On 21 July 2012 the Swedish Medical Products Agency ("SMPA") enacted new Codes of Stature in terms of adverse drug reaction reporting systems for parallel imported drugs (LVFS 2012:19, the "Code").
SMPA's revision of the Code is due to the implementation of the EU directive on pharmacovigilance of medicinal products (European Parliament and Council Directive 2010/84/EU amending Directive 2001/83/EC, the "Directive"). Under the Directive, it is the responsibility of the rights holder of the medical product in the country of export (the "Holder") to monitor the pharmacovigilance of its medicines. However, as SMPA has pointed out in its impact assessment, this presupposes that the Holder receives knowledge of such adverse drug reactions in a timely and accurate manner, in markets that the Holder may not have any presence. The lack of regulations in this regard has been unfortunate, since successful pharmacovigilance is dependent on accurately and timely reporting to the holder of the marketing authorization and to the SMPA. SMPA has therefore introduced a new reporting obligation in the Code LVFS 2012:19.
The Code introduces an obligation on the parallel importer to report all suspected adverse drug reactions to the holder of the marketing authorization of the directly imported product. These reports must be made within seven days from when the parallel importer became aware of the adverse drug reaction. In the situation where the directly imported product is no longer approved for sale in Sweden, the adverse drug reaction report shall instead be sent to the Holder. This report may be drafted in English or in the language of the Holder. This report must be submitted within ten days from when the parallel importer learns of the adverse drug reactions.