Award

Licence variation: spironolactone for acne in women

NHS ENGLAND

This public procurement record has 6 releases in its history.

Award

17 Jan 2025 at 15:30

TenderUpdate

02 Oct 2024 at 15:31

Tender

05 Sep 2024 at 18:21

TenderUpdate

02 Jul 2024 at 16:16

Tender

19 Jun 2024 at 15:45

Planning

08 May 2024 at 14:33

Summary of the contracting process

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.

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Notice Title

Licence variation: spironolactone for acne in women

Notice Description

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.

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-045808
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/001753-2025
Current Stage
Award
All Stages
Planning, Tender, Award

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

85 - Health and social work services


CPV Codes

85100000 - Health services

85149000 - Pharmacy services

Notice Value(s)

Tender Value
£171,500 £100K-£500K
Lots Value
£171,500 £100K-£500K
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
17 Jan 20251 years ago
Submission Deadline
7 Oct 2024Expired
Future Notice Date
14 Jul 2024Expired
Award Date
17 Jan 20251 years ago
Contract Period
2 Dec 2024 - 30 Sep 2026 1-2 years
Recurrence
Not specified

Notice Status

Tender Status
Unsuccessful
Lots Status
Cancelled
Awards Status
Unsuccessful
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
NHS ENGLAND
Contact Name
Leigh Parker
Contact Email
england.commercialqueries@nhs.net, leigh.parker1@nhs.net
Contact Phone
Not specified

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
TLE Yorkshire and The Humber

Local Authority
Leeds
Electoral Ward
Hunslet & Riverside
Westminster Constituency
Leeds South

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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