Questions and answers

1. How can I become a holder of authorisation of distribution of medicinal products?

2. I am a distributor with a distribution authorisation from another EU Member State where the company has also its registered office. Can I distribute medicinal products also within the territory of the Czech Republic?

3. Is it possible to import medicinal products also from third countries?

4. Is it necessary for an entity which distributes only active substances and solely to manufacturers of medicinal products to be a holder of distribution authorisation?

5. What are the basic obligations of a distributor?

6. What about reporting pursuant to the current version of the DIS-13 guideline?

7. For what reason are the access data in respect of reporting of supplies of medicinal products pursuant to DIS-13, actual version, sent not only to the distributor's warehouses but also to its registered office?

8. When it is possible to obtain a GDP certificate for distributor of medicines and what the certificate documented?

9. I hold the authorization for the production of another EU Member State, where is also the headquarters of the company. Can I distribute the medicines in the Czech Republic?

10. Must all supplies of medicinal products accompanied by a certificate of analysis (CoA) and / or batch release certificate by the manufacturer of the medicinal product (CoC)?

11. What should be done when the batch number of a supplied medicinal product does not correspond with the delivery documentation (delivery notes, invoices ...)?

12. What can be a terminal (cross-dock) in connection with the distribution activity?