ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 19, 2012 No. 615

About approval of Rules of maintaining the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products

According to article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of maintaining the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products.

2. Data on products of medical prescription and on medical equipment which are registered in the territory of the Russian Federation before entry into force of this resolution are subject to inclusion in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products.

3. Realization of the powers provided by this resolution is performed in the limits set by the Government of the limiting Russian Federation of number of employees of central office of the Federal Service on supervision in the field of health care, and also the budgetary appropriations provided in the federal budget on management and management in the field of the established functions.

4. This resolution becomes effective since July 1, 2012.

Approved by the Order of the Government of the Russian Federation of June 19, 2012 No. 615

Rules of maintaining the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products

1. These rules determine procedure for maintaining the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products.

2. The state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products (further - the register), is the federal information system containing data on medical products and on the organizations (individual entrepreneurs) performing production and production of medical products.

3. Functioning of the register is performed on the following principles:

a) single input and reuse of primary information;

b) use of electronic documents which legal importance is confirmed with the digital signature;

c) use of the SaaS model.

4. Maintaining the register is performed by the Federal Service on supervision in the field of health care in electronic form by introduction of register entries with assignment of unique number of the register entry in the register.

5. Maintaining the register is performed according to the single organizational, methodological and program and technical principles providing compatibility and interaction of this register with other federal information systems and information and telecommunication networks.

6. Access to the register is provided by means of the authorized access to the information resource placed on the Internet.

7. The register contains the following data:

a) name of medical product;

b) date of state registration of medical product and its registration number, effective period of the registration certificate;

c) the purpose of medical product established by the producer;

d) type of medical product according to the nomenclature classification of medical products approved by the Ministry of Health of the Russian Federation;

e) class of potential risk of use of medical product according to the nomenclature classification of medical products approved by the Ministry of Health of the Russian Federation;

e) code of the All-Russian Product Classifier for medical product;

g) the name and the location of the organization - the applicant of medical product;

h) the name and the location of the organization - producer (manufacturer) of medical product or surname, name, middle name (if is available), the residence of the individual entrepreneur - the producer (manufacturer) of medical product;

i) address of production site or production of medical product;

j) data on interchangeable medical products.

8. Entering into the register of data is performed within 1 working day from the date of decision making about state registration of medical product or about modification of the registration certificate on medical product.

In case of modification of the registration certificate on medical product unique number of the register entry and history of modification shall be kept.

9. The data containing in the register are posted on the official site of the Federal Service on supervision in the field of health care on the Internet and are provided on the inquiry sent to Service. The data containing in the register are updated daily with preserving all editions of the register.

10. The backup copy of the register is created for the purpose of protection of the data containing in it, 2 times a month.

11. Protection of the data containing in the register against unauthorized access is performed according to the Federal Law "About Information, Information Technologies and on Information Security".

12. The data containing in the register are public and are provided to public authorities, local government bodies, other legal entities, and also physical persons.

13. The data containing in the register are provided free of charge.

14. The request for receipt of the data containing in the register goes to the Federal Service on supervision in the field of health care in any form on papers or electronically through the official site of Service on the Internet or the federal state information system "Single Portal of the State and Municipal Services (Functions)". Provision of the data containing in the register is performed within 5 working days from the date of receipt of the corresponding request, including by means of use of system of interdepartmental electronic interaction.

Urgent (in day of receipt of the corresponding request) provision of the data containing in the register is performed on requests of public authorities and local government bodies.

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