Licence variation: spironolactone for acne in women market engagement
Reference ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae · NHS England
Prior notice.
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Description
NHS England has published this Preliminary Market Engagement Notice. It is anticipated that there will be two separate contracts to deliver this, as outlined below. • Contract A: Prepare an application for a major (type II) MHRA Marketing Authorisation variation for spironolactone. • Contract B: Submit the pre-prepared application to the MHRA. Only current Marketing Authorisation Holders of spironolactone are eligible to bid for contract B. The licence variation is to add a new indication to the current licence (marketing authorisation) for spironolactone, for treating acne in women. For contract A, the Successful Supplier would need to prepare a dossier for the MHRA including: • A Risk Management Plan • Clinical Overview • Revised Summary of Product Characteristics and Patient Information Leaflet • Responses to the MHRA's Request(s) for Further Information. For contract B, the Successful Supplier would need to: • Review the draft regulatory modules and supporting documents prepared by contractor A and either confirm they are complete, or request revisions. • Use the final regulatory modules and supporting documents to apply for a major type II licence variat…
Official publications
| Medium | Reference | Date |
|---|---|---|
| FTS | d1d7397f-10cc-485d-accd-931a59f3bdb2-830696 | 26 February 2025 |
| Contracts Finder | d1d7397f-10cc-485d-accd-931a59f3bdb2-830696 | 26 February 2025 |
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