a few examples
LATEST REPORT 2021
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. So it is not surprising that Indonesian pharmaceutical companies would consider our country as a potential port of entry for the European market. And so this happened; two generic Indonesian companies came to us to act as the EU manufacturing autorization holder and EU importation site of their products, both injectables and solid dosage forms.
The most significant Brexit implication for 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 couple of pharmaceuticals which were previously supplied to their European pharmacies from a UK-site. We will procure these products from Asia, have these EU-retested in a European pharmaceutical test laboratory, have these QP-released by one of our EU Qualified Persons, and have these finally shipped to the European warehouses of the client.