ПРАКТИЧЕСКИЕ АСПЕКТЫ ФАРМАКОНАДЗОРА в ЕАЭС. IV научно-практическая онлайн-конференция
Уважаемые коллеги! Приглашаем Вас 15 декабря 2021 на ежегодную научно-практическую онлайн-конференцию по вопросам фармаконадзора, организаторами которой являются ФГАОУ ВО Российский национальный исследовательский медицинский университет имени Н. И. Пирогова, автономная некоммерческая организация «Национальный научный центр [...]
5-fluorouracil (intravenous) — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000007-202012
Taking into account the available data on risk (s) from the literature and spontaneous reports, including in some cases a close temporal relationship, positive challenge-response, and/or re-challenge, PRAC consider that - the relationship between 5-fluorouracil [...]
Composition of a registration dossier
Our company can perform:- preparation of drug samples for evaluation during state registration,- writing sections 2,4-2,7 of the registration dossier,- amending the already submitted documents,- advising on the preparation of the dossier,- if necessary, to [...]
Составление регистрационного досье
Наша компания может осуществить: - подготовку образцов препарата для регистрационной экспертизы, - написание разделов 2,4-2,7 регистрационного досье, - внесение изменений в зарегистрированные документы, - консультирование по вопросам подготовки досье, - в случае необходимости доработать [...]
Kazakhstan has introduced the practice of inspection of medical devices prior to state registration
Medical devices with a medium (e.g., sterile injectable medical devices), high (dental implants, stents), or very high (implantable pacemakers, absorbable suture material) potential risk of use are subject to inspection. The national regulatory agency inspects [...]
Amiodarone — Scientific findings and reasons for changing the conditions of the marketing authorization — PSUSA-00000166-202012
In view of the available data found in the literature and spontaneous reports, including those describing the chronology of drug interactions between Amiodarone and Sirolimus, leading to increased toxicity of Sirolimus, PRAC considers the estimated [...]
The Council of the Eurasian Economic Commission approved the draft «On the Rules for the Regulation of the Circulation of Veterinary Medicines in the Customs Territory of the Eurasian Economic Union.»
The Draft Decision states that: a) registration of veterinary medicinal products and other related procedures stipulated by the legislation of the member states of the Eurasian Economic Union, started and not completed as of the [...]
The marketing authorization holders of medicinal products registered in the Republic of Belarus in order to ensure the submission of the PSUR to the authorized body, as well as to maintain the PSUR submission procedure, are recommended:
- starting from November 01, 2021, to submit the PSUR in accordance with the deadlines specified in the updated draft of the List, in electronic form with the possibility of text search in Belarusian, Russian, [...]