Reporting supplies of distributed human medicinal products

This guideline substitutes DIS-13 version 5 with effect from 1 January 2019

DIS-13_version6.pdf, soubor typu pdf, (138.46 kB)

The Guideline is issued with reference to Section 77, paragraph 1(f) of Act No 378/2007 Coll., on Pharmaceuticals, as amended (hereinafter referred to as the “Act on Pharmaceuticals”) and specifies the procedures for submitting correct and complete electronic reports on the volume of deliveries of distributed medicinal products.

The Guideline has recommending characteristic.