The obligation to report quality defects to Swissmedic is laid down in article 59 of the Law on Therapeutic Products dated 15th december 2000 (LTP, SR 812.21) and in articles 35-39 of the Ordinance on Medicinal Products dated 17th October 2001 (SR 812.212.21).

The circumstances under which a batch is recalled (urgency, scope of recall, information channels) are adapted to the potential risk behind the quality defect noted.

In agreement with the European Union, insufficient quality is classified as follows:
- Class 1
Defects that are potentially life threatening or that could cause serious risk to health
- Class 2
Defects which could cause illness or lead to inappropriate treatment, but are not Class I defects
- Class 3
Defects which may not pose a significant hazard health

Further comments and explanations are given in the following instruction sheet: