Medicines quality defects
Report of suspected deviation from the quality standard (medicine quality defect)
The following persons are obliged to report the medicine quality defects to CInMED:
– marketing authorization holders
– legal and natural persons performing manufacture or marketing of medicines
– healthcare/veterinary professionals that come into contact with the medicine, or with its user
– clinical trial sponsors.
When the patient suspects or notices defects in the quality or packaging of the medicine, it is necessary to contact and report the quality defect to the pharmacist who dispensed the medicine in question, or to the doctor who prescribed it.
Medicine quality defect shall be reported in writing using the Form for reporting the medicine quality defect .
Information about a possible quality defect shall be submitted to CInMED in the following manner:
In person, or by mail to the CInMED address:
Institute for medicines and medical devices
Bulevar Ivana Crnojevića 64a
By e-mail to the address: [email protected]
Reports and documentation submitted via e-mail should also be submitted in person, or by mail to the CInMED address.
If you do not receive the receipt confirmation from CInMED within 12 hours from the moment of sending the report via e-mail, please contact CInMED via telephone to the number:
+382 (20) 310 280 local 41 (within the working hours)
More detailed information on the procedure for reporting, providing infprmation and evaluating documentation on deviations from quality standards of the medicine, as well as the measures and activities taken in relation to the quality defect class are available in the Instruction for handling the reports on the medicine quality defects.