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The National Authority for Quality Management in Health (ANMCS) is a public institution with legal personality, a specialized body of the central public administration in the field quality management in health, which operates under the Government and the coordination of the Prime Minister.

The purpose of ANMCS is to ensure and continuously improve the quality of health services and patient safety, through the standardization and evaluation of health services and accreditation health units.

ANMCS is financed from own revenues and subsidies granted from the state budget, through the budget of the General Secretariat of the Government.

The National Institute of Public Health is a public institution with legal personality, subordinate to the Ministry of Health, which carries out public health assistance, coordinating technical and methodologically, the specialized activity in the field of substantiation, elaboration and implementation of strategies regarding the prevention of diseases, the control of communicable and non-communicable diseases, the control of health in relation to the living and working environment and of public health policies in specific fields, at national and regional level.

Sănătate. Farmacie. e-Health - activitati INSP
Sănătate. Farmacie. e-Health - activitati INSP2
Sănătate. Farmacie. e-Health - activitati INSP3

National Health Insurance House (CNAS) is a public, autonomous institution of national interest, with legal personality, specialized body of the central public administration, whose main object of activity is to ensure the unitary and coordinated functioning of the social health insurance system in Romania.

CNAS subordinates the county health insurance companies (CAS), the Bucharest Municipality Health Insurance Company (CASMB) and the Defense, Public Order, National Security and Judicial Authority Health Insurance Company (CASAOPSNAJ).

During 2022, the population's access to medical services, medicines and medical devices in a fair and non-discriminatory manner was ensured by concluding contracts with all providers who met the evaluation/accreditation criteria. Thus, 25,297 contracts and additional documents were concluded through health insurance companies in all fields of medical assistance.

Sănătate. Farmacie. e-Health - tipuri de asistenta medicala1

The evolution of contracts and additional documents concluded in the period 2018-2022, by type of medical assistance:

Sănătate. Farmacie. e-Health - tipuri de asistenta medicala2

In the year 2022, compared to the year 2021, the number of contracts and additional documents concluded by the social health insurance funds with the medical service providers was in a slight decrease (approximately 1.27%). The fields of healthcare that registered a slight increase are the dental clinic (4.12%), the paraclinical clinic (3.24%) and hospitals (0.72%), and the areas that registered a slight decrease are medical devices in outpatient (2.57%) and primary medicine (2.51%).

On 31.12.2022, there were 10,144 family doctors under contract with health insurance companies, which had a number of: 16,355,740 insured and 3,748,592 beneficiaries of medical services from the minimum package.

Ministry of Health is a specialized body of the central public administration, with legal personality, subordinate to the Government of Romania and represents the central authority in the field of health care public health.

