Reporting quality defects in medicinal products via the FAMHP website

date: 23/12/2019

Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.

If you notice a quality defect in a medicinal product find that might have consequences for patient health or safety, please report it to the Federal Agency for Medicines and Health Products (FAMHP). Current legislation requires medicinal product manufacturers and marketing authorisation (MA) holders to report all quality defects to the FAMHP.

A quality defect is any defect in a medicinal product that might reduce its quality. There are three types of quality defects:

  • chemical, microbiological or particle contamination;
  • qualitative anomalies (for example the appearance of the medicinal product) or quantitative anomalies (for example dosage too low or too high);
  • defective packaging (for example a printing error).

Quality defects may affect certain items in a batch, an entire batch, or multiple batches. On every report of a quality defect, the FAMHP opens an inquiry with the firm responsible for its production and/or marketing. Proven quality defects may lead to batches being recalled or brought into conformity.

How to report a quality defect?
The FAMHP needs specific information in order to effectively process the report. Notification forms are now available on the website. There are different forms depending on the person reporting the quality defect (patient, healthcare professional or pharmaceutical company). The FAMHP also has distinct internal follow-up processes depending on who filed a report. Therefore, be sure to use the correct form according to the capacity in which you are submitting your report.

Ideally, attach a photograph of the defect to your report. This will help our experts in assessing the importance of the reported quality defect.

Last updated on 23/12/2019