Licensing of activities in the field of nuclear energy use
Notification procedure
Notification of the beginning and termination of the activity (operation) of an object of minor epidemiological significance
Notification of the beginning or termination of hygienic training activities for decreed population groups
Notification of the beginning or termination of activities for the wholesale sale of medical products
Notification of the beginning or termination of the retail sale of medical products
Pharmaceutical activity
Pharmaceutical activity is the activity of manufacturing, manufacturing, wholesale and retail sale of medicines, medical devices. The license is issued indefinitely.
List of documents required to obtain a license:
Application of an individual and a legal entity for obtaining a license and (or) an appendix to the license in electronic form, certified by the service provider's EDS;
An electronic copy of the document confirming payment to the budget of the license fee for the right to engage in certain types of activities, except in cases of payment through the payment gateway of the "electronic government";
A form of information on compliance with the qualification requirements for licensing pharmaceutical activities and a list of documents confirming compliance with them (hereinafter referred to as the information form).
Medical activity
Medical activity is the professional activity of individuals who have received higher or secondary professional medical education, as well as legal entities aimed at protecting the health of citizens.
List of documents required to obtain a license:
Our company is ready to provide you with consulting services for obtaining a license and/or an appendix to a license in the field of nuclear energy use, including:
1
Service
Licenses for maintenance, installation, dismantling, charging, recharging, repair of devices and installations, including medical ones, containing radioisotope sources of ionizing radiation or generating ionizing radiation.
2
Using
Licenses for the use of devices and installations generating ionizing radiation.
Development of the necessary administrative documents, namely:
Instructions on radiation safety during the claimed work;
Instructions for personnel actions in emergency situations;
Technological regulations for the execution of the declared works;
Instructions for accounting and control of ionizing radiation sources;
Job description of the person responsible for radiation safety or Regulations on the Radiation Safety service, etc.
Development of draft orders on the appointment of responsible persons;
Advising on the drafting of contracts necessary for obtaining a license and/or an appendix to a license in the field of atomic energy use (radiation monitoring at workplaces, individual dosimetric control of personnel, insurance contract and others);
Preparation of explanatory and guarantee letters to the authorized body in the field of atomic energy use.
More than 70 types of documentation
from certificates of conformity to registration of medicines and medical devices