Section one: Contracting authority
one.1) Name and addresses
NHS England
Quarry House
Leeds
LS2 7UE
Contact
Liz Fleetwood
Country
United Kingdom
NUTS code
UKE - Yorkshire and the Humber
Internet address(es)
Main address
Buyer's address
one.3) Communication
Additional information can be obtained from the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Prior Information Notice - Licence Variation for Anastrozole
two.1.2) Main CPV code
- 33600000 - Pharmaceutical products
two.1.3) Type of contract
Supplies
two.1.4) Short description
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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 33600000 - Pharmaceutical products
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKE - Yorkshire and the Humber
two.2.4) Description of the procurement
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
two.3) Estimated date of publication of contract notice
1 October 2021
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes