Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions.



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 is required to implement a system to monitor the security of its product – a so-called ‘pharmacovigilance’ system.

The Medical Products Agency conducts inspections of market authorisation holders in order to verify that they have implemented a pharmacovigilance system that complies with applicable laws and regulations.

Data protection

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

The Personal Data Act applies to the processing of personal data in connection with pharmacovigilance activities. Pharmacovigilance activities normally include the processing of health information, which is regarded as sensitive personal data. The processing of sensitive personal data normally requires express consent from the individuals concerned. The individuals concerned shall also be informed regarding the processing of their data. The information to be provided must include:

  • the identity of the data controller;
  • the purpose of the processing; and
  • any other information necessary for the individuals concerned to protect their right to privacy.

 The following general data protection requirements should also be considered:

  • Personal data must be adequate, relevant and non-excessive in relation to the purpose of the processing.
  • Personal data must not be processed for any purpose that is incompatible with that for which the information is collected.
  • Adequate security measures for the protection of personal data must be implemented.
  • Data processing and data transfer agreements may be necessary.

Click here to view the full article.