The transfer of pharmaceutical marketing authorizations (“MA”) entails intricate and interconnected procedures. Especially when it comes to imported pharmaceuticals, comprehensive contracts control the process when the foreign licensor company gives a license to a distributor in Türkiye and the products are offered for sale in the Turkish market. Before the MA transfer application is submitted to the Turkish Medicines and Medical Devices Agency (“Agency”), the license transfer procedures are initiated when it is decided to end the contractual arrangement and transfer of the product licenses to another distributor. In this context, MA transfers may occasionally be subject to commercial disputes even before the official application, and various disputes may arise both before and after the MA transfer.
For this reason, once the relevant parties agree since reconciliation in registration transfers – which have a complicated process and can take a long time – it is imperative to manage the formal application before the Agency precisely and swiftly.
The Regulation on the Licensing of Human Medicinal Products (the “Licensing Regulation”) regulates the applications and procedures for the transfer of pharmaceutical MA. With the Guideline on Circumstances Requiring Reissue of a MA for Licensed Pharmaceutical (the “Guideline”), which was published by the Agency last year, in addition to the provisions of the Licensing Regulation, several provisions regarding the information and documents to be submitted in transfer applications were introduced. This year, the Agency made some amendments to the Guideline, and the revised Guideline was published on the official website of the Agency on July 3, 2024.
In line with the amendments made, the scope of the Guideline has been widened, and the Guideline currently contains regulations on the business and procedures related to the following issues:
a) (i) MA transfer procedures, (ii) transition to certified MA, (iii) lost MA / certificate issuance procedures mentioned in the Licensing Regulation.
b) Transactions to change the place of manufacture from abroad to domestic or from domestic to abroad as referred to in the Regulation on Variations in Licensed Human Medicinal Products.
The regulations in question are thought to demonstrate the Agency’s intention to enhance its regulations regarding MA transfers with regard to commercial relations and concerns. It is believed that the ongoing disputes within the current legislative framework may provide insight into this improvement. Consequently, it is expected that the Agency will eventually take the collection of rules it plans to create beyond the guidelines and turn them into legally binding regulations that will apply to everyone.