Monitoring adverse drug reactions

Monitoring suspected adverse drug reactions is an important task and an integral part of the Swedish Medical Products Agency’s appraisal of approved products.

The medical profession is obliged to report more serious side effects and all reports received are assessed and stored in the agency’s database. To raise the quality of this work, a de-centralised reporting system has been established with regional centres in Gothenburg, Huddinge, Stockholm, Lund, Umeå and Uppsala. Via a network located in these centres, the Swedish Medical Products Agency also monitors significant or rare adverse reactions to drugs.

The Swedish Medical Products Agency also collaborates extensively with other EU state authorities to clarify the significance of adverse reactions. Should new studies anywhere show that an approved medicine may have unexpected side effects, authorities around the world are alerted. We then quickly pass on this information to doctors, veterinarians and pharmacists in Sweden and the medicine can be withdrawn from the market at short notice.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information