Planning

Licence variation: spironolactone for acne in women market engagement

NHS ENGLAND

This public procurement record has 1 release in its history.

Planning

26 Feb 2025 at 16:51

Market Engagement Notice
Summary of the contracting process

NHS England has initiated a planning process for the "Licence variation: spironolactone for acne in women market engagement," under the health services industry category. This procurement process, conducted by NHS England located at 7-8 Wellington Street, Leeds, is in the planning stage. The key date to note is the deadline for responses, which is 14 March 2025 at 12 noon. The market engagement started on 26 February 2025, and potential suppliers can register their interest and obtain a Request for Information (RFI) documentation through the Atamis portal. This initiative includes two contracts, one for preparing a major MHRA Marketing Authorisation variation for spironolactone and another for submitting the application to the MHRA.

This tender presents an excellent opportunity for businesses in the health services and project management consultancy sectors to engage with NHS England in a substantial project aimed at enhancing treatment options for acne in women. Companies specializing in regulatory submissions, risk management, and clinical documentation would find this tender particularly suitable. Small and medium-sized enterprises (SMEs) are encouraged to participate, given the suitability criteria outlined in the procurement notice. This initiative provides a platform for companies to collaborate closely with NHS England, potentially leading to a long-term partnership and the chance to contribute to significant advancements in women's health.

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Notice Information

Notice Title

Licence variation: spironolactone for acne in women market engagement

Notice 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 Information for the two contracts. NHS England would also be pleased to offer 1:1 meetings with potential Suppliers to discuss this innovative partnership approach. The Request for Information and further documentation will be available from 26 February 2025 and the deadline for responses will be 14 March 2025 at 12 noon and 1:1 meetings will be 12 noon on 11 March 2025. To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation please go to: http://health.atamis.co.uk. All communications and Request for Information submissions will be conducted via Atamis. The portal can be accessed at any time of the day and it is free to register. This notice signals the intention to conduct an information gathering exercise only. This notice does not constitute a call for competition in its own right. Publication of this notice and/ or any responses to it does not commit NHS England and/or respondents to undertaking or participating in any future procurement process, nor does it provide any process exemptions or preferential treatment to any parties expressing an interest. NHS England will not be liable for costs incurrent by any interested party in participating in the information exercise howsoever arising.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/d1d7397f-10cc-485d-accd-931a59f3bdb2
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
Market Engagement Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
SME
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

72 - IT services: consulting, software development, Internet and support

85 - Health and social work services

CPV Codes

72224000 - Project management consultancy services

85100000 - Health services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
26 Feb 202512 months ago
Submission Deadline
Not specified
Future Notice Date
14 Mar 2025Expired
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Planning
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
NHS ENGLAND
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
LEEDS
Postcode
LS1 4AP
Post Town
Leeds
Country
England
Major Region (ITL 1)
TLE Yorkshire and The Humber
Basic Region (ITL 2)
TLE4 West Yorkshire
Small Region (ITL 3)
TLE42 Leeds
Delivery Location
TLC North East (England), TLD North West (England), TLF East Midlands (England), TLG West Midlands (England), TLH East (England), TLJ South East (England), TLK South West (England)
Local Authority
Leeds
Electoral Ward
Hunslet & Riverside
Westminster Constituency
Leeds South

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts. 

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