Reporting serious undesirable effects

As a responsible person or distributor you have obligations to report serious undesirable effects.

As a responsible person or distributor, you have obligations according to article 23 of Regulation (EC) 1223/2009 on cosmetic products, to without delay, report any serious undesirable effects you become aware of to the competent authority in the EU/EEA country where the effects occurred. The definition of serious undesirable effects is found in article 2.1(p) of Regulation (EC) 1223 /2009 and is stated as follows;

an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death

When serious undesirable effects occurred in Sweden this shall be reported by the responsible person and distributors established in Sweden to the Swedish Medical Products Agency. To help companies reporting serious undesirable effects (SUE) the Commission has established “SUE Reporting Guidelines”.

Note that according to the guidelines SUE shall be reported without delay within 20 days after an employee, regardless of role or function of the responsible person or distributor became aware of the undesirable effect.

 SUE reporting guidelines

How to report a SUE which ocurred in Sweden

1. Download the form called SUE Form A on the European Commission website about serious undesirable effects
2. Fill in the form as comprehensive as possible and send to:

Swedish Medical Products Agency (Läkemedelsverket)
Box 26
753 01 Uppsala

The Swedish Medical Products Agency may contact you as reported undesirable effect to ask for additional information. Non-serious undesirable effects may also be reported to the Swedish Medical Products Agency using the form above.

 
 
 

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