Publication
Compliance Quarterly Türkiye
In this fifth issue of our Compliance Quarterly, we continue to inform our clients about the global and local compliance rules and regulations which impact Turkish businesses.
Authors:
Global | Publication | August 2024
The rapid convergence of digital technologies with healthcare over the past five years (even prior to the COVID-19 pandemic) has transformed how healthcare is delivered to the masses. The promise of digital technologies continues to transform the healthcare delivery model from a traditional model based on a “one-size-fits-all” practice of medicine that was characterized by a provider-centric approach with information silos, to a new model that is focused on patient-centric treatment personalization with high data accessibility and utilization.
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On February 27, 2024, Turkish Pharmaceuticals and Medical Devices Authority has revised the Guideline on Good Distribution Practice (GDP) Audits, mandating that pharmaceutical businesses with permits undergo inspections to ensure compliance with GDP standards. Identified deficiencies must be remedied within a specified period, with evidence submitted to Authority. Moreover, routine controls by Provincial/District Health Directorates will document deficiencies, requiring businesses to address them within 15 days and submit proof of compliance to Authority.
The Regulation on the Importation of Medical Diagnostic Kits was repealed according to an announcement by the Turkish Ministry of Trade. This regulation, which previously governed the importation procedures and standards for medical diagnostic kits, was officially repealed on May 15, 2024, signifying a change in the regulatory approach to these medical devices.
Publication
In this fifth issue of our Compliance Quarterly, we continue to inform our clients about the global and local compliance rules and regulations which impact Turkish businesses.
Publication
The case of Robert Kneschke v. LAION e.V. marks a significant milestone in the legal landscape concerning the use of copyright works for AI training. As the first of its kind in Germany, the outcome of the case has the potential to reshape the intersection of AI development and copyright law, setting a precedent with broad implications for the AI industry and intellectual property protection. With many stakeholders tracking the case closely, the decision in the case could influence similar legal battles across Europe and beyond.
Publication
On 21 May 2024, the European Council (or Council) adopted the so-called ‘Hydrogen and decarbonised gas market package’ (the Gas Package). The package contains a recast of the 715/2009 gas regulation (Gas Regulation) and a recast of the 2009/73 gas directive (Gas Directive) aimed at reforming the existing EU regulatory framework to support the deployment of renewable and low-carbon gases, in particular hydrogen. As such, it represents a major development in the EU gas market.
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