Reporting on adverse effects
A serious adverse effect denotes an adverse effect which causes:
- temporary or permanent functional incapacity;
- congenital abnormalities;
- immediate vital risk or
Manufacturers, importers and distributors are obliged to report serious adverse effects of cosmetic products. End users or medical workers can also report serious adverse effects.
Reporting on serious adverse effects must be done through prescribed forms, which are available in Slovenian and English.
Form A (Slovenian/English) is completed by responsible persons or distributors who are acquainted with severe adverse effects and is submitted to the competent authority in the country in which the adverse effect occurred.
Irrespective of the fact that the form is available in two languages, it is recommended that the form be completed in English to facilitate the exchange of data between the competent authorities.
Completed Form A