New EU Approach On Duplicate Marketing Authorizations Prompts Questions

18 Mar 2021

The European Commission says there is no automatic link between the introduction of a duplicate marketing authorization by the holder of the original medicinal product (be it a chemical or a biological medicinal product) and the increased availability of said medicine.

Original and Copy concept. Rubber Stamp on desk in the Office. Business and work background — The number of duplicate marketing authorization requests has been increasing • Source: Shutterstock

The European Commission has changed how it handles applications from originator companies for duplicate marketing authorizations of chemical medicinal products to ensure that these are granted only on an exceptional basis. It already follows this approach for duplicate MAs of biological medicines.

The new approach could prove tricky for companies to comply with, according to the law firm, Arnold & Porter, which...