General Information
The Czech Decree 23/2000 on foods intended for special nutrition contains a positive list of allowable ingredients as well as rules for labeling. Foreign companies must have a legal presence in the country. Products must be registered with the health authorities and pass a hygiene test at an accredited laboratory. Full product specifications must be then sent along with the results of the hygiene test to the National Institute of Public Health, who will issue an opinion after checking the application with the Institute of Drug Control. Final approval on all food supplements is given by the Ministry of Health, who will receive and consider the opinion from the Institute of Drug Control.
Fortified or Functional Food Ingredients – Pre-marketing notification including a small product dossier of all fortified foods should be provided to the Ministry of Health.
No herbal medicines are included in the national essential drug list. There is a positive list for herbs used for flavoring, as well as three positive lists regulating herbs for teas. The positive lists relating to teas are also used to regulate herbs added to foods. If the herb has a function other than flavoring, its use must be authorized by the Ministry of Health and the National Institute of Public Health and is therefore deemed to be a medication. Medical claims are allowed. Manufacturing compliance is the same as for conventional drugs. The European pharmacopoeia along with national monographs are legally binding.
A post marketing surveillance program monitors adverse events.
National policy along with the related laws and regulations are in the process of development through the efforts of the Ministry of Health.
Contact
Ministry of Health
Institute of Drug Control.
