I.B.10. Record management

Location:
I.B.

The organisation shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow accurate reporting, interpretation and verification of that information [IR Art 12(1), Art 16(1)].

A record management system shall be put in place for all documents used for pharmacovigilance activities, ensuring their retrievability as well as 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 [IR Art 12(1), Art 16(1)].

The record management system should support:

  • the management of the quality of pharmacovigilance data, including their completeness, accuracy and integrity;
  • timely access to all records;
  • effective internal and external communication; and
  • the retention of documents relating to the pharmacovigilance systems and the conduct of pharmacovigilance for individual medicinal products, in accordance with the applicable retention periods.

In addition, marketing authorisation holders shall establish mechanisms enabling the traceability and follow-up of adverse reaction reports [IR Art 12(1)].

In this context, it should be ensured that the fundamental right to personal data protection is fully and effectively guaranteed in all pharmacovigilance activities in conformity with legal provisions. The purpose of safeguarding public health constitutes a substantial public interest and consequently the processing of personal data should be justified if identifiable personal data are processed only where necessary and only where the parties involved assess this necessity at every stage of the pharmacovigilance process (IR Recital 17). As part of a record management system, specific measures should therefore be taken at each stage in the storage and processing of pharmacovigilance data to ensure data security and confidentiality. This should involve strict limitation of access to documents and to databases to authorised personnel respecting the medical and administrative confidentiality of the data.

There should be appropriate structures and processes in place to ensure that pharmacovigilance data and records are protected from destruction during the applicable record retention period.

The record management system should be described in a record management policy.