Publication
International arbitration report
In this edition, we focused on the Shanghai International Economic and Trade Arbitration Commission’s (SHIAC) new arbitration rules, which take effect January 1, 2024.
Compliance Quarterly Türkiye
Healthcare
Authors:
Global | Publication | August 2024
Global
Digital Health 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.
Read the full International Comparative Legal Guide.
Türkiye
The Turkish Pharmaceuticals and Medical Devices Authority has published Guideline on Good Distribution Practice Audits
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.
Regulation on the Importation of Medical Diagnostic Kits is repealed
The Regulation on the Importation of Medical Diagnostic Kits was repealed according to an announcement by the Turkish Ministry of Trade.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which previously governed the importation procedures and standards for medical diagnostic kits, was officially repealed on May 15, 2024, signifying a change in the regulatory approach to these medical devices.
Recent publications
Publication
ECJ confirms public tenders’ restrictions for companies from third countries with no procurement agreement with the EU
EU Member States may allow companies from countries that have not concluded an agreement guaranteeing equal and reciprocal access to public procurement (public procurement agreement) with the EU to participate in public tenders, provided there is no EU act excluding the relevant country.
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