Complaints are registered together with all the submitter’s information. There is a clear distinction made between the complaints regarding the quality of the pharmaceutical products and those regarding the distribution process:

  • In case of a complaint regarding the quality of the products or a potential quality defect, the manufacturer and/or the marketing authorisation holder are notified without any delay;
  • Any complaint regarding the distribution of the products is analysed in order to identify the reasons of the complaint;

After the investigation and the evaluation of the complaints, in case it is necessary, adequate measures will be initiated (for example, preventive and corrective actions – CAPA; notifications to the competent national authorities).