Complaints of medicinal products

The Swedish Association of the Pharmaceutical Industry AB (Läkemedelsindustriföreningens Service AB, LIF) has in cooperation with the Swedish Medical Products Agency (Läkemedelsverket), Apoteket AB (the former National Corporation of Pharmacies) and the distributors (whole sale dealers) developed guidelines for the handling of complaints and recalls as a tool to prepare company specific procedures.

These procedures must make sure that complaints received are given proper judgement and treatment and measures are taken to prevent repeated complaints. A decision shall be made on whether an investigation and possible recall is required.

Complaints of medicinal products may be done due to suspicious defects in quality, counterfeit, fraud or other points of view, which should be addressed to the manufacturer of the medicinal product (and/or the manufacturing authorisation holder).

Complaints will be received from different parts; consumers, health care professionals, pharmacies, retailers (hälsofackhandel, dagligvaruhandel) etc. Everyone running a business with medicinal products is obliged according to the Medical Products Agency’s provisions to have systems to receive and handle complaints.

Complaints can be received by telephone, letter, e-mail etc. Retailers, OTC retailers as well as pharmacies and wholesale dealers, may have different systems to report complaints.

One of these systems is www.reklameralakemedel.se which has been developed by LIF. This service makes it possible for the manufacturers/pharmaceutical companies to receive the complaints to a certain e-mail address through a web form, which is available to all retailers free of charge.

 
 

Related information

   
 

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