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For additional specific…

For additional specific information related to nationally authorised products (including MRP/DCP): CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (July 2023) [Tracked]Template for nitrosamine risk evaluation in marketing authorisation applications

Por |2024-12-19T12:42:50+00:00diciembre 19th, 2024|Noticias|Sin comentarios

European Medicines Regulatory…

European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) An implementation plan agreed in February 2021 sets out how the European medicines regulatory network, together with the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be implementing the outcome of the Art. 5(3) referral. This includes specific measures that the network will take if nitrosamines are [...]

Por |2024-12-19T12:42:50+00:00diciembre 19th, 2024|Noticias|Sin comentarios
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