Hi all,
I have a long question regarding the end of the Brexit Transition arrangements and what happens regarding import into the EU from the end of the year.
My company manufactures IVD devices in the UK and currently has distribution agreements for distribution into the EU. Let's say we have the following set-up:
Manufacturer - UK Based - Registered with the MHRA and sells to UK customers, using distributors for elsewhere
Distributor A - Sweden Based - Distributes to Swedish and Danish customers
Distributor B - Netherlands Based - Distributes to Dutch customers only
From the end of the Brexit transitional period (currently 31st December 2020), we will require an EU ARP which we've put in place. My interpretation of the set-up then becomes:
Manufacturer - UK Based - Registered with the MHRA and sells to UK customers
EU ARP - Germany Based - Registers devices with the local Competent Authority
Distributor (and Importer) A - Sweden Based - Imports and Distributes to Swedish and Danish customers
Distributor (and Importer) B - Netherlands Based - Imports and Distributes to Dutch customers (i.e. based in Netherlands) only
My assumptions with this are that: i. we will be able to have parallel import (I assume it would be on the say-so of the German based Competent Authority?); ii. we will need to amend our distribution agreements to include importation into the EU and have the current distributor ; iii. if neither Distributor A nor B were willing to be an importer, we could utilise a third party that would act as an importer (possibly needing to re-arrange the distributor agreements appropriately to fit), iv. if we don't make the contractual amendments that we will not be able to have an importer into the EU.
Are my assumptions correct and if not, what have I incorrectly assumed or not considered? Hopefully somebody can help!
Thanks
I have a long question regarding the end of the Brexit Transition arrangements and what happens regarding import into the EU from the end of the year.
My company manufactures IVD devices in the UK and currently has distribution agreements for distribution into the EU. Let's say we have the following set-up:
Manufacturer - UK Based - Registered with the MHRA and sells to UK customers, using distributors for elsewhere
Distributor A - Sweden Based - Distributes to Swedish and Danish customers
Distributor B - Netherlands Based - Distributes to Dutch customers only
From the end of the Brexit transitional period (currently 31st December 2020), we will require an EU ARP which we've put in place. My interpretation of the set-up then becomes:
Manufacturer - UK Based - Registered with the MHRA and sells to UK customers
EU ARP - Germany Based - Registers devices with the local Competent Authority
Distributor (and Importer) A - Sweden Based - Imports and Distributes to Swedish and Danish customers
Distributor (and Importer) B - Netherlands Based - Imports and Distributes to Dutch customers (i.e. based in Netherlands) only
My assumptions with this are that: i. we will be able to have parallel import (I assume it would be on the say-so of the German based Competent Authority?); ii. we will need to amend our distribution agreements to include importation into the EU and have the current distributor ; iii. if neither Distributor A nor B were willing to be an importer, we could utilise a third party that would act as an importer (possibly needing to re-arrange the distributor agreements appropriately to fit), iv. if we don't make the contractual amendments that we will not be able to have an importer into the EU.
Are my assumptions correct and if not, what have I incorrectly assumed or not considered? Hopefully somebody can help!
Thanks