Guidance

Reference Medicinal Products (RMPs)

There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications

Great Britain (England, Wales and Scotland): Reference Medicinal Product (RMP)

Reference medicinal products for new generic medicines or other abridged marketing authorisation applications fall within the definition in regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

These regulations include:

  • products that are, or have been, authorised for at least 8 years in the UK (including those authorised by conversion from EU marketing authorisations)
  • products that had an EU marketing authorisation on 1 January 2021 but which did not convert into Great Britain marketing authorisations as the holder opted out of that process.

Data and market exclusivity period entitlements for reference medicinal products approved before 1 January 2021 continue to apply in the UK.

How to check if your authorisation based on ‘European Reference Medicinal Product’ as described in Article 10.1 of Directive 2001/83 (as amended) is valid

Authorisations based on a ‘European Reference Medicinal Product’ that have been granted, and applications that have been submitted to MHRA prior to 1 January 2021, will continue to be valid.

For applications submitted to MHRA from 1 January 2021, The RMP will need to fall within the definition in regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. It is our intention to update these Regulations to reflect the change of implementation dates following the Transition Period.

Non-Great Britain comparator products

Where a comparator product used in bioequivalence and therapeutic equivalence studies is not sourced from the Great Britain market, the applicant should provide evidence that it is representative of the reference medicinal product.

Northern Ireland

The EU medicines legislation will remain applicable in Northern Ireland. Reference medicinal products included in marketing authorisation applications submitted into Northern Ireland should comply with relevant EU legislation.

For Northern Ireland, the definition of a RMP in regulation 48 of the Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 includes UK authorised products and products in relation to which there is an EU marketing authorisation, or in relation to which a Competent Authority of an EEA State has granted a marketing authorisation.

Applicants seeking UK-wide marketing authorisations (Great Britain and Northern Ireland) will be required to comply with requirements applicable in Northern Ireland.

Contact

For further information, please email our Customer Services Centre at RIS.NA@mhra.gov.uk. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020