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 GISMETEO.RU

finance.ua

finance.ua

Services: Registration of medicinal products Services: registration of medical devices Services: registration of BAS and API's Services: registration of medicinal products, medical devices, BAS, ingredients regulatory affairs регистрация лекарств



 
 

 
 
Structure of the dossier:

Dossier for registration of bio-active supplement:

1. Samples of the product.
2. Instruction and recommendations for use.
3. Specification (composition of the product and data regarding identification).
4. Documents from the country of the manufacturer that assures quality and safety of the product (certificates, declarations).
5. Normative documents and technical documentation regarding manufacture process of the product. 
6. Information regarding registration in the manufacturing country.
7. Scientific reports, research protocols and other information assuring safety of the product.
8. Data regarding clinical trials.
9. Veterinary approval / Quarantine approval – if needed.  
10. EAN code.
11. Contract for import to the Ukraine.
12. Power of Attorney for registration.
13. Sanitary-hygienic conclusion.

 


 


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Download dossier structure as MS Word document

 

 

 

 

 

 

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