Checklist: renewing and maintaining the marketing authorisation of a medicinal product

When a medicinal product has been granted a marketing authorisation, the marketing authorisation must be maintained throughout the life cycle of the medicine. This ensures the efficacy, safety and quality of the medicine. We compiled a checklist for you of the most important things to remember.

Renewing a marketing authorisation:

• The marketing authorisation and registration are valid for five years, after which they must be renewed.
• All marketing authorisations and registrations must be renewed at least once in accordance with the medicines directive and the veterinary medicines directive. After this, marketing authorisations and registrations are usually valid indefinitely.

Maintaining a marketing authorisation:

• After a marketing authorisation is granted, the marketing authorisation must be maintained and the marketing authorisation holder must monitor the technological and scientific development of the product.
• All changes which affect the marketing authorisation documentation must be reported to the authorities.
• The classification of the variation is affected by the effect that the changes have on the quality, efficacy and safety of the medicine.

If you need help with the renewal or maintenance of marketing authorisations, please contact Laura Riihimäki-Lampén. You can also learn more about our comprehensive range of regulatory services here.