Outcome of the FMD - IDMP Integration Workshop. 27 th June EMA - London

Transcription

1 Outcome of the FMD - IDMP Integration Workshop 27 th June 2016 EMA - London

2 Meeting Agreements Introduction This is the output from a multiple stakeholder workshop held at EMA on June 27 th. 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 optional element data carrier identifier and should use the value of the product code as used in EMVS (often the GTI). A successful upload in the SPOR system completing with the MAH being provided with the MPID/PCID for each product submitted. Page 2

3 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. Page 3

4 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 resubmit 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 or 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). Page 4

5 Process Diagrams Market Authorisation Process 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. GTI Data Populated within SPOR MAH receives MPID(s) & PCID(s) Full diagrams included as PDF here: Page 5

6 Process Diagrams EMVS Product Master Data Submission Process MAH/MFR sends lightweight master data European Hub receives lightweight master data submission European Hub queries SPOR for data associated with the given product code SPOR Online? European Hub attempts to fetch product master data records from SPOR Product Code found in SPOR? Initial Master Data submission SPOR Online? Additional master data records retrieved from SPOR MAH/MFR sends full-weight master data Parallel Distribution submission? European Hub stores product master data Lightweight data upload rejected Reject submission and request full data set upload 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 Full data set distributed to appropriate EMVS ational Systems Page 6