1. What is the NAMDMR?
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 NAMMD develops national strategies and policies in the field of medicines and medical devices, under the conditions of the law.
The NAMMD is the national authority competent in the field of medical technology assessment, according to criteria developed by the Ministry of Health.
2. How does the NAMDMR regulate medicines and medical devices?
To achieve objectives in its scope, the NAMMD:
a) regulates activities in the field of human medicines 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 medicine 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 NAMMD not regulate?
The NAMMD does not regulate cosmetic products, dietary supplements, controlled substances and veterinary medicines.
4. How does the NAMMD 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 declared interests do not affect work performed.
5. What funding does the NAMMD receive?
Funding of NAMDMR current and capital expenditure is provided from the state budget.
6. How can payments be made to the NAMMD?
Details of NAMMD bank accounts for payment of its invoices are available here.
7. Why does the NAMMD accept money from the pharmaceutical industry? Is this not a conflict of interest?
Companies have to pay a fee for NAMMD 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 NAMMD and the EMA?
Newest medicines 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 NAMMD are only valid in Romania.
9. How can you explain 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 medicine 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 NAMMD monitors the safety of all medicines in regular clinical practice and throughout their availability on the market.
10. If medicinal product regulations are appropriate, are medicines safe?
There are no risk-free medicines. Some of the risks are known at the time of authorisation, while others are only determined later on. Should authorisation of a medicine be rejected because of a particular risk, very few useful medicines would then be available on the market. There are many very valuable medicines; for authorisation, respective benefits are balanced against known risks and, if benefits provided justify potential risks, the NAMMD authorises the medicinal product for marketing. In addition, the NAMMD 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 be included in a clinical trial?
The NAMMD 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 NAMMD 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 medicines that I no longer need or have expired?
They have to be returned to the pharmacy to be destroyed safely.
16. Are food supplements medicines?
Food supplements are products containing concentrated sources of vitamins and minerals. Regulation of dietary supplements is an attribute of the Ministry of Health and of the National Institute of Research and Development for Food Bioresources (Institutului National de Cercetare – Dezvoltare pentru Bioresurse Alimentare =IBA). As with all food products, since thus 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 dietary supplement, the NAMDMR 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.