The Guideline on Co-Marketing of Medicinal Products for Human Use ("Guideline") contains regulations on the evaluation of marketing authorization applications for co-marketed products and the evaluation of authorized co-marketed products. The Guideline published on February 17, 2023, was updated by the Turkish Medicines and Medical Devices Agency and re-published on June 07, 2024.
The Guideline used to stipulate that if variations are made in the main product that also affect…
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I. Introduction
Law
The Industrial Property Code no. 6769 (““IP Code””) entered into force on January 10, 2017.
Conventions
International Convention (Stockholm) (see Appendix 1); Hague Agreement Concerning the International Registration of Industrial Designs (see Appendix 2); Locarno Agreement for the International Classification of Industrial Designs (see Appendix 3); Patent Cooperation Treaty (see Appendix 4(a)); Strasbourg Agreement Concerning the…
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Law
At national level, the main sources of patent law are the:
Industrial Property Code No. 6769 (IP Code);
Regulation on the Implementation of the IP Code;
Regulation on Employees' Invention, Inventions Realised in Higher Education Institutions and Inventions Realised as a Result of Publicly Funded Projects; and
Regulation on the Implementation of the European Patent Convention Regarding the Grant of European Patents in Turkey.
Conventions
Turkey is a party to almost all…
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Amendments to the Regulation on the Procedures and Principles of Media Services ("Regulation") introduced new rules regarding the content rating for television programs. New rules immediately entered into force upon publication in the Official Gazette dated 13.06.2024 and numbered 32575. The new amendments are particularly relevant for news programs and, in some cases, live broadcast programs.
Highlights of the Amendments:
It is regulated that the Content Rating System will…
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Must an award take any particular form?
Article 14(A) of the International Arbitration Law (IAL) provides that an award must include:
the names, surnames, titles and addresses of the parties, their representatives and lawyers;
the legal grounds on which the award is based and, if there is a claim for compensation, the amount of compensation;
the place of arbitration and the date of the award;
the name, signature and a dissenting opinion, if any, of the arbitral tribunal;…
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Similar as in other countries, trademark squatting is also a common problem which foreign brands face in Türkiye. Trademark squatting creates challenges for market entry and registration of trademarks for foreign companies, as well as leading to dilution of the original trademark. Although there are steps to be taken to better prevent squatters, the current intellectual property (IP) legislation still has effective tools to protect the rights of foreign trademark owners and…
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Amendments to the Law on the Protection of Personal Data (“Law”) entered into force as of June 1, 2024. Please review our detailed article here about the amendments to the Law.
The main actions to be taken by data controllers within the framework of the amendments are briefly as follows:
1. Providing Appropriate Safeguards for Transfers Abroad
Except for cross-border transfers that are irregular, occur on one or a few occasions, are not continuous and are not in the ordinary…
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On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (“Draft”) on its official website and announced that opinions regarding the Draft can be delivered to the Agency. Significant amendment proposals that differ from the current regulation are as follows:
In General
In addition to physicians, dentists, and pharmacists, promotion…
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Pharmaceuticals that are not authorized in Türkiye or authorized but not available on the market shall be procured from abroad as per a special authorization and on a case by case basis (Named Patient Program-NPP). This supply can be conducted by public institutions approved by the Ministry ofHealth that are defined as Foreign Pharmaceutical Suppliers (Suppliers) and currently constitute theSocial Security Institution and the Turkish Pharmacists Association. The Suppliers can…
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The Turkish Constitutional Court (“Court”) annulled paragraph 12 of Article 77 of the Consumer Protection Law, which granted the Advertisement Board the power to partially or entirely block access to websites containing unlawful advertising content. The relevant rule was considered to be unconstitutional pursuant to the Court’s decision dated 13 September 2023 and numbered 2022/70 E. - 2023/152 K.
In its decision, the Court ruled that the scrutinized legal rules do not meet…
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The Advertisement Board ("Board") closely monitors the discount sales campaigns, which have become a tradition in e-commerce, held in November and known as "Legendary November Discounts", "Fabulous Friday Discounts", where discounts at various rates are announced for a large number of products. The Board imposes administrative sanctions on discount sales advertisements and practices that deceive and mislead consumers and create the perception that there is a higher price…
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Brand communication of alcoholic products to consumers is strictly prohibited in Türkiye and there is full prohibition of advertisement of alcohol, any manner in all forms of media. This ban includes broadcasts on TV and radio, advertisements in cinema, product placement, printed media, as well as advertisements on social media and digital platforms.
Alibi branding is an alternative mechanism for promotion of alcohol brands and in fact, this is a grey area. Although there is…
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