Licensing Herbal Medicinal Products under the EU Traditional Herbal Medicinal Products Directive (THMPD)

Regulatory Authorities | Guidelines and Legal Texts | Associations and Societies | Pharmacopoeias and Selected Monographs

Regulatory Authorities

European Medicines Agency (EMEA) www.emea.europa.eu
Heads of Medicines Agencies www.hma.eu
Austria www.ages.at
Belgium www.fagg-afmps.be
Bulgaria www.bda.bg
Czech Republic www.sukl.cz
Denmark www.dkma.dk
Estonia www.sam.ee
Finland www.nam.fi
France www.afssaps.sante.fr
Germany www.bfarm.de
Greece www.eof.gr
Hungary www.ogyi.hu
Iceland www.imca.is
Ireland www.imb.ie
Italy www.agenziafarmaco.it
Lithuania www.vvkt.lt
Luxembourg www.ms.etat.lu
Netherlands www.cbg-meb.nl
Norway www.legemiddelverket.no
Poland www.bip.urpl.gov.pl
Portugal www.infarmed.pt
Romania www.anm.ro
Slovakia www.sukl.sk
Slovenia www.jazmp.si
Spain www.agemed.es/
Sweden www.lakemedelsverket.se
United Kingdom www.mhra.gov.uk

Guidelines and Legal Texts

Consolidated Medicines Legislation and Traditional Herbal Medicines Directive ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/consol_2004/human_code.pdf
Notice to applicants and regulatory guidelines medicinal products for human use ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2_en.htm
Scientific guidelines for medicinal products for human use ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol3_en.htm
Good manufacturing practice (GMP) Guidelines ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm
Pharmacovigilance guidelines ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol9_en.htm

Associations and Societies

Austrian Society for Phytotherapy www.phytotherapie.at/
European Herbal Practitioners Association www.users.globalnet.co.uk/~ehpa/
European Scientific Cooperative on Phytotherapy www.escop.com/
German Society for Phytotherapy www.phytotherapy.org/
Netherlands Association for Phytotherapy www.fyto.nl/
Swiss Medical Society for Phytotherapy www.smgp.ch/
United Kingdom Association of Traditional Chinese Medicine www.telinco.com/cma/DrXiu/Atcmuk.html
United Kingdom College of Practitioners of Phytotherapy www.collegeofphytotherapy.com/webccp.htm
Herb Society of the United Kingdom www.herbsociety.co.uk/
United Kingdom National Institute of Medical Herbalists www.nimh.org.uk/
United Kingdom Register of Chinese Herbal Medicine www.rchm.co.uk/

Pharmacopoeias and Selected Monographs

European Pharmacopoeia www.edqm.eu/en/Homepage-628.html
EU Community Monographs www.emea.europa.eu/htms/human/hmpc/hmpcmonographs.htm
EU Community List www.emea.europa.eu/htms/human/hmpc/hmpclist.htm

 

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