The State Service of Ukraine on Medicines and Drugs Control informs!
The procedure for monitoring the compliance of immunobiological drugs used in medical practice the requirements of state and international standards, approved by the order of the Ministry of Health of Ukraine dated October 1, 2014 No. 698 (hereinafter – the Procedure).
In accordance with the Procedure the obligatory laboratory analysis to the indicators of quality specification of quality control methods is subject, in particular vaccines.
Further circulation of a series of immunobiologicals is subject to a positive conclusion on the compliance of immunobiologicals with the requirements of state and international standards.
This Procedure does not apply to immunobiologicals imported to Ukraine in accordance with the Law of Ukraine “On Humanitarian Aid”, “On Charitable Activities and Charitable Organization” and “On Implementation of the Global Fund to Fight AIDS, Tuberculosis and Malaria in Ukraine” program, and for immunobiologicals that have passed the World Health Organization prequalification procedure and were procured as a result of the procurement procedure conducted by a specialized procurement organization for the implementation of a procurement agreement between the Ministry of Health of Ukraine and the relevant specialized procurement organization.
Provide information on the state quality control of influenza vaccines, according to the database of the State Service of Ukraine on Medicines and Drugs Control, as of October 05, 2023
1.GC FLU QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) suspension for injections; 0.5 ml in a prefilled syringe with a disposable needle; 1 syringe in a blister; 10 blisters in a carton pack; manufactured by GC Biopharma Corp., Korea (UA/18246/01/01)
- imported by BioLabs, LLS
- positive conclusion on the compliance of immunobiologicals with the requirements of state and international standards was issued for 114,600 doses of vaccine (11,460 units)
|
Reference number and date of application |
Batch number |
Number of doses |
Number and date of the Certificate / Conclusion |
|
No. 2627 dated 31/08/2023 |
Q60223033 |
460 |
No. 47010/23/26 dated 15/09/2023 |
|
No. 2724 dated 07/09/2023 |
Q60223033 |
35260 |
No. 47011/23/26П dated 15/09/2023 |
|
No. 2792 dated 13/09/2023 |
Q60223033 |
36800 |
No. 47013/23/26П dated 15/09/2023 |
|
No. 2861 dated 18/09/2023 |
Q60223033 |
42080 |
No. 47545/23/26П dated 19/09/2023 |
- VAXIGRIP TETRA SPLIT INFLUENZA VACCINE (TETRAVALENT, INACTIVATED) suspension for injections; 0.5 ml in a prefilled syringe; 1 prefilled syringe with an attached needle in a cardboard box; manufactured by Sanofi Pasteur, France (UA/16141/01/01)
- imported by Sanofi-Aventis Ukraine, LLC
- On October 5, 2023, positive conclusions were issued on the compliance of the immunobiologicals with the requirements of state and international standards for 151,100 doses of vaccine (151,100 units).
|
Reference number and date of application |
Batch number |
Number of doses |
Number and date of the Certificate / Conclusion |
|
No. I/50 dated 07/09/2023 |
X3E722V |
75 550 |
No. 45412/23/10 dated 05/10/2023 |
|
No. I/51 dated 14/09/2023 |
X3E722V |
75 550 |
No. 46757/23/10П dated 05.10.2023 |