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Medicines Law (2015: 315).

Country/Territory
Sweden
Document type
Legislation
Date
2015 (2019)
Source
FAO, FAOLEX
Subject
Livestock, Food & nutrition
Keyword
Food quality control/food safety Inspection Residues Public health Drugs Animal health Research Pests/diseases Animal feed/feedstuffs
Geographical area
Arctic, Europe, Europe and Central Asia, European Union Countries, North Atlantic, North Sea, North-East Atlantic, Northern Europe
Abstract

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.

Full text
Swedish
Website
www.riksdagen.se

References - Legislation

Implements

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.

Legislation | European Union | 2004

Keyword: Drugs, Institution, Authorization/permit, Offences/penalties, Animal health

Source: FAO, FAOLEX