Section one: Contracting authority
one.1) Name and addresses
NHS England
7-8 Wellington Place
Leeds
LS1 4AP
Contact
Leigh Parker
england.commercialqueries@nhs.net
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
Buyer's address
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://health-family.force.com/s/Welcome
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted electronically via
https://health-family.force.com/s/Welcome
Tenders or requests to participate must be submitted to the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
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
C290475
two.1.2) Main CPV code
- 85100000 - Health services
two.1.3) Type of contract
Services
two.1.4) Short description
NHS England requires 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.
To register an interest in responding to this opportunity and obtain a copy of the tender documents 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 85100000 - Health services
- 85149000 - Pharmacy services
- 33000000 - Medical equipments, pharmaceuticals and personal care products
two.2.3) Place of performance
NUTS codes
- UKE - Yorkshire and the Humber
two.2.4) Description of the procurement
NHS England requires 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.
To register an interest in responding to this opportunity and obtain a copy of the tender documents 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.
two.2.5) Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
two.2.6) Estimated value
Value excluding VAT: £1
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Start date
15 October 2024
End date
30 June 2026
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
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 three. Legal, economic, financial and technical information
three.1) Conditions for participation
three.1.2) Economic and financial standing
List and brief description of selection criteria
Selection criteria as stated in the procurement documents.
Minimum level(s) of standards possibly required
Selection criteria as stated in the procurement documents.
three.1.3) Technical and professional ability
List and brief description of selection criteria
Selection criteria as stated in the procurement documents.
Minimum level(s) of standards possibly required
Selection criteria as stated in the procurement documents.
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 000-014716
four.2.2) Time limit for receipt of tenders or requests to participate
Date
31 July 2024
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.6) Minimum time frame during which the tenderer must maintain the tender
Duration in months: 6 (from the date stated for receipt of tender)
four.2.7) Conditions for opening of tenders
Date
19 June 2024
Local time
2:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.4) Procedures for review
six.4.1) Review body
The High Court
The Strand
London
WC2A 2LL
Country
United Kingdom