Licence variation: spironolactone for acne in women

Concepts

• medical equipment and pharmaceuticals
• leeds
• women
• mhra marketing authorisation variation
• acne
• licence variation
• spironolactone
• the current licence
• the variation
• licence

Location

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.

CPV Codes

• 33000000 - Medical equipments, pharmaceuticals and personal care products
• 85100000 - Health services
• 85149000 - Pharmacy services

Indicators

• Contract is suitable for SMEs.

Other Information

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. To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome. Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk