Guidelines

Eurasian union (ex Customs union) : Armenia, Belarus, Russian Federation, Kazakhstan, Kirghizistan

Certification and products compliance

Ukraine

Certification and products compliance

Sanitary Conclusion (Hygiene Certificate)

Ukraine

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Sanitary Conclusion (Hygiene Certificate) Ukraine: main definitions

Ensuring the sanitary and epidemiological welfare of the population is governed by Law No. 4004-XXII issued on February 24, 1994, Directive No. 1109 issued on June 22, 1999on the Sanitary and Epidemiological Control issued by the Cabinetof Ministers of Ukraine, the Decree of the Ministryof Health of Ukraine No. 120 issued on March 14, 2006 about the amendments to the Decree No. 0247 about the temporary regulation for the implementation of the Sanitary and Epidemiological Expertise and the Sanitary Rules for specific activities.
 
Conclusion of the Sanitary and Epidemiological Expertise certify product compliance with regulatory requirements of Ukraine and authorizes the use of products in the field of activity declared.

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Scope and relevant products

Ukrainian customs regulations in force since 2004, and pp. 27 and 97 in particular, require mandatory Sanitary Control of products entering the territory of Ukraine.
 
On the one hand, the Ministry of Health has defined the list of products excluded from control, the products which are not mentioned in this list must be accompanied by the sanitary and epidemiological expertise conclusion issued by the Ministry of Health on basis of expertise implemented by accredited sanitary and epidemiological centres’ and on the other hand, in accordance with the State Sanitary and Epidemiological expertise Conclusion No. 05.02-03/52400 issued on December 27, 2004 the registry of products whose Sanitary and Epidemiological Expertise has been already made, was established.
 
The merchandise which was not included in any of these lists requires the sanitary and epidemiological expertise conclusion (Hygiene Certificate).

Marketing

Before placing on the market, the manufacturer or his representative shall:

  • meet the sanitary requirements of Ukraine (ref: state sanitary and epidemiological expertise conclusion No. 05.02-03/52400 issued on December 27, 2004 (register))
  • provide the technical file
  • provide the instructions
  • apply the procedures for sanitary control
  • obtain a registration/sanitary control certificate and ensure that it is attached to products

How to get it and applicable procedures:

 The following documents are required for Sanitary and Epidemiological Expertise:

  • formal request for expertise
  • documents supporting the provision of samples for testing
  • program of the expertise
  • products description
  • product marks
  • declaration of conformity
Conclusion is issued on the basis of satisfactory results of the expertise by one of accredited sanitary and epidemiological centers. 

Our solutions:

  • obtaining the Sanitary and Epidemiological Expertise conclusion
  • advice on product identification and relevant applicable standards
  • file compilation for sanitary control
  • implementation of product analysis

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More…

Other additional certifications or registrations may be required for consumer products or equipment, the Certificate UkrSEPRO, for example. 

Statutory reference:

  • Act N 4004-XXII issued on February 24, 1994 about assurance of sanitary and epidemiological welfare for the population of Ukraine
  • Directive N 1109 issued on June 22, 1999 about the Sanitary and Epidemiological Control issued by the Cabinet of Ministers of Ukraine
  • Decree of the Ministry of Health of Ukraine N 120 issued March 14, 2006 about the amendments to the Decree N 247 about the temporary regulation for the implementation of the Sanitary and Epidemiological Expertise
  • Decree N 247 about the temporary regulation for the implementation of the Sanitary and Epidemiological Expertise
  • Sanitary Rules for specific activities
  • Conclusion of the State sanitary and Epidemiological expertise N 05.02-03/52400 issued on December 27, 2004 (Register)

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