State Scientific Research Laboratory for
Quality Control of Medicines

Sanitary and epidemiological examination


Since June 2016, all conclusions of the sanitary-epidemiological examination are issued by a new service - State Food Safety and Consumer Protection Service of Ukraine.


Conclusion of the state sanitary-epidemiological examination - a document of the established form, certifying the compliance (non-compliance) of the object of state sanitary and epidemiological examination with medical safety requirements for human health and life, is approved by the relevant chief state sanitary doctor and is mandatory for the owner of the object of examination (http://zakon2.rada.gov.ua/laws/show/z0362-06)


State sanitary and epidemiological examination (SEE) - this is a type of professional activity of bodies, institutions and institutions of the state sanitary-epidemiological service, which consists in a comprehensive study of objects of expertise with the aim of identifying possible dangerous factors in these objects, establishing compliance of the objects of expertise with the requirements of sanitary legislation, and in the absence of relevant sanitary standards - in the justification of medical requirements regarding the object's safety for human health and life.


Object of state sanitary and epidemiological examination - any activity, technology, products and raw materials, construction projects, draft regulatory documents, the implementation (functioning, use) of which may have a harmful effect on human health, as well as existing facilities and current regulatory documents in cases where their harmful the impact is established in the process of functioning (use), as well as in the event of the expiration of the established period of validity of the conclusion of the state sanitary and epidemiological examination.


Conclusion of the SEE necessary in cases of goods imported into the territory of Ukraine, which must necessarily meet the requirements of sanitary and epidemiological examination. This document has legal force not only in the process of customs clearance of the cargo, but also in the future during sale or inspection by the controlling authorities.


The conclusion of the state sanitary-epidemiological examination is also required for some groups of goods that are subject to mandatory certification by UkrSEPRO, for example, for detergents and cleaning products, as well as for food products.

The conclusion of the SES is issued by a body that specializes in this field and must confirm the safety of products for human life and health, as well as compliance with the requirements of hygienic standards.


The SEE conclusion (hygienic certificate) can be classified into three types:


• The conclusion of the sanitary-epidemiological examination for the type of activity (works, services);

• The conclusion of the sanitary-epidemiological examination of the products;

• The conclusion of the sanitary-epidemiological examination on the technical documentation (technical conditions).


The conclusion of the SEE is issued for a period of 1 to 5 years (the term of the decision is affected by the type of products, submitted documents, production conditions and the expert who examines the body's package of documents).


Stages of sanitary-epidemiological examination:


• registration of the relevant application for the examination;

• definition and clarification of the scope of the required expertise;

• execution a contract for payment of works carried out in the examination process;

• examination of documentation;

• carrying out the necessary instrumental and laboratory tests and research;

• issuance of a conclusion with its subsequent entry into the Register that has passed the examination.

To obtain a conclusion of the SEE, the following are required:

• Company details;

• Product sample;

• Company registration documents;

• Contract;

• Certificates of hygiene, quality, safety, country of origin of the producer;

•Completed application;

• Product description (appearance, composition, scope of application) or safety data sheets for certain types of goods;

•Power of attorney.


Attention! On September 20, 2015, the new Law "On Basic Principles and Requirements for the Safety and Quality of Food Products" entered into force, which specifies new requirements for the management of the quality of food products. Domestic enterprises producing food products, as well as enterprises that store food products and sell them, are currently required to monitor production, according to the system that has the abbreviation HACCP.


The conclusion of the sanitary-epidemiological examination is valid for 5 years, regardless of whether it is imported or domestic products. A conclusion on a normative document (TU, Amendment to TU) - can be issued for the term of validity of the normative document, or for 5 years.


On September 20, 2015, the Law "On Amendments to Certain Legislative Acts Concerning Food Products" entered into force, according to which there were changes in the issuing of decisions by the sanitary-epidemiological service.


To date, the conclusion of the sanitary-epidemiological examination is issued by the State Production and Consumer Service at:


• regulatory documentation;

• domestic and imported products of the industrial group (equipment, household items, furniture, etc.);

• cosmetic products (creams, shampoos, balms, etc.);

• household chemicals;

• disinfectants;

• baby food and goods for children;

• pesticides and agrochemicals.


A number of other documents must be obtained for food products, which also include dietary supplements (DD). According to the new legislation, the manufacturer must pay more attention to the quality of products during production itself and regularly monitor both the quality of raw materials and the quality of finished products.


Manufacturers now need to independently regularly conduct periodic control tests of products for safety indicators and microbiology. The product quality management system must now comply with the principles of HACCP.