俄罗斯联邦药品注册 -Registration of medicines in the Russian Federation
Регистрация лекарственных средств в РФ
在进入俄罗斯联邦医药市场之前，每种药品都必须经过注册程序。
Before entering the pharmaceutical market of the Russian Federation, every medicinal product must undergo the registration procedure.
在国外和俄罗斯生产的药品都必须进行国家注册。
State registration is required for medicines manufactured both abroad and in Russia.
该程序确认药品的质量、疗效和安全性。
This procedure confirms the quality, effectiveness and safety of the drug.
形成注册档案 Formation of the registration dossier
形成注册档案 Verification of documentation
专业知识 Expertise
纳入注册 Inclusion in the register
俄罗斯国家药品注册-State registration of medicines
俄罗斯国家药品注册是对药品进行检验并授权其在我国销售和用于医疗目的的过程。 Is the process by which medicines are tested and authorised for sale and use for medical purposes in our country.
在俄罗斯联邦注册药品是一项相当复杂的程序，要求申请人做好充分准备，包括临床试验，并提交大量文件。这可能需要很长的时间和大量的资金投入。
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.
为了避免被俄罗斯国家机构拒绝的风险，并顺利地在俄罗斯联邦注册医药产品，请联系我们的注册专家。我们将在您的医药产品进行国家注册的各个阶段提供专家协助。
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.
根据欧亚经济联盟（EAEU）标准
According to EAEU standards
欧亚经济委员会理事会已将根据国家规则进行注册的可能性延长至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.
根据俄罗斯国家标准注册
According to the national standard
我们支持俄罗斯制造商在2023年12月30日前提交药品注册可享受 10% 的折扣。如果您还有任何疑问，请随时与我们联系--我们将亲自为您解答。
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.
须注册的药品种类：
Categories of medicines subject to registration:
首次出现在俄罗斯市场上的药品；
drugs that first appeared on the Russian market
已在俄罗斯联邦注册，但改变了包装、剂量、名称等的药品；
drugs already registered in the Russian Federation, but changed their packaging, dosage, name, etc.
制剂，其化学成分已被至少一种成分改变；
preparations, the chemical composition of which has been changed by at least 1 component。
俄罗斯药品注册的各个阶段
Stages of drug registration
1.形成药品注册档案并提交俄罗斯卫生部-Formation of the registration dossier and its submission to the Ministry of Health of Russia;
2.核实文件并获得专家审查授权-Verification of documentation and obtaining authorisation for expert review
3.检查质量，检查药品预期收益与潜在风险的比例-Examination of quality and examination of the ratio of the expected benefit to the potential risk of using the medicine;
4.决定俄罗斯药品注册、将其列入俄罗斯医药产品注册登记册并颁发注册证书-Decision on registration of the drug, its inclusion in the register of medicinal products and issuance of a registration certificate
药品注册截止日期
Registration deadlines
自缴费和提交所需文件之日起30个日历日内颁发俄罗斯药品证书。
The certificate is issued within 30 calendar days from the date of payment of the fee and submission of the required documents.
药品注册证书本身的有效期为无限期。
The validity of the certificate itself is not limited.
海关联盟EAC认证中心/上海经合工业设备检测有限公司
公司地址：上海浦东新区高科东路777弄1号楼2017室
联系我们：上海经合工业设备检测有限公司/俄罗斯EAC证机构中国代表处
电话：021-36411223 36411293
邮件：eac@cu-tr.org
手机微信：18621862553
