Europe – European Commission tightens requirements for duplicate MAAs

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after launching a targeted consultation on the practice.

While the notice still foresees an increase in the number of requests for duplicate MAAs, the Commission has closed off the ability of companies to request duplicate MAAs solely to introduce a first generic to their own product.

Typically, the Commission may only grant one authorization to an applicant for a specific medicinal product. However, exceptions to this rule are made in Article 82(1) of Regulation (EC) No 726/2004, which allows the commission to issue duplicate MAAs, “when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons.”…