The pharmacovigilance process can bring many challenges in ensuring patients’ personal data is held and transmitted in line with data protection legislation. To support companies and promote consistent practice, the ABPI, the Pharmaceutical Information & Pharmacovigilance Association (PIPA) and pvlegal have collaborated to publish guidance on this topic.

Guidance notes on UK data protection in post-marketing pharmacovigilance

Collection and transmission of personal data by companies is required by law to monitor medicine safety. The guidance, which is intended to be a helpful reference for companies, covers the areas of:

  • receipt of safety data
  • safety data entry and transfers
  • access
  • rectification and objection rights
  • retention and redaction of personal data
  • security and notification.

The aims of the ABPI, PIPA and pvlegal in drafting this document were twofold, to help companies be compliant with their legal obligations for both pharmacovigilance and data protection but also to promote examples of good practice which should lead to better, more consistent protection of patients’ safety data in the UK. 

You can access the full guidance document here.

Esteban Herrero-Martinez
Head of Regulatory Affairs

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