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Global rules on foreign direct investment (FDI)
Cross-border acquisitions and investments increasingly trigger foreign direct investment (FDI) screening requirements.
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Global | Publication | October 2022
Turkish Medicine and Medical Devices Agency (Agency) has announced the results regarding the supervision and audit of cosmetic and biocidal products such as hand disinfectants, antibacterial liquid soaps and fly repellents which directly contacts with human body for the period between October to December of 2021. Accordingly, administrative fines aggregate amount of which is (i) TL 1,480,000 is imposed on the liable companies regarding incompliance of biocidal products and (ii) 310,000 is imposed on the liable companies regarding incompliance of cosmetic products by the Cosmetic Audit Chamber. Furthermore, a number of biocidal and cosmetic products is found incompliant with the regulations or unlicensed.
The Regulation on Pharmaceutical Businesses and the Products Stored under Pharmaceutical Businesses (Regulation) is published on 15 June 2022 and repealed the Regulation on the Pharmaceutical Warehouses and the Products Stored in Pharmaceutical Warehouses. The Regulation aims to regulate the principles and procedures for the purchase, sale, storing, brokering, distribution, export and transportation of products and active substances in compliance with good distribution practices and locally and globally established standards. The Regulation covers the pharmaceutical business opened and to be opened as per the Law No:984 on Pharmacy Trading Houses and Law No: 1262 on on Pharmaceutical and Medical Preparations and Regulation on Promotional Activities of Human Medicinal Products.
The Regulation on Medical Device Clinical Research is published in the Official Gazette dated 8 July 2022 (Regulation) and entered into force on the date of its publication with the purpose of regulating the procedures and principles regarding post-marketing studies and medical device clinical trials and protecting the rights of the volunteers participating in these trials, within the framework of international agreements which Turkey is party to, European Union standards and good clinical practices. The Regulation covers post-market studies and medical device clinical trials, the places where research can be conducted and the real persons or legal entities who will carry out researches. It is noted that retrospective studies and performance evaluation studies with vitro diagnostic medical devices are outside the scope of the Regulation. The Regulation further states that clinical trials shall find a field of application by referring to the relevant provisions in the Regulation. All financial responsibilities of the clinical trial shall belong to the sponsor and, if applicable, its legal representative, contracted research institutions to which the task has been transferred, and the research team. It is further regulated that no fee shall be charged to the volunteers for any investigational product used in the study, any materials for the use of these products, the cost of examination, examination, analysis and treatments. Researches are recorded in a public database, provided that the confidentiality of personal data is regarded.
Turkish Medicines and Medical Devices Agency (Agency) published the Regulation on the Amending the Regulation on Safety of Drugs on 21 July 2022. The amendment sets forth a definition for district pharmacovigilance manager and his/her obligations as provincial health director to appoint the relevant head or vice-president of the provincial health directorate as the provincial pharmacovigilance officer and informs the Agency of this person's name and contact information. The amendment further stipulates obligations to the Agency in case of any update by the license owner of the risk management plan. Furthermore, the Agency will be able to account the evaluations made by other comparable drug authorities or regional/international institutions within the scope of trust and share information.
Publication
Cross-border acquisitions and investments increasingly trigger foreign direct investment (FDI) screening requirements.
Publication
On February 2, 2024, the Belgian Presidency of the Council of the European Union confirmed that the Committee of Permanent Representatives had signed the Artificial Intelligence (AI) Regulation, referred to as the AI Act. Approval by the EU Parliament followed on 13 March 2024, and the AI Act is likely to appear in the EU’s Official Journal around May 2024. The AI Act aims to establish a stringent legal framework governing the development, marketing, and utilisation of artificial intelligence within the region, thereby marking a significant advancement in the regulation of this burgeoning domain.
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The private credit market and direct lending have grown and diversified immensely in the past decade, offering alternative sources and terms of debt compared to those historically provided by the syndicated leveraged loan and public issuance markets. Consequently, they are fast becoming pivotal components in the capital ecosystem, so much so that the Bank of England consider that the private credit market is currently responsible for approximately $1.8 trillion of debt issuance, which is four times its size in 2015. This growth has been particularly pronounced in Europe and the US but there has also been significant activity in Asia.
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