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...
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Elsevier
2015-05-01
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| Series: | Gaceta Sanitaria |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S0213911115000175 |
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doaj-b94c9f041d294106a14de0e6fef72c9d2020-11-24T23:42:40ZengElsevierGaceta Sanitaria0213-91112015-05-0129322122310.1016/j.gaceta.2015.01.013The effect of the European traditional use directive on the register of herbal medicinal products in SpainNoelia Tejedor-GarcíaCoral García-PastorEstefanía Navalmoral-ArenasJavier Blas-EspadaAntonio Madrigal-MartínezFrancisco Javier de Lucio-CazañaBackground: 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.http://www.sciencedirect.com/science/article/pii/S0213911115000175Traditional medicineComplementary therapiesHerbal MedicineLegislation and jurisprudenceDietary Supplements |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Noelia Tejedor-García Coral García-Pastor Estefanía Navalmoral-Arenas Javier Blas-Espada Antonio Madrigal-Martínez Francisco Javier de Lucio-Cazaña |
| spellingShingle |
Noelia Tejedor-García Coral García-Pastor Estefanía Navalmoral-Arenas Javier Blas-Espada Antonio Madrigal-Martínez Francisco Javier de Lucio-Cazaña The effect of the European traditional use directive on the register of herbal medicinal products in Spain Gaceta Sanitaria Traditional medicine Complementary therapies Herbal Medicine Legislation and jurisprudence Dietary Supplements |
| author_facet |
Noelia Tejedor-García Coral García-Pastor Estefanía Navalmoral-Arenas Javier Blas-Espada Antonio Madrigal-Martínez Francisco Javier de Lucio-Cazaña |
| author_sort |
Noelia Tejedor-García |
| title |
The effect of the European traditional use directive on the register of herbal medicinal products in Spain |
| 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 |
effect of the european traditional use directive on the register of herbal medicinal products in spain |
| publisher |
Elsevier |
| series |
Gaceta Sanitaria |
| issn |
0213-9111 |
| publishDate |
2015-05-01 |
| 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. |
| topic |
Traditional medicine Complementary therapies Herbal Medicine Legislation and jurisprudence Dietary Supplements |
| url |
http://www.sciencedirect.com/science/article/pii/S0213911115000175 |
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