Regulations on Medical Devices numbered 2017/745 (“MDR”), prepared by the EU Commission, has been published and will enter in force on 26 May 2020. As a non-EU country, TITCK published an announcement on 30 December 2019 that harmonization of the new rules established by the MDR with the Turkish regulations continues.
On 1 February 2020, Presidential Circular numbered 2020/1 was published in Official Gazette numbered 31026 on the transition period for the UK’s exit from…
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With medicines, the rule is clear: The general public cannot be the audience to any promotional activity, whatsoever, of pharmaceutical products. However, with medical devices, the rule in place in the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Medical Device Promotion Regulation”) has caused confusion in the past. The rule states that medical devices that must exclusively be applied by healthcare personnel, and those that are included in the…
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The Regulation on the Importation, Production, Processing and Supply of the Food Supplements (the “Regulation”) was published by the Ministry of Food and Forestry (the “MoA”) on 2 May 2013 in the Official Gazette, and came into force as of 2 August 2013.
The said Regulation is not only the first regulation that has been drafted, particularly on food supplements, but also includes unique provisions with regard to the control and approval mechanism to be established over food…
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The packaging and labelling requirements for cosmetic products are regulated under Cosmetic Law numbered 5324 (the “Law”) and the Regulation on Cosmetics (the “Regulation”) of the TITCK of the MoH.
In addition to the Law and the Regulation, the Guidelines on the Promotional Activities of Cosmetic Products and the Regulation on the Health Claims of the Products that are Offered for Sale with a Health Claim (“Health Claim Regulation”) are still applicable, which means…
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The protection of personal data and personal health data is regulated under Personal Data Protection Law (“DPL”) numbered 6698. The DPL provides that the general rule for the processing of personal data is that such data may only be processed with the explicit consent of the data subject.
As for sensitive personal data (data relating to race, ethnic origin political beliefs, philosophical beliefs, religion, denomination or other faiths, clothing and attire, membership of an…
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In a recent decision, the Federal Court of Germany ruled that the platforms displaying third party products as search results for the searches based on keywords that are identical to a trademark on e-commerce web sites shall be liable for breaches in the trademarks rights, in the event that these platforms use an algorithm with an active role in determining the products to be displayed. The Court has also decided that AdWords ads directed to these lists also constitute a…
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Dicle Doğan and Fatma Sevde Tan, Gun + Partners
On 18 February 2020, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language), stating that the Price Evaluation Commission had raised the Euro exchange rate to be used in pricing of the drugs to TRY3.8155 for 2020. The new exchange rate became effective on 19 February 2020.
By way of background, the Euro exchange rate used for approving drug prices in Turkey is determined as per the…
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Dicle Doğan and Fatma Sevde Tan, Gun + Partners
On 27 February 2020, the Turkish Medicines and Medical Devices Agency published Guidelines on the Import of Research Products to be used in Clinical Research (Turkish language). Pursuant to the Regulation on Clinical Research published in the Official Gazette dated 13 April 2013 and numbered 28617, permission from the agency is required for the manufacturing and import of products to be used in clinical research conducted in…
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THE FIRST DETAILED INFORMATION WAS PROVIDED REGARDING THE POST-GRANT OPPOSITION SYSTEM BEFORE THE EUROPEAN PATENT OFFICE (“EPO”)
FICPI-Turkey held the ninth of its traditional roundtable meetings at Turkish Patent and Trademark Office (“Türk Patent”) on 13 December 2019. The meeting was moderated by Selin Sinem Erciyas, who is the Vice President of the Board of Directors of FICPI-Turkey and Serkan Özkan, who is an Intellectual Property Expert at Türk Patent. The post-grant…
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Following the enactment of The Law on Amendment of Certain Laws No. 7226 (“Law”), which entered into force upon publication in the Official Gazette dated 26 March 2020, the terms determined as per the Industrial Property Code (“IP Code”), applied either by the Turkish Patent and Trademark Office (“Office”) or before the relevant courts as statute of limitations for filing lawsuits, has been suspended.
As per the Law, all terms suspended for the period between March 13, 2020…
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In scope of the measures taken to prevent COVID-19 outbreak from spreading within our country, the Presidential Decree on Suspension of the Enforcement and Bankruptcy Proceedings dated 21 March 2020 and numbered 2279 (“the Presidential Decree”), which was issued based on Article 330 of the Enforcement and Bankruptcy Act, has entered into force upon publication in the Official Gazette dated 22 March 2020 and numbered 31076.
As per this Presidential Decree, all of the…
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The Law on Amendment of Certain Laws No. 7226 entered into force upon publication in the Repeated Official Gazette dated 26 March 2020 and numbered 31080. With the Law No. 7226, the procedural terms will be suspended until 30 April 2020 in order to prevent any loss of rights in regard to trials, due to the measures taken for COVID-19 outbreak.
In this respect;
Any and all terms in scope of the acquisition, use or extinction of a right, including the terms for filing…
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