Notifying a change of marketing status and sunset clause (veterinary medicines)

Marketing authorisation holders for veterinary medicines are required to notify the European Medicines Agency (EMA)  without delay of any action they intend to take to remove a centrally authorised veterinary medicinal product from the market.

Marketing authorisation holders must inform EMA before taking any such action, including the reason for doing so, via Service Now by selecting Veterinary Regulatory > Pre-Submission-Vets.

The legal basis for this obligation is Article 58(13) of Regulation (EU) 2019/6.

From the entry into force of the Veterinary Medicinal Products Regulation on 28 January 2022, the sunset clause does not apply to veterinary medicines. Marketing authorisation holder do not need to submit yearly marketing status updates on their centrally authorised products after this date.

The sunset clause under Regulation (EU) 726/2004 states that the marketing authorisation of a medicine ceases to be valid if it is not placed on the market within three years of authorisation or is removed from the market for three consecutive years.