ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of March 28, 2024 No. 385

About approval of Rules of provision, confirmation and cancellation of permission to production and application of the biomedical cellular products intended for execution of individual medical appointment

According to article 32.1 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

1. Approve the enclosed Rules of provision, confirmation and cancellation of permission to production and application of the biomedical cellular products intended for execution of individual medical appointment.

2. 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 the Ministry of Health of the Russian Federation, and also the budgetary appropriations provided to the Ministry in the federal budget on management and management in the sphere of the established functions.

3. This resolution becomes effective since September 1, 2024 and is effective till September 1, 2030.

Approved by the Order of the Government of the Russian Federation of March 28, 2024 No. 385

Rules of provision, confirmation and cancellation of permission to production and application of the biomedical cellular products intended for execution of individual medical appointment

1. These rules establish procedure and conditions of provision, confirmation and cancellation of permission to production and application of the biomedical cellular products intended for execution of individual medical purpose of the biomedical cellular product which is specially made for the certain patient directly in the medical organization in which such biomedical cellular product is applied (further respectively - permission, individual biomedical cellular product) and also modification of the register of permissions.

2. Provision of permission of the medical organization, its confirmation or cancellation, and also modification of the register of permissions are performed by the Ministry of Health of the Russian Federation (further - allowing body). Permission is effective is termless on condition of its confirmation each 5 years from the date of provision of permission or the last confirmation of permission.

Confirmation of availability of permission is entry in the register of permissions about provision of permission.

3. The decision on provision of permission is made based on the conclusion about ethical justification of production and application of the individual biomedical cellular product which is drawn up by results of ethical examination of individual biomedical cellular product which will be organized and carried out by the council on ethics created according to part 1 of article 14 of the Federal law "About Biomedical Cellular Products" (further - council on ethics) and the biomedical expertize of individual biomedical cellular product which is carried out by the commission of experts of the federal state budgetary institution which is under authority of allowing body and providing execution of powers of allowing body for issue of permissions to performing clinical trials of biomedical cellular products and (or) state registration of biomedical cellular products (further - expert organization).

4. For provision, confirmation, cancellation of permission and modification of the register of permissions the payment is not levied.

5. For obtaining by the medical organization in which it is planned to make and apply individual biomedical cellular product (further - the applicant), the applicant represents permissions to allowing body in electronic form, signed by the simple digital signature, either the strengthened qualified digital signature, or the strengthened unqualified digital signature which certificate of key of check is created and is used in the infrastructure providing information and technological interaction of the information systems used for provision of the state and municipal services electronically in the procedure established by the Government of the Russian Federation with use of the federal state information system "Single Portal of the State and Municipal Services (Functions)" (further - the single portal) the statement for provision of permission with application of copies of the following documents and following data:

a) the specification on individual biomedical cellular product constituted in form according to part 2 of article 7 of the Federal law "About Biomedical Cellular Products";

b) the draft of the regulating documentation on individual biomedical cellular product;

c) projects of prototypes of primary package and secondary package of individual biomedical cellular product;

d) the report on the conducted preclinical research of individual biomedical cellular product;

e) draft of regulations of production of individual biomedical cellular product;

e) information leaflet of the patient;

g) the draft of the instruction for application of individual biomedical cellular product containing the data specified in subitems "a" - "N", "p" and "r" Item 13 of part 2 of article 9 of the Federal law "About Biomedical Cellular Products";

h) the documents confirming availability at the applicant of department (chamber) of intensive therapy and resuscitation;

i) data on results of earlier conducted scientific research of clinical application of the individual biomedical cellular product made (made) on developed technology, and (or) about results of earlier conducted scientific research of clinical application of similar products (in case of availability).

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