俄罗斯原料药API注册
Active Pharmaceutical Ingredients registered in Russia
俄罗斯原料药注册（Active Pharmaceutical Ingredients）： 指的是药物活性成分，也就是我们通常所说的原料药。
原料药注册
活性药物-用于制造药物的任何物质或物质混合物。
为了成功组织和支持药物注册，我们提供以下服务：
1、对用于制造药物的药用物质进行完整的注册
2、对药物成分中未包含的药物进行完整的注册流程
3、形成一揽子文件，以获取针对药品生产商的工厂的俄罗斯GMP证书
4、药品注册档案的修订。
5、根据联邦法律No. 61“关于药品流通”，考虑到自01/01/2017起生效的变更和补充。
第一阶段
1、获得药品制造商的俄罗斯GMP证书
2、为生产现场创建卷宗并向监管机构提交卷宗
3、获得国家医学和良好实践研究所专家的检查工厂许可
4、进行检查并得出有关物质制造商符合指定GMP要求的结论
第二阶段
1、档案的预检查（分析）
2、初步分析合规档案，为客户咨询
3、文件翻译和公证
4、根据联邦法律第15号，携带药品的注册档案和法规文件。 61
5、在卫生部门户网站上注册，形成电子申请表
第三阶段
1、API质量专业知识
2、药品质量控制程序的初步复制
3、向俄罗斯联邦卫生部提交药物档案
4、支持注册过程，获得有关药物注册的决定
注册认证联系021-36411223 gost@gost.org.cn 手机微信：18621826553
俄罗斯原料药注册法规 https://www.fsvps.ru/fsvps/laws/204.html
Раздел I. Постановление Правительства РФ от 25.12.1998 N 1539 (ред. от 27.11.2006) "О ввозе в Российскую Федерацию и вывозе из нее лекарственных средств и фармацевтических субстанций"
Раздел II. Положение о ввозе в Российскую Федерацию и вывозе из нее лекарственных средств и фармацевтических субстанций
Registration of pharmaceutical substances
Active pharmaceutical substance - any substance or mixture of substances intended for the manufacture of medicines.
For the successful organization and support of the registration of pharmaceutical substances, we provide the following services:
Conducting a complete registration process for pharmaceutical substances for the manufacture of medicines
Conducting a complete registration process for pharmaceutical substances not included in the composition of medicines
Formation of a package of documents for obtaining the Russian GMP certificate for a plant of a manufacturer of pharmaceutical substances
Amendments to the pharmaceutical registration dossier. substances and in the regulatory document substances
The registration procedure is described in accordance with Federal Law No. 61 “On the Circulation of Medicines”, taking into account the amendments and additions that entered into force on 01.01.2017.
1 STEP
Obtaining a Russian GMP certificate for a pharmaceutical substances manufacturer
Creation of a dossier for a production site and submission of a dossier to a regulatory body
Obtaining permission to inspect the plant by specialists of the State Institute of Medicines and Good Practices
Conducting an inspection and obtaining a conclusion on the compliance of the substance manufacturer with the specified GMP requirements
2 STEP
Pre-examination (analysis) of the dossier
Initial analysis of compliance dossiers, consultation for the client
Translation and notarization of documents
Bringing the registration dossier and regulatory document for a pharmaceutical substance in accordance with Federal Law No. 61
Registration on the portal of the Ministry of Health, the formation of an electronic application
3 STAGE
API Quality Expertise
Preliminary reproduction of pharmaceutical substance quality control procedures
Submission of a pharmaceutical substance dossier to the Ministry of Health of the Russian Federation
Supporting the registration process, obtaining a decision on the registration of a pharmaceutical substance
