Market Availability of Products and Parallel Trade

The export of products that are produced for and imported to the Turkish market after being introduced to the market may restrict patients’ access to treatment. Additionally, pharmaceutical products that are purchased at prices significantly lower than those in many other countries and then exported can influence the market prices in other countries. In this context, the Circular No. 2014/11 on the Availability of Pharmaceutical Products in the Market prepared by the Agency outlined the necessary measures to prevent potential pharmaceutical supply issues in the Turkish market.

On 29 December 2023, the Guideline on Export Conditions for those other than Pharmaceutical Wharehouses was published by the Agency and came into effect. The guideline aims for products to be exported by authorised companies which are not pharmaceutical warehouses to comply with Good Distribution Practices and relevant national and international standards. Export of products to other countries without a valid export permit has been prohibited.

Domestic manufacturers or companies that have authorised human medicinal products in Türkiye and/or abroad can export their products either directly through their own companies or via authorised companies. Authorized companies can only apply for an export permit certificate for the products they are authorised to export. If a company is part of or affiliated with a domestic manufacturer or a company that is authorised for pharmaceutical products for human use in Türkiye and/or abroad, it must apply for an export permit certificate for the authorised products. Companies that wish to export products they have manufactured domestically under their own trademark but for which they do not have authorisation, they must also apply for an export permit.

While this guideline aims to prevent the export of pharmaceutical products without the knowledge of the holders of the product authorisation, no legal steps have yet been taken to prevent pharmaceutical warehouses from exporting legal products without the approval of the rightful holders of authorisation.

In 2021, the Guideline on Products which are Counterfeit, Smuggled, or Outside the Legal Supply Chain was prepared to define the responsibilities of stakeholders in combating counterfeit, smuggled or illegal supply chain products, from a public health and safety perspective. The main objective of this guideline is to involve various stakeholders in the fight against counterfeit products and assign specific responsibilities to them. However, some challenges in the implementation process by the Agency may limit the effectiveness of this Guideline in fully addressing the fight against counterfeit pharmaceutical products in Türkiye.