Licence Variation: Spironolactone for acne in women

Concepts

• health services
• leeds
• women
• mhra marketing authorisation variation
• acne
• spironolactone
• the licence variation
• the current licence
• variation
• licence

Location

Leeds

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.

CPV Codes

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

Indicators

• Bids should cover the whole contract.
• Renewals are not available.
• Financial restrictions apply.
• Professional qualifications are sought.
• Award on basis of price and quality.