Opportunity

Licensing Spironolatone for Acne in Women

  • NHS England

F02: Contract notice

Notice reference: 2024/S 000-028524

Published 5 September 2024, 7:21pm



Section one: Contracting authority

one.1) Name and addresses

NHS England

7-8 Wellington Place

Leeds

LS1 4AP

Contact

Leigh Parker

Email

leigh.parker1@nhs.net

Country

United Kingdom

NUTS code

UK - United Kingdom

Internet address(es)

Main address

https://www.england.nhs.uk/

Buyer's address

https://www.england.nhs.uk/

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

Licensing Spironolatone 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 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.1.5) Estimated total value

Value excluding VAT: £171,500

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 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.

This will be procured through an open tender using PCR 2015 regs.

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: £171,500

two.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Start date

2 December 2024

End date

30 September 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

7 October 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

5 September 2024

Local time

4:00pm


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

Internet address

https://www.judiciary.uk/courts-and-tribunals/high-court/