There have been some eventful days recently in terms of important pharmaceutical regulations and legislation: Community pharma strategy to which we dedicated a post on LinkedIn Proposal for a Data Governance Regulation. Re-use of certain public sector data, including health […]
Global action in the fight against the COVID-19 pandemic. Joint statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO), supported by the Spanish Medicines and Health Products Agency (AEMPS), with regulatory agencies adopting […]
In the next issue of the Comunicaciones journal, CEFI is pleased to count on the expert opinion of Jesús Rubí Navarrete, Deputy Director of the Spanish Data Protection Agency (AEPD) and Rafael Garcia Gozalo, Executive Advisor and Head of the […]
Natividad Calvente Cestafe, Director of Innovation, Training and Institutional Relations at the General Council of Pharmaceutical Associations contributes to a monographic issue of the journal Cuadernos de Derecho Farmacéutico [Pharmaceutical Law Review] with a magnificent article on early access to […]
The reference price system and annual reference price orders are intended to contribute to the sustainability of the SNS. They should also promote the right balance between innovative generic/biosimilar, competition and competitiveness in the pharmaceutical and health market. Price decisions […]
El sistema de precios de referencia y las sucesivas ordenes anuales de precios de referencia pretenden contribuir a la sostenibilidad del SNS. También deben fomentar el justo equilibrio entre innovador-genérico/biosimilar, la competencia y la competitividad en el mercado farmacéutico y […]
Issue 74 (July-September 2020) of the journal Cuadernos de Derecho Farmacéutico is available online. Monographic issue ‘Spanish National Health System changes for innovation, efficiency and patient service’. Contents: CEFI position paper. Spanish National Health System changes for innovation, efficiency and […]
The Ministry of Health has published Draft Order SND/ /2020, of, by which the price reference system for medicinal products in the Spanish National Health System will be updated in 2020. The text is available for consultation and comments on […]
Amidst the current health, social and economic crisis caused by the Covid-19 pandemic and in a context conducive to reflection and debate with the creation of the Commission for the Social and Economic Recovery of Spain after Covid-19, CEFI has […]
The European Council has reached a historic agreement on a EUR 750 billion package for rebuilding the European economy following the COVID-19 pandemic: EUR 390 billion in direct aid and EUR 360 billion in loans. Spain will receive EUR 140 […]
Disponible en la web el número 73 (abril-junio 2020) de la revista Cuadernos de Derecho Farmacéutico. Sumario: La protección judicial de los datos de registro de los medicamentos y el derecho de exclusividad comercial: una asignatura pendiente en España, que […]
Una reciente sentencia del TJUE (asunto C‑786/18), pronunciándose sobre las cuestiones prejudiciales planteadas por el Tribunal Supremo alemán y tras estudiar el alcance del artículo 96, apartado 1, de la Directiva 2001/83, prohíbe la distribución de muestras gratuitas de medicamentos […]
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