Tender Details

Country: United Kingdom
Summary: Licence Variation: Spironolactone for Acne in Women Market Engagement
GBT Ref No: 115420047
Deadline: 14 Mar 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: CF-2900000D0O000000rwimUAA
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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:

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Licence Variation: Spironolactone for Acne in Women Market Engagement - Greatbritain Tender

The NHS ENGLAND, a Government sector organization in United Kingdom, has announced a new tender for Licence Variation: Spironolactone for Acne in Women Market Engagement. This tender is published on GreatbritainTenders under GBT Ref No: 115420047 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-03-14.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.