5. What are the basic obligations of a distributor?

The rights and obligations of a distributor are defined in Section 13 and Section 77 of the Act on Pharmaceuticals.


A basic overview of obligations:

  • to obtain medicinal products only from other distributors or from manufacturers who manufacture or import these medicinal products;
  • to distribute only to persons authorised by law;
  • to have an effective system of recalls of medicinal products;
  • to maintain records in appropriate extent as required by the law;
  • to comply with the rules of good distribution practice;
  • to cooperate with the employees of bodies authorised to carry out inspections;
  • to report, on a regular basis,  supplies of human medicinal products to SÚKL.