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. Background.
European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation ... and to ensure the quality of their medicinal products. Secondly as a result of the Article 5(3) referral, ... • an as simple implementation as possible from an organisational perspective;
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