Standard

Explanatory notes to accompany the RMP list

Published 6 November 2026

1. Scope

Please read these notes before consulting the list.

The list includes the following reference medicinal products (RMPs) first authorised for sale in the UK in the period January 2014 – December 2021:

• New active substances and fixed combinations (other than vaccines, cell-based medicines and plasma derived products) that start a new global marketing authorisation are included. These will have been authorised under Human Medicines Regulations 2012 (HMRs) regulation 50 (full applications) and 55 (combination products) or the EU equivalent at the time of authorisation
• Paediatric Use Medicinal Products (PUMAs).
• Medicinal products currently authorised under HMR regulation 54 (including those which are established medicines)

2. Global marketing authorisation (GMA)

Only the initial authorisations that started the global marketing authorisation are listed; subsequent line extensions within the same GMA are not included, except in the case of orphan medicinal products with more than one orphan market exclusivity period authorised in the time frame covered by the list.

3. Changes of ownership

Changes of ownership (where the MA has been transferred to a new MA holder and the original MA cancelled) are reflected in the list.  Authorisations granted under Regulation 56 (informed consent) which cross refer to an authorisation for a reference medicinal product without cancellation of the original MA are not included.

4. Applications for generic, hybrid and biosimilar medicines

Applications for generic, hybrid and biosimilar medicines (made under HMRs 51B, 52B and 53B respectively) can be submitted one day after expiry of data protection. MHRA may grant them at any time thereafter and they can be marketed one day after expiry of market exclusivity. Refer to note 7 for orphan medicinal products.

5. Start dates for reference products

5.1 For reference medicinal products that are converted EU community authorisations, the start dates for data protection, marketing exclusivity, any extensions awarded prior to 1 January 2021 and their remaining protection periods have been carried over from the EU authorisation.  In those cases, the start date for data and market protection is the date of EC notification of the decision to the marketing authorisation holder. This can be verified in the European Commission Register of Medicinal Products. Refer to section 7 for specific rules on orphan medicinal products.

5.2 For RMPs that have been approved through mutual recognition or decentralised procedures prior 1 January 2021, the start date for data and market protection is the earliest date of grant in an EU member state. 

5.3 For reference products authorised nationally by the MHRA on or after 1 January 2021, the product birth date and start of data and market protection is the UK grant date

6. Extensions to market exclusivity

A 1-year extension to market exclusivity is awarded if, during the first eight years following grant of the initial marketing authorisation, the marketing authorisation holder for the reference medicinal product obtains one or more new therapeutic indications, and during the scientific evaluation prior to their authorisation, the licensing authority considers that the new indication(s) bring a significant clinical benefit in comparison with existing therapies (HMRs regulation 51(B)(7)).  Any such extension will be reflected in the marketing exclusivity date in the list.  The extension can only be awarded once.

Following exit of the UK from the EU, the scope of indications and the award of extensions to market exclusivity for RMPs in the EU may not be the same as in UK.

7. Orphan medicinal products

7.1 In the case of RMPs that are also orphan medicinal products, the rules regarding data protection and market exclusivity run in parallel with orphan rewards which provide orphan market exclusivity

This means that in the UK a generic, hybrid or biosimilar application can be submitted after expiry of the 8-year data protection period, but MHRA cannot grant it until 10 years after authorisation of the reference product as it remains within the  orphan exclusivity period .

7.2 Orphan medicinal products benefit from a further two years of orphan market exclusivity  if they have complied with an agreed paediatric investigation plan, the results of which have been submitted to the MHRA, the compliance statement has been issued prior to the expiry of the initial 10-year period, and the Summary of Product Characteristics updated accordingly. This extension will be reflected by orphan market exclusivity dates in the list.

7.3 If a second or subsequent orphan indication is granted to an orphan medicinal product, the global marketing authorisation may benefit from a further year of market exclusivity if applied for, (refer to note 5) and the new indication may benefit from its own 10-year orphan market exclusivity period.  As the scope of orphan market exclusivity is defined by the authorised therapeutic indication the market exclusivity expiry dates may differ for different indications.

7.4 For more information about market exclusivity of all medicinal products that have been authorised as orphan medicinal products in the UK (including expired orphan designations), the UK Orphan Register must be consulted. The information published in  the list of reference medicinal products should be read in conjunction with the UK orphan registers.

8. Public assessment reports (PARs)

Public Assessment Reports on new indications will confirm whether additional market exclusivity (if applied for) has been awarded.

