Transcription of Implementation Process Article 5(3) Nitrosamine
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Implementation Process Article 5(3) Nitrosamine
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. EMA/425645/2020 22 February 2021 European Medicines Regulatory Network approach for the Implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for Nitrosamine impurities in human medicines European Medicines Regulatory Network approach for the Implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for Nitrosamine impurities in human medicines EMA/425645/2020 Page 2/14 Table of contents 1.
triggered by the EMA Executive Director (ED) requesting the CHMP to conduct a scientific evaluation on the presence of nitrosamine impurities in human medicines containing chemically synthesised active pharmaceutical ingredients (APIs). The procedure was foreseen to run in a 2-step approach as follows:
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