The Medical-Treatment Facilities Act defines the medical treatment facilities as organizationally separate structures on functional principle in which physicians or dentists, individually or with the assistance of other medical and non-medical specialists, carry out diagnostics, treatment and rehabilitation of patients, follow-up care of patients, consultations, prophylactics, etc. A new type of medical treatment facility has been introduced with the latest amendments to the Medical-Treatment Facilities Act1 – an organizationally separate structure in which medical assistants, nurses, midwives or rehabilitators provide and carry out independently health care, manipulations and activities related to health promotion, prevention and prophylactics of diseases.

The medical treatment facilities are established under the Commerce Act in observance of the Medical-Treatment Facilities Act which provides for numerous special requirements – i.e., with regard to the name, scope of activity and management of the company (the medical treatment facility).

The medical treatment facilities carry out their activity only upon obtaining a permit or being registered under the conditions and by the procedure set forth in the Medical-Treatment Facilities Act. Medical treatment facilities for outpatient care are subject to registration and those for hospital care need to obtain a permit in order to legally carry out their activity. This article covers the procedure for registration of medical treatment facilities for outpatient care – ambulatories for primary or specialized medical care (individual or group practices), ambulatories for health care, medical centers, diagnostic and consultative centers, independent medical diagnostic laboratories, dental centers, etc.

The procedure is regulated by Art. 40 et seq. of the Medical-Treatment Facilities Act. The registration is performed by the Executive Director of the Executive Agency “Medical Supervision”, keeping public register of the medical treatment facilities. Registered medical treatment facilities are provided with a certificate of registration.

Application and Necessary Documents

The registration procedure commences with an application – in a standard form to be found on the website of the Executive Agency “Medical Supervision”. The application should be submitted to the respective Regional Health Inspectorate – personally or through an authorized person (e.g., a lawyer).

The application should contain information about the unified identity code of the company or cooperation from the Commercial Register and the following documents need to be enclosed thereto:

Rules on the organizational structure, activity and internal order of the medical treatment facility;

Names of the persons – shareholders or stockholders of the company or members of the cooperation, establishing group practice;

Diploma for the respective higher education of the persons who will manage or, respectively, work in the medical treatment facility;

Document for acknowledged specialty of the persons who will manage or, respectively, work in the medical treatment facility;

Documents for paid state fees.

Pursuant to the latest amendments to the Medical-Treatment Facilities Act there will be no longer a requirement to present permit by the competent state authority where medical equipment with a source of ionizing radiation will be used in the medical treatment facility; instead, it has been provided that the availability of such permit will be established ex officio as part of the compliance examination process as described here below.

On the day of receiving the application the Regional Health Inspectorate sends ex officio a request to the Bulgarian Medical Association, the Bulgarian Dental Association, the Bulgarian Association of Professionals in Health Care and the Bulgarian Dental Technicians Association, for issuance of certificates for entry in their registers of the physicians, dentists, medical assistants, nurses, midwives, rehabilitators or dental technicians, who will manage and/or work in the medical treatment facility.

The circumstances regarding criminal convictions of the persons – members of the management and supervisory bodies of the medical treatment facility, when they are Bulgarian citizens, are to be established ex officio2. The persons – members of the management and supervisory bodies, who are not Bulgarian citizens, should present a conviction status certificate or other similar document.

Processing of the Application

Within 10 days from submission of the application the Regional Health Inspectorate examines the compliance of the medical treatment facility with the health requirements and the approved medical standards, as well as checks for the availability of license for use of ionizing radiation sources for medical purposes (when the medical treatment facility will use medical equipment with ionizing radiation source). Where it finds that the respective requirements in the medical treatment facility have not been met, the Regional Health Inspection gives instructions and provides a time period for their rectification, which may not be longer than three months.

Within three days after the check has been performed and the requested certificates have been obtained, the Director of the Regional Health Inspectorate sends the documents to the Executive Agency “Medical Supervision”.

In case of incompleteness of the presented documents the Executive Agency “Medical Supervision” informs the applicant about that (in writing and within 10 days) and provides a time period for its rectification.

Within one month from the receipt of the documents, the Executive Director of the Executive Agency “Medical Supervision” issues a certificate of registration of the medical treatment facility or gives a motivated refusal to register the medical treatment facility.

Fees

Pursuant to the Tariff on the Fees Collected under the Medical-Treatment Facilities Act: for obtaining a certificate of registration as a medical treatment facility for outpatient care a state fee in the amount of 52 Levs is due upon initial entering into the register.

Pursuant to the Tariff on the Fees Collected by the State Health Control Authorities and the National Centers for Public Health Affairs under the Health Act: upon registration of a medical treatment facility a state fee in the amount of 92 Levs is due for carrying out an examination for observance of the health requirements.

Footnotes:

1 The article has been updated on 13.07.2020 in connection with amendments to the Medical-Treatment Facilities Act (effective as of 16.06.2020).

2 The article has been updated on 14.01.2018 in connection with amendments to the Medical-Treatment Facilities Act (effective as of 01.01.2018).