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<article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" article-type="research-article" dtd-version="1.1d1" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher">REMEDIUM</journal-id><journal-title-group><journal-title>REMEDIUM</journal-title></journal-title-group><issn publication-format="print">1561-5936</issn><issn publication-format="electronic">2658-3534</issn><publisher><publisher-name>Joint-Stock Company Chicot</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1396</article-id><article-id pub-id-type="doi">10.32687/1561-5936-2022-26-1-21-25</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Article</subject></subj-group></article-categories><title-group><article-title>Bringing registration dossiers in line with the requirements of the EAEU is the number one priority for pharmaceutical industry enterprises</article-title></title-group><contrib-group><contrib contrib-type="author"><name name-style="western"><surname>Plotnikov</surname><given-names>A. V.</given-names></name><bio></bio><email>plotnikov.a@ekolab.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author"><name name-style="western"><surname>Koroleva</surname><given-names>T. A.</given-names></name><bio></bio><email>-</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff id="aff-1">Closed Joint Stock Company "EKOlab"</aff><pub-date date-type="epub" iso-8601-date="2022-12-15" publication-format="electronic"><day>15</day><month>12</month><year>2022</year></pub-date><volume>26</volume><issue>1</issue><fpage>21</fpage><lpage>25</lpage><history><pub-date date-type="received" iso-8601-date="2022-03-29"><day>29</day><month>03</month><year>2022</year></pub-date></history><permissions><copyright-statement>Copyright © 2022,</copyright-statement><copyright-year>2022</copyright-year></permissions><abstract>In accordance with the Agreement on Uniform Principles and Rules for the Circulation of Medicines within the Eurasian Economic Union dated December 23, 2014, starting in 2026, the circulation of medicines in the territory of all EAEU member states: Russia, Belarus, Kazakhstan, Kyrgyzstan and Armenia, will be governed by supranational legal acts and norms of the Union. In order not to lose sales markets, domestic pharmaceutical manufacturers must, by December 31, 2025, bring all registration dossiers for drugs registered earlier to comply with the requirements of the Union, and obtain registration certificates in the EAEU format. The article analyzes the amount of work that needs to be done to bring one registration dossier for a medicinal product in line with the Union's requirements, presents the time costs and the main emphasis is on a project-based approach to solving the problem of transition to the EAEU legal norms.</abstract><kwd-group xml:lang="en"><kwd>registration and examination rules</kwd><kwd>harmonization</kwd><kwd>EAEU</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>правила регистрации и экспертизы</kwd><kwd>приведение в соответствие</kwd><kwd>ЕАЭС</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Помазанов В. В., Марданлы С. Г., Борисов В. Ю. Экологическая лаборатория. Владимир; 2012. 184 с.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Ситникова Е. А., Марданлы С. Г., Рогожникова Е. П. Система фармаконадзора на реальном предприятии // Разработка и регистрация лекарственных средств. 2018. № 2. С. 170-172.</mixed-citation></ref></ref-list></back></article>
