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Certificate of Hygiene / Sanitary-Epidemiological Conclusion

Certificate of Hygiene / Sanitary-Epidemiological Conclusion

The solution of sanitary and epidemiological services, to call it differently, Hygiene or Health Certificate is a document which confirms that the products manufactured in the territory of Ukraine, imported or exported beyond it, meets the sanitary and epidemiological norms approved by the Ministry of Healthcare of Ukraine (Ministry of Health).

The objects of sanitary-epidemiological service Solutions are:

  • Products;
  • The project of Technical Specifications;
  • Changes to the Technical Specifications;
  • Technological instructions.

The solution of sanitary-epidemiological service may be issued for the following term:

  • If it is given for domestically produced products – for 3 or 5 years;
  • If it is issued for foreign-made products - 1 year, 3 years (per consignment / under Contract);
  • If it is a project of Technical Specifications - for the duration of the Technical Specifications.
  • If it changes to the Technical Specifications - for the duration of the Technical Specifications.

There are two different kinds of Solutions of sanitary-epidemiological service by its intended purpose:

  • For customs clearance, ie for imported products, to present it to the custom authorities, according to the Resolution of Cabinet of Ministers of Ukraine number 1031 of 05.10.2011;
  • For trading in the internal circulation, according to the Decision of the Ministry of Health № 25 dated 26.12.2008.

Please note, that destination object of examination that indicated in the Solution / Conclusion of Service, depends on the further use of the product in your shopping networks. For example drugstore chains, require designation "for pharmacy chains", trade - "for the wholesale and retail trade", etc.

Procedure for sanitary-epidemiological expertise consist from next stages:

  • Applying for hygienic assessment of the goods.
  • Defining the scope and cost.
  • Conclusion of the Agreement with the applicant to carry out the necessary works.
  • Check the documentation and examination of samples.
  • Making the decision based on the results of hygiene inspections.
  • Conclusion the decision of the sanitary and epidemiological inspections.

Sanitary Inspection Bodies determine validity decision based on:

  • Type of product;
  • The features of production;
  • And other conditions that characterize the epidemiological significance of product.

Determine what permits are needed and what are their features for imported products is possible only on the basis of analysis of UCG FEA codes (Ukrainian Classification of Goods of foreign economic activity).

Determine what permits are needed and what their features are for products manufactured in Ukraine can be made by normative document which is used for manufacturing of a product.

You should also consider that even if there is no need to obtain particular Solutions of sanitary-epidemiological service on the stage of customs clearance, does not mean that it is negate requirement of its obtaining for further circulation of goods within the country. Ie Solution/Conclusion can be requested while retail.

In case of imported goods, a Solution / Conclusion of sanitary-epidemiological service is required for:

  • baby goods;
  • food;
  • products for everyday life;
  • products that come into contact with human skin or with food.

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