The export of products manufactured and imported for the Turkish market, may restrict patients' access to treatment after their launch. In addition, pharmaceutical prices in Türkiye are much cheaper compared to many other countries, and this has an impact on prices in other markets. The Circular No. 2014/11 on the Availability of Medicines in the Market issued by the Agency stated that necessary measures will be taken to prevent problems in pharmaceutical supply that may occur in the Turkish market.
On 29 December 2023, the Agency published Guidelines on the Conditions for Pharmaceutical Export Made by Companies Other than Pharmaceutical Warehouses (the "Guidelines"). The Guidelines has been prepared to ensure the shipment and export of pharmaceutical products and dietary foods for special medical purpose in compliance with national and international standards, while protecting public health.
The Guidelines aims to ensure that authorized companies export products by good distribution practices and relevant national and international standards. The export of the products without a valid export permit has been prohibited.
Domestic manufacturers or companies that have licensed pharmaceutical products in Türkiye and/or abroad in their own name will be able to export their products through their own companies or their authorized companies. These authorized companies will be able to apply for an export permit only for the authorized products. Domestic producers or a company controlled and affiliated with a company with a pharmaceutical product for human use licensed in its own name in Türkiye and/or abroad should apply for the issuance of an export permit for the products they have been authorized. Companies without a license but wishing to export products domestically manufactured under their own trademarks should also apply for an export permit.
Export-authorized companies must demonstrate their connections with Turkish market authorization holders through the trade registry gazette and to have a company registration on the Agency's electronic application system (EBS).
Both the company holding the marketing authorization and the exporter will be jointly and severally liable for the transactions carried out. In the event of any problems with the products exported by such companies, the authorized exporter is obliged to inform the health authority of the country of export and the Agency.
With these new rules, it is evident that the supervision mechanism for pharmaceutical exports has also been improved in addition to the monitoring and supervision of pharmaceutical manufacturing, import, and distribution through the Drug Tracking System (ITS) developed by the Agency. Unauthorized and uncontrolled exports of pharmaceuticals, which have been increasing over the last decade, are expected to decrease thanks to the conditions imposed by the new Guidelines. The introduction of regulations on exports is beneficial for the industry, especially as there are increasing examples of products imported into Türkiye being exported without the authorization and knowledge of the marketing authorization holders and products being sold in various countries, sometimes without complying with the required conditions of special storage, transportation and distribution, which subsequently harms public health. Although everyone is expected to comply with the Circular on the Availability of Medicines in the Market, it was impossible to prevent parallel exports without the control mechanisms outlined in the Guidelines. Legal barriers are now preventing pharmaceutical warehouses or other entities from exporting drugs without proper authorization from the Agency and the necessary notifications of the products are made through the ITS.
The Guidelines is an important reference source for pharmaceutical exporters and provides guidance on a wide range of issues, from authorization processes to the responsibilities of companies and the required documentation. Therefore, companies should carefully review the new regulations outlined in the Guidelines and update their export procedures accordingly.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.