21.11.2020 The Ministry of Economic Development of the Russian Federation, as a representative of the Russian side, sent an official letter to the EEC to object to the decision to prolong transition period. The transition period of the Rules of marketing authorization supposed to be extended until the 31st  of December, 2022, as announced…

During World Antimicrobial Awareness Week, MedSafety application was launched by the support of WHO and MHRA in the Kyrgyz Republic. Contact us for further information, if you are looking for pharmacovigilance service provider including LCPPV service in this region: [email protected]

Based on the results of the meeting of the EEC Working Group on Medicinal Products as of 05.10.2020 – 07.10.2020, the following important amendments to the EAEU legislative acts are planned to be introduced: • extension of the transition period to allow manufacturing authorisation of medicinal products under the national legislation of the Member States…

New Rules for the preparation of patient information leaflet and summary of product characteristics for medicinal products and medical devices was approved by order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. ҚR DSM-101/2020. The changes was adopted in the framework of harmonisation of national legislation with the…

The terms of recognition of the national GMP and the union GMP during national renewal and variation procedures were extended until December 31, 2025 by theamendments to the Resolution No. 93 dated November 3, 2016. ● this will allow manufacturers to maintain the life cycle of products on the national markets until the end of…

Зарегистрируйтесь для участия в серии вебинаров посвященных фармаконадзору в ЕАЭС. Не упустите свой шанс получить универсальное пособие для самой широкой аудитории специалистов отрасли! Особенность курса – практический мастер-класс по подготовке ПООБ, который включает разбор распространённых ошибок и замечаний Регуляторного органа. Детальную информацию о программе Web-курсa и условиях участия Вы можете найти по ссылкам: Программа мероприятия…

The Eurasian Economic Commission Council has developed amendments to the technical regulations of the Union in the field of food supplements and specialised products: TR CU 021/2011 and TR CU 027/2012. The draft document has been published on the EAEU legal portal docs.eaeunion.org. Discussion will last from 09/03/2020 to 11/02/2020. The draft document establishes special…

Компания SmartPharma Group приглашает Вас принять участие в Web-курсе – SmartPharmacovigilance. Вашему вниманию предлагается универсальное пособие для самой широкой аудитории специалистов отрасли. Серия вебинаров ориентирована как на изучение ключевых основ фармаконадзора, эффективное выполнение функций УЛФ, так и на освоение более специфичных аспектов. Особенностью данного курса является также наличие практической части. Участники мастер-класса по подготовке ПООБ…

Order of the Ministry of Health of Ukraine No 1349 dated 09.06.2020 outlines revised rules of the submission and expertise of the documents for GMP certification  and recognition of the foreign GMP certificates, including: • priority consideration for some categories medicinal products • qupdated list of the documents submitted for certification and recognition in the…

With the recent addition of Intertek’s Sweden-based Notified Body, Intertek Medical Notified Body, to the European Commission’s NANDO database, the number of Notified Bodies designated to issue CE Mark certifications under the Medical Devices Regulation (MDR) now totals 14. The list of Notified Bodies now designated to at least some components of the MDR following the…