--- title: "Licence variation: spironolactone for acne in women" ocid: "ocds-h6vhtk-045808" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-045808" markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-045808.md" json_url: "https://d3tenders.com/contract/ocds-h6vhtk-045808.json" source: "Find A Tender Service" current_stage: "Award" buyer: "NHS ENGLAND" published: "2025-01-17" --- # Licence variation: spironolactone for acne in women Buyer: NHS ENGLAND Current stage: Award OCID: ocds-h6vhtk-045808 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-h6vhtk-045808) [Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-045808.json) ## Summary NHS England is seeking a supplier to apply for a major (type II) MHRA Marketing Authorisation variation for spironolactone, with the goal of adding a new indication for the treatment of acne in women. This procurement, categorised under Health Services (CPV Code: 85100000), is at the tender stage and is being executed through an open procedure. The successful supplier will be responsible for the preparation and submission of a comprehensive dossier to the MHRA, including a Risk Management Plan, and if approved, the consequent update of relevant patient and product information. The procurement, based in the UKE region, was announced on 2nd September 2024, with tender submissions due by 7th October 2024, and the contract expected to run from 2nd December 2024 to 30th September 2026. Key contact for this procurement is Leigh Parker at NHS England, Leeds. This tender presents a substantial opportunity for businesses specialising in pharmaceutical services, particularly those with expertise in obtaining regulatory approvals and authorisation variations. The open procedure allows various suppliers to compete, especially those equipped to handle detailed MHRA submissions. It is an excellent opportunity for businesses in the healthcare and pharmaceutical sectors to expand their portfolio and work with NHS England, a major national health authority. Suppliers with proven quality and compliance standards in pharmaceutical and health services would be well-suited to participate and potentially grow their business through this contract. ## Notice NHS England required a supplier to apply for a major (type II) MHRA Marketing Authorisation variation for spironolactone. The variation is to add a new indication to the current licence (marketing authorisation) for treating acne in women. The Successful Supplier would need to prepare a dossier for the MHRA including a Risk Management Plan, 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. ### Lot Information Lot 1 NHS England required a supplier to apply for a major (type II) MHRA Marketing Authorisation variation for spironolactone. The variation is to add a new indication to the current licence (marketing authorisation) for treating acne in women. The Successful Supplier would need to prepare a dossier for the MHRA including a Risk Management Plan, 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. ## Key Details | Field | Value | | --- | --- | | Publication source | Find A Tender Service | | Latest notice | https://www.find-tender.service.gov.uk/Notice/001753-2025 | | Notice type | Planning Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Open | | Procurement method details | Open procedure | | Tender suitability | Not specified | | Awardee scale | Not specified | | All stages | Planning, Tender, Award | ## Dates | Field | Value | | --- | --- | | Publication date | 17 Jan 2025 | | Submission deadline | 7 Oct 2024 | | Future notice date | 14 Jul 2024 | | Award date | 17 Jan 2025 | | Contract period | 2 Dec 2024 - 30 Sep 2026 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £171,500 | | Lots value | £171,500 | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Unsuccessful | | Lots status | Cancelled | | Awards status | Unsuccessful | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | NHS ENGLAND | | Locality | LEEDS | | Post town | Leeds | | Postcode | LS1 4AP | | Country | England | | ITL 1 | TLE Yorkshire and The Humber | | ITL 2 | TLE4 West Yorkshire | | ITL 3 | TLE42 Leeds | | Local authority | Leeds | | Electoral ward | Hunslet & Riverside | | Westminster constituency | Leeds South | | Delivery location | TLE Yorkshire and The Humber | ## CPV Codes ### Divisions - 85 - Health and social work services ### Codes - 85100000 - Health services - 85149000 - Pharmacy services ## Release History - 17 Jan 2025 at 15:30 - Award - Award Notice - https://www.find-tender.service.gov.uk/Notice/001753-2025 - 2 Oct 2024 at 15:31 - TenderUpdate - Tender Notice - https://www.find-tender.service.gov.uk/Notice/031592-2024 - 5 Sep 2024 at 18:21 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/028524-2024 - 2 Jul 2024 at 16:16 - TenderUpdate - Tender Notice - https://www.find-tender.service.gov.uk/Notice/020184-2024 - 19 Jun 2024 at 15:45 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/018965-2024 - 8 May 2024 at 14:33 - Planning - Planning Notice - https://www.find-tender.service.gov.uk/Notice/014716-2024 ## Notice URLs - https://health-family.force.com/s/Welcome - https://www.england.nhs.uk/ - https://www.england.nhs.uk// - https://www.judiciary.uk/courts-and-tribunals/high-court/ ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-h6vhtk-045808. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-045808.json.