The export of addictive substances and preparations is only possible with an export permit issued by the Ministry of Health of the Czech Republic. The list of addictive substances is set out in Government Regulation No. 463/2013 Coll., on lists of addictive substances.
Import of addictive substances and preparations is only possible with an import permit issued by the Ministry of Health of the Czech Republic and an export permit issued by the country of origin of the consignment if such a permit is required there for export.
Export and import permits are not required for the cases referred to in Section 20(2) and Section 21(2) of Act No. 167/1998 Coll., on Addictive Substances and Amendment of Certain Other Acts.
Transit is only possible with an export permit issued by the Ministry of Health of the Czech Republic and an export permit issued by the country of origin of the consignment if such a permit is required there for export. The consignment must not be unloaded from the means of transport during transport.
Addictive substances and preparations must not be placed in bonded warehouses and free zones.
MEDICAMENTS
TRAVELLERS
Medicaments that are sold in countries outside the European Union may be imported into the Czech Republic only in volume that corresponds to the usual need for a personal journey into the Czech Republic (e.g., vacation, visitation, etc.).
CONSIGNMENTS
The area of medicaments is governed by Act No. 378/2007 Coll., on medicaments and on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals).
The decisive authorities of the state administration include the State Institute for Drug Control (hereinafter “SIDC“) in the case of human medicine, and the Institute for State Control of Veterinary Biologicals and Medicines (hereinafter “ISCVBM") in the case of veterinary medicine.
Imports of medicinal preparations from third countries are subjected to the issuance of a “license to manufacture medicinal preparations". Such imports can be performed solely by persons authorized to do so by SIDC, if human medicaments are concerned, or ISCVBM in the case of veterinary medicaments. Authorized manufacturers of human medicines are listed at www.sukl.eu and in the case of veterinary medicines under the link www.uskvbl.cz/en
The term “third countries" means all states with the exception of the Member States of the EU and the states associated in the European Economic Area (Norway, Iceland, and Liechtenstein).
The decision about the issuance of a license to manufacture medicinal preparations contains:
- an identification of the entity,
- types and extent of authorized manufacturing, including a list of medicinal preparations to be imported,
- address(es) of the place(s) of manufacturing and quality control,
- names and surnames of qualified persons,
- and/or obligations imposed on the applicant.
