Renewals and variation applications

After a marketing authorisation has been granted, the holder of a marketing authorisation or registration is obliged to actively maintain the marketing authorisation or registration.

The holder of a marketing authorisation for a medicinal product or traditional herbal medicinal product must notify the authority of all changes that will affect the marketing authorisation documentation of the product. Changes are reported using variation applications ((hum & vet) (Application form for variation to a marketing authorisation).

Marketing authorisations and registrations must be renewed within five years of the granting of the marketing authorisation. Renewal is applied for with the renewal application ((hum & vet) (Application form for renewal of a marketing authorisation).