DMVO Information meeting 14-12-2018...3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja,...

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DMVO Information meeting 14-12-2018 The Danish Medicine Verification Organization

Transcript of DMVO Information meeting 14-12-2018...3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja,...

Page 1: DMVO Information meeting 14-12-2018...3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja, Nomeco HCL) –have chosen stand alone solutions SSI - Verilite Lægemiddelstyrelsen/NCA

DMVO Information meeting

14-12-2018

The Danish Medicine Verification Organization

Page 2: DMVO Information meeting 14-12-2018...3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja, Nomeco HCL) –have chosen stand alone solutions SSI - Verilite Lægemiddelstyrelsen/NCA

56 days to 9th. of February 2019 Equaling 36 work days

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What would you like to discuss?

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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

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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

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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

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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

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Page 24: DMVO Information meeting 14-12-2018...3PL’er (DHL, DSV, 3D logistik, Movianto, Movilitas, Freja, Nomeco HCL) –have chosen stand alone solutions SSI - Verilite Lægemiddelstyrelsen/NCA

Next meeting

Next information meeting will take place the 18th

of January 2019 – same place and time

Feedback is welcome – send an email to

[email protected]

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