Submitting a medicinal product quality complaint

What is a medicinal product?

Medicinal product:
a) any substance or combination of substances presented as having properties of treating or preventing disease in human beings; or
b) any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis;

To check if the product you wish to file a complaint for is a medicinal product, please search for it here.

If the product you are complaining about is not a medicinal product or if your complaint does not strictly refer to quality but to other aspects (e.g. price, pharmacy activity), please contact the following competent authorities, as appropriate:

– The Ministry of Public Health – The Directorate for Medicines and Medical Device Policy
– The National Authority for Consumer Protection
– The National Sanitary, Veterinary and Food Safety Authority

What information does the National Agency for Medicines and Medical Devices of Romania need in order to solve your complaint?

The information you provide is very important to us. In order to solve your complaint, we need information such as:
– product’s name;
– manufacturer;
– batch, date of manufacture and expiry date mentioned on the product’s packaging;
– details of the issue (what, when, where, how it happened);
– if possible, copies of the prescription, medical documents and receipt for the product purchase as well as any other information that could help us evaluate the complaint;
– your contact details

Complaints must be submitted in writing to the National Agency for Medicines and Medical Devices:
– by mail: 48 Av. Sănătescu, sector 1, Bucharest 011478
– by fax: 0213163497
– by e-mail: click here

Please provide your contact details. During the complaint resolution process, if necessary, we will contact you in order to obtain additional information and upon completion we will notify you in writing of the outcome of our investigations.