The Guideline on the Scheduling Process of Applications for Marketing Authorization for Medicinal Products for Human Use

The Turkish Medicines and Medical Devices Agency (the "Agency") published the Guideline on the Scheduling Process of Applications for Marketing Authorization for Medicinal Products for Human Use (the “Guideline”) on 12 October 2023, and it will come into effect on 1 January 2024.

The Guideline as developed to establish procedures and principles regarding the scheduling processes for applications for medicinal products for human use for which the preliminary assessment is found appropriate after review by the Agency. As per the Guideline, the Agency will release two monthly lists on its official website. The first will include active substances awaiting scheduling for human medicinal product marketing authorization applications for which preliminary evaluation has been approved and the second list will contain active substances for human medicinal products for which the marketing authorization process has started. These lists will be updated in the first week of each month.

If multiple first biosimilar product applications exist among marketing authorization applications for medicinal products for human use with preliminary approval, the marketing authorization process will only proceed for the first three applications based on their application date, in accordance with Article 7 of the Guideline.

Application files are assesed by the Preliminary Review Unit in the order of their application date. Medicinal products for human use that receive preliminary approval will be included in the scheduling list, prioritized by group category and their application date within that group.

Applications submitted prior to the implementation of the Guideline are not subject to its provisions.

You may review the Guideline in Turkish from here.