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    Lawyers Işık Özdoğan, LL.M.

    Işık Özdoğan, LL.M.

    Moroğlu Arseven
    [email protected]

    Işık is a specialist in intellectual property, with a global reputation for advising clients on all aspects of counseling, strategy, prosecution, enforcement, litigation, transactions, and regulatory issues. She leads the intellectual property team, supporting a broad portfolio of high-profile companies and intellectual property right owners, at all stages of establishing, commercializing and protecting their assets in Turkey.

    Işık advises and represents clients about trademarks, patents, industrial designs, copyrights, domain names, online infringement, unfair trade, customs processes, as well as seizures of counterfeit or grey market goods, among other issues. Her support spans a range of industries, notably including fashion, retail, luxury goods, FMCG, cosmetics, and pharmaceuticals. She has significant experience supporting foreign clients to navigate local intellectual property issues, often in complex or contentious circumstances with important commercial consequences. She has developed a reputation for offering clear and concise guidance, which considers each client’s expectations and commercial goals in Turkey.


    Practice Areas & Work Department

    Unfair Trade Practices

    Trademarks

    Patents and Utility Models

    Anti-Counterfeiting

    IP Litigation

    IP Portfolio Management

    Copyrights

    Industrial Designs

    Domain Names and Internet Infringement


    Languages

    Turkish

    English


    Memberships

    International Trademark Association (INTA)

    MARQUES

    Pharmaceutical Trade Marks Group (PTMG)

    Association for the Protection of Intellectual Property (AIPPI)

    European Communities Trade Mark Association (ECTA)

    The Regulation on Market Control of Human Medicinal Products Entered Into Force

    The Regulation focuses on market control for licensed medicinal products, active substances, and special medical purpose foods, excluding magistral medicines. Periodic market control activities will be organized based on risk parameters set by the Agency. Samples will be taken from products' locations and active substance production sites. The Regulation outlines responsibilities for sample acceptance and examination. Complaints and identified issues can trigger additional market controls. Risky products found during inspections may undergo routine market control. Violations are subject to sanctions per relevant regulations on medicinal products and foods for special medical purposes.
    Işık Özdoğan, LL.M.

    Beşeri Tıbbi Ürünlerin Piyasa Kontrolü Yönetmeliği Yürürlüğe Girmiştir.

    Yönetmelik kapsamında, (i) Kurum tarafından ruhsatlandırılmış veya izin verilmiş beşeri tıbbi ürünlerin, (ii) bunların üretiminde kullanılan etkin maddelerin, (iii) özel tıbbi amaçlı gıdaların piyasa kontrol faaliyetleri yer almaktadır. Majistral ilaçlar ise Yönetmelik kapsamında değildir. Yönetmelik kapsamında yer alan ürün ve etkin maddeler için belirli periyotlarla piyasa kontrol faaliyeti düzenlenecektir. Piyasa kontrol programına alınacak etkin maddeler ve ürünler, Kurum tarafından belirlenen risk parametrelerine göre saptanacaktır. Belirlenen bu ürünlerin numunelerinin alınacağı yerler İlaç Takip Sistemi verileri uyarınca belirlenecektir.
    Işık Özdoğan, LL.M.

    Guideline on Import Applications and Marketing Authorization has been Updated

    The Turkish Medicines and Medical Devices Agency has updated the Guideline on Import Applications and Marketing Authorization. The updated Guideline, effective from June 5, 2023, includes new procedures such as market authorization for blood products, import procedures for promotional samples, and notifications for the production of pharmaceutical raw materials. Applications can be made electronically, but physical submission of documents may be required. Import transactions should take place at the designated customs office, and specific packaging details and information on packaging companies must be provided. Import notifications should be submitted within 15 days, and rejected notifications can be resubmitted with additional information and documents.
    Işık Özdoğan, LL.M.

    Tıbbi Cihazları ve İn Vitro Tanı Cihazlarını Piyasadan Çekme ve Geri Çağırma Kılavuzu Yayımlandı

    "Tıbbi Cihazları ve İn Vitro Tanı Cihazlarını Piyasadan Çekme ve Geri Çağırma Kılavuzu", Türkiye İlaç ve Tıbbi Cihaz Kurumu'nun (TİTCK) tıbbi cihazların ve in vitro tanı cihazlarının piyasadan çekilmesi ve geri çağırılması konusundaki görevlerini belirleyen bir rehberdir. Kılavuz, TİTCK'nın risk değerlendirmesi yapma, önlemler alarak cihazların geri çekilmesini sağlama, iktisadi işletmelere bilgilendirme yapma, takip etme ve geri çekme/geri çağırma kararlarını bildirme gibi yetkilerini içerir. Ayrıca, iktisadi işletmecilerin sorumlulukları, sınıflandırma kıstasları ve gönüllü çekme/geri çağırma esasları da kılavuzda yer almaktadır. Bu kılavuz, TİTCK tarafından yayınlanmıştır ve piyasadan çekme/geri çağırma süreçlerine ilişkin ayrıntılı bilgiler içermektedir.
    Işık Özdoğan, LL.M.

    Withdrawal and Recall Guideline of Medical Devices and In Vitro Diagnostic Devices has been Published

    The Turkish Medicines and Medical Devices Agency (TITCK) has published a guideline to establish procedures and principles for the withdrawal and recall of medical devices and in vitro diagnostic devices. The guideline outlines TITCK's authority, economic operators' responsibilities and the classification criteria for non-conformity, which is divided into three categories. The responsible enterprise must establish a procedure for the withdrawal and recall of devices, conduct risk-based studies, not supply non-conforming devices to the market, and take relevant measures within the scope of TITCK's withdrawal and recall plans. Economic enterprises not responsible for withdrawal or recall must stop using and putting the devices into service and inform TITCK upon request.
    Işık Özdoğan, LL.M.