(исключения из числа) частных фармакопейных статей
English translation: (exclusions from the) specific pharmacopoeial monographs
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| 21:22 Aug 19, 2020 |
| Russian to English translations [PRO] Medical - Medical: Pharmaceuticals / Clinical Trials | |||||||
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|  Selected response from: Oleg Lozinskiy Russian Federation Local time: 11:03 | ||||||
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| 4 | (procedure of) (exclusion from the list of) non-official pharmacopeia articles |
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| 3 | (exclusions from the) specific pharmacopoeial monographs |
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| Discussion entries: 6 | |
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Answers
7 mins confidence: 
(exclusions from the) specific pharmacopoeial monographs Explanation: * -------------------------------------------------- Note added at 15 мин (2020-08-19 21:37:49 GMT) -------------------------------------------------- Unofficial translation AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION (Moscow, 23 December 2014) Article 5 Harmonization of the State Pharmacopoeia of the Member States 1. Member States shall take measures to establish the pharmacopoeial requirements of the Union through the consistent harmonization of pharmacopoeial monographs (general and specific) of the Pharmacopoeias of the Member States. ... 3. Pharmacopoeial monographs (general and specific), approved by the Pharmacopoeial Committee of the Union, jointly form the Pharmacopoeia of the Union which is approved by the Commission. 4. Specific pharmacopoeial monographs of the Pharmacopoeia of the Union which establish requirements for the quality of medicinal products, intended for circulation within the Union, are developed in accordance with the concept as referred to in paragraph 2 of this Article. https://www.google.ru/search?newwindow=1&biw=1045&bih=730&tb... |
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20 hrs confidence:
(procedure of) (exclusion from the list of) non-official pharmacopeia articles Explanation: A pharmacopeia article pertains to a product with INN (International Non-proprietary Name) and becomes a monograph only when it is officially recognized in the pharmacopeia (ЧФС) Частные фармакопейные статьи являются документами, в которых прописано качество и безопасность препаратов. Издают их для лекарств под международным непатентованным названием. (FB.ru: https://fb.ru/article/284171/farmakopeynaya-statya-osnovnyie... Note: The above will be a non-official pharmacopeia article (ОФС) Общая фармакопейная статья является государственным стандартом качества лекарств. В нем прописаны требования к препаратам............................. Фармакопейная статья принимается руководством департамента, а затем проходит регистрацию в организации, которая осуществляет деятельность по выпуску лекарств - ( FB.ru: https://fb.ru/article/284171/farmakopeynaya-statya-osnovnyie... This will be an official monograph. |
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