The New Regulation on Licensing of Human Medicinal Products prepared by the TMMDA entered into force upon its publication in the Official Gazette numbered 31686, dated December 11, 2021. The Regulation on Licensing of Human Medicinal Products reflects up-to-date processes present in TMMDA practice that were absent in its previous iteration dated 2005, and provide compatibility with the EU directive numbered 2001/83/EC.
In order to ensure supply continuity an exception for drugs that are the only diagnosis or treatment method available for a disease in Turkey has been introduced. Allowing the approval of license/permit/registration certificate transfers without the need of a court decision. Furthermore, if at least one commercial batch of a licensed human medicinal product is not available in domestic or foreign markets for an uninterrupted 30 months, the market authorization will be suspended instead of cancelled. In addition, if the marketing authorization holder fails to notify the Agency at least 30 days before the marketing authorization holder is for any reason unable to supply a product to the market, fails to fulfil other obligations listed in the Regulation, or if the medicinal product for human use which is essential for public health and the sustainability of access to medicines, is not placed on the market by the marketing authorization holder within 6 months from the date when it is requested by the TMMDA, then the marketing authorization will be suspended. The TMMDA decides on the suspension of the marketing authorization based on results of an assessment that include the safety of the relevant nonconformity.
At the end of 2022, an export ban was introduced to guarantee the availability of products in the market and to prevent the export of products imported to Turkey. There is also a desire to encourage “Declaration of Supply and Maximum Production Capacity” by pharmaceutical companies to the Pharmaceutical Track and Trace System (“ITS”). It has been stated that the ITS will be open for data entry during the first week of each month, and that both entries and updates must be completed within the first week of each month. It is thought that the TMMDA will be able to leverage this data to observe the supply and demand balance in the market and intervene to protect public health when needed.