Q1: What are the assumptions regarding the multi-market products under consideration in Cyprus and Greece?
A1: The following assumptions are made regarding the multi-market products:
The multi-market products under consideration are currently in Cyprus.
Some batches (or parts of batches) may currently be physically located in Greece, but their details were uploaded to Cyprus anyway.
Any products that are only for the Greek market will be treated as new products to be added as normal.
Q2: What will happen if Greece is added as a market for a product but the associated serial numbers are not uploaded to Greece?
A2: If Greece is added as a market and the serial numbers are not uploaded to the Greek system (HMVS), the following scenarios may occur:
Pack updates (PSUM/PSUN):
Updates will be sent to both Greece and Cyprus.
Since HMVS in Greece will not have any information about these serial numbers, it will raise alerts, unless it is configured not to do so.
Verifications by OBPs (VBOP):
Verifications may be directed to Greece instead of Cyprus.
HMVS in Greece will not recognize these serial numbers and will respond with a timeout. If this occurs after SR 1.16 deployment, the EU Hub will then try to verify the serial numbers with Cyprus.
Cyprus:
All packs from existing batches scanned in Cyprus are presumably already known to Cyprus, and this should not cause any issues.
At some point, packs from Greece that are part of existing batches already known to Cyprus will likely enter Cyprus and be scanned by pharmacists. This will not be a problem.
Packs from Greece that are part of new batches will eventually enter Cyprus and be scanned by pharmacists. OBPs should upload the batch details as usual, especially since Greece has been retrospectively added as a market for the product.
Greece:
Until the serial numbers are uploaded to HMVS, if a Greek pharmacy scans a pack, an IMT (Inter-Market Transaction) request will be directed to the Cyprus national system.
Q3: What will happen if Greece is added as a market for a product and the associated serial numbers are uploaded to Greece?
A3: If Greece is added as a market and the serial numbers are uploaded to HMVS, the following scenarios may occur:
PPD (Product Pack Data):
Cyprus will receive the batch information again. It is uncertain how this will affect the status of the packs in Cyprus, but the Hub will still indicate that the batch was successfully distributed to Cyprus, even if Cyprus rejects the update.
Pack updates (PSUM/PSUN):
Updates will be sent to both Greece and Cyprus.
HMVS in Greece will now recognize these serial numbers, and their status will be "Active" in Greece, even if some of the packs have been decommissioned in Cyprus.
Verifications by OBPs (VBOP):
Verifications may be directed to Greece instead of Cyprus.
HMVS in Greece will respond that the packs are currently "Active."
Cyprus:
All packs from existing batches scanned in Cyprus are already known to Cyprus, and this should not cause any issues.
At some point, packs from Greece that are part of existing batches already known to Cyprus will likely enter Cyprus and be scanned by pharmacists. This will not be a problem.
Packs from Greece that are part of new batches will eventually enter Cyprus and be scanned by pharmacists. OBPs should upload the batch details as usual, especially since Greece has been retrospectively added as a market for the product.
Greece:
If packs are scanned in Greece, they will be recognized by HMVS, so there will be no issues.
Q4: What issues could arise if HMVS is unaware of certain serial numbers when packs are scanned in Greece or Cyprus?
A4: If HMVS in Greece is unaware of the serial numbers when a pack is scanned, it could result in the following issues:
HMVS will raise alerts because it does not recognize the serial numbers.
Verifications by OBPs may lead to a timeout because HMVS does not know the serial numbers. If SR 1.16 has been deployed, the EU Hub will attempt to query Cyprus if Greece was checked first.
IMT requests may be triggered, where a Greek pharmacy scanning a pack directs the request to the Cyprus national system instead of resolving it in Greece.
Q5: How will pack updates (PSUM or PSUN) be handled between Greece and Cyprus when Greece is added as a market for the product?
A5: When Greece is added as a market for a product, pack updates (PSUM or PSUN) will be directed to both Greece and Cyprus. Depending on whether the serial numbers have been uploaded to Greece:
If serial numbers are not uploaded to Greece:
HMVS in Greece will raise alerts because it won’t recognize the serial numbers.
Verifications may time out unless handled by the EU Hub.
If serial numbers are uploaded to Greece:
HMVS in Greece will recognize the serial numbers, and packs will be marked as "Active" in Greece, regardless of their status in Cyprus.
Q6: What is the impact on Cyprus when batch details are uploaded to both Greece and Cyprus after Greece has been retrospectively added as a market?
A6: In Cyprus, the following impact is expected:
Packs from existing batches that are already known to Cyprus will not cause any issues when scanned by pharmacists in Cyprus.
Packs from Greece that are part of existing batches known to Cyprus will eventually enter Cyprus and be scanned by pharmacists without any problems.
Packs from Greece that are part of new batches will enter Cyprus, and OBPs should upload batch details as normal. Since Greece has been retrospectively added as a market, no issues are anticipated with these updates.
Q7: What is the impact on Greece when batch details are uploaded to both Greece and Cyprus after Greece has been retrospectively added as a market?
A7: In Greece, the following impact is expected:
Once the serial numbers are uploaded to HMVS, packs scanned in Greek pharmacies will be recognized by the system without any problems.
If serial numbers are not uploaded, IMT requests will be directed to the Cyprus system, potentially causing verification delays or errors until the serial numbers are correctly uploaded to HMVS.