Legislation within the Swedish Medical Products Agency’s area of control

The control and supervision of the Medical Products Agency concerns three main product areas: Medicinal Products, Cosmetic and Hygiene Products and Medical Technical Products. Part of the control is to approve new medical products. The supervision includes for example control of the production of the products, quality guarantees and monitoring side effect reports.

Sweden joined the EU in 1995 and has since harmonised its legislation with that of the European Community. Therefore, Swedish medicinal legislation is essentially the same as that of the rest of the EU. The Swedish Medical Products Agency takes an active part in developing new legislation in cooperation with the other EU member states.

EC Directives are transposed into acts and ordinances by the Swedish Government and into provisions by the Medical Products Agency. These provisions are published in the MPA’s own Code of Statutes, LVFS. EC Regulations are directly applicable in the EU-member states. The authority of the MPA to issue regulations is primarily laid down in the Medicinal Products Act (SFS 2015:315) and the Medicinal Products Ordinance (SFS 2015:458).

EC-Directives and Regulations

For Directives and Regulations in English, please see Eur-lex.

 

 
 

External links

 

Related information

Printed versions of the Codes of statutes can be ordered from:

Fritzes kundservice
SE–106 47 STOCKHOLM
SWEDEN

   
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information