Health regulation passed the commission

Administrative fines ranging from 500 thousand lira to 5 million lira will be imposed on those who sell, advertise, distribute and market medical devices and provide technical services outside of the places permitted by the Ministry and the procedures determined.

Administrative fines within the scope of the regulation will be increased by one for each recurrence detected within one year. The Turkish Medicines and Medical Devices Agency and the highest civil administrator of the locality will be authorized to implement the administrative fine.

With the amendments to the Health Services Fundamental Law, the Turkish Medicines and Medical Devices Agency will be able to request all kinds of financial information and documents, including those prepared electronically, from real or legal persons and public institutions and organizations within the scope of the inspection of products and services falling within its scope of duty.

The Ministry of Health and its affiliated and related institutions will determine the criteria for products and services used in the field of health informatics and technology and decide on their suitability. In addition, the Ministry of Health and its affiliated and related institutions will inspect medical devices, products, information management systems, software and systems that can exchange data with information management systems within the conditions stipulated in the relevant legislation and the procedures and principles determined by the Ministry.

According to the amendment to the Public Procurement Law, regulations will be made to ensure that medical products produced by the Presidency of the Turkish Health Institutes (TÜSEB) and companies with more than half of their capital belonging to TÜSEB will be directly purchased by other public administrations operating in the field of health and to rapidly meet the needs of public administrations.

With the amendment to the Law on Optometry, opticians will be obliged to keep records regarding their establishment activities in accordance with the procedures and principles determined by the Ministry of Health.

Those who act contrary to optician practices will be given administrative fines ranging from 100 thousand lira to 1 million lira.

If the prohibitions within the scope of "optic practices", "optic institution", "responsible manager", "being in the institution", "exceptions", "optic title", "registration" and "audit" in the Law are repeated within 5 years, the administrative fine will be applied twice and the optician who violates "optic practices" for the third time within this period will be banned from the profession for one year.

The proposal also includes regulations regarding the opticians-opticians chambers and the Turkish Opticians-Opticians Association, in line with the annulment decision of the Constitutional Court.

Accordingly, opticians and opticians who are not members of chambers, with the exception of those who work in primary and permanent positions in public institutions and organizations and public economic enterprises, and pharmacists who have an optician's license and who practice pharmacy activities together in the same place, will not be able to engage in professional activities.

Natural persons and private legal entities who want to open and operate an optician's establishment will be obliged to register their establishments with the trade or tradesmen registry they are affiliated with within 30 days and have it announced in the registry gazette.

A chamber will be established in each province with at least 150 registered professionals within its borders. Chambers will gain legal personality by reporting their establishment to the Ministry of Health through the Union Central Executive Board.

The organs of the opticians-opticians chambers will consist of the "General Assembly", the "Board of Directors" and the "Disciplinary Board".

In line with the proposal accepted by the commission, the "Audit Board" is added to these bodies.

The general assembly will be formed by the members registered in the chamber and will meet once a year in September. If a majority is not reached in the first meeting, a meeting will be held the next day with the current members.

The proposal determines the number of members and duties of the general assemblies, boards of directors, disciplinary boards and audit boards of the chambers of opticians and opticians.

The Turkish Opticians-Opticians Association will consist of a "Grand General Assembly", a "Central Executive Board", a "Central Supervisory Board", and a "High Disciplinary Board". The Grand General Assembly will consist of representatives elected in the general assemblies of the chambers.

In the general assemblies of the chambers, from among the members who have completed 5 years of actual professional experience, to represent the chamber in the Grand General Assembly; 5 representatives will be elected for chambers with 150 members, 5 representatives for chambers with up to 300 members, plus one member for every 75 members over 150, and 7 representatives for chambers with more than 300 members, plus one member for every 300 members over 300, a Grand General Assembly representative and an equal number of substitute representatives.

The Grand General Assembly will meet once every two years in November. In addition to the ordinary meeting, an extraordinary meeting will be held upon the written request of one third of the Grand General Assembly representatives or the Central Executive Board. If a majority cannot be reached at the first meeting, a meeting will be held the next day with the representatives present.

The proposal determines the duties of the organs of the Turkish Opticians-Opticians Association.

With the article to be added to the Law on Optometry, members of the profession who do not fulfill the duties assigned to them by the law and other legislation related to the profession, who engage in actions and behaviors that do not comply with the honor of the profession, or who act contrary to the decisions of the General Assembly will be subject to "reprimand", "fine" and "suspension of professional practice". The regulations stipulate the conditions for "reprimand", "fine" and "suspension of professional practice".

The proposal amends the Decree Law No. 663 on Certain Regulations in the Field of Health, in line with the annulment decision of the Constitutional Court.

Accordingly, a fee not exceeding 2 million liras will be charged according to the tariffs to be determined by the Ministry for all kinds of licensing, product production and sales permits, responsible directorate certificates, permits and certificates to be issued or approved by the Ministry and its affiliated institutions. These tariffs will be applied each year by increasing them according to the revaluation rate determined and announced in accordance with the relevant provision of the Tax Procedure Law for the previous year, effective from the beginning of the calendar year. However, no fee may be charged for documents that are encouraged to be obtained by the Ministry.

Licenses that authorize real or legal persons to provide a certain service in the field of health or to open hospitals and similar health institutions, within the framework of the plans of the Ministry and its affiliated institutions, will be issued by the Ministry and its affiliated institutions for a price to be determined by auction. The granting of a license will not replace the permit or license required for the relevant activity. The procedures and principles of granting a license will be determined by the Ministry.

Within the scope of the regulation, the amounts collected from licenses and permits will be recorded as revenue in the general budget or in the budgets of affiliated institutions with special budgets, depending on the relevance; 75 percent of the amounts collected within the scope of licenses will be recorded as revenue in the International Health Services Corporation, and 25 percent in the general budget.

The proposal includes regulations that will ensure that personnel employed under contract will be subject to the same practices as other civil servants who have similar status due to their acts and behaviors that violate discipline.

It will be possible to assign expert personnel to district health directorates with a district population of over 100 thousand.

Pharmacies, pharmaceutical businesses and license or permit holders shall bring the records of drugs that they have notified to the tracking system before March 15, 2025 but do not have in their actual stock, or the records of drugs that they have not notified to the tracking system but have in their actual stock, in line with the actual situation by making the necessary notifications on the tracking system within 3 months from the date of publication of the regulation, excluding narcotics, psychotropic and controlled drugs. Sanctions will not be imposed on those who eliminate non-compliances within the framework of this regulation.