Tag Archives: drug

Roszdravnadzor: Amendments to the Federal Law on the Circulation of Medicinal Products

  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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Сиролимус и его аналоги в составе внутрисосудистых стентов

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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Sirolimus and its analogues in the composition of intravascular stents

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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О лекарственных средствах в составе медицинских изделий и трудностях регистрации

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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About pharmaceutical agents in the composition of medical devices and registration difficulties

In March 2017, Order 11n “On the Approval of the Requirements Imposed on the Contents of the Technical and User Documentation Provided by the Manufacturer (Maker) of a Medical Device,” came into force. This document specifies the requirements to the technical and user documentation for medical devices including those which contain drugs. However the interpretation of these requirements by Roszdravnadzor

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IAS for drugs

As a result of media requests regarding the functioning of the information and analytical system (IAS), the Ministry of Health of the Russian Federation and Roszdravnadzor report the following: At the present time, as part of the improvements being made to the State Procurement System, the Ministry of Health of the Russian Federation together with interested federal authorities, has been

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Aspects of Registration of Medical Devices Containing Pharmaceutical Drugs

Among the exceptional diversity of medical devices varying in their purpose, mechanism of action, design properties, complexity, technical and functional characteristics, a special category of devices should be singled out: devices containing pharmaceutical drugs. Any manufacturer intending to obtain state registration for such devices in the Russian Federation will find it useful to learn in advance about certain possible difficulties

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Order No. 403n of the Ministry of Health of Russia dated 11 July 2017

On 22 September 2017 Order No. 403n of the Ministry of Health of Russia dated 11 July 2017 came into effect in the territory of the Russian Federation Order No. 403n of the Ministry of Health of Russia “On approval of the rules for dispensing medicinal products for medical use, including immunobiological medicinal products by pharmacy organizations, individual entrepreneurs licensed

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Identification of drugs

The Resolution of the Russian Government named “On performance of the experiment for labeling with control (identification) signs and monitoring of the turnover of certain types of medications destined for medical usage” was signed. On January 24, 2017, Chairman of the Government of the Russian Federation Dmitry Medvedev signed the Resolution of the Government of the Russian Federation No. 62

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