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Questions and answers A…

Questions and answers A question-and-answer document is available for marketing authorisation holders on implementing the Article 5(3) CHMP opinion. It covers the following: Outcome of the Article 5(3) referral and its relation to lessons learned exercise from nitrosamines detected in sartansPrinciples, methodology and scope for nitrosamine management in human authorised productsGuidance for establishing and reporting acceptable intake limits derived from implemented approaches: carcinogenic [...]

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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