EUROPEAN HEALTH DATA SPACE

EUROPEAN HEALTH DATA SPACE

EUROPEAN HEALTH DATA SPACE

On April 24, 2024, the European Parliament approved the proposal for a regulation establishing the creation of the European Health Data Space. This innovative initiative aims to improve access to personal health data across the European Union, safeguarding the interests of the citizen in securely sharing information, by giving you full control over your data. This new paradigm will also allow the use of health data in electronic format for research and public health purposes, under certain conditions, improving decision-making based on concrete data, reducing waste arising from the repetition of complementary diagnostic means and drive improvements in healthcare.

REFORM OF EUROPEAN PHARMACEUTICAL LEGISLATION

REFORM OF EUROPEAN PHARMACEUTICAL LEGISLATION

REFORM OF EUROPEAN PHARMACEUTICAL LEGISLATION

On April 10, 2024, the proposal for the reform of EU pharmaceutical legislation was approved, for a new European directive and regulation, to promote innovation, guarantee access to medicines and more affordable prices, while supporting research, namely new antibiotics, the competitiveness and attractiveness of the EU pharmaceutical industry, with stricter environmental standards and the strengthening of preparedness and response mechanisms for crisis situations.

IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION

IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION

IMPLEMENTATION OF THE MEDICAL DEVICE REGULATION

On April 5, 2024, Decree-Law no. 29/2024, with effect from July 4, 2024, defining the provisions applicable to economic operators, healthcare institutions that manufacture and use devices in their respective facilities, as well as the rules applicable to use and traceability of devices, the designation and supervision of the activities of notified bodies, surveillance and market surveillance, also including conditions and requirements that the reprocessing and use of reprocessed single-use devices must comply with in the national territory.

Estratégia regulamentar e requisitos, viabilidade e planificação de metas alcançáveis, regulatory intelligence, submissões às autoridades, traduções técnicas, pareceres e relatórios especializados.

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