俄罗斯保健品认证，俄罗斯及欧亚联盟EAEU膳食补充剂（保健品）的国家注册（SGR）
我们的注册可能性
我们在俄罗斯注册营养补充剂（保健品BAA）的可能性：
1、国内外生产的生物活性补充剂（BAAs）的注册
2、营养补充剂专家的高级咨询。
3 、有监督的翻译（针对外国制造商）。
4 、起草规范和操作手册（针对本地生产商）。
5 、在提交上市许可之前，组织NS产品的实验室测试。
6、为国家注册的目的组织和监督NS产品的专业知识。
7、组织和监督Rospotrebnadzor（俄罗斯卫生和消费者权利机构）的NSD专业知识。
8、修改现有专家报告和国家注册证书。
我们为生物活性食品补充剂（BAA）的注册提供复杂的解决方案。 该程序相当复杂，并且是分阶段进行的：
I阶段 "档案资料的初步审查
1、对档案材料进行初步的专家评估，客户咨询
2、确定是否需要进行实验室测试
3、评估所提交文件的完整性及其是否符合注册机构规定的要求。
4、计算注册费用，与客户协调
第二阶段：提交卷宗和样品供专家鉴定
拟定合同和检测中心的申请书
翻译制造商的文件（对于外国营养补充剂）。
包装档案资料
对专家鉴定的控制
如果通知机构要求，提供补充材料和数据 接收专家报告
第三步 "产品测试
对第二阶段中确定的NS进行实验室测试。
第四阶段 "向Rospotrebnadzor提交档案资料
汇编和修改档案资料
完成申请
控制专家审查
如果Rospotrebnadzor要求，提供补充材料和数据
第五阶段 "完成注册程序，进入国家登记册
获得国家注册证书，将其交给客户
膳食补充剂的注册条款：
1、1-2周（最少7天） 产品测试。
2、测试是在专家审查期间进行。专家报告（2个月），取决于复杂程度 - 如果有必要，可以加快 - 1个月。3、国家注册（3-4周）根据复杂程度，必要时可加速至10天。
注册的费用
测试和专业知识的费用取决于膳食补充剂的成分数量，并为每个产品单独商定。
国内生产的膳食补充剂注册所需文件和数据清单（下载）。
俄罗斯及欧亚联盟膳食补充剂国家注册的监管框架
TR CU 021/2011 "关于食品的安全性
TR CU 022/2011 "关于标签的食品
TR CU 027/2012 "关于某些类型的特殊食品的安全，包括膳食治疗和膳食预防营养品
TR CU 029/2012 "食品添加剂、调味剂和加工助剂的安全要求
TR CU 005/2011 "关于包装的安全性
海关联盟委员会2010年5月28日决定批准的《受卫生和流行病学控制（监督）的货物的统一卫生流行病学和卫生要求》№299
SanPiN 2.3.2.1290-03 "组织生产和流通生物活性食品补充剂（BAA）的卫生要求
Registration of dietary supplements
Our possibilities for registering
BAS registration in Russia:
1、Registration of biologically active additives (BAAs) of domestic and foreign production
2、Consultation of NS expert in advance
3、Supervised translation of the documents (for foreign manufacturers)
4、Working out Technical Specification and Process Specification (for local manufacturers)
5、Organisation of the laboratory tests of NS before the application for state registration
6、Organise and monitor the expert evaluation of NS for the purpose of state registration
7、Organisation and monitoring of NSD evaluation in Rospotrebnadzor (Russian Agency for Health and Consumer Rights).
8、Modifying the existing expert report and state registration certificate.
We offer a complex solution for registration of dietary supplements. The procedure is rather complicated and consists of several stages:
Stage I: Preliminary Examination of the Dossier
1、A preliminary expert evaluation of the dossier, consulting with the customer
2、Determination of the need for laboratory tests
3、Calculating the completeness of the submitted documents and their compliance with the registration authorities' requirements
4、Calculating the cost of registration, co-ordination with the customer.
Stage II: Submission of dossier and samples for expert evaluation
Drawing up contracts and applications for the testing centre
Translation of manufacturer's documents (for foreign nutritional supplements)
Compiling dossier
Control over expertize process
Provision of additional materials and data in case of requests by the competent authority Receiving expert report
Stage III - Product testing
Carrying out laboratory tests on the NS identified in Stage II.
Stage IV "Submission of the dossier to Rospotrebnadzor
Compiling and finalizing the dossier
Drawing up the application
Control of expert review process
Provision of additional materials and data in case of requests from Rospotrebnadzor
V Stage "Completion of the registration process, entry into the state register
Obtaining state registration certificate, handing it over to the Customer
Period of registration of dietary supplements:
1、Products testing is 1-2 weeks (minimum of 7 days).
2、Tests are performed during the expert examination. Expert report (2 months) depends on the complexity; if necessary, it can be accelerated up to 1 month. 3. State Registration (3-4 weeks) Depending on the complexity, it can be accelerated up to 10 days if needed.
Cost of registration
The cost of tests and expertise depend on the quantity of components of dietary supplements and should be agreed on individually for each product.
List of documents and data required for registration of dietary supplements of domestic production （下载）
The list of documents and data required for registration of dietary supplements of foreign production
Regulatory framework for dietary supplements
TR CU 021/2011 "On the safety of food products
TR CU 022/2011 "Foodstuffs with regard to labelling
TR CU 027/2012 "On safety of certain types of specialized food products, including dietary therapeutic and dietary prophylactic nutrition
TR TR CU 029/2012 "Food additives, flavorings and food additives safety requirements".
TR CU 005/2011 "On the safety of packaging
Uniform Sanitary Epidemiological and Hygienic Requirements to Goods Subject to Sanitary and Epidemiological Control (Surveillance) approved by Decision of the Customs Union Commission on May 28, 2010 № 299
SanPiN 2.3.2.1290-03 "Hygienic requirements for the organization of production and circulation of biologically active food supplements (BAA)
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