NEWS: Users, transactions and alerts

The number of users of The National Medicine Verification System (NSOL)

Marketing authorisation holders (MAH) numbers by mid-June 2022

  • Registered MAH: 382
  • of which with recognized reduced user fee (MAH with small revenues): 63

End-users (pharmacies and wholesalers): 100% connection to NSOL

 

NSOL availability and transactions

  • The NSOL is stable for a long time and meets the set objectives and requirements of the Regulation.
  • Average system response time (Service level Agreement defined with NSOL provider – Solidsoft Replay – was met):
    • The end data center transaction time for pharmacies < 300 ms is 99.65 %.
    • The end data center transaction time for pharmacies < 350 ms is 99.69 %.
    • The end data center transaction time for MAH bulk transactions < 10 s is 99.37 %.
  • In March 2022, the largest number of transactions in the system – 41,507,912 – was made. The second largest number was in March 2021 – 40,983,903. Among the TOP10 months in terms of transactions in the system, March is represented a total of three times.
  • The number of successful end-user decommissions was the largest to date in the 50th week of 2021 – 10,203,810. Until then, and since then, the number of decommissions has not exceeded 10 million per week.

 

Status of FMD in the Czech Republic at the end of 2021 – alerts

Percentage distribution of closed alerts in 2021 by groups

Type (group)                    

 % of alerts in 2021

Pharmacies
                       
18,58 %
OBP/MAH/parallel distributors
   
68,40 %
Wholesalers
                          
 4,85 %

Intermarket operations       

1,56 %

Another             

6,60 %

 

Status of FMD in the Czech Republic in 2022 - alerts

February—April 2022

Type (group)                   

Alert rate (according to EMVO)

Pharmacies
 
 11 %

OBP/MAH/parallel distributors    

 82 %

Wholesalers

 2 %

Intermarket operations     

 0 %

Another

5 %

 

Alert rate: 0.01% in April 2022 (weeks 14 - 17)

Week 14            0.008

Week 15            0.008

Week 16            0.007

Week 17            0.008

 


COMPARISON CZ WITH THE OTHER COUNTRIES IN EU: RATE OF ALERTS IN RELATION TO THE TOTAL NUMBER OF SCANS – PER COUNTRY – IN DECLINING ORDER – WEEKS 15 AND 17

MAY 2022 EMVO MONITORING REPORT

  • In the selected weeks under review, the Czech Republic is the best of all EU countries with the lowest rate of alerts.
  • NOOL has been long-term trying to communicate directly with the subjects that are most involved in the generation of alerts.

 

  • The rate of closed alerts from total alerts number in the first five months of 2022 decreased compared to the previous year. The NOOL team intensively points out MAH and end-users to investigate the generated alerts as soon as they occur and to use the correct end state after their closing.
  • NCA (SÚKL) focuses on the issue, how the alerts are investigated and what percentage of them are closed, how much remains to be solved. MAH and end-users are contacted regularly if they do not solve alerts for more than 30 days. NCA recommends using the NOOL Alert Management System.
  • Attempts to change the status and set the status of the alert, which already exists (A7 alerts make up almost 60%), are the most involved in number of alerts – these are so-called technical errors.
  • Compared to the previous period, the proportion of errors caused by parallel distributors has not changed and the proportion of end-user errors marked as technical errors is the 2nd most significant (mostly errors that can be eliminated – reader settings, capslock, switched keyboard, scan speed, etc.) – alerts A3, A2.

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