Product license maintenance overview

Following approval, MAHs must ensure that Product Licence maintenance measures are implemented to ensure that the licence granted to the manufacturer or authorisation holder is maintained; this is critical in continuing to sell and distribute approved products.

In the EU/UK the licence is in the form of a Marketing Authorisation (MA), in the USA this is a Product Licence (PL). The MA 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 manufacturer is continuing to make and sell innovator products, outsourcing manufacture to other sites or third parties, supplying generic formulations, or marketing a wholly outsourced product, it is the responsibility of the MA holder to ensure and maintain product compliance and conformance to assure patient safety at all times.

Regulatory agency intervention in the form of audits and granting variations should be a formality, rather than a challenge, as MA/PL holders should have robust systems in place to self-manage these activities.

Requirements to undertake upon certification

Activities that a Product Licence/Marketing Authorisation maintenance holder is legally required to undertake once certificate is granted include (but is not limited to) the following:

  • Regulatory impact assessment of change controls
  • Licence maintenance through the submission of variations, supplements and renewals
  • Regulatory compliance and conformance management to avoid registration drift
  • Maintenance of a self-audit programme
  • Post marketing surveillance, including pharmacovigilance (PV and QPPV) and the submission of Periodic Safety
  • Update Reports (PSURs)
  • Maintenance of post-approval and regulatory commitments