-
Procedure for registration of medicines in the Eurasian Economic Union (EAEU)
The supranational registration of medicinal products provides new opportunities to work in the common EAEU market. The first applications for registration of medicines in accordance with the Agreement on common principles and rules of circulation of medicines within the framework of the Eurasian Economic Union (Agreement) of December 23, 2014 and the Rules of registration…
-
The bill on changing the order of import of medical devices into the territory of the Russian Federation for registration
We want to draw your attention to a very important bill. It intends to replace the current Order of the Ministry of Health of the Russian Federation № 7n “On Approval of the Procedure for Import of Medical Devices into the Russian Federation for the Purposes of State Registration”. Comparison of the existing Order with the new…
-
WHAT ARE THE RISKS OF WITHDRAWAL OF MEDICAL PRODUCTS FROM THE UKRAINE LAW ON PUBLIC PROCUREMENT?
The European Business Association is concerned about the draft Law of Ukraine No. 2563, which was registered by the Verkhovna Rada of Ukraine on December 10, 2019. It proposes to exclude medical products from the scope of the Law of Ukraine “On Public Procurement”. In other words, bidders for medical devices were asked not to…
-
Management and operation of pharmacovigilance system in EAEU. Critical aspects.
SmartPharma Group is delighted to invite you to participate in a two-day training event “Management and operation of pharmacovigilance system in EAEU. Critical aspects”.20-21th of February 2020,Vilnius, Lithuania. DON’T MISS YOUR CHANCE TO ATTEND A UNIQUE TRAINING EVENT ! For detailed information, please, refer to the informational flyer and seminar programme. For registration or any additional information…
-
UKRAINE’S PARLIAMENT SUPPORTED TWO DRAFT LAWS ON PUBLIC PROCUREMENT OF MEDICINES AND MEDICAL PRODUCTS
Deputies voted in favour of the draft laws No. 2538 “On Amendments to Some Legislative Acts of Ukraine to Improve the Affordability of Medicinal Products, Medical Devices and Other Goods Purchased by an Authorized Person for Healthcare Procurement” and No. 2539 “On Amendments to the Tax Code of Ukraine to Improve the Affordability of Medicinal…
-
The Ministry of health updated the register of maximum wholesale prices for medicines under the “affordable medicines programme”
The new version of the Register as of January 02, 2020 is available on the official website of the agency for review by pharmaceutical manufacturers. The Ministry of Health noted that the prices, as in the past, are calculated by reference comparison with prices for similar medicines in neighbouring Poland, the Czech Republic, Hungary, Slovakia…
-
Suspension of use of medicines due to non-compliance with requirements of pharmacovigilance legislation
The Federal Service for Supervision in the Sphere of Healthcare (Roszdravnadzor) informs about the decision of the Ministry of Health of Russia to suspend the use of a range of medicinal products. The decision was made based on the conclusion of Roszdravnadzor in accordance with the Order of the Ministry of Health of Russia No.…
-
Changes in the legislations guiding medicines circulations in Republic Belarus
On the 31st of December 2019 significant changes have been made to the procedure of medicines сirculation in the Belarus Republic: “Gospharmnadzor” is to be established until May 1, 2020 as a state body responsible for pharmaceutical supervision and auditing of entities involved in medicines circulation at any stage (manufacture, release, storage, etc.). 3-month accelerated registration procedure will be…
-
The next two months, all market representatives should become participants in the labelling system.
According to the new Resolution of the Government of the Russian Federation No. 1954, all participants in the medicines turnover should register in the labelling system from January 1 to the end of February 2020. From July 1, 2020 the circulation of medicines without digital codes will be prohibited. Amendments to the Resolution of the…
-
Kazakhstan approved the Rules for Use of Unregistered Medicines and Medical Products
Order of the Minister of Health of the Republic of Kazakhstan dated December 25, 2019 No. KR of DCM-151 approved the Rules of use of medicines and medical products not registered in the Republic of Kazakhstan for the provision of medical care based on indications for a particular patient or for the provision of medical…
Blog
Copyright © 2026 smart-pharma.group