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New version of the Danish GCP executive order

25 June 2013

On 1 July 2013, a new version of the Danish executive order on good clinical practice in clinical trials of human medicines enters into force.

Among the updates are:

  • Pursuant to the present section 13(2), the sponsor must supply, i.e. pay for the investigational medicinal product. It has now been added to section 13(2), 2nd sentence that the sponsor can make an agreement with the hospital, deciding that the hospital supplies the investigational medicinal product if the patient already receives the product as part of the treatment.
  • The trial subject must receive the investigational medicinal product free of charge, but the Danish Health and Medicines Authority can make an exemption if the purpose of the trial cannot be fulfilled. Now, it becomes possible also to make an exemption if the investigational medicinal product is used to treat an indication in the summary of product characteristics, and the trial subject is treated with the product regardless of participating in the trial and the trial subject pays for the product himself.
  • The sponsor must ensure that monitoring takes place before, during and after the trial according to the nature and risks of the trial.

You can find the new version of the executive order in Danish at Retsinformation.