Sanitary and Epidemiological Service permission

If you have decided to start your own business, then you will be likely to obtain permission of SES at state Sanitary-Epidemiological Service (SES) as the legal requirements of sanitary and epidemiological surveillance are used almost to all activities. Under Ukrainian legislation all the companies that produce, import or sell products (including food), acquire land, are engaged in construction or reconstruction of buildings, are going to open medical or cosmetic facilities, etc. should get this type of permission.

Scope of SES permits is very wide. It is regulated by numerous regulations. For this reason, it is very hard to meet requirements of SES, go through the procedures of expertize and obtaining a SES permit, to get clear information about your rights and obligations without professional legal support is very difficult.

Under the Law of Ukraine „On ensuring sanitary and epidemiological welfare” from February, 24, 1994 № 4004-XII (Articles 15, 16, 17, 25), Sanitary and Epidemiological Service bodies are authorized to conduct following licensing procedures for entrepreneurs:

– Coordination on the provision of land for construction;

– Approval of production facilities location;

– Issuance of SES permits on certain activities conduction;

– Issuance of SES permits on certain activities conduction coordination;

– Approval (in fact – SES permit) of project, scientific and technical documentation for the construction, reconstruction, commissioning of new and reconstructed objects of industrial, social, cultural and other purposes;

– Coordination on the development, production and use of new vehicles, machinery, equipment and other capital goods, new technologies;

– Preparation of conclusions (in fact – SES permit) for the implementation and use of products manufactured abroad and in the absence of data on its safety for health in Ukraine;

– Preparation of conclusions (in fact – SES permit) for the development and production of new food products, new processes of production and processing;

– Issuance of SES permits for production, storage, transport, use of biotechnology products and other biological agents.

 

The issuance of a SES permit

It is known that there is almost complete lack of regulations that govern issuance of specific SES permits. An exception is the Regulation on the procedure for issuing by SES bodies conclusions of compliance with health standards of objects and structures that are put into exploitation, and the readiness of companies to work for obtaining a permit for starting work approved by the Chief Sanitary Doctor of Ukraine April 23, 2001, №51.

We should single out the next regulations, which govern some issues on SES permits issuance:

– Interim arrangements for public health expertise, approved by the Ministry of Health of Ukraine on October 9, 2000. Number 247;

– Order of the Ministry of Health of Ukraine „On issuance of conclusion of the State Sanitary and Epidemiological Service on compliance with existing requirements of facilities to sanitary norms and rules for certain types of economic activity” of August, 13, 2001 Number 333 – approved forms of appropriate SES conclusions;

– List of works and services in the area of sanitary and epidemiological welfare, performed and provided for a fee, approved by the Cabinet of Ministers of Ukraine on October, 15, 2002 № 1544 – determined the preparation and issuance of SES permits and SES conclusions to paid work and services.

Thus, only the procedure for issuing by SES bodies conclusions of compliance with health standards of objects and structures that are put into exploitation, and the readiness of companies to work for obtaining a permit for starting work are regulated. Legal aspects of this  procedure are defined by Regulation on the procedure for issuing by SES bodies conclusions of compliance with health standards of objects and structures that are put into exploitation, and the readiness of companies to work for obtaining a permit for starting work approved by the Chief Sanitary Doctor of Ukraine April 23, 2001, №51. Under this regulation:

– SES conclusion is an integral document that is the basis for issuing permits to start work by regional branches of State supervision bodies on labor protection;

– Issuing SES conclusion is performed on self-financing basis;

– For obtaining SES conclusion an applicant submits: 1) application; 2) Certificate on state registration; 3) Charter of the company with a list of activities; 4) Documents for the use of the premises; 5) Positive conclusion on the project documentation; 6) Hygienic conclusions on raw materials and finished products used in industrial equipment; 7) The results of previous medical examinations of workers in accordance with the current health legislation;

– SES conclusion is issued within 10 days since receipt of the application and required documents;

– State sanitary-epidemiological service are entitled to request additional materials from the applicant;

if the request of the State Sanitary and Epidemiological Service of the applicant to provide additional documents – term review of the documents set after receipt requested additional documents.