The National Agency for Medicines and Medical Devices of Romania (NAMMDR), a public institution subordinated to the Ministry of Health, operates on the basis of Law no. 134/2019 on the reorganisation of the National Agency for Medicines and Medical Devices, as well as for the amendment of some ruling provisions and of the Regulation on the organisation and operation of the National Agency for Medicines and Medical Devices of Romania, approved through Order of the Minister of Health no. 857/2022.
The NAMMDR is the competent national authority in the field of medicinal products for human use, medical devices and medical technology assessment of medicinal products for human use, high-performance medical devices and equipment, self-funded from the collection of tariffs charged according to the legislation in force and subsidy granted from the state budget.
In achieving the objectives in its field of activity, the NAMMDR collaborates with the Ministry of Health, central and local public administration institutions, professional organisations, as well as with other national and international organisations in the healthcare field.
The NAMMDR actively participates, through its experts appointed as members, in the meetings of the scientific committees and working groups of the European Medicines Agency (EMA) as well as of other European bodies in the field of the medicinal product and medical devices.

The areas of activity of the NAMMDR consist of:
– the authorisation of medicinal products for human use, of the manufacturing and wholesale distribution units of medicinal products for human use;
-surveillance of manufacturing and wholesale distribution units and of the quality of medicinal products placed on the market and in-use control of medicinal products for human use;
– inspection for surveillance of the activity of community pharmacies, local distribution offices, closed circuit pharmacies and drug stores at least once every 5 years or whenever required;
– regulation of the field of medical devices;
-supervision of the market of medical devices;
– approval of units performing marketing activities and services in the field of medical devices;
– the registration of medical devices placed on the market or put into operation in Romania, national manufacturers, authorised representatives, importers and distributors of medical devices;
– the inspection and control of medical devices in use;
-the issuance of free sale certificates for medical devices;
– the issuance of customs approvals, in line with the provisions of Article 12 b) of Order of the Minister of Health no. 1009/2016 on registration of medical devices into the national database, as further amended and supplemented;
– the assessment, designation and monitoring of bodies performing the assessment of compliance in the field of medical devices;
– medical technology assessment of medicinal products for human use, medical devices and high-performance equipment;
– authorisation of clinical investigations for medical devices and assessment of the performance of in vitro diagnostic medical devices;
-authorisation of clinical trials for medicinal products for human use, as well as of the sites where these studies are carried out;
-monitoring the safety of medicinal products for human use through pharmacovigilance activity.

Strategic objectives of the NAMMDR:
– Protection and promotion of public health, by accomplishment of the NAMMDR primary role, namely the warranty of compliance of authorised medicinal products with the required standards, related to their quality, efficacy and safety;
– Protection and promotion of public health, by accomplishment of the NAMMDR primary role, namely the warranty of compliance of medical devices with the required standards, their efficacy and their acceptable level of safety;
– Ensuring access for the patients to safe, effective and good quality medicinal products and medical devices;
– increasing the capacity for intervention and prevention of the entry of falsified medicinal products and medical devices into the legal supply chain (authorised for distribution);
– Fulfilment of the NAMMDR role of communication, as an expert and reliable source of accurate and timely information related to the medicinal product for human use, by providing clear and timely information to healthcare professionals, patients, the pharmaceutical industry and the general public;
– Permanent contribution to the shaping of the legal frame in the field of medicinal products for human use, medical technologies assessment and medical devices by promoting effective collaboration of the NAMMDR at European and international level;
– Increasing the NAMMDR contribution to providing scientific expertise within the European medicinal products and medical devices regulatory networks.

Brief history
For over 50 years now, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) has represented the medicinal product regulatory authority in Romania and, since 2015, the competent national authority in the field of medical devices and medical technologies assessment, as well.
Initially known as the Institute for the Control Medicines and Pharmaceutical Research, on its setup in 1956, the name of the institution was further changed in 1960, to become the State Institute of Drug Control and Pharmaceutical Research (ICSMCF) and later on, between 1999 – 2010, by reorganisation of the former ICSMCF, the institution operated as the National Medicines Agency. The National Agency for Medicines and Medical Devices of Romania (NAMMDR) is established through Emergency Government Ordinance no. 72/2010, as result of the merger of the National Medicines Agency with the Technical Office for Medical Devices.
The decisive step in the evolution of the National Medicines Agency, as of 1999, was the adoption of specific landmarks, to constantly direct its policies and practice, i.e. European landmarks, primarily those of the then newly-founded European Medicines Agency (EMEA, nowadays EMA).
On 01.01.2000, according to Order of the Minister of Health no. 802/1999, the structure of the National Medicines Agency also included the Centre for the State Control of Biological Products for Human Use.
By the time of joining the EU in 2007, the NMA had had the opportunity to assign 26 active observers for participation in EMA scientific committees and working groups.
Due to Romania’s accession in 2003 to the European Convention on elaboration of a European Pharmacopoeia, the latter’s quality standards have become mandatory for all raw and starting materials as well as for medicinal products manufactured both in Romania and abroad.
In June 2006, Romania became visible on the EudraNet map, by successful NMA connection to the computer network of European competent authorities in the field of medicinal products for human and veterinary use, under permanent coordination and monitoring of the EMA.
As early as 1958, the Ministry of Health set up its own laboratory for technical testing of medical devices. The laboratory operated as an independent legal entity under the Ministry of Health until 1973, when it became a technical distinct entity within the Station for Verification and Maintenance of Medical Devices (SVMMD).
On 1 February 2005, the SVMMD was reorganised through Law no. 176/2000 (republished), under the name of the Technical Office for Medical Devices (TOMD). Through call for European funds, the only medical devices certifying body in Romania was established in this institution, also notified in Brussels.
As of 10.10.2014, through the publication in the Official Gazette of Law no. 132/2014 on approval of Government Emergency Ordinance no. 2/2014 on amendment and supplementation of Law 95/2006 on healthcare reform, as well as for the amendment and supplementation of certain regulatory acts, the NAMMD, through its Regulatory Department for authorisation and market surveillance, is the competent and decision-making authority for medical devices, taking over its powers from the Ministry of Health.
Government Decision no. 315/23.04.2014 redefined the main attributions of the NAMMD in the field of the medicinal product for human use, including the elaboration of the list of reimbursed and free medicinal products, in collaboration with the Ministry of Health and the National Health Insurance House. The NAMMD becomes, from this date, the competent national authority in the field of medical technologies assessment.
Later on, through the emergence of Law no. 134/2019 on the reorganisation of the National Agency for Medicines and Medical Devices, as well as for the amendment of certain regulatory acts, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) was established as a public institution with legal personality and as a specialised body of the central public administration, subordinated to the Ministry of Health, maintaining its quality as a competent national authority in the field of medicinal products for human use, medical devices and health technologies assessment.
This new regulatory act concerned the organisation and financing of the public institution, in order to strengthen and increase its ability to achieve its mission and objectives, to contribute to the protection and promotion of public health and to fulfil its specific duties established by law.
With the emergence of this Law, the staff scheme was expanded (the maximum number of positions being 500), a provision intended to significantly improve the institutional capacity of the competent authority from human resources viewpoint, in accordance with the complexity and diversity of its attributions and the activities that derive from these.
The changes were also related to the structuring of the institution, on general directions, directions, services, bureaus and compartments, offering the possibility, within the organisational structure, through decision of the NAMMDR president, to organize laboratories, units for territorial inspection and/or control and surveillance of the medicinal product market/surveillance of the medical devices market/in-use medical devices, for approval of activities in the field of medical devices, as well as for control through periodic assessment of medical devices, in compliance with the maximum approved number of positions.