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.

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Building projects dominate our list of new projects this quarter as two companies requested our support for the construction of their pharmaceutical production laboratories. One of these concerns a facility for the production of radiopharmaceutical parenterals, requiring the careful integration of GMP requirements and radiological safety requirements. The other facility is a compounding pharmacy where dermatological formulations will be developed and dispensed. For both facilities we will be involved in the design, construction and validation process. Subsequently we will act as Qualified Person (QP) for both facilities for an as yet undefined period.  Read the rest of this entry »

This quarter two USA companies called for our support to initiate a clinical study in the Netherlands. While CRO’s usually are well-equipped to design and finalize the trial protocols, creating the appropriate supply chain to all investigational centers is quite a different story. Such a supply chain from the USA to EU-investigational centers will have to include an EU-import license for investigational products as well as a QP-release of the batches to be used in the clinical study. While these issues already might discourage you to consider starting a trial, things get even worse when opioids are involved for which additional regulations are applicable. Fortunately, we know the way out of this regulatory labyrinth.

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Borderline issues frequently occupy our minds as an increasing number of pharmaceutical companies consider changing the regulatory status of their products from pharmaceuticals to medical devices. Not only the regulatory pathway leading to the final certification is by far the easiest for medical devices, also the requirements for proof of efficacy are less stringent. Over the years we have witnessed quite a few of such transitions and this quarter we have been involved in a similar transition for homeopathic medicines caused by the extreme tightening of regulations for these products imposed by our recent (2007) new law on medicinal products.

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This quarter we have become Council Partner of the Gerson Lehrman Group (www.glgroup.com). This group concerns a worldwide consulting management platform currently including over 200,000 experts covering quite a few business domains. We were invited to participate with the Healthcare Group thanks to our overall knowledge of, and experience with, European and Dutch pharmaceutical issues. Likewise, some clients already could benefit from our more general overview of the Dutch healthcare system. All our senior consultants now have entered this fascinating area of high-level consulting.

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Medicinal gases required our thorough attention this quarter. These products were relatively late recognized as medicinal products, similar to radiopharmaceuticals which likewise were unregulated products before 1992. Only in recent years the first marketing authorizations for medicinal gases  have been granted in NL, leading to the uncommon appearance of patient leaflets on oxygen cylinders to be delivered to hospitals, nursing homes and home care patients.

In hospitals this recognition has led to the formal involvement of hospital pharmacists in the supply and distribution of various gases to the operating theatres and wards. We audited one particular hospital to assess the compliance of this involvement with the GM/DP-regulations.
In addition, a leading supplier of medicinal gases in NL asked us to support their regulatory affairs department with respect to both national and European procedures.

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This quarter we have intensified the development of our Market Access Program (MAP) which is meant for the support of non-EU customers who want to enter the Dutch and/or European market. Not only classical regulatory product support, related to the approval and maintenance of marketing authorizations, is part of this program. It also includes support with respect to the necessary licenses for manufacturing and/or distribution.

Other pre-marketing elements of this program include supply chain design and pricing & reimbursement, while post-approval elements are pharmacovigilance and compliance-control of advertising and promotional materials. Already three overseas companies are participating in such programs and take advantage of the wide areas of experience as present within our team. Contact us if you are also interested in any of these elements or in the full program for your products or company.

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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.

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