1. What is the NAMMDR?
The National Agency for Medicines and Medical Devices of Romania is a public institution operating as a legal entity subordinated to the Ministry of Health, set up by law, following the merger of the National Medicines Agency with the Medical Devices Technical Office.
The NAMMDR develops national strategies and policies in the field of medicinal products and medical devices, under the conditions of the law.
The NAMMDR is the competent national authority in the field of medical technologies assessment, according to the criteria developed by the Ministry of Health.

2. How does the NAMMDR regulate medicinal products and medical devices?
To achieve objectives in its scope, the NAMMDR:
a) regulates activities in the field of human medicinal products and medical devices, through the Ministry of Health, to ensure application of the legal framework and setup of specific regulatory provisions;
b) develops national policies and strategies in the field of the medicinal product and medical devices;
c) supervises and checks compliance with regulations specific to its scope;
d) represents the state or the Ministry of Health internally and externally in its field.

3. What does the NAMMDR not regulate?
The NAMMDR does not regulate cosmetic products, food supplements, controlled substances and medicinal products for veterinary use.

4. How does the NAMMDR ensure objectivity of its assessors?
Each staff member submits a declaration of interests, each family member included and the respective head of department ensures that the declared interests do not affect the activity performed.

5. What funding does the NAMMDR receive?
The NAMMDR is self-funded from funds consisting of the collection of fees charged according to the legislation in force; the financing of the NAMMDR is also provided from the state budget.

6. How can payments be made to the NAMMDR?
For invoice fees issued in foreign currency (EURO): IBAN account = RO39RNCB0080164254290007
For invoice fees issued in LEI: IBAN account = RO09TREZ70120G365000XXXX
For accommodation expenses: IBAN account = RO41TREZ23G665050100113X
For transport expenses: IBAN account = RO74TREZ23G665050200601X

7. Why does the NAMMDR accept money from the pharmaceutical industry? Is this not a conflict of interests?
Companies have to pay a fee for NAMMDR operations such as assessment of dossiers submitted for marketing authorisation, or assessment of advertising and educational materials. Such assessments are carried out by staff with no interests in the pharmaceutical industry.

8. What is the difference between the NAMMDR and the EMA?
The newest medicinal products are authorised by the European Medicines Agency (EMA), thus ensuring their availability in all Member States as well as their standardised use in all EU Member States. Any EMA authorised medicinal product may be marketed in all EU Member States, whereas authorisations granted by the NAMMDR are only valid in Romania.

9. How can you explain the occurrence of several adverse reactions after authorisation of medicinal products?
For the purposes of authorisation, medicinal products are only tested in a relatively small number of patients and therefore rare adverse reactions remain undetected at that time. Use in current medical practice means exposure to the respective medicinal product of a much greater number of patients, in an uncontrolled environment, which increases the possibility of detecting unexpected, rare and sometimes serious adverse reactions. To identify any new safety issues, the NAMMDR monitors the safety of all medicinal products in regular clinical practice and throughout their availability on the market.

10. If medicinal product regulations are appropriate, is the medicinal product safe?
There are no risk-free medicinal products. Some of the risks are known at the time of authorisation, while others are only determined later on. Should authorisation of a medicinal product be rejected because of a particular risk, very few useful medicinal products would then be available on the market. There are many very valuable medicinal products; for authorisation, respective benefits are balanced against known risks and, if benefits provided justify potential risks, the NAMMDR authorises the medicinal product for marketing. In addition, the NAMMDR ensures that the public is informed about the risks so that decisions can be made.

11. I’m leaving on vacation. Can I take my medication with me abroad?
Yes, if it is for personal use. At the same time, however, we recommend that you also take a few documents, a copy of the medical prescription or a letter from your family doctor, explaining the presence of your medication.

12. What do I have to do in order to be included in a clinical trial?
The NAMMDR does not recruit volunteers to take part in clinical trials. We recommend you talk to your doctor.

13. I would like to report an adverse drug reaction
If you think you or another person is experiencing an unwanted or harmful reaction, please let us know. You can do this using the “Report an adverse reaction” section.

14. Can you make suggestions about my current treatment or my health condition?
The NAMMDR cannot provide advice to every patient regarding their treatment. We suggest discussing this with your doctor or a pharmacist.

15. What should I do with the medicinal products that I no longer need or have expired?
Expired and/or unused medicinal products from the population will be collected at public or private hospitals, which are obliged to receive them for their final disposal.

16. Are food supplements medicinal products?
Food supplements are products containing concentrated sources of vitamins and minerals. Regulation of food supplements is an attribute of the Ministry of Health and of the National Institute of Research and Development for Food Bioresources (Institutul National de Cercetare – Dezvoltare pentru Bioresurse Alimentare = IBA). As with all food products, since this is prohibited by both food-specific and medicinal product-related legislation, food supplements may not legally claim a medicinal effect. To establish the medicinal product status of a product marketed as a food supplement, the NAMMDR investigates its ingredients and studies its public presentation. Generally, medicinal product regulations do not apply to products only containing vitamins and minerals, unless they are placed on the market to treat or prevent illnesses or health hazards.

17. I cannot find the answer to my question. How can I contact the NAMMDR to answer my question?
You can send an e-mail to secretariat@anm.ro or dial the phone numbers in the “Contact us” section.