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Tender Details
- Country: United Kingdom
- Summary: Licence Variation: Spironolactone for Acne in Women Market Engagement
- GBT Ref No: 115420047
- Deadline: 14 Mar 2025
- Competition: ICB
- Financier: Self Financed
- Purchaser Ownership: Public
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: CF-2900000D0O000000rwimUAA
- Purchaser's Detail :
- Description :
- NHS England has published this Preliminary Market Engagement Notice. It is anticipated that there will be two separate contracts to deliver this, as outlined below.
• Contract A: Prepare an application for a major (type II) MHRA Marketing Authorisation variation for spironolactone.
• Contract B: Submit the pre-prepared application to the MHRA. Only current Marketing Authorisation Holders of spironolactone are eligible to bid for contract B.
The licence variation is to add a new indication to the current licence (marketing authorisation) for spironolactone, for treating acne in women.
For contract A, the Successful Supplier would need to prepare a dossier for the MHRA including:
• A Risk Management Plan
• Clinical Overview
• Revised Summary of Product Characteristics and Patient Information Leaflet
• Responses to the MHRA's Request(s) for Further Information.
For contract B, the Successful Supplier would need to:
• Review the draft regulatory modules and supporting documents prepared by contractor A and either confirm they are complete, or request revisions.
• Use the final regulatory modules and supporting documents to apply for a major type II licence variation from the MHRA.
• If granted, update the 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 Informat... - Documents :
Purchaser : NHS ENGLAND
7-8 Wellington Street Leeds LS1 4AP GB
Contact Person : Leigh Parker
Email :leigh.parker1@nhs.net
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