Czech Republic

Policy

National laws and regulations on herbal medicines were introduced in 1997 in law No.79 which regulates both conventional pharmaceuticals and herbal medicine, and herbal medicine is considered as prescription and over the counter medicine. The Czech Decree 23/2000 on foods intended for special nutrition contains a positive list of allowable ingredients as well as rules for labelling.  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. A post marketing surveillance program monitors adverse events. Czech Republic has implemented the reformed EU Common Agriculture Policy, which focuses on the establishment of a common organisation of agricultural markets across member countries, which also covers the sector of medicinal plants and herbs. A major new reform of the CAP is currently being prepared for the period after 2013.

Contact

Ministry of health of the Czech Republic
Address: Ministry of Health 
PO Box 81 
Palacky us. 375 / 4 
128 01 Prague 
Tel: +420 2 2497 1111 
Fax: +420 2 2497 2111
Website: http://www.mzcr.cz/
Institute of Drug Control
Website: http://www.sukl.cz/en02/en02.htm

Laws & Regulations

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 is 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       
http://www.mzcr.cz/
 
Institute of Drug Control     
http://www.sukl.cz/en02/en02.htm
 

Standards & Guidelines

In 2003, in Decree No. 47/2000, the Ministry of Health and the Ministry of Agriculture determined to call on practising Good Clinical Practice and detailing the conditions of clinical trials.

National laws and regulations on herbal medicines were introduced in 1997 in law No.79 which regulates both conventional pharmaceuticals and herbal medicine, and herbal medicine is considered as prescription and over the counter medicine. The Cesky lekopis 2002 (Pharmacopoeia bohemica MMII) is the national pharmacopoeia containing two legally binding parts: the European pharmacopoeia in translation and national monographs. Manufacturing these products must adhere to the regulatory requirements and the same GMP rules that are used for conventional pharmaceuticals. The safety requirements for herbal medicines are similar to conventional pharmaceuticals and assessment during the registration process. There were 230 registered herbal medicines as on November 2003 and no herbal medicines are listed under the national essential drug. Herbal medicines are sold in Czech Rebublic in pharmacies as prescription and over the counter medicines and in special outlets. Herbal medicines wholesalers provide reports on data for volume and value of national market sales for herbal medicines.

Czech Republic is also one of EU and OECD member countries, and follows the simplified regulatory approval process on Traditional herbal medicinal products under the EU Directive on Traditional Herbal Medicinal Products (THMPD) formally known as The Directive 2004/24/EC.

Contact

Ministry of health of the Czech Republic
Address: Ministry of Health 
PO Box 81 
Palacky us. 375 / 4 
128 01 Prague 2 Electronic registry of the Ministry of Health
Tel: +420 2 2497 1111 
Fax: +420 2 2497 2111
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: http://www.mzcr.cz/