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Small Markets (Brexit)
Small Markets (Brexit)
Will the serialised PLGB packs scanned in the markets that trigger alerts have a new alert type, and if so, will the OBP receive this alert?
If a product is not registered in GB but serialised packs are shipped/exported to GB, is it allowed to ship the serialised packs from 2023 onwards? Is there any requirement to be considered for the non-registered products?
How to treat the batches that go to Great Britain and Northern Ireland at the same time?
Will the alerts due to GB packs scanned in other EU markets only apply to dispensing transactions?
Until when is it required to upload GB-only pack data to SecurMed?
What do PLGB and GBMA stand for?
How will the EMVS be adapted to support the expected update of the DR?
What guidance did the European Commission provide in its Notice published on 22nd December 2020?
As many companies supply NI from Great Britain, what would be your recommendations or best practice solutions to supply packs to the NI market?
Are we able to send either serialised (incl. legacy packs) or non-serialised stock (new goods) to NI from Great Britain? And do these new goods need to be re-tested or released?
Do we have to decommission all the batches that are already in the UK after 31st December 2020?
Should OBPs decommission packs as “exported” if verifying after 1st January 2021? (specifically for data uploaded before 31st December 2020 but still awaiting EU/UK Importation QP certification)?
Should UK legacy packs, physically exported to EU markets (via parallel distribution), be “checked out” or “exported” by the repacking companies (if traded in EU countries) after 1st January 2021?
If GB packs are not meant to be uploaded after 1st January 2021, should packs uploaded after 1st January 2021 be [decommissioned as] exported?
After 1st January 2021, will it be possible for a pharmacy to decommission a pack serialised under FMD rules in NI?
Would the UK Government be open to the possibility of GB End-Users still being connected to the EMVS or a similar system?
Post-Brexit, will the MHRA enforce End-User readiness in NI?
What is the current level of End-User readiness in NI, and what is it now (from 1st January 2021 onwards)?
Could you provide more information concerning the fees for MAHs for the UK NI MVS?
Were UK MAHs/OBPs automatically disconnected from the EMVS on 1st January 2021?
In Great Britain (England, Wales, and Scotland), will SecurMed’s NMVS still be active?
Has there been any updates on an ISO code for Great Britain?
How will the reporting data for EU FMD be performed in regards to Brexit and Northern Ireland?
How do we decide what packs to load into the UKNI NMVS?
Is it required to upload data for packs/batches destined for the GB market only?
Will there be the possibility of using NI (as an ISO/market code) in the EMVS in future?