Cancelled Mandatory Accreditation for Health Facilities

Cancelled Mandatory Accreditation for Health Facilities

Last week, the Resolution of the Cabinet of Ministers No. 215, adopted on March 13, 2019, came into force, amending the procedure for accrediting a health care institution and the licensing conditions for carrying out economic activity in medical practice.
The completion of the accreditation is now voluntary. Although, in this case, the institutions without the accreditation certificate will be able neither issue sick leaves nor provide medical services in the areas of assisted reproductive technology and transplantation, or conduct clinical trials.
The accreditation of medical institutions is initiated upon their receiving a license to carry out the economic activities for medical practice, a license to carry out the economic activities for the production of medicines, the wholesale and retail trade in medicines, the import of medicines, with the exception of the active pharmaceutical ingredients. Previously, the licensed institutions had to wait for the period of two years before applying for the accreditation.
The extraordinary accreditation may be initiated by a medical institution in order to be upgraded not before than a year after the preliminary accreditation was approved by the Ministry of Health.
On the results of the extraordinary accreditation, the main Accreditation Commission may decide whether to assign a certain accreditation category to the institution or to lower the category level of the institution or to revoke the accreditation certificate.
The time required to prepare documents for the accreditation is also reduced. From the list of the documents, submitted for the accreditation, the form No. 20, the mandatory statistical reporting, was withdrawn.
For the institutions with the reformed legal status, that is from public into municipal non-commercial enterprises, the validity of the accreditation certificate will be extended without the accreditation procedure.
The Cabinet of Ministers abolished the use of the local protocols for medical care, regarding the licencing terms.
The medical institutions with all forms of ownership are required to make public the information about the availability of the medicines, the consumables, the medical devices and food products for a special dietary consumption.
The government also recalls that on December 27, 2017, the changes for the implementation of the economic activities in health practice were made to the Licensing Conditions, that helped to reduce the volume of documents, required to obtain a license. In particular, the sanitary and epidemiological inspection of the subject was seized. These changes involve health care institutions and individual entrepreneurs, providing primary medical care.