Article 16: Record management and data retention

1.   The national competent authorities and the Agency shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.

They shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.

2.   The national competent authorities and the Agency shall arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years after the system has been formally terminated.

Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has expired. However, the documents shall be retained for a longer period where Union law or national law so requires.