Section one: Contracting authority
one.1) Name and addresses
NHS England
7&8 Wellington Place
Leeds
LS1 4AP
Contact
Leigh Parker
Country
United Kingdom
Region code
UKE - Yorkshire and the Humber
Internet address(es)
Main address
Buyer's address
one.4) Type of the contracting authority
Ministry or any other national or federal authority
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Licence variation: spironolactone for acne in women
Reference number
C301713
two.1.2) Main CPV code
- 85100000 - Health services
two.1.3) Type of contract
Services
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 85149000 - Pharmacy services
two.2.3) Place of performance
NUTS codes
- UKE - Yorkshire and the Humber
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Quality criterion - Name: Quality / Weighting: 60
Quality criterion - Name: Social Value / Weighting: 10
Cost criterion - Name: Price / Weighting: 30
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.1) Previous publication concerning this procedure
Notice number: 2024/S 000-031592
Section five. Award of contract
A contract/lot is awarded: No
five.1) Information on non-award
The contract/lot is not awarded
No tenders or requests to participate were received or all were rejected
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
The High Court
The Strand
London
WC2A 2LL
Country
United Kingdom
Internet address
https://www.judiciary.uk/courts-and-tribunals/high-court/
six.4.4) Service from which information about the review procedure may be obtained
The High Court
The Strand
London
WC2A 2LL
Country
United Kingdom