1st Quarterly Update 2008
Pricing and reimbursement applications belong to our activities ever since the Dutch government introduced the reimbursement system for medicinal products in 1995, better known as the GVS-system (GeneesmiddelenVergoedings-Systeem). But never before we had four of such applications on our desk simultaneously, including a relatively simple IA-application for new candidates to be included in an existing cluster, the inclusion of a complete new group of products (allergens) in the system, as well as the introduction of a new cluster of products. If the GVS-system (as well as this information) is abracadabra to you and you are involved in pricing and reimbursement in the Netherlands, we would be glad to explain this to you in more detail.
Contract-packaging and contract-warehousing still get quite some interest from pharmaceutical companies and many of these already have outsourced significant parts, if not all, of these activities to third parties. As a consequence we regularly get involved in such third parties and so we are this quarter. One of our colleagues currently acts as Qualified Person on an interim basis for one of the major Dutch contract packaging companies. It is expected that this position will be taken over by a new employee in the near future, but some support during the transition period probably will remain necessary. Another exciting project in this area is the construction of a completely new storage and packaging facility in the Netherlands for one of the major global logistics services providers. This facility should be up and running as of early 2009, leaving us ample time for the design and implementation of the required GDP- and GMP-systems.
Apart from such “post-approval” activities there is still such thing as a marketing authorization (MA) to be obtained for the medicinal products you wish to store or pack. Unfortunately, a MA will never be granted without the relevant clinical studies necessarily to be included in MA-applications, and we process such MA-applications on a very regular basis. But, in turn, such clinical studies have their own regulatory framework and also need to be approved beforehand by a medical-ethical-committee. Just like the “post-approval” pricing and reimbursement applications you may call upon us for support with such “pre-approval” applications in case you would consider to execute a clinical study in the Netherlands. Just contact Chantal Ruijl-Vandierendonck (ch.ruijlvandierendonck@bfc.nl) if you need more info on this subject, she has processed quite a few of such applications in recent months.
