An adverse reaction is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
Adverse reactions may also arise after medication overdose, misuse, abuse and medication errors.
Any patient/consumer or healthcare professional (physician, pharmacist, nurse, midwife etc.) can report suspected adverse reactions occurring after the use of human medicinal products, including those occurring after the use of vaccines.
The National Agency for Medicines and Medical Devices of Romania (NAMMDR) encourages the reporting of adverse reactions and provides the following reporting channels:
| If you have reported an adverse reaction to NAMMDR using one of the above-mentioned channels, please share your opinion about this experience by contacting us by email at: adr@anm.ro. Your feedback is important; it will help us to improve our interaction with you. |
| If you have any questions or concerns regarding how to report an adverse reaction to NAMMDR, you may send an email to: adr@anm.ro or call us at: +4031 423 2419 (available on Monday-Thursday, 09:30-16:30 and on Friday, 9:30-14:00). |
| Please be informed that the suspected adverse reactions can also be reported to the marketing authorisation holder (MAH) of the involved medicinal product. MAH details are available in section 6 of the Package leaflet of the product. If you choose to send the report to MAH, we recommend not to report the same adverse reaction to NAMMDR, in order to avoid creating duplicate reports in the European database of adverse reactions to medicines, named EudraVigilance. |
If you experience an adverse reaction to a medicinal product and need a medical advice, please contact your treating physician, a pharmacist or nurse. Only they are qualified to give you recommendations on the medical measures needed to be taken.
The National Agency for Medicines and Medical Devices of Romania cannot provide medical advice. In case of a medical emergency, call 112!
If a child has been poisoned with a medicine, a chemical substance, or has ingested caustic soda, acids, call the TOXAPEL service! TOXAPEL is intended to inform the population on how to provide first aid to a poisoned child until ambulance arrives or until hospital admission.