General Information
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 medicine 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: [email protected]
Website: http://www.mzcr.cz/
Updated: March 2012
