products.
For more detail, refer to our guidance on types of application.
See our guidance on orphan medicinal products.
The initial publication includes products which started a Global Marketing Authorisation in the period from 1 January 2014 until 31 December 2021. The list will be extended in due course and periodically updated to reflect updated information.
Please read the explanatory notes before referring to the list. For queries about this page please e-mail RIS.NA@MHRA.gov.uk, and include ‘Data and market protection’ in the email subject line.