Position paper 22 November 2016

Handling of Post-approval Changes to Marketing Authorizations


Following the initial launch and throughout a drug product’s commercial life, changes that might impact the product’s quality and safety profile will inevitably occur.

These changes may include modifications to raw materials, analytical methods, suppliers, manufacturing equipment, processes and sites and are a consequence of continual improvement, implementation of innovative technologies, efficiencies of production or increases in scale to improve the availability of drug products for patients.

Variations, also known as post approval changes, are necessary in order to comply with evolving regulatory requirements. After receiving market approval, drug products are used in a wider population that brings further knowledge to its safety profile. It is important that such information is reflected in the product labelling in a timely manner for the benefit and safety of patients and healthcare professionals. Thus post approval changes to the originally approved dossier are an essential part of a product’s lifecycle. Therefore, it is important that new product knowledge is managed in a structured and planned way to enable continual improvement, to encourage innovation, state of control, and to ensure uninterrupted product availability for patients.