Regulation Amending the Regulation on Therapeutic Apheresis Centers and Units
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Published on April 2, 2026, this Ministry of Health regulation amends the 2019 Regulation on Therapeutic Apheresis Centers and Units. It clarifies and expands the definition of peripheral blood stem cell collection to explicitly include hematopoietic stem cells mobilized into peripheral blood from patients or donors via apheresis following mobilization procedures. The regulation updates the scope of activities permitted at therapeutic apheresis centers, now explicitly including the temporary safe storage of collected peripheral blood stem cells until they are transferred to a cell processing unit. It also corrects terminology in physical facility requirements, replacing 'döşeme' (flooring/furnishing) with 'zemin' (floor/ground), and restricts where such centers may be established—prohibiting placement in areas designated solely for support services without medical service units. Important staffing restrictions are introduced: responsible specialists and technical supervisors must work full-time and are prohibited from simultaneously holding the title of responsible specialist or technical supervisor at more than one private healthcare facility. This dual-employment ban applies to both physician and non-physician technical supervisors. Finally, the transitional provision is updated to protect the existing rights of personnel who hold therapeutic apheresis certificates issued under the previously repealed 2019 regulation, ensuring continuity for certified practitioners. The regulation entered into force on its publication date.
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Key Changes
- Redefined 'peripheral blood stem cell collection' to explicitly cover hematopoietic stem cells mobilized post-mobilization and collected via apheresis from patients or donors
- Expanded the permitted activities of therapeutic apheresis centers to include temporary safe storage of collected peripheral blood stem cells until transfer to a cell processing unit
- Prohibited therapeutic apheresis centers from being established in areas designated solely for support services without medical service units
+ 3 more changes with Pro
Obligations
What this law requires
Therapeutic apheresis centers must explicitly include hematopoietic stem cells mobilized into peripheral blood from patients or donors via apheresis following mobilization procedures within the definition of peripheral blood stem cell collection activities.
Therapeutic apheresis centers must provide temporary safe storage of collected peripheral blood stem cells until transfer to a cell processing unit.
Therapeutic apheresis centers must not be established in areas designated solely for support services without medical service units present.
Responsible specialists (sorumlu uzman) must work on a full-time basis and are prohibited from simultaneously holding the title of responsible specialist or technical supervisor at more than one private healthcare facility.
Technical supervisors must work on a full-time basis.