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1.1. EAEU Pharmaceutical Market: Introduction to EAEU and the Agreement on the Single Market - YouTube
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Welcome to PhED,
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Pharmaceutical Education and Development! I鈥檓 your host, Ravil Niyazov. This video was prepared by
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Alex Schneider, Dmitriy Rozhdestvenskiy, Margarita Dranitsyna, Andrey Vasilyev, Elena Gavrishina,
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Dmitriy Kulichev and I in order to provide a high-level description of the system
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for governing medicinal products for human use in the Eurasian Economic Union.
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This is the first video on our YouTube channel made in English and is intended
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to inform those of you who are interested in the single pharmaceutical market of the EAEU.
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Within the video, we鈥檙e going to describe
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some historical aspects regarding to how the single pharmaceutical market was found within the EAEU,
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the main documents laying down the rules governing medicinal product for human use in the EAEU,
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including the relationship of those documents with European Union, ICH, EMA, WHO, MHRA, FDA
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etc. laws, regulations, and guidelines, and regulatory aspects of applying for, or maintenance of,
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a marketing authorization for a medicinal product in the Eurasian Economic Union Member States.
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Please supports us by subscribing to our channel on YouTube or following me on Facebook and LinkedIn!
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Within these series of videos, we鈥檙e going to discuss the following topics:
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The Foundation of the Eurasian Economic Union and creation of
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harmonized principles for governing medicinal products for human use within the EAEU.
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The regulations and guidelines adopted to this date to govern the single market of
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pharmaceutical products within the EAEU as well as the documents under preparation.
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Finally, the general description of marketing authorization
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and related procedures will also be provided and main features of the major procedures will be outlined.
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We will start with a brief discussion of how the Eurasian Economic Union was created.
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The history of the Eurasian Economic Union begins with the Agreement on the Customs Union
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which was reached between Belarus, Kazakhstan, and Russian Federation in 1995.
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Later on, other Member States also joined the Union.
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Four years later, in 1999
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the Treaty of the Customs Union and Eurasian Economic Space was signed into law by the founding states,
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namely Belarus, Kazakhstan, and Russia.
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In late 2000, another treaty was adopted by those three, establishing the Eurasian Economic Community.
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In 2003, the Eurasian Economic Space was established.
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However, all of these measures were political rather than economic.
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Consequently, in October of 2007, Belarus, Kazakhstan, and Russia
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concluded a new Treaty on the Customs Union.
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The Treaty became effective in 2010,
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but the customs procedures between countries were canceled in the middle of 2011 only.
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In November of 2011 the Declaration of the Eurasian Economic Integration was adopted,
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and from the beginning of 2012, the Eurasian Economic Space began operating.
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The main purpose of the integration was to remove barriers to mutual trade.
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In May 2014, the Treaty of the Eurasian Economic Union was concluded,
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and beginning from January of 2015 the EAEU started functioning.
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More detailed information on the EAEU can be found elsewhere.
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Currently, there are five Member States in the EAEU.
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Three of them, the Republic of Belarus, the Republic of Kazakhstan, and Russian Federation,
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are the founding Member States which conceived the Union.
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The two other Member States, Kyrgyzstan and Armenia, joined the Union later on, in 2014 and 2015 respectively.
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After this brief introduction to the EAEU and its inception,
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let鈥檚 proceed to the description of the single pharmaceutical market of the Eurasian Economic Union.
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The Single Market of medicinal products for human use was established
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by the Agreement on the common principles and rules of medicinal products circulation
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within the Eurasian Economic Union in December of 2014.
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The Agreement laid down the main principles governing human medicinal products
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as well as the main terms and definitions related to the area of human pharmaceuticals.
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Those main principles are outlined in the appropriate articles of the Agreement.
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The following core principles of governing medicinal products for human use include:
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Governance of medicinal products shall be based on international standards.
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In this regard, the European Union鈥檚 legal framework is considered the main benchmark
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while other legal systems play a supplementary role.
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Functioning of the Common Market of medicinal products within the Union shall be based on GxP.
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Harmonization of the pharmacopoeial standards of the Member States shall take place.
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Non-clinical and clinical studies and trials in the Member States
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shall be conducted in accordance with GLP and GCP principles.
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Granting a marketing authorization and assessment of medicinal products in the Member States
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shall be carried out using harmonized rules.
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Product information shall also be harmonized.
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Manufacturing of medicinal products shall be in accordance with GMP.
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GxP inspections shall be conducted using harmonized standards.
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Wholesale distribution, transportation, and storage of medicinal products shall be in accordance with GDP.
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Pharmacovigilance activities shall be conducted in accordance with GVP.
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Official supervision of medicinal products is also subject to harmonization between the Member States.
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The Common Register of Authorized Medicinal Products of the Eurasian Economic Union
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and information databases in the area of medicinal products,
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as well as the Union Information System in the area of medicinal products,
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shall be created to facilitate management and oversight of medicinal products.
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The procedure for communication between competent authorities of the Member States
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where restrictions on medicinal products have been imposed shall be established.
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Cooperation between the competent authorities of the Member States shall take place.
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All those principles are detailed in the appropriate regulations and requirements
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which have been adopted under the Agreement. We will review these regulations and requirement further on.
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Similar agreements were reached in the area of medical devices and veterinary medicinal products.
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