Brexit
LJ
2 authors30 articles
EU HUB | Brexit - UK and Ireland shared packs scenarios
Extension Derogation Brexit 2022
EU HUB | What is the legal basis for the exit of UKNI from the EMVS?
EU HUB | When does the Regulation (EU) 2023/1182 (Windsor Framework) become applicable?
EU HUB | What is the consequence for medicine packs aiming to be distributed in UKNI as of 1 January 2025?
EU HUB | What will happen to the UKNI Medicines Verification System after 31 December 2024, should the Regulation (EU) 2023/11821 enter into force on 1 January 2025?
EU HUB | Are there any new technical requirements or specifications that we need to adhere to in order to maintain connectivity with the EU Hub?
EU HUB | Are there new data exchange protocols or encoding standards that need to be implemented?
EU HUB | Will there be any changes in data formats or standards required for transmitting data to and from the EU Hub system post disconnection of the UKNI?
EU HUB | How will the OBPs’ existing data in the EU Hub which includes the target market “GB” be affected by these changes?
EU HUB | How are error responses standardized, and what response codes are used to communicate different types of errors or exceptions?
EU HUB | When should an OBP update the Product Master Data (PMD) which has the market “GB” as one of the designated markets?
EU HUB | Can an OBP upload “GB” single market pack data after 31 December 2024?
EU HUB | Can OBPs upload multi-market packs with the “GB” as one of the designated markets after 31 December, 2024?
EU HUB | What will happen to packs uploaded before 1 January 2025?
EU HUB | How will Product Master Data of single-market GB products be amended on EU-Hub after 1 January 2025? Will it be automatically removed from EU-Hub and OBPs are required to amend only multi-market products with exclusion of GB?
EU HUB | What should be the status of the pack in the EMVS of an EU/EEA pack supplied to the UKNI market?
EU HUB | Which transactions and reports will be affected by NIXIT?
EU HUB | How will the updated EU Hub system integrate with our existing IT infrastructure and systems?
EU HUB | How will the updated EU Hub system handle increased volumes of data and transactions, particularly during peak periods?
EU HUB | What provisions are in place for disaster recovery and redundancy to minimize the risk of data loss or system downtime?
EU HUB | What third-party service providers for us as the OBPs or dependencies are critical for the operation of the EU Hub system, and how will UKNI disconnection impact these relationships?
EU HUB | Are there any changes to existing APIs or the introduction of new ones with the update?
EU HUB | Are there new endpoints introduced or existing endpoints deprecated as a result of regulatory changes or system updates?
EU HUB | Can a UK pharmaceutical company act as an OBP for non-UK MAHs after 31 December 2024, should the Regulation (EU) 2023/11821 enter into force on 1 January 2025*
EU HUB | What are UKNI legacy packs?
EU HUB | What will happen if end-users (pharmacies, wholesalers, etc) in EU/EEA countries need to verify/(undo) decommission UKNI single market legacy packs in their possession after 1 January, 2025*
EU HUB | Will there be any training or support provided to help us adapt to these changes?
EU HUB | Are there resources available to assist with troubleshooting or addressing any issues that may arise during the transition period?
EU HUB | How will you communicate updates and provide ongoing support regarding these changes?