On the Principle of Unity
Eurasia Intergovernmental Council made a principal decision to launch a united medicines market in the Eurasia Economic Union.
Subsequently a package of documents used to implement the Agreement on united principles and rules of circulation of medicinal drugs within the Eurasia Economic Union of December 23, 2014, united standards of assuring safety, quality and efficacy of manufactured drugs have been approved.
The document concerns the principle of unity for marketing authorization by union member-states, meeting the good practice requirements (manufacture, preclinical and clinical trials), distribution, pharmacovigilance, quality control by pharma manufacturers, according to the harmonized pharmacopoeial standards of the Union and to ensure the quality of drugs thought establishment of the institute of authorized persons and activity of pharmaceutical inspectorates covering the whole system of good practices.
The above provisions will ensure the unity of key life cycle stages for drugs in circulation in the five union member-states, and facilitate the market integration into the global system of development, production and usage of drugs offering manufacturers broad opportunities for product launches in the united union market and outside.