Reporting quality defects

Medicinal products for human and veterinary use

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.


Unit Market Monitoring
Hallerstrasse 7
CH-3012 Bern

Phone: +41 58 462 05 80
Fax: +41 58 462 07 22

Print contact