The Istanbul Civil Court for Intellectual and Industrial Rights has granted a preliminary injunction to remove a pharmaceutical product from the foreign drug list of the Turkish Medicines and Medical Devices Agency (TMMDA). The drug was supposed to be supplied via the named patient programme (NPP) and was removed on the grounds of patent infringement. Further, the supplier company has been prevented from directly or indirectly commercialising the product, which includes its…
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Civil Procedure Code No. 6100 (“CPC”) entered into force on 01 October 2011 by replacing the former Civil Procedure Code No. 1086. One of the most significant mechanisms introduced by the CPC was preliminary examination.
Under Turkish law, first stage of a trial is the initiation of a lawsuit and exchange of petitions, which is followed by the preliminary examination. During the preliminary examination, the court examines the causes of action, initial objections, points of…
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Sensitive and non-sensitive personal data can be transferred abroad if the explicit consent of the data subject is obtained.
Furthermore, other legal grounds will also apply to the transfer of personal data to the foreign country. However, the destination country must have “sufficient protection” in order to conclude the transfer abroad based on legal grounds (except for having obtained explicit consent). A list of jurisdictions that provide sufficient protection is to be…
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Sensitive and non-sensitive personal data may be transferred to third parties if the explicit consent of the data subject is obtained, or if one of the additional legal grounds is applicable for such transfer.
The Data Protection Law does not provide a definition for a third party; therefore, any individual or entity (other than the data controller and the data subject) may be considered a third party. This creates a problem, especially in relation to transfers between data…
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On 19 February 2021, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language), stating that the foreign exchange rate between the euro and Turkish lira for drug prices would be raised to EUR1 to TRY4.5786 as of 20 February 2021.
The euro exchange rate used for approval of drug prices in Turkey is determined as per the Decision on the Pricing of Human Medicinal Products (decision). Pursuant to the decision, the euro exchange rate is…
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On 14 March 2021, the Turkish Medicines and Medical Devices Agency published the Guidelines on Applications for Electronic Scientific Meetings and Electronic Product Promotion Meetings (Turkish language). Electronic meetings have become more important because of the COVID-19 pandemic, and the guidelines have been published to answer questions raised in practice. They also introduce stricter rules for electronic meetings.
Key provisions of the guidelines are as…
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