Registration of bio-active supplements (BAS)

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Biologically active substances and special food – products that are intended for food and manufactured in a special composition or in a special way and definitely differ from the usual food products, with specific direction for use. Direction of use must comply with the requirements and categories of people who will use these products, such as features of the digestive system, the special physiological conditions (for the body young and infants). In this case, these products can have a positive effect in the controlled use.

In accordance with the legislation of Ukraine (Cabinet of Ministers of Ukraine № 1023 of 26 July 2006 p.) September 1, 2006, all of bioactive supplements are assigned to the group of special foods. Assigning to bioactive supplements the category of special foods (CSF) is performed by the MOH of Ukraine conducting the state sanitary-epidemiological examination, the results of which the state registration of CSF is made.

After the approval of the conclusion of sanitary-epidemiological examination, the defined number is assigned and the CSF is listed the National Register.

The procedure for BAS registration takes an average of 2-3 months after the submission of the registration dossier. 

Description of the procedure: 

1. Providing initial consultations on registration of products;

2. After you decided to register products with our help, both parties sign a Confidentiality Agreement;

3. For determination of the cost for registration procedure you send us a registration dossier for the inner primary examination.

4. We conduct initial evaluation of registration dossier, define the scope of work and draw up a list of the missing documentation;

5. We inform you about the primary price and negotiate on terms of payment; if they are suitable for you – we start registration procedure after payment of service fee.

6. We translate the necessary parts of the dossier, including the certified translations;

7. We adopt the dossier in accordance with the law, prepare and co-ordinate the application;

8. Submit an application and dossier to the authorities of Ministry of Health of Ukraine;

9. Accompany the registration procedure during the examination;

10. We send you request for samples, receive them and carry out the customs clearance of the samples (for a separate fee);

11. We get the original conclusion of sanitary-epidemiological expertise;

12. We send you the original conclusions of the sanitary-epidemiological expertise.

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Dossier for registration of bio-active supplements BAS