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Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

A market authorisation holder must operate a pharmacovigilance system to:

  • monitor medicinal product safety;
  • assess the possibilities for mitigating risks; and
  • take appropriate measures.

This entails appointing a qualified person responsible for pharmacovigilance who must meet certain requirements in regard to education and qualification. Among others, the marketing authorisation holder must:

  • keep a detailed description of the applied pharmacovigilance system (pharmacovigilance system master file) and on request make a copy of such description available to the Danish Medicines Agency (DMA);
  • keep records of suspected adverse reactions and make these available to the DMA;
  • electronically report information on suspected serious adverse reactions to the European Medicines Agency’s database for adverse reactions within 15 days of receiving knowledge of such suspected reaction;
  • electronically report information on suspected non-serious adverse reactions to the European Medicines Agency’s database for adverse reactions within 90 days of receiving knowledge of such suspected reaction; and
  • prepare and submit periodic safety update reports to the DMA.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

In general, Danish data protection legislation applies to the processing of personal data in connection with conducting safety monitoring. As of May 25 2018, Danish data protection legislation comprises the General Data Protection Regulation. Therefore, the applicable data protection rules (whether the Danish data protection legislation or, as of May 25 2018, the General Data Protection Regulation) must be complied with.

Under existing Danish data protection legislation and the forthcoming General Data Protection Regulation, safety monitoring need not be notified to or authorised by the Danish Data Protection Agency.

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