Legal & Regulatory > Turkey

Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of similar Court of Appeal decisions.   For pharmaceuticals in particular, negative declaratory relief is considered as an effective market-clearing tool. Anyone with an interest in a pharmaceutical product sufficient to…

The shockwaves from the UK’s exit from the European Union have resounded across the continent, including in Turkey, where the country’s pharmaceutical and medical devices regulator has had to adjust its guidance on CE-mark certified devices. Leading lawyers from top Turkish law firm and PharmaBoardroom legal partner Moroğlu Arseven explain the current situation.   CE Certificate Requirement in Turkey The Regulation on CE Marking, published in the Official Gazette on, and effective as of, 23 February 2012 (the “Regulation”) governs…

The COVID-19 pandemic continues to spread rapidly across the globe amid critical supply shortages of medical devices and medicines. The rapid spread of the virus, on the one hand, threatens supply chains and causes shortages, on the other hand, it also strengthens global solidarity.   Brands from different sectors make an effort towards helping in the fight against the pandemic. Fashion brands are manufacturing masks, luxury cosmetic brands are supporting disinfectant manufactures, the entrepreneur ecosystem swept into seeking alternative ways to…

The low-down on the situation regarding biosimilars & biologics in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? Generic medicines include identical molecules with the original reference product, and these molecules are small and chemically stable molecules produced through chemical synthesis. However, biosimilar is the name…

The ins and outs of localization in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Localization is a developing and ongoing plan in Turkey. Increasing employment, attracting foreign investment, and maintaining the quality reached…

Keen to learn more about orphan drugs & rare diseases in Turkey? Read on! Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in your country? There is no definition of rare diseases in Turkey.   2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition…

The legal framework for regulatory reforms in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? No proposals for reform exist or are expected in the short term. However, minor amendments of existing laws and regulations may occur. The Draft Regulation on the Registration, Surveillance and Tracking…

Patents and trademarks in Turkey – an overview. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? Both patents and trademarks are regulated under the Industrial Property Rights Law numbered 6769 entered into force on 10 January 2017 (“IP Law”). Any sign, including words, shapes, colours, letters, numbers,…

An insight about product liability in Turkish Pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Medicinal product liability arises from the Code of Obligations as tort liability and contractual liability, as well as from the Consumer Protection Law. To claim under tort law, the claimant must prove the existence…

The lowdown on the situation regarding traditional medicines and OTC products in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are pharmaceutical preparations which have specific indications for use, which are specifically administered according to the specified dose and posology,…

Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications…

Preclinical and clinical trial requirements in Turkey – a legal guide. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for drugs are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Clinical trials for medical devices are regulated…

An intro to the legal situation for regulatory, pricing and reimbursement in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Turkey’s Ministry of Health (“Ministry”) is the main regulatory and responsible authority for drugs, biologicals and medical devices. Regulatory authorities with jurisdiction…