Product Licence Maintenance
Product Licence Maintenance involves ensuring the licence granted to the manufacturer or authorisation holder is maintained, so they can continue to sell and distribute the approved product. In the UK the licence is in the form of a Marketing Authorisation Application (MAA), in the USA this is a Product Licence (PL). The MAA and PL are both legal documents that MUST be maintained throughout the product’s marketing lifetime; this is the responsibility of the MA or PL holder.
Whether a company is continuing to manufacture and sell innovator products, outsource manufacture to various sites or third parties, supply generic formulations, or market a wholly outsourced product, it is the responsibility of the MA holder to maintain compliance and conformance of the product and all processes to assure patient safety at all times. Regulatory agency intervention in the form of audits and granting variations should be a formality, rather than being feared, as MA / PL holders should have robust systems in place to self-manage these activities.
Post Product Licence and Marketing Authorisation Maintenance activities that a holder is legally required to undertake include:-
• Regulatory Impact Assessment of Change Controls
• Licence Maintenance through the submission of Variations, Supplements and Renewals
• Regulatory Compliance and management Conformance to avoid Registration Drift
• Maintenance of a Self-Audit programme
• Post Marketing Surveillance, including Pharmacovigilance and the submission of Periodic Safety Update Reports (PSURs)
• Maintenance of Post-Approval and Regulatory Commitments
How Woodley BioReg can help with Product Licence Maintenance
Woodley BioReg works with clients to ensure their Product Maintenance occurs seamlessly. We help companies develop and implement schemes to attain excellence in all aspects of regulatory requirements, compliance and conformance. We provide full service support in all aspects of licence maintenance from identifying areas of concern and risk, through to developing and implementing bespoke, sustainable solutions. Our Flexible Resourcing Solutions play a welcome part in ensuring client objectives and deliverables are not compromised.
For more information on Product Licence Maintenance please contact us.