Community herbal monographs; Directive 2004 24 EC; European herbal medicines regulation; Traditional use registration
Indexed keywords
HERBACEOUS AGENT;
PLANT MEDICINAL PRODUCT;
BOOK;
CHINESE MEDICINE;
CLINICAL ASSESSMENT;
CLINICAL EVALUATION;
CLINICAL SUPERVISION;
COMMUNITY MEDICINE;
DRUG ADMINISTRATION ROUTE;
DRUG BIOAVAILABILITY;
DRUG DOSE;
DRUG EFFICACY;
DRUG MARKETING;
DRUG NOMENCLATURE;
DRUG SAFETY;
DRUG SYNTHESIS;
DRUG USE;
EUROPEAN UNION;
HEALTH CARE SYSTEM;
HERBAL MEDICINE;
HERBAL MONOGRAPH;
HUMAN;
LAW;
MEDICAL SOCIETY;
PHARMACOLOGICAL PARAMETERS;
REGISTRATION;
REVIEW;
SELF MEDICATION;
STRENGTH;
TRADITIONAL MEDICINE;
DRUG APPROVAL;
DRUG LEGISLATION;
LEGISLATION AND JURISPRUDENCE;
PHYTOTHERAPY;
STANDARDS;
DRUG APPROVAL;
EUROPEAN UNION;
HUMANS;
LEGISLATION, DRUG;
MEDICINE, TRADITIONAL;
PHYTOTHERAPY;
PLANT PREPARATIONS;
Directive 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use. 28.11.2001 L 311/67-127
Directive 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use. 28.11.2001. Official Journal of the European Communities. L 311/67-127.
COM(2008) 584 final: COMMISSION OF THE EUROPEAN COMMUNITIES: 'Communication from the Commission to the Council and the European Parliament concerning the Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC, as amended by Directive 2004/24/EC, on specific provisions applicable to traditional herbal medicinal products', Brussels, 29.9.2008. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0584:FIN:en:PDF
EMA/322570/2011 Rev. 3: European Medicines Agency. Uptake of the traditional use registration scheme and implementation of the provisions of Directive 2004/24/EC (Status 31 December 2012). Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Report/2011/05/WC500106706.pdf
Regulation (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency L 136/1-33
Regulation (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union 30.4.2004. L 136/1-33
European Commission. DG Health & Consumers. The Rules Governing Medicinal Products in the European Union': Available at http://ec.europa.eu/health/documents/eudralex/index-en.htm
CMDh/287/2013/Rev.1: Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh) February 2013
CMDh/287/2013/Rev.1: Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh). Q&A TRADITIONAL HERBAL MEDICINAL PRODUCTS: February 2013: Available at: http://www.hma.eu/fileadmin/dateien/Human-Medicines/CMD-h-/Questions-Answers/CMDh-287-2013-Rev1-2013-02-clean-pdf
ENTR/F2/SM D(2007): European Commission. DG Enterprise and Industry. Consumer goods. Pharmaceuticals. Notice to applicants Volume 2a
ENTR/F2/SM D(2007): European Commission. DG Enterprise and Industry. Consumer goods. Pharmaceuticals. Notice to applicants Volume 2a. Procedures for marketing authorisation. Chapter 3 Community Referral Procedures. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a-chap3-rev09-2007-en.pdf
European Medicines Agency. Interested parties to the HMPC. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about-us/document-listing/document-listing-000223.jsp&mid=WC0b01ac058003529f
European Medicines Agency website Assessment - proposals, prioritisation and status
European Medicines Agency website. Herbal medicinal products: Community herbal monographs. Assessment - proposals, prioritisation and status. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document-listing/document-listing-000212.jsp&mid=WC0b01ac058003380a#section2
EMA/HMPC/494079/2007: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC)
EMA/HMPC/494079/2007: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). Inventory of herbal substances for assessment. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2009/12/WC500017723.pdf
EMA/HMPC/278067/2006: European Medicines Agency Overview of assessment work. Priority list
EMA/HMPC/278067/2006: European Medicines Agency. Committee on herbal medicinal products (HMPC). Overview of assessment work. Priority list. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2009/12/WC500017724.pdf
EMEA/HMPC/31897/2006: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC)
EMEA/HMPC/31897/2006: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Public
EMA/HMPC/501139/2011: Committee on Herbal Medicinal Products (HMPC)
EMA/HMPC/501139/2011: Committee on Herbal Medicinal Products (HMPC). HMPC work programme for 2012-2015. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Work-programme/2011/12/WC500119957.pdf
ESCOP 2003/2009: European Scientific Cooperative on Phytotherapy. ESCOP Monographs 2nd ed.+ supplement, Thieme, Stuttgart; 2003/2009
ESCOP 2003/2009: European Scientific Cooperative on Phytotherapy. ESCOP Monographs. The Scientific Foundation for Herbal Medicinal Products. 2nd ed.+ supplement, Thieme, Stuttgart; 2003/2009
WHO 1999-2009: World Health Organisation. WHO Monographs on Selected Medicinal Plants - Volume 1-4. Available at: http://apps.who.int/medicinedocs/en/d/Js16713e/
EMA/HMPC/345132/2010: European Medicines Agency Regulatory Q&A on herbal medicinal products
EMA/HMPC/345132/2010: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). Regulatory Q&A on herbal medicinal products. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2011/03/WC500104038.pdf
EMA/HMPC/186645/2008: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC)
EMA/HMPC/186645/2008: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC). Reflection paper on the level of purification of extracts to be considered as herbal preparations. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2011/01/WC500100375.pdf
EMEA/HMPC/246736/2005: Committee on Herbal Medicinal Products: Public statement on "CPMP list of herbal drugs with serious risks, dated 1992": Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/04/WC500089951.pdf
European Medicines Agency: Human regulatory. Scientific guidelines. Multidisciplinary
European Medicines Agency: Human regulatory. Scientific guidelines. Multidisciplinary. Herbal medicinal products. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general-content-000497.jsp&mid=WC0b01ac05804545f1
Scientific Opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille)
(46 pp.)
EFSA Scientific Opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille) EFSA J. 11 7 2013 3302 (46 pp.)
EMA/HMPC/124695/2011: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC)
EMA/HMPC/124695/2011: European Medicines Agency. Committee on Herbal Medicinal Products (HMPC): Procedure for the systematic review of Community herbal monographs and supporting documents. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2011/07/WC500109143.pdf
EMEA/HMPC/104613/2005: Committee on Herbal Medicinal Products (HMPC). Guideline on the assessment of clinical safety and efficacy in the preparation of community herbal monographs for well-established and of community herbal monographs / entries to the community list for traditional herbal medicinal products / substances / preparations. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003644.pdf
EMA/HMPC/473587/2011: Committee on Herbal Medicinal Products (HMPC) Public statement on the interpretation of therapeutic indications appropriate to traditional herbal medicinal products in Community herbal monographs. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Public
European Commission 2011: Questions & answers: registration of traditional herbal medicinal products. Available at: http://ec.europa.eu/dgs/health-consumer/docs/traditional-herbal-medicinal-products-en.pdf
EMA/HMPC/402684/2013: Committee on Herbal Medicinal Products (HMPC). Questions & Answers on the EU framework for (traditional) herbal medicinal products, including those from a 'non-European' tradition. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural-guideline/2014/05/WC500166358.pdf.
EMA/HMPC/833398/2009: Committee on Herbal Medicinal Products (HMPC): Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/02/WC500123448.pdf