Regulatory Situation of Herbal Medicines - A Worldwide Review
(1998; 49 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoACKNOWLEDGEMENTS
Ver el documentoFOREWORD
Abrir esta carpeta y ver su contenidoI. INTRODUCTION
Cerrar esta carpetaII. REGULATORY SITUATION
Abrir esta carpeta y ver su contenidoAfrica
Abrir esta carpeta y ver su contenidoThe Americas
Abrir esta carpeta y ver su contenidoEastern Mediterranean
Cerrar esta carpetaEurope
Ver el documentoGeneral aspects
Ver el documentoAttempts to Meet the Need for Harmonization
Ver el documentoAustria
Ver el documentoBelgium
Ver el documentoBulgaria
Ver el documentoDenmark
Ver el documentoEstonia
Ver el documentoFinland
Ver el documentoFrance
Ver el documentoGermany
Ver el documentoGreece
Ver el documentoHungary
Ver el documentoIceland
Ver el documentoIreland
Ver el documentoItaly
Ver el documentoNetherlands
Ver el documentoNorway
Ver el documentoPortugal
Ver el documentoSpain
Ver el documentoSweden
Ver el documentoSwitzerland
Ver el documentoTurkey
Ver el documentoUnited Kingdom
Abrir esta carpeta y ver su contenidoSouth East Asia
Abrir esta carpeta y ver su contenidoWestern Pacific
Ver el documentoIII. CONCLUSION
Ver el documentoIV. REFERENCES
 

Austria

The Austrian drug law does not distinguish between medicinal products made from chemical substances and those made from plants or natural substances. An abridged registration is possible for certain non-prescription medicines. This is laid down in section 17a of the Austrian Drug Law [40]. This means that with respect to quality and safety a detailed assessment is not performed. A list of active substances and excipients qualifying for the abridged procedure was published in 1989 [41] and was last modified in 1992 [42]. It lists some 500 substances and medicinal plants/parts of plants/essential oils etc., for which the simplified procedure according to section 17a can be used. The requirements for the documents that have to be submitted are listed in sections 15 and 17a of the Austrian Drug Law.

In principle, medicinal products can only be sold in pharmacies. An exemption is laid down in section 59, para 3 of the Austrian Drug Law stating that certain products which do not have any risk are allowed to be sold outside pharmacies, e.g., in drug stores. A list of these products of which many are medicinal plants has been published officially, and contains a description of the medicinal plant/part of plant, the wording for the indication and the dosage recommendation [43].

Ir a la sección anterior Ir a la siguiente sección
 

Última actualización: le 3 mayo 2013