Updates in Licensing Regulations for Medical Practice

Adjustments to licensing regulations for medical practice are now both necessary and an opportunity for enhancing the quality and efficiency of medical service provision. These new requirements are a response to the swift and constant changes in the healthcare sector, aiming to uphold legality and adhere to European standards of medical practice.

The changes in licensing conditions for economic activities within the medical practice sector, introduced by Government Resolution No. 1393 of December 27, 2023, "On Amendments to Licensing Conditions for Economic Activities in the Field of Medical Practice," have become pivotal aspects of regulation. These adjustments are integrated into Cabinet of Ministers Resolution No. 285 of March 2, 2016. Among the notable initiatives is the stipulation for ensuring unimpeded access for mobility-impaired population groups to medical facilities. However, this aspect represents only one facet of these modifications.

This article covers all the significant innovations in licensing conditions for conducting economic activities within medical practice and their impact on the operational dynamics of healthcare facilities.

Inclusivity of Premises, Specifically the Obligation to Ensure Access for Mobility-Impaired Population Groups

This entails providing the specified category of citizens with the opportunity to freely access medical facilities, ensuring convenient movement within them and on the surrounding premises, physical safety, unimpeded entry, and easy navigation.

Essentially, it is established that every medical institution must provide conditions for unrestricted access to mobility-impaired population groups. This applies to every location where medical activities are conducted, whether it be a healthcare institution or the practice of an individual entrepreneur. In the case of multiple buildings or premises within a medical institution, the document certifying compliance with inclusivity requirements must now be provided for each of them.

This document is issued by a specialized entity holding the relevant qualification certificate. Information from this document is incorporated into the records concerning the state of the material and technical base, as well as the presence of personnel with the indication of their educational and qualification levels.

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Prohibition on Managing Healthcare Facilities by Residents of Aggressor Countries

This prohibition extends to license applicants, license holders, and their successors. They are not permitted to be under the direct or indirect control of residents of states engaging in armed aggression against Ukraine and/or whose actions create conditions for the emergence of a military conflict and the use of military force against Ukraine.

Protocol for Handling Suspensions and Restorations of Medical Licenses

For the first time, the procedure for actions in case of suspension or restoration of a medical license has been defined. This includes the approval of forms for relevant statements. In the event of a full suspension of the license for a period not exceeding six months, the licensee is required to submit a statement of the established format to the licensing authority. If the licensee intends to restore the license, they must submit a statement to the licensing authority for full restoration of the license and provide information on the elimination of the circumstances that led to the full suspension of its operation.

Please note: Before the license is restored, the licensee must completely cease medical practice.

Documents Preparation, Submission, and Storage

The recent changes introduce specific requirements for documenting the status of material and technical resources, as well as the presence of personnel with indications of their educational and qualification levels:

• Documents prepared by license applicants, license holders, or license successors must be in the state language and signed by the respective individual, namely the licensee or successor, or another authorized person.
• For documents submitted in hard copy, they must be printed in a 12-point font size. Handwritten submissions must be filled out using printed letters and digits.
• For documents submitted electronically, it is mandatory to include an electronic digital signature.
• Page numbering is now required.
• The requirement for binding and sealing information with a stamp has been removed.

Legal Assistance for Healthcare Facilities: Swift Adaptation to New Licensing Regulations

In accordance with the recent Resolution, enterprises holding licenses for economic activities in the medical field before March 30, 2024, are required to submit details regarding their material and technical resources, as well as the qualifications of their staff, to the licensing authority within one year. This must be done while considering the amendments discussed in this article.

Given the complexity and extent of these changes, having an experienced attorney with a thorough understanding of the medical industry is essential. Our law firm offers expert support to healthcare facilities and professionals, assisting them in comprehending, adjusting to, and implementing the updated requirements.

We provide comprehensive solutions to ensure legal compliance under the revised licensing regulations, ensuring seamless operations amidst evolving regulatory landscapes. Contact us to maintain stability and confidence in your medical practice.

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