CEP dossier
Russian translation: досье для CEP
| 13:00 Jul 10, 2020 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / Certificate of Suitability | |||||||
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|  Selected response from: didimblog Russian Federation Local time: 03:19 | ||||||
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| 3 +1 | досье для CEP |
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| Discussion entries: 1 | |
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Answers
9 hrs confidence: 
peer agreement (net): +1
peer agreement (net): +1| cep dossier досье для CEP Explanation: Досье, предоставляемое для получения сертификата CEP. --- To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation...: - a completed application form..., - a dossier in CTD format..., - a single copy of the Quality Overall Summary (QOS). ... Content of the Dossier Detailed information on what an application should contain is described in the documents below. Refer to the document relevant to your application. - Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R - Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2 1R) - ...". https://www.edqm.eu/en/certificate-suitability-new-applicati... "Сертификация на соответствие требованиям ЕФ ... Требования к досье, предоставляемому на сертификацию, содержатся в рекомендациях EDQM PA/PH/CEP (04)1, 4R «Требования к досье по качеству и микробиологической чистоте фармацевтических субстанций», опубликованных в феврале 2007 г.". https://www.remedium.ru/health/detail.php?ID=42816 --- "Сертификат соответствия требованиям монографии Европейской Фармакопеи (eng CEP "Certificates of Suitability to the Monographs of the European Pharmacopoeia") (синоним Сертификат Европейской Фармакопеи, выданный EDQM) - означает, что качество субстанции контролируется в соответствии с требованиями соответствующей монографии Европейской Фармакопеи". http://www.consultpharma.ru/index.php/ru/documents/vocabular... |
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