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
Additional information can be obtained from 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
Body governed by public law
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
C283360
two.1.2) Main CPV code
- 85149000 - Pharmacy services
two.1.3) Type of contract
Services
two.1.4) Short description
NHS England has published this Prior Information Notice (PIN) in relation to securing 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.
NHS England would like to gather soft intelligence from the market and is publishing a Request for Information.
The Request for Information and further documentation will be available from 8 May 2024 and the deadline for responses will be 12 noon on 22 May 2024.
To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation 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)
- 33000000 - Medical equipments, pharmaceuticals and personal care products
- 85149000 - Pharmacy services
- 33600000 - Pharmaceutical products
two.2.3) Place of performance
NUTS codes
- UKE - Yorkshire and the Humber
two.2.4) Description of the procurement
NHS England has published this Prior Information Notice (PIN) in relation to securing 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.
NHS England would like to gather soft intelligence from the market and is publishing a Request for Information.
The Request for Information and further documentation will be available from 8 May 2024 and the deadline for responses will be 12 noon on 22 May 2024.
To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation 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.2.14) Additional information
This notice signals the intention to conduct an information gathering exercise only. This notice does not constitute a call for competition in its own right. Publication of this notice and/ or any responses to it does not commit NHS England and/ or respondents to undertaking or participating in any future procurement process, nor does it provide any process exemptions or preferential treatment to any parties expressing an interest. NHS England will not be liable for costs incurrent by any interested party in participating in the information exercise howsoever arising.
two.3) Estimated date of publication of contract notice
15 July 2024
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes