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.