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Sie suchen in allen Bereichen nach dem Autor Dranov M.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenCurrent Regulatory Requirements in Russia
Rubrik: europharm
(Treffer aus pharmind, Nr. 03, Seite 367 (2015))
Current Regulatory Requirements in Russia / The European view (Part 2)*Part 1 s. Pharm. Ind. 2015;77(2):208–212 · Dranov M · Dr, Willmar Schwabe GmbH & Co. KG, Karlsruhe
Russia still has its own format for the application dossier. Russian language is mandatory for all documents, including bibliographic references. A European dossier in Common Technical Document (CTD) format is not accepted by the Russian authorities, and its content has to be reorganised according to local requirements [ 6 ], as described below. Article 18 of law No. 61-FZ lays down the complete basic structure of the application dossier. Table 2 compares the Russian requirements to the EU CTD format. The numbers in the first column corresponds to the articles of the law; the numbers in the second column correspond to ...
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Alex Dranov, M.D.R.A.
MerkenCurrent Regulatory Requirements in Russia
Rubrik: europharm
(Treffer aus pharmind, Nr. 02, Seite 208 (2015))
Current Regulatory Requirements in Russia / The European view (Part 1)*Note: All terms used in this work are in compliance with the current European regulatory terminology for human medicinal products. The data-lock point for the information included was 1 May 2014. Since the regulatory framework evolves rapidly, thorough update should be done before basing any decisions on the content of this publication. · Dranov M · Dr, Willmar Schwabe GmbH & Co. KG, Karlsruhe
Application Form Anatomical Therapeutic Chemical classification Commonwealth of Independent States Certificate of Analysis Certificate of a Pharmaceutical Product Clinical Trial Authorisation Common Technical Document Curriculum Vitae Decentralised Procedure European Article Number European Union Good Manufacturing Practice High-performance liquid chromatography International Non-proprietary Name Marketing Authorisation Application Marketing Authorisation Holder Master of Drug Regulatory Affairs Ministry of Health Mutual Recognition Procedure Normative Documentation (documentation on quality) Package Information Leaflet Periodic Safety Update Report Qualified Person Qualified Person for Pharmacovigilance Summary of Product Characteristics Thin-layer chromatography Union of Soviet Socialist Republics or Soviet Union World Trade Organization Since the early 1990s, the new ...
