ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of February 2, 2023 No. 153

About approval of Rules of transfer to the organizations performing production of medicines and (or) medical products, donor blood and (or) its components

According to part 2 of article 17.1 of the Federal law "About Donorship of Blood and Its Components" Government of the Russian Federation decides:

1. Approve the enclosed Rules of transfer to the organizations performing production of medicines and (or) medical products, donor blood and (or) its components.

2. This resolution becomes effective since March 1, 2023 and is effective till March 1, 2029.

Approved by the Order of the Government of the Russian Federation of February 2, 2023 No. 153

Rules of transfer to the organizations performing production of medicines and (or) medical products, donor blood and (or) its components

1. These rules establish procedure for transfer of donor blood and (or) its components by the subjects of the address of donor blood and (or) its components specified regarding 1 article 15 of the Federal law "About Donorship of Blood and Its Components" (further - supply agencies), to the organizations performing production of medicines and (or) medical products (further - the organizations receivers).

2. Supply agencies perform transfer of donor blood and (or) its components prepared with observance of the mandatory requirements established by the order of the Government of the Russian Federation of June 22, 2019 No. 797 "About approval of Rules of procurement, storage, transportation and clinical use of donor blood and its components and about recognition voided some acts of the Government of the Russian Federation" (further - Rules of procurement), including with observance of requirements to the organization of activities of subjects of the address of donor blood and (or) its components on procurement, storage, transportation of donor blood and (or) its components, and also the requirements to the organization of security system approved by the Ministry of Health of the Russian Federation.

3. Supply agencies for the purpose of the safety of donor blood and (or) its components transferred to the organizations receivers perform traceability of data on the donor, the donations prepared donor blood and (or) its components, consumable materials (containers, reagents, solutions, medicines), samples of blood of the donor, contractors, and also about compliance to safety requirements of the carried-out works on procurement of donor blood and (or) its components according to requirements of Rules of procurement.

4. Traceability of data, stipulated in Item 3 these rules, is reached by means of their identification at all stages from physical examination of the donor before transfer of donor blood and (or) its components to the organizations receivers, including storage and utilization, with consecutive entering of the relevant information into medical documentation and the database on implementation of the actions connected with safety of donor blood and its components, development, the organization and promotion of donorship of blood and its components.

5. The organizations receivers provide traceability of units of donor blood and (or) its components creating series (batch) of medicine and (or) series (batch) of medical product for taking measures in case of identification of risk for safety in case of production of series (batch) of medicine and (or) series (batch) of medical product and informing supply agency, stipulated in Item 20 these rules.

6. Transfer of donor blood and (or) its components which are not conforming to requirements of Rules of procurement, the organizations receivers for production of the medical products intended for diagnostics is allowed.

7. In the presence the organization receiver in engineering procedure has productions of medicines at least 2 orthogonal stages of inactivation and (or) elimination of viruses transfer by supply agencies of the plasma which did not pass karantinization or being on quarantine storage is allowed.

8. The decision on suitability of donor blood and (or) its components for transfer to the organizations receivers and about change of the status of donor blood and (or) its components on "donor blood and (or) its components, suitable for use" is accepted by supply agencies on the basis:

a) checks of compliance of the prepared units of donor blood and (or) units of the components of donor blood to measure values specified in the specification which form is given in appendix No. 1;

b) information of the database of donorship of the blood and its components specified in Items 3 - 8 parts 3 of article 20 of the Federal law "About Donorship of Blood and Its Components";

c) results of blood tests of the donor on availability of markers of haemo inoculable infections;

d) biochemical indicators of peripheral blood;

e) results of check of appearance of donor blood and (or) its components and lack of damage of container.

9. Donor blood and (or) its components shall meet specifications, approved between supply agency and the organization receiver. The recommended form of the specification is given in appendix No. 1 to these rules.

10. The supply agency provides to the organization receiver for its request information, stipulated by the legislation the Russian Federation in the sphere of the address of donor blood and (or) its components, about procurement and storage of the transferred donor blood and (or) its components, necessary for preparation or change of the main file (master file) of plasma of blood according to the decision of Council of the Eurasian economic commission of November 3, 2016 for No. 89 "About approval of Rules of carrying out researches of biological medicines of the Eurasian Economic Union".

11. The organizations receivers are provided with donor blood and (or) its components supply agencies by transfer of donor blood to them and (or) its components based on concluded by them with the organizations receivers in accordance with the legislation of the Russian Federation:

a) the paid agreement (contract) for performance of works on procurement and storage of donor blood and (or) its components;

b) the agreement (contract) providing transfer of donor blood and (or) its components for the purpose of its conversion, production and return of medicines and (or) medical products or their delivery in the state (municipal) organizations in accordance with the terms of the agreement (contract).

12. For the purpose of transfer of donor blood and (or) its components by supply agencies and the organizations receivers are in accordance with the legislation of the Russian Federation determined:

a) amount of subjects to procurement and transfer of donor blood and (or) its components;

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