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Medicines Law (2015: 315).

País/Territorio
Suecia
Tipo de documento
Legislación
Fecha
2015 (2019)
Fuente
FAO, FAOLEX
Materia
Ganado, Alimentación y nutrición
Palabra clave
Control de calidad de los alimentos/inocuidad de los alimentos Inspección Residuos Salud pública Medicamentos Sanidad animal Investigación Plagas/enfermedades Alimentos para animales/piensos
Área geográphica
Ártico, Europa, Europa y Central Asia, Países de la Unión Europea, Atlántico Norte, Mar del Norte, Atlántico Nordeste, Europa Septentrional
Resumen

This Law provides rules for the manufacture, importation and placing on the market of medicinal products for human use and veterinary medicinal products and which have been manufactured industrially or through an industrial process. Application for approval for sale may be required under Regulation (EC) No 726/2004. The Law also concerns veterinary medicinal product intended for animal species used for food production and containing a new active substance. An approval or a registration for the sale of a veterinary-medical medicinal product which has been notified in another EEA country shall, upon application, be recognized in Sweden, if there is no reason to believe that the medicinal product could present a serious risk to human or animal health or to environment. Approval shall be obtained from the Medical Products Agency. The Swedish Medicines Agency shall be responsible for a system for pharmacovigilance that aims to collect, record, store and scientifically evaluate data on suspected adverse reactions to medicinal products that have been approved for sale. The Law shall also apply to medicines for animals including premixes for mixing in feed.

Texto completo
Sueco
Página web
www.riksdagen.se

Referencias - Legislación

Implementa

Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

Legislación | Unión Europea | 2004

Palabra clave: Medicamentos, Institución, Autorización/permiso, Infracciones/sanciones, Sanidad animal

Fuente: FAO, FAOLEX