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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 31, 2020 No. 1771

About approval of features of marginal state regulation of selling prices of producers on the medicines included in the list of vital and essential drugs and introduction of amendments to separate acts of the Government of the Russian Federation

According to part 9 of article 61 of the Federal law "About Drug Circulation" Government of the Russian Federation decides:

1. Approve enclosed:

features of marginal state regulation of selling prices of producers on the medicines included in the list of vital and essential drugs;

changes which are made to acts of the Government of the Russian Federation.

2. 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 October 31, 2020 No. 1771

Features of marginal state regulation of selling prices of producers on the medicines included in the list of vital and essential drugs

1. This document determines features of marginal state regulation of selling prices of producers on the medicines included in the list of vital and essential drugs (further respectively - marginal selling price, medicines), in case of items out of stock or risk of emergence of items out of stock of medicines in connection with pricing on them.

2. The Federal Service on supervision in health sector carries out based on information arriving from subjects of drug circulation for medical application monitoring of items out of stock (risks of its origin) or absence in the address of medicines in connection with pricing on them.

In case of identification of items out of stock (risks of its origin) the Federal Service on supervision in health sector creates based on data and information according to appendices No. 1 - the 3rd conclusion about items out of stock (risk of its origin) or about absence in the address of medicines in connection with pricing on them on the approved Federal Service on supervision in health sector to form (further - the conclusion) and represents it to the Ministry of Health of the Russian Federation.

3. On availability of items out of stock (risks of its origin) can specify decrease in index of variation of intake of medicine in civil circulation in the Russian Federation (Iotkl) less than minus of 30 percent, calculated by formula:

 

Формула к ПП РФ от 31.10.2020 г. №1771

where:

Of - quantity of dosage forms of the medicines carried to one international unlicensed (either chemical, or grouping) to the name and having identical way of introduction (equivalent dosage forms and the dosages) introduced into civil circulation in the Russian Federation in 6 months preceding month of forming of the conclusion;

Oplan - quantity of dosage forms of the medicines carried to one international unlicensed (either chemical, or grouping) to the name and having identical way of introduction (equivalent dosage forms and dosages) which is planned to be introduced into civil circulation in the Russian Federation in the next 6 months, according to the data provided according to item 4 of this document;

Op - quantity of dosage forms of the medicines carried to one international unlicensed (either chemical, or grouping) to the name and having identical way of introduction (equivalent dosage forms and the dosages) introduced into civil circulation in the Russian Federation in 30 months preceding month of forming of the conclusion.

If all medicines carried to one international unlicensed (either chemical, or grouping) to the name and the introductions (equivalent dosage forms and dosages) having identical way, have identical total quantity of dosage forms in secondary (consumer) package, it is allowed to perfrom measure calculation of Of, Oplan and Op in consumer packagings.

4. For preparation of the conclusion the Federal Service on supervision in health sector requests in machine-readable type (format) at:

holders or owners of registration certificates of the medicines (authorized by them persons), carried to one international unlicensed (either chemical, or grouping) to the name and having identical way of introduction (equivalent dosage forms and dosages), data on the planned input amount in civil circulation in the Russian Federation of medicines in form according to appendix No. 2 to this document by means of private office in the automated information system of the Federal Service on supervision in health sector;

federal state budgetary institution "Center of Examination and Quality Control of Medical Care" of the Ministry of Health of the Russian Federation information on availability of medicines in clinical recommendations, standards of medical care or actions for immunoprevention and of possibility (impossibility) of their replacement about form according to appendix No. 3 to this document;

The Ministries of Health of the Russian Federation and the Ministry of Industry and Trade of the Russian Federation the available data on items out of stock (risks of its origin) or on absence in the address of medicines in connection with pricing on them.

Submission of required data and information is performed within 10 working days from the date of sending an inquiry of the Federal Service on supervision in health sector.

5. The Ministry of Health of the Russian Federation no later than 5 working days from the date of receipt of the conclusion places in private office of the holder or owner of the registration certificate of the medicine (authorized by it persons), specified in the conclusion (further - the applicant), on the official site on the Internet on the portal on maintaining the state register of medicines in private office (further - private office) the applicant the offer on marginal re-registration of selling price on medicine according to this document.

6. In case of receipt of the offer specified in Item 5 of this document, the applicant within 10 working days from the date of receipt of such offer places the following documents and data in electronic form in private office:

a) the statement for marginal re-registration of selling price on medicine with indication of the selling price offered to marginal re-registration on medicine;

b) calculation of the selling price offered to marginal re-registration on medicine with appendix of the proving documents confirming need of marginal re-registration of selling price on medicine;

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