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 and dated December 11, 2021. It has been seen that the purpose aimed with the Regulation on Licensing of Human Medicinal Products is reflecting up-to-date processes present in the TMMDA practice but did not exist in the previous regulation dated 2005 and provide compatibility of the legislation with the EU directive numbered 2001/83/EC.
An exception has been introduced for the products to prevent problems with the availability of drugs, which is the only diagnosis or treatment method available for disease in Turkey as acceptance of the transfer application regarding the license/permit or registration certificate without waiting for the court decision. Secondly, with the addition made to the provision on suspension of the marketing authorization, if at least one commercial batch of a licensed human medicinal product is not available in the domestic or foreign markets for an uninterrupted 30 months, the marketing authorization is suspended instead of cancellation. In addition, if the marketing authorization holder fails to notify the Agency at least 30 days before the occurrence of a situation in which the marketing authorization holder will not be able to place a product on the market for any reason, 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 of the request, despite being requested by the TMMDA, the marketing authorization will be suspended. The TMMDA decides on the suspension of the marketing authorization based on the assessment results, including 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 imported products to Turkey. Similarly, it is aimed to initiate an application for the “Declaration of Supply and Maximum Production Capacity” of pharmaceutical companies to the Pharmaceutical Track and Trace System (“ITS”). It has been stated that ITS will be opened for data entry in the first week of each month, and both entries and updates must be completed within the first week of each month. With the processed data, it is thought that the TMMDA can observe the supply and demand balance in the market and intervene to protect public health when needed.