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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 30, 2020 No. 955

About features of input in civil circulation of medicines for medical application

The government of the Russian Federation decides:

1. Approve the enclosed Regulations on features of input in civil circulation of medicines for medical application.

2. The medicines for medical application imported into the Russian Federation, and also introduced into civil circulation according to the Provision approved by this resolution are subject to the address before the termination of expiration date.

3. This resolution is effective till January 1, 2021.

4. This resolution becomes effective from the date of its official publication.

Russian Prime Minister

M. Mishustin

Approved by the Order of the Government of the Russian Federation of June 30, 2020 No. 955

Regulations on features of input in civil circulation of medicines for medical application

1. This Provision determines features of input in civil circulation without drawing means of identification of the medicines for medical application made during the period from July 1, 2020 to October 1, 2020 and also import to the Russian Federation without drawing means of identification for the purpose of input in civil circulation of medicines for medical application, except for the medicines for medical application intended for providing persons sick with hemophilia, mukovistsidozy, by hypophysial nanism, disease to Gosha, malignant new growths lymphoid, haematogenic and related it fabrics, multiple sclerosis, persons after the organ transplantation and (or) fabrics (further - medicines) made outside the Russian Federation till October 1, 2020.

2. Release by customs authorities of the medicines imported (imported) into the Russian Federation according to customs procedures of release for internal consumption or reimport, and also input in civil circulation of medicines are performed based on approval by the Federal Service on supervision in the field of health care of import to the Russian Federation, input in civil circulation of the medicine which is drawn up based on the decision of the interdepartmental commission on issue of approvals created under the Federal Service on supervision in the field of health care on the address of medicine (further respectively - the interdepartmental commission, approval).

3. Approval is issued for a period of 45 calendar days.

4. The form of approval affirms the Federal Service on supervision in the field of health care.

5. The Federal Service on supervision in the field of health care creates the interdepartmental commission, regulations on the interdepartmental commission and its structure affirm. The interdepartmental commission representatives not below the deputy manager of structural division of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Federal Customs Service, the Federal Service on supervision in the field of health care, the operator of monitoring system of movement of medicines for medical application are included (further - monitoring system).

6. The holder or the owner of the registration certificate of medicine or person authorized by it (further - the applicant) by means of use of personal account in the automated information system of the Federal Service on supervision in the field of health care (further - information system) submits the statement for issue of approval in which are specified:

a) the name, the address of the holder or owner of the registration certificate of medicine, and also the identifier of the subject of drug circulation appropriated in monitoring system;

b) data on registration of the holder or the owner of the registration certificate of medicine as the taxpayer in country of incorporation (for the Russian legal entities - identification taxpayer number, for foreign legal entities - country of incorporation, the name of registering body, registration number, code of the taxpayer in country of incorporation (incorporation) or its analog);

c) the name of medicine (the trade name and international unlicensed, either grouping, or chemical), and also the global identification number of trade item registered in monitoring system (in the presence);

d) registration number in the state register of medicines and date of state registration;

e) the list of production sites and the address of places of implementation of production of medicine (in case of availability of several participants of production process of medicine it is necessary to specify each participant according to the performed production stage);

e) total quantity of units of medicine with indication of the units of measure declared for the purposes of import to the Russian Federation or introductions in civil circulation;

g) 10-unit code of the single Commodity nomenclature of foreign economic activity of the Eurasian Economic Union (for the medicines made out of the territory of the Russian Federation and imported into the Russian Federation including from state members of the Eurasian Economic Union).

7. The following documents and data are enclosed to the application for issue of approval:

a) the copy of the document in Russian from the holder or the owner of the registration certificate of the medicine confirming power of the applicant on submission of documents for receipt of approval;

b) reasons for impossibility of drawing funds of identification for packaging of medicine according to requirements of the Federal Law "About Drug Circulation", including under customs locks;

c) copies of delivery agreements and installation of the equipment for drawing funds of identification for each of the production sites specified in the statement, and also development or completion of the software for the purpose of ensuring information exchange with monitoring system (in Russian);

d) the actions plan on implementation of monitoring system with indication of final readiness date of the producer to drawing funds of identification for packaging of medicine and data transmission about drawing in monitoring system.

8. The Federal Service on supervision in the field of health care within one working day from the date of receipt of the documents and data specified in Items 6 and 7 of this provision sends the arrived documents and data to the interdepartmental commission in the form of electronic documents.

9. The interdepartmental commission within 5 working days from the date of receipt of documents and data makes the decision on possibility (impossibility) of issue of approval.

Criteria for adoption of the decision by the interdepartmental commission are determined in the regulations on the interdepartmental commission approved according to Item 5 of this provision.

10. The decision of the interdepartmental commission goes in electronic form to the Federal Service on supervision in the field of health care within one working day from the date of its registration.

11. Within 3 working days from the date of receipt of the decision of the interdepartmental commission the Federal Service on supervision in the field of health care draws up the corresponding approval or refusal in issue of approval and directs him to the applicant in electronic form signed by the strengthened qualified digital signature.

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