The procedure for registration of medicines in Ukraine is in the stage of harmonization with the registration in the European Union, which leads to regular updating of the regulatory framework and some changes in the organization of work on registration. However, the new registration of pharmaceuticals for human use now includes three main stages: preparatory step, registration process and fulfillment
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The procedure of registration, re-registration of medicines, as well as amendments to the registration dossier in Ukraine is somewhat different from the Russian procedures. For example, in Ukraine it is mandatory to comply with the IFU for a drug with the instructions of the reference European state (if the drug is registered in the EU), the national expert center of
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As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a
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On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the Circulation of Medicinal Drugs and Medical Devices – FarmMedObrashchenie – 2018” (hereinafter FMO-2018), a Laboratory Services and Confidentiality Agreement was signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor in the presence of Mr. Mikhail Murashko, the Head of
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In the medical device market, there is a large number of products that contain various chemicals in the composition – active pharmaceutical substances, ancillary substances, as well as precursors of narcotic substances. This article is devoted to the peculiarities of the import of such devices. What are narcotic substances and their precursors? According to Federal Law No. 3 “On Narcotic
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There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors. (details by link) However, medical devices can contain not only pharmaceutical substances but excipients. According to Federal Law 61 “On circulation of Medicinal Products” excipients are substances of inorganic or organic origin used in the
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Federal Law No. 140-FZ dated June 04, 2018 On Amendments to the Federal Law On the Circulation of Medicinal Products entering into force on June 15, 2018 has been designed to amend the procedure for the submission of documents for the purpose of the state registration of medicinal products, confirmation of the state registration, and introduction of amendments into
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В настоящее время регистрация медицинских изделий, в состав которых входят лекарственные средства, является темой для обсуждения многих производителей, дистрибьюторов, и других участников рынка медицинских изделий . (См. статью «О лекарственных средствах в составе медицинских изделий и трудностях регистрации»). Трудности регистрации, появившиеся в связи с изменением российского законодательства, коснулись и такой группы изделий как внутрисосудистые стенты с лекарственным покрытием. Стенты, выделяющие
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At the present time registration of medical devices containing pharmaceutical substances is the topic for discussion for many manufacturers, distributors and other participants of the medical device market (see the article About pharmaceutical agents in the composition of medical devices and registration difficulties). Difficulties in the registration connected with the changes of Russian regulation touched upon drug-eluting intravascular stents. Stents capable
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В марте 2017 года вступил в силу приказ 11н «Об утверждении требований к содержанию технической и эксплуатационной документации производителя (изготовителя) медицинского изделия». В этом документе, в том числе изложены требования к документации на изделие, в состав которого входят лекарственные средства. Однако трактовка данных требований со стороны Росздравнадзора многократно осложнила процесс регистрации таких изделий. В сентябре 2017 года 38 компаний производителей
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