Preparation fault report
- Permit or other obligation
- Public service
Despite of quality assurance, mistakes can happen during the production so that there are drugs in the circulation that do not fulfil the quality requirements or that can be harmful to the users. Product faults must be reported to Fimea without delay.
Do the following
Fault reports can be submitted by phone or by e-mail. Urgent reports outside working hours should be notified by phone.
If the information is provided by phone, it must be provided in writing as well. For written reports, the electronic form on the Fimea website should be used. Product fault reporting form and reporting form regarding contact point for product faults can be found on the Forms page.
To whom and on what terms
Marketing authorisation holder is primarily responsible for taking care of the product fault. Pharmacies, hospital pharmacies, pharmaceutical centres and military pharmacies are primarily responsible for taking care of product faults that concern drugs produced by themselves. All businesses in the pharmaceutical sector are responsible for the adequacy of the necessary measures relating to the faults.