4th Quarterly update 2009

This quarter our Healthcare Inspectorate intensified its surveillance of the use of biocides (i.e. disinfectants) in hospitals. This is related to the implementation of the EU- Biocides Directive in our national law which included a grandfathering of all currently available disinfectants if these were applied for by 15 September. All disinfectants not included in the national database at that time were no longer acceptable for use in hospitals. However serious problems emerged with one of our clients as some (skin-)disinfectants are classified as a medicinal product and thus are exempted from the Biocide – directive. While ignoring this exemption, the Inspectorate mistakenly issued a ban on this medicinal product and it subsequently took us quite some effort to undo this ban and to eliminate the consequent false perceptions in the market. Still, in the future more attention may be needed to this issue as within the EU demarcation initiatives may be launched which could lead to a sharpened distinction between skin disinfectants and biocides and which could lead to a reclassification of some of the medicinal products and/or biocides within the EU.

Over the years we have supported quite a few contract packaging companies within our country with respect to GMP-issues or acting as interim Qualified Person. This quarter a new client was added to this list who is to start a complete new packaging facility for unit-dose packs. These new unit dose packs for hospitals will not remove the tablet or capsule from its original blister as is the case in current unit-dose packaging facilities. On the contrary, the original multi-dose blister will be cut and the resulting single-dose blister will be packed into a secondary packinging. This secondary packaging will contain name, batch details and barcodes identifying the tablet. The paramount advantage of this packaging method is that the original shelf-life of the dosage form remains fully valid, while traditional unit-dose packs involve a change of primary packaging material and therefore the original stability data no longer apply. Sooner or later this situation will no longer be acceptable to our Inspectorate.

Over the years we have learned pretty well how to support non-EU companies wishing to launch their medicinal products or medical devices on the Dutch or European market. However, this quarter we had to do it the other way around as one of our customers will start distributing a medical device on the Canadian market in 2010. As a consequence we had to align the existing EN 13485 system for medical devices of our client with the Canadian Medical Device Regulations SOR/98-282. Fortunately, these regulations hardly differ from the EU regulations and therefore we only got some minor corrections to apply enabling our Notified Body, recognized as a conformity assessment body by the Canadian authorities, to issue the Canadian medical device license to our client.