title: The effect of the European traditional use directive on the register of herbal medicinal products in Spain.
abstract: 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.
  
  
  CONCLUSIONS
  In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected.
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain. Electronic address: ntejedor@hotmail.com.
authors.forename: Noelia
authors.initials: N
authors.lastname: Tejedor-García
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain.
authors.forename: Coral
authors.initials: C
authors.lastname: García-Pastor
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain.
authors.forename: Estefanía
authors.initials: E
authors.lastname: Navalmoral-Arenas
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Blas-Espada
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Madrigal-Martínez
authors.affiliation: Departamento de Biología de Sistemas, Universidad de Alcalá, Alcalá de Henares, Madrid, Spain.
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: de Lucio-Cazaña
mesh_terms: D019587:Dietary Supplements; D005062:European Union; D005569:Formularies as Topic; D029001:Herbal Medicine / Q000331:legislation & jurisprudence* / Q000592:standards; D008004:Licensure; D040541:Marketing; D008519:Medicine, Traditional; D013030:Spain
keywords: Complementary therapies; Complementos alimenticios; Dietary Supplements; Herbal Medicine; Legislación y jurisprudencia; Legislation and jurisprudence; Medicina de hierbas; Medicina tradicional; Terapias complementarias; Traditional medicine