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俄罗斯饲料添加剂注册

俄罗斯饲料添加剂注册,饲料添加剂认证,饲料

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俄罗斯饲料添加剂注册,饲料添加剂认证,饲料

200819发布的第1号关于《批准联邦动植物卫生监督局行使国家有关发放动物、动物源性产品、动物药剂、饲料和饲料添加剂、应检产品的进、出口和过境许可证职能的行政条例》命令,对应执行国家兽医检疫监督的产品的进出口程序做出了规定。

发证机关:Rosselhoznadzor俄罗斯联邦动植物卫生监督局

注册证书有效期:无限期

注册证书:任何单位都可以注册,不需要俄罗斯代理商

动物用药品和饲料添加剂的国家注册 由俄罗斯农业监督署根据俄罗斯联邦机构 " 全俄国家动物用药品和饲料质量和标准化监督中心 " ( 以下用首字母缩写 ) 的鉴定,自递交注册文件和材料之日起在六个月内进行。
每种形式(药品形式)的动物用药品和饲料添加剂的注册许可证有效期为无限期。

动物用药品或饲料添加剂国家注册需要的文件 :

1. 申请书 ;

2. 营业执照

3. 植物检验检疫证书

4、原产地证书

5ISO9001质量体系证书

6 商标注册证,专利证书 ;

7 动物用药品或饲料添加剂组成成分一览表及其数量 ;

8、根据自 1998 6 22 起施行的 № 86-ФЗ 号联邦《药品法》的要求制定的动物用药品或饲料添加剂使用说明书 ;

9、药品和添加剂介绍 ;

10、药品和添加剂质检方法 ;

11、临床研究结果报告 ;

12.药理学和毒理学分析报告 ;

13、兽医学研究测试报告 ;

14、以供质量鉴定的药品和添加剂样品 ;

15 药品和添加剂的建议售价 ;

19、其他国家动物用药品或饲料添加剂的注册证明证书 .

制定动物用药品或饲料添加剂使用说明书的要求

I . 基本知识

1. 药品或添加剂的名称(俄文和拉丁文名称),别名。

2. 成分。药品或添加剂的有效物质和辅助物质的成分和化学名称。

3. 形状 ( 药品形状 ). 外形 . 物理和化学特性 ( 组合状态 , 颜色 , 透明度 , 在水中和其他溶剂中的溶解度 )

4. 出厂状态。 药品或添加剂的分装 , 包装 , 标志 , 保存和运输条件 , 有效期。  

II . 药理学(生物学)特性

5. 药品或添加剂的作用机理 .

6. 药品或添加剂的基本药理学、生物学和其他特性 ( 生物可达性 , 毒性 , 药理动力 , 机体排出物 , 免疫 , 致反应性 , 营养成分及其他 )  

III . 使用方法

7. 使用指示 ( 列举 ).

8. 药品或添加剂的使用方法和条件,指明动物种类、方式、剂量 ( 一次用量 , 昼夜用量 , 次数 , 疗程 ), 饭前或饭后 , 规定的饮食制度等

9. 可能出现的副作用和并发症。预防和治疗方法 ( 解毒药 , 去活处理 , 中和作用 ).

10. 和其他药品或添加剂的相容性 .

11. 使用禁忌症 .

12. 使用药品或添加剂后被和迫屠宰情况下畜产品可供使用的期限 .  

IV. 个人预防措施  

13. 遵守预防措施、个人卫生规则,在接触药品或添加剂的工作时利用防护手段。

14. 提供给受害者的急救措施。 推荐的解毒药 .

注册要求资料如下:

(часть 6 введена Федеральным законом от 11.10.2010 N 271-ФЗ)

Статья 19. Принятие решения о выдаче экспертному учреждению и совету по этике__

An application for state registration of a drug shall include the following information:
1) the name and address of the applicant and (or) the manufacturer of the drug and
address of the place of production of the drug;
2) the name of the drug (or nonproprietary
chemical and trade names);
3) a list of substances that are the components of the drug, indicating the amount of
each of them;
4) pharmaceutical form, dosage, way of administration and use, shelf life of the
drug;
5) a description of pharmacological, pharmacodynamic and immunobiological properties of the
drug;

3. Registration dossier is formed of the following documents:
1) draft models of primary and secondary (consumer) packaging of the drug
drug;
2) The document, translated into Russian, confirming that the manufacturer
complies with all the requirements of production and manufacturing
quality control of drugs, issued by the competent authority in the country of
manufacturer

3) The draft regulatory document or legal instrument for drug
preparation or instruction relevant pharmacopoeial monograph;
4) The scheme of technological process of production of the drug, its description and
(Or) the scheme of the technological process of the pharmaceutical substance, its description;
5) The document, translated into Russian, confirming that the manufacturer
of the pharmaceutical substance complies with the rules of organization and control of the Quality of Medicines issued by the competent authority of pharmaceutical substance’s country of origin, which shall contain:
a) name of the pharmaceutical substance (or nonproprietary
chemical and trade names);
b) the name and address of the manufacturer of pharmaceutical substance;
c) the shelf life of pharmaceutical substance;
6) a document containing information regarding the quality of pharmaceutical substances
used in the manufacture of drugs;
7) The regulatory documents or regulations on pharmaceutical substance,
any indication of the relevant pharmacopoeial monograph;
8) information on the conditions of storage, transportation and other drug
information;
9) report on the results of preclinical studies of the drug’s
medical use, containing a description of the results and statistical analysis
results of preclinical studies;
10) report of the results of preclinical studies of drug and
Clinical trials of medicines for veterinary use;
11) the draft protocol of the clinical trials of medicines for
medical use;
12) Investigator's Brochure;
13) patient information leaflet;
14) information about payments and compensation to patients (healthy volunteers, healthy patients)
(Hereinafter - the patients), attracted to conducting clinical trials of medicinal
the drug for medical use, bioequivalence studies and (or)
therapeutic equivalence;
15) report on the results of international multicenter clinical trials of
the drug for medical use, some of which were held in
Russian Federation;
16) draft instructions for using a drug that contains the following
Information:
a) name of drug (or nonproprietary
chemical and trade names);
b) The dosage form of the name and the quantity of
(Activity) of pharmaceutical substances and excipients;
c) Pharmacological drug group;
d) indications for use;
e) contraindications for use;
e) the dosage, route of administration, if necessary, while taking medication
drug, duration of treatment (including the children before and after one year);
g) safety precautions when using;
h) symptoms of overdose, measures to assist in overdose;
and) an indication, if necessary, the features of the drug in
first call or when its abolition;
a) A description, if necessary, actions, medical (medical assistant), a specialist in the field
veterinary medicine, the patient, the owner of the animal you missed taking one or more doses
drug;
l) the possible side effects when using the drug;
m) interaction with other drugs and (or) food;
n) an indication of capabilities and features of the medical use of medicinal
the drug by pregnant women, women during breast-feeding, children
adults with chronic diseases;
a) information about the possible effects of the drug for medical use
n) the expiry date and reference to the prohibition of the drug after
expiry date;
p) storage conditions;
c) an indication of the need to keep the drug out of reach
for children;
t) an indication, if necessary, special precautions for the destruction of
unused medications;
a) timing of the possible use of animal products after the introduction of
animal drug for veterinary use;
p) the name, address of the manufacturer of the drug and address of the place
production of the drug;
x) conditions of release;
17) translated into Russian and a duly certified copy of the document
confirming the registration of the drug if it is registered outside the
Russian Federation;

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