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俄罗斯联邦的兽药认证可以以两种形式进行：
?自愿GOST R符合性声明
?以GOST R系统注册认证的产品符合性声明。

只有在正式自愿确认产品符合性俄罗斯GOST标准的情况下，俄罗斯联邦才能对兽药进行自愿认证。制造商/供应商先经过GOST标准检测合格后才可以自愿性自我声明。

产品符合性声明是一份官方认证声明证书，证明兽药完全符合适用的GOST合格评定程序的要求。对提交文件中所含信息（在符合性声明中）准确性的责任由相关兽药的制造商，销售商或供应商承担。

俄罗斯联邦的官方制造商或代表各外国制造商利益的组织（前提是该组织具有在俄罗斯联邦境内注册的法人实体的地位）有权通过产品符合性声明。制造商（表演者/销售者）采用的符合性声明须经认可的认证机构正式官方注册。

俄罗斯联邦的兽药认证需要哪些文件？

申请文件包括：
?卫生部的国家注册证书（复印件）/注册证书。
?章程（适用于法人实体，复制）。
?州税务机关的注册证明（复印件）。
?申请公司的全部细节，包括担任主管和总裁职位的人员详细信息。
?兽药生产许可证。
? 技术文档。
?使用兽医认证药物的说明，注册证书以及产品质量证书（如果有）。


为了增加俄罗斯联邦成功获得兽药认证的机会，建议提交其他文件表明认证产品符合法律规定的要求和标准。

俄罗斯联邦兽药认证的步骤是什么？
有几阶段：
?提交申请并提供一整套产品认证文件。
?分析整套文件，包括最终决定申请和选择适当的认证/申报方案。
?抽样。
?药物样本测试过程。
?对测试结果进行客观分析。
?关于拒绝或签发合格/声明文件的决定。
?颁发证书/声明。
?对获得合格证书的产品进行检查控制。

Certification of veterinary drugs in the Russian Federation can be carried out in two forms:
? Voluntary form-certificate GOST R.
? In the form of acceptance and registration of the declaration of conformity of products with the established standards, in the system GOST R.

Voluntary certification of veterinary drugs in the Russian Federation is possible only when there is official voluntary confirmation of product conformity. The manufacturer / supplier knows for sure which standards and GOSTs are to be tested.

The declaration of conformity of products is an official document certifying that the veterinary drug fully meets the requirements that are appropriate for undergoing the conformity assessment procedure. Responsibility for the accuracy of the information contained in the submitted document (in the declaration of conformity) is borne by the manufacturer, seller or supplier of the relevant veterinary drug.

The official manufacturers of the Russian Federation or organizations that represent the interests of the respective foreign manufacturers (provided that the organization has the status of a legal entity registered in the territory of the Russian Federation) have the right to adopt a declaration of product conformity. The declaration of conformity adopted by the manufacturer (performer / seller) is subject to official registration by accredited certification bodies.


What documents are required for certification of veterinary drugs in the Russian Federation?

The set of documents includes:
? Certificate of state registration (copy) / Registration Certificate of the Ministry of Health.
? Charter (for legal entities, copy).
? Certificate of registration with the state tax authority (copy).
? Full details of the applicant company, including data of the persons holding the positions of the head and chief accountant.
? License for the manufacture of veterinary drugs.
? Technical documentation.
? Instructions for use of a certified drug for veterinary use, its registration certificate, as well as product quality certificates (if any).


To increase the chances of successful certification of veterinary drugs in the Russian Federation, it is recommended that other documentation be presented, which in one way or another may indicate that the certified product complies with the requirements and standards established by law.


What are the steps involved in certification of veterinary drugs in the Russian Federation?




There are several such stages:
? Filing an application and providing a complete set of documentation for product certification.
? Analysis of the complete set of documentation, including the final decision on the application and selection of the appropriate certification / declaration scheme.
? Sampling and identification process.
? Processes associated with the organization of the testing of samples of drugs that have been selected and identified as a result of the previous stage.
? An objective analysis of the test results.
? Decision on refusal or issuance of a document of conformity / declaration.
? Issuance of certificate / declaration.
? Inspection control of products that received a certificate of conformity.

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