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Recent projects

a few examples

 

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USA projects

 

 

A typical USA project involves a pharmaceutical manufacturer wanting to introduce its medicinal product into a number of European countries. We start with obtaining the required marketing authorisations (MA’s) which includes an audit of the manu- facturing sites. Subsequently we, as BFN, distribute the product in the EU on behalf of the client for whatever period. Finally we transfer the MA’s to a then established Dutch subsidiary of this USA company. Simultaneously we take care of the provision of the importation license for this subsidiary.

​By now, we have applied this validated model to quite a few EU market entries of American pharmaceuticals. The last project will start in Q3 2026.

In late 2023 we obtained an import-license for an investiga- tional gentherapy product of a USA-client. 

Asian adventures

 

 

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.

Brexit

 

 

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.

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