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Registration of Food Supplements

The registration procedure is based on the following legislation:

- Ratification of temporary procedure for sanitary and hygienic inspection Order (including alterations under the order No.120) of the Ministry of Health of Ukraine No.247 dated on 09.10.2000

- Article 28 of the Law of Ukraine implementation on safety and quality of food products Order, including Products classification procedure to the category of food products for special dietary use, functionary food products and dietary supplements and State registration procedure of food products for special dietary use, functionary food products and dietary supplements

Structure of the registration dossier:

Following list of documents is required for sanitary-hygienical expertise of the food supplement,in Ukraine :

Power of Attorney

  1. Information about name, composition and indications of the food supplement, or it’s special abilities and recommendations of the manufacturer on it’s use.
  2. Normative documents (methods of quality control of the finished product), technological instruction, specification.
  3. Project of the package design.
  4. Declaration of compliance (for example – to Directive 2002/46/EC), certificate of the state registration of manufacturer company, manufacturing license.
  5. Scientific reports, results of clinical and preclinical studies, publications, expert reports.

Letter from manufacturer that product does not include active medical ingredients and GMO