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?

Yes, it is possible (Section 75, paragraph 4 of the Act on Pharmaceuticals refers) in the case of a person who has obtained a distribution authorisation in any of the Community Member States. This distributor is obliged to notify SÚKL (guidelines DIS-10) in advance of its commencement of distribution in the Czech Republic, to evidence its distribution authorisation issued by another Member State, to provide contact details (address of the registered office, tel., fax, email) and other information on the scope of distribution and on the location of distribution warehouses. Furthermore, the duty to report supplies of distributed human medicinal products (guidelines DIS-13) shall be applicable thereto. If, however, such distributor establishes distribution warehouses in the Czech Republic, the duty to obtain distribution authorisation from SÚKL in advance shall be also applicable thereto.