俄罗斯兽药注册和饲料添加剂注册要求资料registration of veterinary preparations and fodder additives for animals in Federal Russian
THE LIST OF DOCUMENTS FORMING THE CASE FILE WHILE APPLYING FOR STATE REGISTRATION:
- Document confirming State registration of the Company,( in Russian);
- Address of manufacturer
- Product name including international generic name, scientific name in Latin, main synonyms, original name of product in case it already registered as Trade Mark according Russian Law.
- List of the Ingredients of Product and quantity ( Certificate of the components)
- Administration and dosages (in Russian) -instruction
- Certificate of the analysis
- Methods of the analysis of finish product.(with translate in Russian) Preclinical Trials Report, Stability Trials Report while keeping
- Pharmacological and Toxicological Trials Reports (researches include: definition of acute toxicity, the subchronic toxicity, irritating action on a surface of a body and ( or) mucous membranes, depending on application and allergic action).
- Residue determination of the pharmacological speciality with protocols investigation ( very important)
- Clinical Trials Report (researches include results of application in dozes during time and to those kinds of animals which will be written to instructions on application)
- Commercial Samples for expertise (3-4 of each commercially packed and standards of substances of active components)
- Short description of production with control points+ GMP( ISO)certificate
- Label sample ( in Russian)
- Documents about registration outside Russia
- List of Documents.
- Reference Letter (on the Head Paper)( in Russian)
- Date Safety Sheet
- Free sale certificate
- The literary review
- Price proposals(from Russian company- seller)
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