9. Patent protection

Intellectual property protection afforded by patents or other legislation is distinct from the regulatory protection periods set out in the HMRs and is not captured by the information in the this RMP list.

10. General information

The published information will be updated to include more recently authorised RMPs and extensions to market exclusivity.

10.1 The information is for reference purposes only – it does not extinguish or prejudice the rights of marketing authorisation holders who are lawfully entitled to data protection or marketing exclusivity, the validity of which remains a matter subject only to the applicable legislation.

10.2 New applications and variations are granted daily so the date of latest data update should be noted when referring to the list. Changes to the marketing authorisations or notifications made to the MHRA after that date may not be reflected in the list. 

10.3 The list will be updated periodically to reflect ongoing changes. These links to publicly accessible sources may be useful to verify the reference information published by MHRA. Note that discrepancies can arise when sources are updated at different times.

• MHRA Products
• UK PIPs
• UK Orphan Register
• EC Register of Medicinal Products
• EMA
• MRI Product Index

10.4 MHRA has compiled the information from publicly available records and  its own database. Whilst every reasonable effort has been made to ensure the information is accurate, MA applicants for generic, hybrid or biosimilar applications should conduct their own due diligence to verify data protection periods before submitting their application and marketing a medicinal product.

MA Holders of RMPs should contact MHRA with supporting information if they believe that the published information  requires amendment. Please use this contact address:  RIS.NA@MHRA.gov.uk, and include ‘Data and market protection’ in the email subject line.

11. How to interpret the tabulated information

Column A: Active Substance Name	The name(s) of the active substance(s) to which the marketing authorisation (MA) relates.
Column B: Licensed Product Name (current or as last authorised)	The current or last registered name of the Reference Medicinal Product (RMP).
Column C: Marketing Authorisation Number current (if any)	The current MA number of the RMP. If the RMP has undergone a change of ownership, the current MA number will be shown here. Where there has been a series of changes of ownership, only the originator product and current product details (if any) will be listed. If the MA for the RMP has been cancelled without being transferred to another MA holder, “none” will appear in this column.
Column D: Current Authorisation Holder company (if any)	The name of the current MA holder, if any. “None” will appear if the MA for the RMP has been cancelled, or if it was transferred through a change of ownership and that change of ownership was subsequently cancelled.
Column E: UK Authorisation Status	This relates to the MA in Column C. If there is a current MA, “granted” will appear here. If there is no currently granted MA, “none” will appear.
Column F: Product Date of Birth of RMP applicable in the UK	For products authorised nationally by the MHRA, this will be the UK grant date. For products that are converted community authorisations, this will be the EC Date of Notification as it appears on the EC Register of Medicinal Products. See note 5.
Column G: Expiry date of data protection of the RMP applicable in the UK	The expiry date of data protection for the Reference Medicinal Product applicable in the UK, calculated from the birth date of the RMP.
Column H: Expiry date of market exclusivity period of the RMP applicable in the UK	The expiry date of market exclusivity for the Reference Medicinal Product applicable in the UK, calculated from the birth date of the RMP and including any extension period awarded.
Column I: Market extension awarded Yes/No under regulation 51(B)(7)	“Yes” will appear if an extension to the original marketing exclusivity period has been awarded. “No” appears if not, or if the extension is due to orphan rewards.
Column J: Orphan status – see note 7	“Yes” will appear if the product has been designated as an orphan medicinal product at the time the list was published. The orphan register is not live but is updated regularly, so it should be checked in case protection periods have changed since publication.
Column K: Orphan market exclusivity expiry dates	If the product is an orphan, the orphan market exclusivity expiry date(s) are shown; otherwise, “N/A” will appear. There may be more than one date if multiple indications have been granted at different times.
Column L: Orphan Designation Numbers	If the product is an orphan, the orphan designation number assigned to each separate indication is shown here; otherwise, N/A will appear.
Column M: Product authorisation number (starting the GMA)	The original MA number(s) starting the global marketing authorisation (GMA).
Column N: Authorisation holder (at start of GMA)	The original MA holder of the GMA.
Column O: Legal basis of authorisation (RMP)	The legal basis of the submission of the originator product that started the global marketing authorisation.
Column P: GMA route of approval	The route of application and approval for the application that started the GMA. MA holders of authorisations originally authorised through the EMA centralised route were [offered the opportunity to convert these to UK MAs at the time of UK exit from the EU. See GB marketing authorisations for centrally authorised products