Export habit-forming substances, preparations, precursors and auxiliary substances (as listed in Ordinance 304/1998 Coll.) is allowed only with an export licence issued by the Ministry of Health (such substances are listed in Appendices to Act No. 167/1998 Coll.).
Export of habit-forming substances, preparations and precursors are allowed only with an import licence issued by the Ministry of Health and an export licence from the country of origin of the consignment, if also requested for such export.
Export and import licences are not required in cases as stipulated in Section 20(2) and in Section 21(2) of Act No. 167/1998 Coll.
Transit is allowed only with an export licence issued by the Ministry of Health and an export licence from the country of origin of the consignment, if also requested for such export. Consignments may not be unloaded for the relevant means of transport in the course of transport.
Habit-forming substances, preparations and precursors must not be placed in bonded warehouses, free zones and free warehouses.
Medicaments that are sold in countries outside the European Community may be imported into the Czech Republic only in volume that corresponds to the usual need for a personal journey into the CZ / EC (eg. vacation, visitation, etc.).
The area of medicaments is governed by Act No. 79/1997 Coll., on medicaments and on modifications and amendments of certain related legislation, as amended by further legislation.
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 then case of veterinary medicine.
Imports of medicinal preparations from third countries are subjected to the issuance of a “licence to manufacture medicinal preparations”. Such imports can be performed solely by persons authorised to do so by SIDC, if human medicines are concerned, or ISCVBM in the case of veterinary medicaments. Authorised manufacturers are listed on the address: www.sukl.cz under the link of “Authorised Manufacturers” and www.uskvbl.cz.
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 licence to manufacture medicinal preparations contains:
• an identification of the entity;
• types and extent of authorised 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.