Section one: Contracting authority/entity
one.1) Name and addresses
NHS England
7-8 Wellington Place
Leeds
LS1 4AP
Contact
Leigh Parker
Country
United Kingdom
Region code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Licensing Spironolactone for Acne in Women
Reference number
C301713
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 000-028524
Section seven. Changes
seven.1.2) Text to be corrected in the original notice
Section number
II.1.1.1
Instead of
Text
Licensing Spironolatone for Acne in Women
Read
Text
Licensing Spironolactone for Acne in Women