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发布时间 | 所属地区 | 所属机构 | 语言 |
---|---|---|---|
2024年05月10日 | -- | -- | 英语 (English) 中文 |
Published date: 8 May 2024
Last edited date: 8 May 2024
Open early engagement - This means that a procurement idea is currently active, it is in the early stage of development and judging interest from potential suppliers.
Medical equipments, pharmaceuticals and personal care products - 33000000
Health services - 85100000
Pharmacy services - 85149000
LS2 7EU
CF-2355600D0O000000rwimUAA
8 May 2024
22 May 2024
Service contract
Yes
No
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.
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.
Licence variation: Spironolactone for acne in women
Follow the instructions given in the description or the more information section.
Leigh Parker
NHS England, Leeds
Leeds
LS2 7EU
United Kingdom
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