Licence variation: Spironolactone for acne in women

NHS England has published this Prior Information Notice (PIN) in relation to securing 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.

NHS England would like to gather soft intelligence from the market and is publishing a Request for Information.

The Request for Information and further documentation will be available from 8 May 2024 and the deadline for responses will be 12 noon on 22 May 2024.

To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation 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.