Prior Information Notice - Licence Variation for Anastrozole

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NHS England and NHS Improvement (NHSEI) has published this Prior Information Notice (PIN) in relation to regulatory work to secure a licence variation for Anastrozole. The PIN seeks to gather information and feedback from pharmaceutical manufacturers of anastrozole, to inform NHSEI’s strategy to contract for this regulatory work. Lot 1: The Medicines Repurposing Programme has been established by NHS England and NHS Improvement (NHSE/I, the “Authority”) to identify and pursue opportunities to strengthen the evidence base, licensing, supply, cost-effectiveness and equitable adoption of medicines used outside of their original marketing authorisation. The Programme is jointly sponsored by NHSE/I, the Department of Health and Social Care (DHSC), Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), and National Institute for Health Research (NIHR). Further details can be found at: https://www.england.nhs.uk/medicines-2/medicines-repurposing-programme/  The Medicines Repurposing Programme is inviting those interested organisations to express an interest to seek a major (type II) MHRA Marketing Authorisation variation for anastrozole. The variation is to add a new indication to the current licence using published evidence. The selected company (the “Bidder”) would need to prepare a dossier for the MHRA, 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, according to the regulatory review. Interested organisations can access the PIN and register their interest here https://health-family.force.com/s/Welcome  We will also be making time available for individual organisation discussions with NHSEI between 13th and 24th September 2021 should this be considered helpful. Once registered, please contact liz.fleetwood1@nhs.net with your availability. Deadline is 24th September @ 12:00noon