Reporting a suspected quality defect of a medicinal product

CInMED must be notified without delay of any suspected deviation from the quality standards of a medicinal product (quality defect), as well as of any suspicion of the presence of falsified medicines on the Montenegrin market, in the manner described below.

Who should report a suspected quality defect?

Reports on suspected quality defects may be submitted to CInMED by:

• Marketing authorization holders;
• Manufacturers of medicinal products;
• Wholesalers;
• Healthcare professionals;
• Veterinary professionals;
• Sponsors of clinical trials;
• The Ministry of Health, the competent Veterinary Authority, the Customs Administration, the Ministry of Interior, or other state institutions;
• Whistleblowers – usually employees involved in the manufacture of medicinal products or in the manufacturer’s quality control laboratories;
• Employees of CInMED.

If a patient suspects or notices deficiencies in the quality or packaging of a medicine, they should report the suspected defect to the pharmacist who dispensed the medicine or to the physician who prescribed it.

How to submit a report of a suspected quality defect?

1.   In person or by post to the following address:
   Institute for Medicines and Medical Devices
   Bulevar Ivana Crnojevića 64a
   81000 Podgorica
   Montenegro
2.   By e-mail to: [email protected]
   If you do not receive confirmation of receipt within 12 hours after submitting a report by e-mail, please contact CInMED by telephone at the numbers listed below.
3.   By telephone
   +382 20 310 280 (working days, 07:00–15:00)
   +382 69 512 779 (emergency mobile phone for urgent reports outside working hours, weekends, and public holidays).

What should be submitted?

When submitting a report of a suspected quality defect, the completed Reporting Form for Suspected Quality Defects or Deviations from Quality Standards must be provided, together with supporting documentation, where applicable.

More information

Detailed information on the procedure for reporting suspected quality defects, as well as on the measures and activities undertaken depending on the defect classification, can be found in the Guideline for Reporting a Suspected Quality Defect of a Medicinal Product.