Licence Variation: Spironolactone For Acne In Women

  Address - United Kingdom

  Contact details - 565656565

  Tender notice no. - 76454545

  MT Ref Id - 81564056

  Document Type - Tender Notices

Description - Description: 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 cu rrent 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 In

Mt Ref Id - 81564056

Deadline - May 08, 2025