Many factors come into place, including compliance with regulations, not just in the sphere of pharmaceutical law but also with regard to financial arrangements with doctors and the transparency of those arrangements, intellectual property, publication of results, liability and scientific integrity.
We advised an international pharmaceutical company on the necessary marketing authorisations and manufacturer's authorisations for the distribution of pharmaceuticals in Europe (2013, 2014). International companies commonly have to explore the most tax-efficient options for distributing pharmaceuticals in Europe. The legal entities involved must hold the correct authorisations and permits. Tax advisers do not always take account of this. We proactively ensure that their distribution methods are fully compliant, bearing in mind the financial parameters.
Foods have to comply with a whole raft of European rules. The customs authorities inspect goods that are imported into the EU from outside the EU. We analysed the case, gathered relevant data and held discussions with the customs authorities. In this case, the consignment was soon released.
Many factors come into play, including compliance with regulations, not just in the sphere of pharmaceutical law but also with regard to financial arrangements and the transparency of those arrangements, intellectual property, publication of results, liability and scientific integrity.
Increasingly complex (biotechnology) pharmaceuticals are supported by medical devices and apps offered by the pharmaceutical manufacturer. Their supply to doctors and hospitals and the use of these devices by doctors and patients is heavily regulated: from licences to use mainly web-based technology and liability for the accuracy of data to the protection of patient privacy and regulations on inducements (Code for Pharmaceutical Advertising). We drew up terms and conditions and contracts, so that the programme can be used correctly.
Following an amendment to the Regulations, the CGR (Foundation for the Code for Pharmaceutical Advertising) reviewed a complaint that had previously been dismissed because the CGR had declared that, under the Regulations, it was outside its competence. The CGR dismissed the objection for formal reasons. (abstract (Dutch))