Periodic safety update reports

• a list of the adverse reactions known to the company,
• an estimate of the number of humans or animals exposed to the medicinal product,
• an overall safety evaluation of the medicinal product,
• proposals for new safety measures, if relevant.

Who must submit periodic safety update reports?

All pharmaceutical companies that hold a marketing authorisation for a human or veterinary medicinal product are obliged to submit periodic safety update reports. However, this obligation does not extend to holders of parallel import licences.

Pharmaceutical companies must submit safety update reports to the Danish Medicines Agency according to the following intervals:

• every six months after authorisation in Denmark and until the product has been placed on the European market,
• every six months for the first two years after the product has been placed on the European market,
• annually for the subsequent two years,
• thereafter at three-yearly intervals, and
• in connection with the submission of an application to renew the marketing authorisation.

What happens to the periodic safety update reports?

The Danish Medicines Agency reviews the safety update reports and checks, among other things, that all reported adverse reactions are listed.

As part of the review, we take into account:

• the scientific quality of the report and whether relevant scientific literature has been considered,
• the scientific conclusions and any proposals for improving the safety of the product.

The outcome of the review may imply that the summary of product characteristics and the package leaflet need to be changed.

PSUR Worksharing

The next PSUR submission should, if possible, be harmonised with the active substance's Data Lock Point (DLP) under the EU synchronisation project (for more information about EU synchronisation of PSUR submission, please see the factbox to the right).

Further information

• Executive order no. 1214 of 7 December 2005 on requirements for the layout of adverse reaction reports and periodic safety update reports, etc. (Bekendtgørelse nr. 1214 af 7. december 2005 om krav til udformning af bivirkningsindberetninger og periodiske sikkerhedsopdateringer m.v.)
• Executive Order no. 1238 of 12 December 2005 on monitoring of adverse reactions from medicinal products (Bekendtgørelse nr. 1238 af 12. december 2005 om bivirkningsovervågning af lægemidler)

See the executive orders in the factbox to the right (in Danish only).

Danish Medicines Agency, last updated on 24 September 2008.