Section one: Contracting authority/entity
one.1) Name and addresses
NHS England
1st Floor, Quarry House, Quarry Hill
Leeds
LS2 7UE
Contact
Leigh Parker
england.commercialqueries@nhs.net
Country
United Kingdom
NUTS code
UKE - Yorkshire and the Humber
Internet address(es)
Main address
Buyer's address
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Licence Variation: Spironolactone for acne in women
Reference number
C290475
two.1.2) Main CPV code
- 85100000 - Health services
two.1.3) Type of contract
Services
two.1.4) Short description
NHS England requires a supplier to apply for a major (type II) MHRA Marketing Authorisation variation for spironolactone. The variation is to add a new indication to the current licence (marketing authorisation) for treating acne in women. The Successful Supplier would need to prepare a dossier for the MHRA including a Risk Management Plan, apply for the licence variation, and if granted update their licence, Summary of Product Characteristics and patient information leaflet with the new indication and related data.
To register an interest in responding to this opportunity and obtain a copy of the tender documents please go to: http://health.atamis.co.uk. All communications and Request for Information submissions will be conducted via Atamis. The portal can be accessed at any time of the day and it is free to register.
Section six. Complementary information
six.6) Original notice reference
Notice number: 2024/S 000-018965
Section seven. Changes
seven.1.2) Text to be corrected in the original notice
Section number
II.2.7.4
Instead of
Date
30 June 2026
Read
Date
30 September 2026