a few examples
LATEST REPORT 2023
First USA project
One typical project involved a USA pharmaceutical manufacturer wanting to introduce its skin-disinfection product into a number of European countries. We started with obtaining the required marketing authorisations (MA’s) through a decentralized procedure. This included an audit by our Dutch pharmaceutical inspectorate of the USA manufacturing site as this was pre-MRA. Subsequently we as BFN distributed the product in the EU on our behalf for more than a year and finally we transferred the MA’s to a then established Dutch subsidiary of this USA company. Simultaneously we took care of the provison of the importation license for this subsidiary.
Indonesia is one of the fast developing south-east Asian countries which has a particular orientation towards the Netherlands for historical reasons. And so two generic Indonesian companies came to us to act as the EU manufacturing authoriza-tion holder and EU importation site of their products, both injec-tables and solid dosage forms.
And in late 2021 we entered into a cooperation with a Korean company to support their European market supply.
Next to Korea came China as we were contracted by a major Chinese biopharmaceutical company to act as the EU-importer for their newly developed monoclonal oncolytic antibody. This import is expected to start after EMA-approval in 2024.
The most significant Brexit implication for (veterinary) pharmaceuticals is that supply from the UK to the EU does no longer count as distribution but is now subject to EU-import regulations and requires another license regimen. Likewise, UK companies can no longer act as marketing authorization (MA) holder of European pharmaceuticals. So, we recently started supporting a major European healthcare solution provider, based in the UK, as the EU-importer of a number of pharmaceuticals. Likewise, we now support one of the major UK veterinary manufacturers with their supply of the EU-market.