Registration (certification) of bio-active supplements (BAS) in Ukraine

Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. They are marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc.

Foodstuffs of animal and plant origin may present intrinsic hazards, due to microbiological contamination. Microbiological criteria are tools that can be used in assessing the safety and quality of foods. Due to reasons related to sampling, methodology and uneven distribution of micro-organisms microbiological testing of finished food products done alone is however insufficient to guarantee the safety of a foodstuff tested. The safety of the foodstuffs must principally be ensured by a more preventative approach, such as product and process design and the application of Good Hygiene and Manufacturing Practices (GHP, GMP) and the Hazard Analysis Critical Control Point (HACCP) principles.

In accordance with Ukrainian legislation (Decree of Cabinet of Ministers of Ukraine № 1023 from July 26, 2006) that group of products belongs to the «foods for special dietary use». Since the dietary supplements are food products, they can be administered only in oral form: tablets, capsules, syrup, oral solution (beverage), creams and gels to be added to food, etc. All food supplements are object of value added tax (VAT 20%). Registration of bio-active supplements is performed by MOH of Ukraine on basis of sanitary and epidemic conclusion. Registered special food products are included into the State register.

BAS registration procedure usually takes about 3 month from the dossier submitting date. Expiry date of sanitary and epidemic conclusion is unlimited.

Cost of our service fee for marketing authorization of food supplement depends on several factor:

- Product complexity (price for a multi-component product will be higher);

- Number of products submitted for registration (the larger your order is, the more discount we offer);

- Documentation language (translation needed or not), need for import of samples, etc.

Company MEDREG have great experience and knowledge of the marketing authorization process and

we are an official company with all the necessary permissions for this kind of activity.

We will be glad to answer any technical questions on the procedure registration in Ukraine.

Dossier for registration of bio-active supplement:

  1. Power of Attorney

  2. Application for registration

  3. Information about name, composition and indications of the food supplement, or its special abilities and recommendations of the manufacturer on its use

  4. Normative documents (test methods of quality control of the finished product), technological instruction, specification

  5. Project of the package design

  6. Declaration of compliance, certificate of the state registration of manufacturer company, manufacturing license

  7. Scientific reports, results of clinical and preclinical studies, publications, expert reports

  8. Letter from manufacturer that product does not contain active medical ingredients and GMO

  9. Samples of the product.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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