Ecolex Logo
Le portail au
droit de l'environnement
Résultats de la recherche » Législation

Medicines Law (2015: 315).

Pays/Territoire
Suède
Type du document
Législation
Date
2015 (2019)
Source
FAO, FAOLEX
Sujet
Bétail, Alimentation et nutrition
Mot clé
Contrôle de qualité alimentaire/innocuité des produits alimentaires Inspection Résidus Santé publique Médicaments Santé des animaux Recherche Parasites/maladies Aliments pour animaux
Aire géographique
Arctique, Europe, Europe et Asie Centrale, Pays de l'Union Européenne, Atlantique Nord, Mer du Nord, Atlantique du Nord-Est, Europe du Nord
Résumé

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.

Texte intégral
Suédois
Site web
www.riksdagen.se

Références - Législation

Implemente

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.

Législation | Union européenne | 2004

Mot clé: Médicaments, Institution, Autorisation/permis, Infractions/sanctions, Santé des animaux

Source: FAO, FAOLEX