RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of October 9, 2020 No. 965

Some questions of implementation of the pilot project on procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2, for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus

Cabinet of Ministers of Ukraine decides:

1. Agree with the offer of the Ministry of Health concerning implementation of the pilot project on procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2, for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus.

2. Approve the Procedure for implementation of the pilot project on procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2, for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus which is applied.

3. Bring in resolutions of the Cabinet of Ministers of Ukraine of June 16, 1998 No. 920 "About approval of the Procedure for conversion and storage of donor blood and its components, their realization and the medicines made of them" (The Official Bulletin of Ukraine, 1998, No. 24, the Art. 889) and of March 20, 2020 No. 225 "Some questions of purchase of the goods, works and services necessary for implementation of the actions directed to prevention of origin and distribution, localization and liquidation of flashes, epidemics and pandemics of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus in the territory of Ukraine" (The Official Bulletin of Ukraine, 2020, No. 31, the Art. 1074, the Art. 1077, No. 42, the Art. 1361, No. 54, the Art. 1660, No. 75, the Art. 2405) - with the changes made by the resolution of the Cabinet of Ministers of Ukraine of October 9, 2020 No. 922, changes which are applied.

4. Provide to the Ministry of Health acceptance of necessary measures for implementation of the pilot project for procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2, for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2, caused by coronavirus according to the requirements determined by the Procedure approved by this resolution.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 9, 2020 , No. 965

Procedure for implementation of the pilot project on procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2, for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus

1. This Procedure determines the mechanism of implementation of the pilot project by procurement of specific (hyperimmune) plasma of the blood containing antibodies to SARS-CoV-2 (further - hyperimmune plasma), for contract manufacturing of immunoglobulin from it for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus (further - the project).

2. Participants of project implementation are the Ministry of Health, specialized agencies and institutions of blood transfusion and the relevant divisions of healthcare institutions which belong to the sphere of management of the Ministry of Health (further - specialized agencies), subjects of managing which in accordance with the established procedure perform production of medicines of blood in the territory of Ukraine and have the license for production of medicines from plasma of blood of the person (further - the subject of managing).

3. For project implementation between specialized agencies and subjects of managing the contract for contract manufacturing of immunoglobulin for use in treatment of sharp respiratory disease of COVID-19, of SARS-CoV-2 caused by coronavirus is signed (further - the agreement). The form of the approximate agreement is approved by the Ministry of Health.

4. Purchase of test systems for testing of persons for antibodies to SARS-CoV-2, of other consumable materials and reagents which are necessary for procurement of hyperimmune plasma and their transfer to specialized agencies is performed at the expense of the means provided to the Ministry of Health in the government budget.

5. For the purpose of ensuring virus safety with specialized agencies the research of each sample of donor blood received during donation directly from system for blood extraction without violation of its integrity, with use is conducted:

serological methods of research (IFA / І HLA elektrokhemilyuministsentny) for identification of infectious markers of haemo inoculable infections: superficial anti-gene of viral hepatitis B, antibodies to viral hepatitis C, anti-genes and antibodies of viruses of immunodeficiencies of the person (VICh-1 and VICh-2), syphilis;

molecular and genetic methods of researches - genamplifikatsionny testing (PTsR) in mini-pools for detection of remaining balance of nucleinic acids of causative agents of infections: RNA of human immunodeficiency virus (HIV RNA), RNA of virus of hepatitis C (VGS RNA) and DNA of virus of hepatitis B (VGV DNA);

test systems for identification of antibodies to SARS-CoV-2.

6. Specialized agencies provide weekly to the Ministry of Health information on amounts of the hyperimmune plasma prepared by them.

7. Quarantine storage of hyperimmune plasma which is prepared by specialized agencies is performed on capacities of subjects of managing in accordance with the terms of the agreement.

Subjects of managing provide quarantine storage of the received hyperimmune plasma with providing "holodovy chain" with limited access for strangers during the term of quarantine storage.

The term of quarantine storage of hyperimmune plasma constitutes:

for plasma which is tested by serological and molecular and genetic methods of research for markers of haemo inoculable infections, - 60 calendar days from the date of its procurement;

for plasma which is tested for markers of haemo inoculable infections by serological methods of research, - 180 calendar days from the date of its procurement. The term of quarantine storage of such plasma can be reduced to 60 calendar days from the date of its procurement on condition of additional testing of such plasma by molecular and genetic methods of research by markers of haemo inoculable infections by the subject of managing.

The plasma processed by validirovanny methods of reduction of pathogens (virus inactivation) is not subject to quarantine storage.

8. The decision on carrying out clinical testing of the immunoglobulin made by the subject of managing under the agreement and their termination accepts in accordance with the established procedure the Ministry of Health.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info