A recall of a medicinal product means that the product will be withdrawn from the market. A recall will be necessary when a product could cause damage, injury or inconvenience to the consumer and may affect one or several batches or the whole product.
The Swedish Association of the Pharmaceutical Industry AB (Läkemedelsindustriföreningens Service AB, LIF) has in cooperation with the Medical Products Agency (Läkemedelsverket), Apoteket AB (the former National Corporation of Pharmacies) and the distributors (wholesale dealers) developed guidelines for the handling of complaints and recalls as a tool to prepare company specific procedures.
Code of statutes (in Swedish)
Läkemedelsverkets föreskrifter (2004:6) om god tillverkningssed för läkemedel
Läkemedelsverkets föreskrifter (LVFS 2009:11) om partihandel med läkemedel
Degree of seriousness
In the recall form the Rapid Alert System (RAS) classification should be stated in accordance with the “Procedure for Handling Rapid alerts and Recalls arising from Quality Defects”.
Further information will be found at the web site of EMA:
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
The classification states the degree of seriousness:
Class I: Potentially life threatening or could cause a serious risk to health.
Class II: Defects that could cause illness or mistreatment, but are not Class I.
Class III: Defects that may not pose a significant hazard to health, but withdrawal may have been initiated for other reasons.
The Medical Products Agency is responsible for ensuring that the Rapid Alert is sent on to the other authorities in the Rapid Alert System.
A new recall form has been developed for handling recalls and should be used.
Recall of medicinal product.doc (word format, in Swedish)
Initiating a recall
Everyone manufacturing or trading medicinal products has to have systems for handling recalls. Procedures must be in place for a possible recall when a medicinal product has been judged to be recalled.
A recall can be initiated by the manufacturer/pharmaceutical company or by the Medical Products Agency. Before a recall is started the Medical Products Agency always should be contacted for information and advice on the extent of the recall and current RAS classification.
Normally a recall may be necessary only from the dealers, hospitals and drug supplies at hospitals etc. But, if during the investigation/assessment of the issue/case the defect is judged to be serious and may be potentially life threatening or could cause a serious risk to health, the product may also be recalled from the consumers.
All decisions of recalls must be taken in consultation with the Medical Products Agency.
Contact the responsible persons for complaints and recalls:
Phone: +46 18 17 46 00
Fax: +46 18 54 85 66
The final recall form as a pdf document should be sent to email@example.com for publishing on the Medical Product Agency’s web site and to firstname.lastname@example.org for registration and filing.
Every recall in accordance with this system is published here:
Indragningar (Information in Swedish)