What is a medicinal product quality defect?
A medicinal product quality defect is any defect that can influence a medicinal product’s quality. There are three types of quality defects:
- chemical or microbiological contamination, or contamination with particles;
- deviations in quality (e.g. appearance) or in quantity (e.g. underdose or overdose);
- packaging defects (e.g. printing errors).
Quality defects may or may not cause damage to patients or health care professionals. Quality defects may affect certain parts of medicine batches, entire batches or various batches.
Manufacturers and marketing authorisation holders (MA) of medicinal products are legally obliged to report quality defects in medicinal products for human and veterinary use to the FAMHP.
How to report a quality defect to the FAMHP?
To report a quality defect, send an email to industry@fagg-afmps.be.
An FAMHP employee is available 24/7 for handling urgent quality defects in an on-call service via rapidalert@fagg.be. The on-call service is reserved for extremely urgent quality defects reports by health care professionals or pharmaceutical companies.
Update your contact information with the FAMHP
To be able to process quality defect reports quickly and efficiently, the FAMHP must be able to contact affected companies at all times.
For urgent cases, production authorisation holders or licensed wholesalers are legally obliged to provide the FAMHP with a telephone number and fax number at which the authorisation holder is available 24/7. This contact information must be up to date at all times.
Any change in contact information must be reported to the FAMHP using the online contact form.
Contact
industry@afmps-fagg.be