2015 was the year of development of integration processes within the Eurasian Economic Union (EEU) reflecting the trends due to both the interests of the economic development and other spheres of human activity and the next round of globalization of political and economic processes in the modern world. The implementation of vitally important geopolitical and economic interests of the member countries depends on the effectiveness of cooperation of states with the use of EEU opportunities.
Law of the Republic of Belarus No. 297-З dated July 15, 2015, ratified the Agreement on the Unified Principles and Rules of Medicinal Products Circulation within the Eurasian Economic Union and Law of the Republic of Belarus No.298-З dated July 15, 2015, ratified the Agreement on the Unified Principles and Rules of Medical Devices Circulation (medical devices and medical equipment) within the Eurasian Economic Union. A number of drafts of legal acts on regulation of different stages of medicinal products and medical devices circulation in EEU were developed with the active participation of the experts from the Belorussian side.
In connection with the entry into force from May 21, 2015, of the new version of Law of the Republic of Belarus No. 203-З dated November 17, 2014, “On medicinal products”, the normative documents, determining the new level of regulation of a post-registration circulation of medicinal products aimed at strengthening control over their safety and efficacy by forming the National System of Pharmacovigilance, were adopted.
According to the results of the contest “Competence-2014” held by the Belarusian State Centre for Accreditation (BSCA) RUE and timed to World Accreditation Day, the Laboratory of Pharmacopoeial and Pharmaceutical Analysis of the Center for Examinations and Tests in Health Care UE (UP) is recognized as the winner in the field of testing of pharmaceutical, medical and perfumery-cosmetic production in 2015. The pharmacopoeial articles for the second volume of the State Pharmacopeia of the Republic of Belarus that will be republished in 2016 are prepared by the specialists of the Laboratory.
For addressing the issues of organizing and carrying out inspections of the industrial production of medicinal products for compliance with requirements of Good manufacturing practice (GMP), the Consulting Department of Quality Assurance was transformed into the Department of Good Pharmaceutical Practices with the functions assigned to it on the GMP conformity assessment of pharmaceutical productions as well as examination of documents for the proposal on issuing the Certificate of a Pharmaceutical Product (CPP) on medicinal products intended for export.
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From the bottom of my heart, I wish everybody a Merry Christmas and a Happy New Year! May the year 2016 bring many pleasant and vivid impressions, will become the herald of happiness and joy. Let your energy and optimism help you achieve the desired goals and new heights.