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The concept of development of the pharmaceutical industry in Uzbekistan: joint projects, labelling, GMP

The President of the Republic of Uzbekistan Shavkat Mirziyoyev held a meeting to analyse ongoing work on the development of the pharmaceutical industry and procurement of medicines to the population, as well discuss the priority activities for the future. According to the information provided, 41 new pharmaceutical enterprises have been created in Uzbekistan, over the…
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Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU

Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU The Eurasian Economic Union (EAEU) is an international organization for regional economic integration, established by the Treaty on the Eurasian Economic Union, which currently includes 5 countries – Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan. The EAEU ensures the freedom of goods movement,…
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Approval of the Interim Rules for the Regulation of Prices on Medicines in the Republic of Kyrgyzstan.

In order to ensure the implementation of the state policy on the regulation of prices for medicines, the Government of the Republic of Kyrgyzstan approved Decree No. 579 of 10.29.2019 on the approval of the Interim Rules for the Regulation of Prices on Medicines in the Republic of Kyrgyzstan. Price regulation is introduced for a…
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Draft order of the Ministry of Health of Ukraine “Amending the Procedure of Confirmation of the Compliance of Manufacturing Conditions of Medicinal Products to the Requirements of Good Manufacturing Practice”

On August 14, 2019, a draft order was published on the website of the Ministry of Health of Ukraine, which provided for changes to the GMP confirmation procedure in Ukraine (MoH Order No. 1130 of December 27, 2012). The purpose of the changes is to ensure effective state control over the quality of medicines and…
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Kazakhstan has changed the rules of medical devices classification

Order of the Minister of Health of the Republic of Kazakhstan dated DSM-129 amended the Rules of Medical Devices Classification depending on the degree of potential risk of use. The Rules apply to medical devices manufactured and imported on the territory of the Republic of Kazakhstan. Depending on the degree of potential risk of use,…
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MPU is preparing to carry out public procurement of medicines at the expense of the state budget starting from 2020

The State Enterprise “Medical Procurement of Ukraine” (MPU) is preparing for the procurement of pharmaceuticals and medical devices at the expense of the state budget starting from 2020. “The State Enterprise in partnership with the Kyiv School of Economics has been developed organizational possibilities for procurement at the expense of the state budget of Ukraine…
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Expert: the majority of EAEU registration files are rejected

As of early September, the unified information system of the Eurasian Economic Union contained about 100 applications for registration of medicinal products. The Unified Register of the Union contains information on 3 medicines that have already been registered within EAEU and another 4 on the wayto be added to the register – is the procedure…
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Russian Federation has Presented New Contracts on Drug Labelling for Foreign Manufacturers

The Ministry of Industry and Trade of the Russian Federation has published several documents within the project of drugs labelling for foreign manufacturers. The draft order was developed in order to establish a procedure for charging fees for the provision of marking codes to foreign legal entities. Labelling codes are provided by the operator of…
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Information on the submission of EAEU files in XML format

Please be advised that the file submitted in the framework of the EAEU at the PHC stage will be accepted in XML format. Detailed information about this procedure can be found in: Rules of registration and examination of medicinal products for medical use. The Resolution of the Council of the Eurasian Economic Commission № 78…
