Quite a few licensing projects for wholesale and/or manufacturing companies we “harvested” this quarter. The most interesting ones include an on-the-border project where a facility will be situated right on the border, partly in Germany and partly in the Netherlands. Hmmmmm, what Inspectorate then will audit this facility? Another one regards a medical device company who started to invoice for medicinal product shipments from another licensed manufacturing site somewhere in the EU but was not made aware of the fact that according to the new 2013 EU GDP Guidelines such invoicing requires a pharmaceutical wholesale license. Quite a lot of regulatory work for a low-risk activity such as invoicing but that are the consequences when you use Dutch invoicing for fiscal reasons. A similar fiscal route has been chosen by a major generic company with manufacturing sites in India and the USA , this project not only included the licensing process but also will need our support as EU Qualified Person to release the medicinal products coming from these sites.
From a quality point of view we had to put quite a lot of effort into impurities this quarter. One project included a toxicological evaluation of various impurities in a parenteral project for which the new ICH Q3D Guideline on Elemental Impurities proved very helpful. Another project was about particulate contamination in a collagen implantable device. This was a personal return to history since, already in the late eighties of the last century we were acting as Qualified Person in a Dutch collagen manufacturing site.
Regulatory-wise we have harvested two decentralized procedures (DCP’s) for which our sister company Baggerman FarmaNet will act as the marketing authorization holder. We have processed similar requests for MA-holderships from various pharmaceutical companies in the past as well, including MA’s in different European countries. Time and time again, the lack of procedural harmonization, or to be more precise the varying level of bureaucratic document processing, across the EU surprises us. Yet another DCP will start in August including a product manufactured in south-east Asia. This project showed some delay due to non-compliant API-manufacturing in India.
Being a marketing authorization holder implies significant responsibilities for pharmacovigilance. These responsibilities have been made easier by a surprising recent initiative launched on 11 May by the European Medicines Agency (EMA) including the start of a literature monitoring service. Benefits of this service to the pharmaceutical industry include efficiency gains and resource savings, improved data quality and a reduction of duplicates. It is only fair that there is also some harvesting to come for our clients as well.