On 29 December 2023, the Turkish Medicines and Medical Devices Agency ("Agency") has published Guidelines on the Conditions for Pharmaceutical Export Made by Companies Other than Pharmaceutical Warehouses (the "Guidelines"). The Guidelines has been prepared in order 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 products are exported by authorized companies in accordance with Good Distribution Practices and relevant national and international standards. It has been prohibited to export products without a valid export permit.
Domestic manufacturers or companies that have licensed pharmaceutical products in Turkey 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 expert permit only for the authorized products. Domestic producers or a company controlled and affiliated with a company that has a pharmaceutical product for human use licensed in its own name in Turkey and/or abroad should apply for the issuance of an export permit for the products which they have been authorized. Companies that do not have a license but wish to export products domestically manufactured under their own trademarks should also apply for an export permit.
Export-authorized companies are required to demonstrate their connections with Turkish license 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 license and the exporter will be jointly and severally liable for the operations and 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 in addition to the monitoring and supervision of the pharmaceutical manufacturing, import and distribution supervised through the Drug Tracking System (ITS) developed by the Agency, the supervision mechanism for pharmaceutical exports has also been improved. Unauthorized and uncontrolled exports of pharmaceuticals, which have been increasing over the last 10 years, are expected to decrease thanks to the conditions imposed by the new Guidelines. The introduction of regulations on exports is considered to be beneficial for the industry, especially as there are increasing examples of products imported into Turkey being exported without the authorization and knowledge of the marketing authorization holders, and products being sold in various countries, sometimes without complying with the special storage, transportation and distribution conditions required to apply to the product, which subsequently harms health. Although everyone is expected to comply with the Circular on the Availability of Medicines in the Market, it was not possible to prevent parallel exports in the absence of the control mechanisms outlined in the Guidelines. There are now, legal barriers preventing pharmaceutical warehouses or other entities from exporting drugs without proper authorization obtained from the Agency.
The Guidelines is an important reference source for pharmaceutical exporters and provides guidance on a wide range of issues, from authorisation processes to the responsibilities of companies and the required documentation. It is therefore recommended that companies 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.
