dmvo information meeting 14-12-2018...3pl’er (dhl, dsv, 3d logistik, movianto, movilitas, freja,...
TRANSCRIPT
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DMVO Information meeting
14-12-2018
The Danish Medicine Verification Organization
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56 days to 9th. of February 2019 Equaling 36 work days
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What would you like to discuss?
19-12-20183
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Agenda
▪ Status in DK
□ News from DMVO
□ News from Lægemiddelstyrelsen/NCA
▪ What is DMVS
□ The system and a demo of the system
□ Onboarding to DMVS
□ Onboarding of pharmacies
□ The Downtime Information System - DIS
▪ Status on stakeholders
▪ Other topics
□ Alert handling
▪ Questions
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DMVO News
▪ EMVO – NMVO agreement
▪ Release 4 – Primarily reports
▪ Code freeze from 15th of January – cancelled
□ New release: 4.1. end January 2019
▪ Yearly fee
▪ From implementation to operational phase
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Yearly fee for DK
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Fee models in EU
19-12-20187
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DMVS - PRD
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114153
240
10511088
19 2950
83 85
0
200
400
600
800
1000
1200
August Septermber Oktober November December
Number of Batches MAH'er
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DMVS - PRD
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194215
455738
587433
1395104
1505710
19 29 50 83 850
200000
400000
600000
800000
1000000
1200000
1400000
1600000
August Septermber Oktober November December
Number of Packs MAH'er
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Alerts in PRD
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1
45
65
0
5
10
15
20
25
30
35
40
45
50
A2 A3 A7 A24
Alert overview from 25/10 to 12/12 2018
A2 - Batch id mismatchA3 - Pack not foundA7 - Pack alread in requested stateA24 - Status change could not be performed
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Number of inquiries to DMVO
19-12-201811
69
178
278
30
260
142
90
234
209
109 111
369
0
50
100
150
200
250
300
350
400
Januar Februar Marts April Maj Juni Juli August September Oktober November December
Number of inquiries to [email protected]
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News from Lægemiddelstyrelsen/NCA
▪ Update of Q&A
□ Update of point 28 is soon to come
▪ Process description and alert handling from the
lægemiddeldatabasen/ the drug database per stakeholder
▪ Taksten will shortly be updated
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EMVS System Diagram
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ArvatoNMVS database
Country C
EUHUB
End Users
OBP(Parallell importer)
OBP(Manufacturer)
Wholesaler
Mnf site0001
ArvatoNMVS database
Country D
End Users
Wholesaler
Mnf site0010
SolidsoftNMVS database
Country A
End Users
Wholesaler
SolidsoftNMVS database
Country B
End Users
Wholesaler
EMVO NMVO
EU HUB: A «router» to/between National Systems & OBP
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Process for onboarding to DMVS
▪ DMVO ([email protected]) sends an email containing the registration info
and a ”verifying answer” to be applied in a mail from:
□ Solidsoft EMVS Authorization ([email protected])
□ The email address given to “Danmarks Apotekerforening/The Danish
Pharmacy Association should be stated
□ A temporary username and a passcode is send from DMVS
□ Using the instructions in the first email, the user is completing the registration
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Onboarding of pharmacies
▪ Instructions sent by email
▪ DMVO has made a step-by-step guidance for technical registration
of pharmacies, which can be found on the homepage of DMVO:
www.dmvo.dk
▪ A tutorial video will be available ultimo December on www.dmvo.dk
▪ Questions can be directed to: [email protected]
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Verification
19-12-201818
NMVS-Connect
▪ 3 PL’er:
□ Freja
□ DHL
□ 3D Logistik
□ Statens Serum Institut
□ And more……
GTIN: 11DSARUHH10PU8E00TS4
Serie nr.: 12O77LITJHKTV49HBDJ4
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Downtime Information System: DIS
▪ 2 types of downtime:
□ “Planned” – EMVO has to be
oriented a month in advance
□ “Not planned” - no impact on
End Users due to back-lock
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▪ EMVO DIS example:
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Example of planned downtime announcement
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Stakeholders in DK
Status on stakeholders in DK
▪ Wholesalers – Nomeco & TMJ are ready
▪ Hospital pharmacies – Successful UAT, system-wise ready for PRD –supplement with stand alone solution
▪ Pharmacies – 13 pharmacies (7 new within the last week)
▪ IT suppliers of pharmacy systems, Cito It is ready, NNIT expects implementation primo February 2019.
▪ ApoPro (online pharmacy) – integrated solution
▪ 3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja, Nomeco HCL) – have chosen stand alone solutions
▪ SSI - Verilite
▪ Lægemiddelstyrelsen/NCA – Taksten has been updated and the process of establishing new investigation procedures has begun and will shortly be published
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Other topics
▪ Alert handling
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Time for questions
19-12-201823
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Next meeting
Next information meeting will take place the 18th
of January 2019 – same place and time
Feedback is welcome – send an email to
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