Tag Archives: EAEU

Unified Customs Register of Intellectual Property Objects of the Member States of the Eurasian Economic Union.

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The Unified Customs Register of Intellectual Property Objects of the Member States of the Eurasian Economic Union (hereinafter referred to as the Unified Register) was introduced into effect by Article 385 “The Unified Customs Register of Intellectual Property Objects of the Member States”[1] of Appendix No. 1 to the Treaty on the Customs Code of the Eurasian Economic Union of

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Что означает «расширение географии» при регистрации ЛП по требованиям ЕАЭС?

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Со вступлением в силу законодательства ЕАЭС, касающегося регистрации лекарственных препаратов, появился целый спектр новый терминов, понимание которых является ключевым при определении стратегии обращения препарата в государствах-членах ЕАЭС. Одним из таких терминов является «расширение географии». Расширение географии – регистрация препарата в государствах-членах ЕАЭС, где он не был зарегистрирован ранее, при приведении досье в соответствие с требованиями ЕАЭС. Например, препарат А был

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New types of drug registration under the requirements of the EAEU.

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At the end of March 2022, Decision No. 36 of the EEC Council came into force, which introduced some adjustments to the existing drug registration system (Decision No. 78). For example, the following “types” of marketing authorization became possible: registration of drugs with post-registration obligations, registration of drugs in exceptional cases, conditional registration of drugs, accelerated registration of drugs. In

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Market of medical devices in Armenia.

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Until recently, there was no legal basis for regulating the circulation of medical devices in Armenia. The sale and import of medical equipment and products for medical use, according to the local legislation of the Republic of Armenia, did not require state registration. However, accession to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within

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Normative document for the pharmaceuticals

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Normative document for the pharmaceuticals. According to the definition of Decision No. 78 “On the Rules for Registration and Examination of Medicines for Medical Use” ‘normative document’means a document establishing requirements for the quality control of a medicinal product (it contains a specification and a description of analytical procedures and tests or references thereon, as well as appropriate acceptance criteria

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