The Ministry of Health has the following departments, respectively specialized structures::
  • Direction of human resources policy in health;
  • Directorate of human resources policies in health;
  • The control body of the ministry;
  • General Legal Directorate;
  • Heritage and acquisitions department;
  • Directorate of personnel and sanitary structures;
  • General economic direction;
  • State sanitary inspection;
  • General direction of project implementation and monitoring;
  • General direction of medical assistance;
  • General Directorate of Public Health and Health Programs;
  • Pharmaceutical and Medical Devices Directorate;
  • Directorate for monitoring implementation of regional hospitals;
  • World Bank Project Management Unit.
The main objectives of the Directorate for the policy of medicine and medical devices in 2022 consisted of:
  • authorization and supervision of pharmaceutical establishments;
  • authorizing and supervising activities with drugs, narcotic and psychotropic substances and preparations;
  • regulating the field of medicines and medical devices and approving the maximum prices of medicines for human use;
  • the elaboration of the legislative framework corresponding to these objectives in compliance with the regulations of the European Union and the other international treaties to which Romania is a party.
The direction has the following structure::
  • Drug pricing and policy service;
  • Pharmaceutical department and medical devices;
  • Regulatory department in the field of psychotropics and narcotics;
  • Department coordinating the evaluation of medical technologies.
  • The Pharmaceuticals and Medical Devices Division accomplished the following:
    • Issuance of operating authorizations for newly established retail pharmaceutical units: 149 operating authorizations for rural pharmacies, 12 operating authorizations for closed circuit pharmacies and 53 drugstores;
    • Issuance of operating authorizations for pharmaceutical retail distribution units in the event of a change in the legal entity holder (sale/takeover of authorizations) as a result of the change of the initially issued operating authorization, as well as in the event of the loss of the operating authorization (issue of a duplicate): 393 changes of to the holder-legal person, with the issuance of a new operating authorization, 4 duplicates of the operating authorizations, following their loss;
    • The entry of mentions in the operating authorization through the issuance of annexes, as a result of the modification of the initial authorization conditions, materialized by the issuance of a total number of 4261 annexes to the operating authorizations;
    • Supervision and control inspections in order to resolve some complaints: 29;
    • Addresses for responses to complaints submitted by County Pharmacists' Colleges and certain natural and legal persons (without travel within the territory): 72.
    • Updating the database for pharmaceutical retail distribution units and displaying them on the website of the Ministry of Health, in accordance with the provisions of Law 266/2008, republished, with subsequent changes and additions, by introducing a number of approximately 3282 changes;
  • The regulatory department in the field of psychotropics and narcotics is the specialized structure of the Ministry of Health through which the control of compliance with the legal regime of plants, narcotic and psychotropic substances and preparations is exercised, at the national level, according to Law no. 339/2005. The department's activity in 2022 consisted of the analysis and verification of documentation, the preparation and release of:
    • 6 authorizations for activity with narcotics and psychotropics - distribution and storage;
    • 26 medical office permits;
    • 3 ambulance permits;
    • 3 research permits;
    • 3 authorizations for laboratories;
    • 477 import authorizations for narcotics and psychotropics;
    • 347 export authorizations issued by economic agents for drugs with narcotic and psychotropic content;
    • 18 manufacturing authorizations for narcotic drugs and psychotropics issued to producers;
    • 150 certificates of possession of drugs with narcotic and psychotropic content for patients traveling to another state;
    • 1,306 approvals issued to units authorized for the activity with narcotics and psychotropics (i.e. pharmacies, pharmaceutical warehouses, medicine manufacturers, medical service provision units, ambulance services) to start the procedure for destroying narcotic and psychotropic products of inadequate quality, products with a deadline of expired and returned narcotics from deceased patients;
    • Carrying out 2 surveillance inspections
    • 100 updates of the authorizations due to the change of the headquarters/offices, of the responsible persons, substance lists, etc.;
    • Response to 48 petitions and interpellations specific to the field of regulation and control in the field of narcotics and psychotropics;
  • The drug pricing and policy service carried out the following activities in 2022:
    • Regular updating of the catalogs containing medicines for human use authorized to be placed on the market in Romania (i.e. CANAMED and CATALOGUL PUBLIC);
    • Correction and updating of the prices of medicines for human use included in the catalogues;
    • Starting and completing a number of about 90 files by ensuring the procedures regulated by the Order of the Ministry of Health no. 85/2013 and Ministry of Health Order no. 1540/2021, with subsequent amendments and additions, in order to ensure the availability of medicines on the Romanian market in situations of temporary, permanent discontinuity or lack of them on the market in our country;
    • the elaboration of normative acts in the field of the prices of medicines for human use authorized to be placed on the market, as well as in the field of medicines secured by the authorization procedure for special needs;
    • the elaboration of answers to the questions formulated by the members of the Romanian Parliament, the petitions/requests addressed to the ministry or directly to DFDM by other structures of the ministry, in the field of activity specific to the structure;
    • collaboration with DAPP/DAPP representatives and authorized distributors through the special needs procedure for the efficient management of the availability of insured medicines on the Romanian market;
    • collaboration in the field of activity with the National Agency of Medicines and Medical Devices in Romania, the National Health Insurance House, other institutions and other structures of the ministry in the process of developing some normative acts, strategies and proposals in order to improve the legislative framework;
    • the completion in February 2022 of the process of correcting the prices of medicines for human use authorized to be placed on the market in Romania started in 2021, a process that required an important resource of time and involves a significant volume of information/documents subject to analysis.

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