News Category: Regulatory news
Brexit has resulted in substantial changes to the way in which medicines and medical devices are imported from Great Britain to Ireland.
We wish to remind you of the changed processes and to outline the key responsibilities that remain with the manufacturer / exporter / importer of the medicine or medical device. You must:
have oversight of your supply chain;
understand the new requirements applicable to product being imported from GB or being transported via the UK landbridge under the customs transit procedure;
liaise with your logistics’ companies and to be satisfied that appropriate arrangements are in place to manage the new customs requirements, and;
have oversight/ access to all necessary travel documents/ numbers such as the pre boarding notification (PBN) ID and / or Master Reference Number(s) (MRNs) so that any issues impacting on supply of critical medicines and medical devices can be resolved on a timely basis.
Detailed guidance in relation to Brexit and the associated customs requirements is available on the Revenue website.
For ease of reference, the HPRA has compiled information on some recent guidance issued by Revenue. Companies should ensure that they are familiar with all relevant guidance and are in a position to comply with any customs requirements relevant to their products.