Q2 2013 Drug-device borderline

This quarter the processing of an unusually high number of license applications for pharmaceutical companies was started by our team, including 5 wholesale license applications and 1 manufacturing license application. Not all of these represent straightforward wholesaling or manufacturing companies as two of these are involved in complex European supply chains. We have dealt with such complex chains, involving pharmaceutical responsibilities fragmented over multiple countries and sites, on a number of occasions before and this experience is indispensable for the proper execution of these projects. Another license is meant to support the direct delivery of medicinal products to hospital wards rather than to the hospital pharmacy. Such direct deliveries gain increasing interest from Dutch hospitals due to the significant decrease of product handling associated with this concept.

Borderline issues between different categories of products frequently appear on our table due to the ever expanding regulatory framework for pharmaceuticals, cosmetics, medical devices and biocides. With the recent introduction of the new Cosmetics Directive and the Biocide Directive, all these product categories now need formal registration at the national or European level. And so, this quarter we got a request from a client to prepare the application for a biocide according to the EU Biocide Directive. Products on the biocide – medicinal product borderline, as in this case, usually are intended for skin antisepsis and skin disinfection and then multiple classifications are possible for a given product depending on the intended purpose. It is paramount to carefully formulate this intended purpose of the product in line with the classification sought.

However, some medicinal products even reach the patient without such registration as is the case with so called “named patient programs”, in which approval is sought from the Healthcare Inspectorate for the dispensing of medicinal products lacking such registration. A typical situation refers to patients leaving a clinical trial before the registration and when these patients favorably respond to the treatment such approval is usually granted for these patients during the period until the marketing authorization is granted. Another project regarded an oncolytic drug which is registered in various EU-countries, but not in the Netherlands, and which is included in some treatment protocols for various cancers. We successfully managed these named-patient applications enabling hospitals to proceed with treatment programs in the interest of their patients.