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.
Information for healthcare professionals concerning the granting of EMC or EFC credits for reporting adverse reactions to the NAMMDR
✓ Reporting adverse reactions to the NAMMDR by physicians is credited under the National Continuing Medical Education Programme with 5 EMC credits for one report, but no more than 2 per year.
✓ Reporting adverse reactions to the NAMMDR by pharmacists is credited under the National Continuing Pharmaceutical Education Programme with 10 EFC credits for one report.
We hereby inform you that, in order to be granted EMC or EFC credits, the NAMMDR transmits the physician’s/pharmacist’s personal data from adverse reaction reporting by healthcare professionals to the Romanian College of Physicians and the Romanian College of Pharmacists. Consequently, by reporting adverse reactions to the NAMMDR, healthcare professionals give their consent to the transmission of the physician’s/pharmacist’s personal data from adverse reaction reporting to the Romanian College of Physicians/the Romanian College of Pharmacists, in order to receive EMC/EFC credits.
Please note that EMC/EFC credits are only provided for adverse reactions reported by physicians/pharmacists directly to the NAMMDR and EMC/EFC credits cannot be given for adverse reactions reported by physicians/pharmacists to Marketing Authorisation Holders.
Information about the processing of personal data from adverse reaction reporting
We would like to inform you that the processing and storage of personal data from adverse reaction reporting is performed by the NAMMDR in compliance with the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) adopted by the European Parliament and the Council of the European Union.
We would also like to inform you about the transmission of personal data from the reporting of suspected adverse reactions to vaccines to the National Institute for Public Health (INSP), in accordance with the collaboration protocol agreed between the NAMMDR and the INSP no. 1304/30.01.2020 as further amended and supplemented, in order to investigate cases of adverse reactions, but also in order to process other relevant statistical data, with the possibility of being contacted by the mentioned Institution in order to obtain additional medically relevant information.
The physician’s/pharmacist’s personal data from adverse reaction reporting by them is sent to the Romanian College of Physicians and the Romanian College of Pharmacists, in order to receive EMC and EFC credits.
Hence, by reporting adverse reactions to the NAMMDR, healthcare professionals and patients give their consent to the processing and storage of personal data by the NAMMDR, through the Pharmacovigilance and Risk Management Directorate, as well as to the transmission of this data to the National Institute for Public Health.
Moreover, by reporting adverse reactions to the NAMMDR, healthcare professionals give their consent to the transmission of the physician’s/pharmacist’s personal data from adverse reaction reporting to the Romanian College of Physicians/the Romanian College of Pharmacists, in view of receiving EMC/EFC credits.