Transcription of Practical guidance for procedures related to Brexit for ...
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Practical guidance for procedures related to Brexit for ...
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, 2020. Reproduction is authorised provided the source is acknowledged. 16 March 2020 EMA/478309/2017 Rev. 51 human Medicines Evaluation Division Veterinary Medicines Division Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure This Practical guidance complements Notice to stakeholders withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products, which has been drafted jointly by the European Commission and EMA and is available on the EMA website.
Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release). Also the site for batch control (where each batch undergoes full qualitative analysis, a quantitative analysis of at least all the active substances and other tests necessary to ensure the quality of the
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