Guidelines and Forms

Medicinal Products - Distribution

  Name En. v. Valid. since Replaces Amends
DIS-15 version 1 Monitoring and control of storage and transportation temperatures for pharmaceuticals by manufacturers and wholesalers No 15.1.2009 DIS-15 -
DIS-14 version 1 Humanitarian aid shipments containing medicinal products No 15.1.2009 DIS-14 -

pdf.pngDIS-13 version 4, soubor typu pdf, (89.86 kB)

Reporting of deliveries of distributed medicinal products Yes 1.4.2011 DIS-13, rev.3 -
DIS-12 version 1 Guidelines for distribution of medicinal substances and excipients to persons authorised to prepare medicinal products No 15.1.2009 DIS-12 -
DIS-11 version 1 Guidelines for Good Distribution Practice of human medicinal products No 15.1.2009 DIS-11 -

DIS-10 version 1

Notification of the commencement of distribution activities / notification of a change in information on the distributor performing distribution activities within the territory of the Czech Republic based upon distribution authorisation for medicinal products issued by another EU member state

Yes 23.1.2009 DIS-10 -
DIS-8 version 1 Application for an authorisation/change to authorisation for distribution of medicinal products No 23.1.2009 DIS-8 -