Outcome of the FMD - IDMP Integration Workshop EMA - London 27 th - - PowerPoint PPT Presentation

Outcome of the FMD - IDMP Integration Workshop EMA - London

27th June 2016

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Meeting Agreements

• Introduction

– This is the output from a multiple stakeholder workshop held at EMA

• n June 27th.
• Market Authorisation Phase.

– MAH submits data to SPOR system in IDMP format in accordance to the Art57 legal requirements. – During the submission, the MAH should also complete the IDMP

• ptional element ‘data carrier identifier’ and should use the value of

the ‘product code’ as used in EMVS (often the GTIN). – A successful upload in the SPOR system completing with the MAH being provided with the MPID/PCID for each product submitted.

FMD – IDMP Integration Workshop 27-06-2016

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Meeting Agreements

• EMVS Master Data Submission Phase.

– Assuming that the MAH has completed the SPOR submission and has populated the ‘data carrier identifier’ the master data submission to the EMVS (European Hub) can be made using a lightweight data payload including the product code value. – The EMVS will use the product code to obtain the full data set from.

• If the SPOR system is unable to return the data set (e.g. the product

code has not been uploaded to IDMP), the submission to EMVS will fail and the error returned.

– The MAH must amend the IDMP product record to include the ‘data carrier identifier’ element.

– Once updated, the submission process to EMVS can be retried.

• This process will quickly force compliance at the authorisation submission

phase (to include the product code value) as it will be impossible to ship product (because the EMVS submission will be blocked) until the product code/’data carrier identifier’ element is part of the product registration.

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Meeting Agreements

• EMVS Master Data Submission Phase (2).

– If the IDMP system is unavailable(e.g. off-line for maintenance purposes), the MAH will be able to submit a full EMVS data set.

• Where known, the full data set should include the evCode or PCID.
• If subsequently the IDMP system becomes ‘online’, the MAH can must re-

submit the data using the lightweight data set, and all the previously uploaded data will be overwritten by the SPOR authoritative set.

– Parallel traded products remain an issue to be fully addressed within SPOR and the current Art57 systems and therefore, until a full SPOR

• r current Art57 capability is in place for parallel distributed products,

a full data set submission to EMVS will be expected. (i.e. no SPOR/Art57 data exchange).

FMD – IDMP Integration Workshop 27-06-2016

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Process Diagrams

FMD – IDMP Integration Workshop 27-06-2016

Full diagrams included as PDF here:

IDMP Submission MAH requests product authorisation & sends product data. MAH should voluntarily complete the optional element data carrier identifier and use the value of the EMVS product code, e.g. GTIN Data Populated within SPOR MAH receives MPID(s) & PCID(s)

Market Authorisation Process

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Process Diagrams

FMD – IDMP Integration Workshop 27-06-2016

EMVS Product Master Data Submission Process

Initial Master Data submission MAH/MFR sends lightweight master data European Hub receives lightweight master data submission Product Code found in SPOR? European Hub queries SPOR for data associated with the given product code Additional master data records retrieved from SPOR Full data set distributed to appropriate EMVS National Systems MAH has to update SPOR and re-try Reject Submission and provide error (product code not found in SPOR) MAH receives normal distribution success message SPOR Online? Reject submission and request full data set upload Lightweight data upload rejected MAH/MFR sends full-weight master data European Hub stores product master data Parallel Distribution submission? SPOR Online? European Hub attempts to fetch product master data records from SPOR Y Y Y Y N N N N