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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?

Pursuant to the Medicines Act and Executive Order 898 (June 23 2016) on pharmacovigilance, the holder of a marketing authorisation must:

  • maintain a pharmacovigilance system;
  • appoint a person responsible for the pharmacovigilance system;
  • immediately report new and significant information regarding the product's risk/benefit balance to the Medicines Agency;
  • report suspected or unexpected serious adverse reactions to the Medicines Agency and other bodies within 15 days.;
  • report non-serious adverse reactions within 90 days; and
  • submit periodic safety update reports to the Medicines Agency.

While the medicinal product is marketed, the marketing authorisation holder must notify the Medicines Agency in case of any permanent or temporary cessation of marketing, and of the reasons for such cessation. In addition, the holder must notify and explain any decision:

  • to withdraw the product from the market;
  • to withdraw the marketing authorisation; and
  • not to renew the marketing authorisation.

Data protection

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

The Act on Processing of Personal Data applies to pharmacovigilance activities when the processing of personal data relating to an identified or identifiable person is conducted for medical or scientific purposes.

However, pursuant to the Medicines Act and Executive Order 410 (May 9 2012) mandatory safety monitoring of medicinal products need not be notified or authorised by the Data Protection Agency.

The exemption from notification does not apply to the processing of sensitive personal data in relation to non-interventional trials, research and statistics projects and the collection of biological material for future research if the biological material is expected to be used in trials of medical products or in the testing of medical devices.

Notwithstanding that notification is not required, the Act on Processing of Personal Data and any other relevant legislation must still be complied with. Accordingly, pharmacovigilance activities will be subject to the act and the data subject’s rights.

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