The effect of the European traditional use directive on the register of herbal medicinal products in Spain.

Background Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. Methods We consulted the herbal medicinal plant and d...

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Autores: Tejedor García, Noelia, García-Pastor, Coral, Navalmoral-Arenas, Estefanía, Blas-Espada, Javier, Madrigal-Martínez, Antonio, De Lucio-Cazaña, Francisco Javier
Tipo de recurso: artículo
Fecha de publicación:2015
País:España
Institución:Universidad Francisco de Vitoria
Repositorio:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
Idioma:inglés
OAI Identifier:oai:ddfv.ufv.es:10641/5368
Acceso en línea:https://hdl.handle.net/10641/5368
Access Level:acceso abierto
Palabra clave:Traditional medicine
Complementary therapies
Herbal Medicine
Legislation and jurisprudence
Dietary Supplements
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spelling The effect of the European traditional use directive on the register of herbal medicinal products in Spain.Tejedor García, NoeliaGarcía-Pastor, CoralNavalmoral-Arenas, EstefaníaBlas-Espada, JavierMadrigal-Martínez, AntonioDe Lucio-Cazaña, Francisco JavierTraditional medicineComplementary therapiesHerbal MedicineLegislation and jurisprudenceDietary SupplementsBackground Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. Methods We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. Results Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. Conclusion In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected.Elsevier20152015-01-0120152015-01-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10641/5368reponame:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoriainstname:Universidad Francisco de VitoriaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddfv.ufv.es:10641/53682026-06-11T12:44:57Z
dc.title.none.fl_str_mv The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
title The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
spellingShingle The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
Tejedor García, Noelia
Traditional medicine
Complementary therapies
Herbal Medicine
Legislation and jurisprudence
Dietary Supplements
title_short The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
title_full The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
title_fullStr The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
title_full_unstemmed The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
title_sort The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
dc.creator.none.fl_str_mv Tejedor García, Noelia
García-Pastor, Coral
Navalmoral-Arenas, Estefanía
Blas-Espada, Javier
Madrigal-Martínez, Antonio
De Lucio-Cazaña, Francisco Javier
author Tejedor García, Noelia
author_facet Tejedor García, Noelia
García-Pastor, Coral
Navalmoral-Arenas, Estefanía
Blas-Espada, Javier
Madrigal-Martínez, Antonio
De Lucio-Cazaña, Francisco Javier
author_role author
author2 García-Pastor, Coral
Navalmoral-Arenas, Estefanía
Blas-Espada, Javier
Madrigal-Martínez, Antonio
De Lucio-Cazaña, Francisco Javier
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Traditional medicine
Complementary therapies
Herbal Medicine
Legislation and jurisprudence
Dietary Supplements
topic Traditional medicine
Complementary therapies
Herbal Medicine
Legislation and jurisprudence
Dietary Supplements
description Background Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. Methods We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. Results Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. Conclusion In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected.
publishDate 2015
dc.date.none.fl_str_mv 2015
2015-01-01
2015
2015-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10641/5368
url https://hdl.handle.net/10641/5368
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
instname:Universidad Francisco de Vitoria
instname_str Universidad Francisco de Vitoria
reponame_str DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
collection DDFV. Repositorio Institucional de la Universidad Francisco de Vitoria
repository.name.fl_str_mv
repository.mail.fl_str_mv
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