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Master Thesis

Création d’un marché pharmaceutique commun au sein de l’union économique eurasiatique (UEEA)

Abstract : The Eurasian Economic Union (EAEU) is an international economic integration organisation consisting of 5 member states: Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. It was created with the aim of ensuring comprehensive modernisation, cooperation and competitiveness of national economies and creating conditions for stable development in order to improve the living standards of the population of the member states. Regarding the creation of a common pharmaceutical market in the EAEU, common principles and rules for the authorisation and circulation of medicinal products are introduced in accordance with the Eurasian Economic Union Agreement of 29 May 2014. The Agreement on Common Principles and Rules for the Circulation of Medicines in the Eurasian Economic Union of 23 December 2014 is a fundamental document for the establishment of a common market for human medicines. Common rules for expertise of medicinal products, common rules of GMP, GCP, GCP, GLP, common rules for inspection, pharmacopoeia, common requirements for labelling of medicinal products and many other legislative acts have been approved. Marketing authorisation for medicinal products under the common EU rules will be mandatory from January 2021. At the same time, all medicines authorised under national procedures will have to be brought into line with the EAEU requirements by the end of 2025, the so-called re-attestation procedure. This procedure for re-attestation of a medicine within the EAEU will be explained through an applied case.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03323131
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Submitted on : Friday, August 20, 2021 - 1:32:29 PM
Last modification on : Saturday, August 28, 2021 - 3:12:30 AM
Long-term archiving on: : Sunday, November 21, 2021 - 8:47:53 PM

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Pharmacie_2021_Lahitette.pdf
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Laurie Lahitette. Création d’un marché pharmaceutique commun au sein de l’union économique eurasiatique (UEEA). Sciences du Vivant [q-bio]. 2021. ⟨dumas-03323131⟩

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