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Procedure for registration of medicines in the Eurasian Economic Union (EAEU)

Procedure for registration of medicines in the Eurasian Economic Union (EAEU)

10/02/2020 admi nistrato

The supranational registration of medicinal products provides new opportunities to work in the common EAEU market. The first applications for…

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Filed under: decentralized procedure, EAEU Rules, medicinal products, Procedure for registration, reference State, special procedure, The applicant

The bill on changing the order of import of medical devices into the territory of the Russian Federation for registration

04/02/2020 admi nistrato

We want to draw your attention to a very important bill. It intends to replace the current Order of the Ministry…

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Filed under: manufacturer is national, Ministry of Health of the Russian, new draft law, registrations, toxicological studies

WHAT ARE THE RISKS OF WITHDRAWAL OF MEDICAL PRODUCTS FROM THE UKRAINE LAW ON PUBLIC PROCUREMENT?

30/01/2020 admi nistrato Leave a comment

The European Business Association is concerned about the draft Law of Ukraine No. 2563, which was registered by the Verkhovna…

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Filed under: "Prozorro", draft Law, medical devices, procurement

Management and operation of pharmacovigilance system in EAEU. Critical aspects.

29/01/2020 admi nistrato

SmartPharma Group is delighted to invite you to participate in a two-day training event “Management and operation of pharmacovigilance system in EAEU.…

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UKRAINE’S PARLIAMENT SUPPORTED TWO DRAFT LAWS ON PUBLIC PROCUREMENT OF MEDICINES AND MEDICAL PRODUCTS

28/01/2020 admi nistrato Leave a comment

Deputies voted in favour of the draft laws No. 2538 “On Amendments to Some Legislative Acts of Ukraine to Improve…

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Filed under: laws No. 2538, medicines and medical products

The Ministry of health updated the register of maximum wholesale prices for medicines under the “affordable medicines programme”

admi nistrato

The new version of the Register as of January 02, 2020 is available on the official website of the agency…

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Filed under: medicinal products, pharmaceutical manufacturers, Register of Wholesale Limit Prices

Suspension of use of medicines due to non-compliance with requirements of pharmacovigilance legislation

21/01/2020 admi nistrato

The Federal Service for Supervision in the Sphere of Healthcare (Roszdravnadzor) informs about the decision of the Ministry of Health…

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Filed under: medicinal products, pharmacovigilance, Roszdravnadzor, safety of the medicinal product, serious undesirable reactions

Changes in the legislations guiding medicines circulations in Republic Belarus

11/01/2020 admi nistrato

On the 31st of December 2019 significant changes have been made to the procedure of medicines сirculation in the Belarus Republic: “Gospharmnadzor” is to…

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Filed under: Belarus, changesinlegislation egistration #Belarus #EAEU, EAEU

The next two months, all market representatives should become participants in the labelling system.

10/01/2020 admi nistrato Leave a comment

According to the new Resolution of the Government of the Russian Federation No. 1954, all participants in the medicines turnover…

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Filed under: medical institutions, medicines, Resolution, System for Monitoring of Medicines

Kazakhstan approved the Rules for Use of Unregistered Medicines and Medical Products

admi nistrato Leave a comment

Order of the Minister of Health of the Republic of Kazakhstan dated December 25, 2019 No. KR of DCM-151 approved…

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Filed under: approved, Kazakhstan, medicines and medical products, Minister of Health, regulation

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  • The Russian side opposed to postpone Implementation period of the EAEU Rules of marketing authorisation 03/12/2020
  • MedSafety app launch in the Kyrgyz Republic 25/11/2020
  • Important amendments to the EAEU legislative acts 20/10/2020

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