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Order adapting French law to Regulation (EU) 2017/746 of the Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
28/04/2022 -
El Reglamento (UE) n.º 2017/746 del Parlamento Europeo y del Consejo, de 5 de abril de 2017, sobre los productos sanitarios para diagnóstico «in vitro»,...
Technical note Pro Pharmacopoeia, submitted for public inquiry (texts attached)
25/01/2022 -
Los textos, implementados en la 11.ª edición de la Farmacopea Francesa, se publicarán mediante decisión del Director General de la Agencia Nacional Francesa para la...
Order adapting French law to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
29/12/2021 -
El objetivo principal de la Orden es:
— excluir del régimen general de investigación la investigación con seres humanos relacionada con los Productos Sanitarios...
Draft implementing decree amending Implementing Decree No 228/2008 on the marketing authorisation of medicinal products, as amended.
14/10/2021 -
t finalises the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council in the field of registration dossier requirements applicable to medicinal products for human...
Draft decree on the supply of units of certain medicinal products to pharmacies pursuant to the Law of 10 February 2020 on combating waste and on the circular economy
08/10/2021 -
El presente Proyecto de Decreto prevé:
— por una parte, la posibilidad de que los farmacéuticos minoristas expidan unidades de determinados medicamentos;
Decree-Law allowing the reprocessing and reuse of single-use devices pursuant to Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 and laying down the sanctions regime applicable to their infringements
28/09/2021 -
El proyecto de Decreto-ley tiene por objeto establecer las normas necesarias para el reprocesamiento y la reutilización de los productos de un solo uso, de conformidad con el...
PRELIMINARY BILL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
10/06/2021 -
El proyecto de Ley completa y establece los procedimientos de aplicación del Reglamento (UE) n.º 2017/746.
Los artículos que dan lugar a esta...
Order on the management of waste from electrical or electronic equipment associated with sharp medical devices used by patients undergoing self-treatment and users of self-tests
04/02/2021 -
Article L4211-2-1 of the Public Health Code introduces the obligation to implement an extended producer responsibility (EPR) chain for the management of sharp infectious clinical waste produced by...
