Article 18: General requirements

1.   The Agency and national competent authorities shall cooperate in the monitoring of the data available in the Eudravigilance database.

2.   Marketing authorisation holders shall monitor the data available in the Eudravigilance database to the extent that they have access to that database.

3.   Marketing authorisation holders, the national competent authorities and the Agency shall ensure the continuous monitoring of the Eudravigilance database with a frequency proportionate to the identified risk, the potential risks and the need for additional information.

4.   The competent authority of each Member State shall be responsible for monitoring the data originating in the territory of that Member State.