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俄羅斯聯邦藥品注冊 -Registration of medicines in the Russian Federation

Регистрация лекарственных средств в РФ

在進入俄羅斯聯邦醫藥市場之前，每種藥品都必須經過注冊程序。 

Before entering the pharmaceutical market of the Russian Federation, every medicinal product must undergo the registration procedure.

在國外和俄羅斯生產的藥品都必須進行國家注冊。 

State registration is required for medicines manufactured both abroad and in Russia.

該程序確認藥品的質量、療效和安全性。

This procedure confirms the quality, effectiveness and safety of the drug.

形成注冊檔案 Formation of the registration dossier

形成注冊檔案 Verification of documentation

專業知識 Expertise

納入注冊 Inclusion in the register

俄羅斯國家藥品注冊-State registration of medicines

俄羅斯國家藥品注冊是對藥品進行檢驗并授權其在我國銷售和用于醫療目的的過程。 Is the process by which medicines are tested and authorised for sale and use for medical purposes in our country.

在俄羅斯聯邦注冊藥品是一項相當復雜的程序，要求申請人做好充分準備，包括臨床試驗，并提交大量文件。這可能需要很長的時間和大量的資金投入。

Registration of a medicinal product in the Russian Federation, being a rather complex procedure, requires the applicant to make thorough preparations, including clinical trials, and to submit a large amount of documentation. It can take a long time and require significant financial outlays.

為了避免被俄羅斯國家機構拒絕的風險，并順利地在俄羅斯聯邦注冊醫藥產品，請聯系我們的注冊專家。我們將在您的醫藥產品進行國家注冊的各個階段提供專家協助。

To avoid the risk of rejection by the state authority and to register a medicinal product in the Russian Federation without problems, contact the specialists of shanghai SEC. We provide expert assistance at all stages of state registration of your medicinal product.

根據歐亞經濟聯盟（EAEU）標準

According to EAEU standards

歐亞經濟委員會理事會已將根據國家規則進行注冊的可能性延長至2023年12月31日。

The Council of the Eurasian Economic Commission has extended the possibility of registration under national rules until 31 December 2023.

根據俄羅斯國家標準注冊

According to the national standard

我們支持俄羅斯制造商在2023年12月30日前提交藥品注冊可享受 10% 的折扣。如果您還有任何疑問，請隨時與我們聯系--我們將親自為您解答。

We support Russian manufacturers and offer a 10% discount on registration until 30 December 2023. If you still have any questions, please do not hesitate to contact us - we will answer you personally.

須注冊的藥品種類：

Categories of medicines subject to registration:

首次出現在俄羅斯市場上的藥品；

drugs that first appeared on the Russian market

已在俄羅斯聯邦注冊，但改變了包裝、劑量、名稱等的藥品；

drugs already registered in the Russian Federation, but changed their packaging, dosage, name, etc.

制劑，其化學成分已被至少一種成分改變；

preparations, the chemical composition of which has been changed by at least 1 component。

俄羅斯藥品注冊的各個階段

Stages of drug registration

1.形成藥品注冊檔案并提交俄羅斯衛生部-Formation of the registration dossier and its submission to the Ministry of Health of Russia;

2.核實文件并獲得專家審查授權-Verification of documentation and obtaining authorisation for expert review

3.檢查質量，檢查藥品預期收益與潛在風險的比例-Examination of quality and examination of the ratio of the expected benefit to the potential risk of using the medicine;

4.決定俄羅斯藥品注冊、將其列入俄羅斯醫藥產品注冊登記冊并頒發注冊證書-Decision on registration of the drug, its inclusion in the register of medicinal products and issuance of a registration certificate

藥品注冊截止日期

Registration deadlines

自繳費和提交所需文件之日起30個日歷日內頒發俄羅斯藥品證書。

The certificate is issued within 30 calendar days from the date of payment of the fee and submission of the required documents.

藥品注冊證書本身的有效期為無限期。

The validity of the certificate itself is not limited.

海關聯盟EAC認證中心/上海經合工業設備檢測有限公司

公司地址：上海浦東新區高科東路777弄1號樓2017室

聯系我們：上海經合工業設備檢測有限公司/俄羅斯EAC證機構中國代表處
電話：021-36411223   36411293
郵件：eac@cu-tr.org 
手機微信：18621862553