A government bill has recently been presented in Sweden in order to implement the EU Directive (2012/26/EU) of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance. The key elements relate to the Swedish Medicine Act (SFS 1992:859) and, in particular, include an obligation on marketing authorization holders to report to the Swedish Medical Products Agency in the event they temporarily or permanently suspend the marketing of a medicinal product within Sweden. Reforms are also proposed to the Medicinal Products (Trading) Act (SFS 2009:366), concerning controls of wholesale trade of medical products for human use performed in relation to states of the European Economic Area. The amendments are proposed to enter into force on 28 October 2013.

Topic also reported in the IP & Technology Review April issue.