CHAPTER II

Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Section 2

Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders

Record management and data retention
Article 12
1
Marketing authorisation holders 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.
Marketing authorisation holders 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.
Marketing authorisation holders shall establish mechanisms enabling the traceability and follow-up of adverse reaction reports.
2
Marketing authorisation holders shall arrange for the elements referred to in Article 2 to be kept for at least five years after the system as described in the pharmacovigilance system master file has been formally terminated by the marketing authorisation holder.
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 ceased to exist. However, the documents shall be retained for a longer period where Union law or national law so requires.
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)