Licence variation: Spironolactone for acne in women

Descriptions

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. This notice signals the intention to conduct an information gathering exercise only. This notice does not constitute a call for competition in its own right. Publication of this notice and/ or any responses to it does not commit NHS England and/ or respondents to undertaking or participating in any future procurement process, nor does it provide any process exemptions or preferential treatment to any parties expressing an interest. NHS England will not be liable for costs incurrent by any interested party in participating in the information exercise howsoever arising.