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A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
Published on: October 6, 2023
Cross-border healthcare: Directive 2011/24 and the Greek law
Abstract:
The Greek legal framework on healthcare is characterized by the complexity of an immense number of laws and regulatory acts, particularly regarding the national health system. In the face front of that problem, the Directive stands as an effort (and an opportunity) to achieve a regulatory rationalization. The Law 3918/2011 established the National Organisation for Healthcare (EOPYY). EOPYY is the unique national contact point in the country for the purposes of the Directive, having a responsibility to ensure that the services provided by its affiliated healthcare providers meet certain quality and safety standards. Furthermore, the Greek legal system encompasses an integrated body of legislation on informed consent, privacy, and data protection, as well as an explicit reference to the 'quality, safety and efficiency' of medical services, and provisions related to reimbursement issues that need further regulatory specification.
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