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Medicines Law (2015: 315).

Country
Type of law
Legislation
Date of original text
Source

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.
Date of consolidation/reprint
Notes
Consolidated version as amended last by SFS 2019:324.
Repealed
No
Source language

English

Legislation Amendment
No
Original title
L kemedelslag (2015:315).