1.1. EAEU Pharmaceutical Market: Introduction to EAEU and the Agreement on the Single Market

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

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