This quarter definitely has been about manufacturing licenses and analgesics. By coincidence we started processing not less than 3 manufacturing license applications for logistic sites in the last months. Or maybe it was no coincidence after all, as many logistic service providers want to extend their service portfolio and their clients increasingly have a need for minor packaging activities to be performed at logistic sites. Minor as they are, they still fit the definition of  “pharmaceutical manufacturing” and therefore a manufacturing license is needed together with an EU Qualified Person to take full pharmaceutical responsibility of the manufacturing operations. Particularly with an increased flow of generics coming from India to the EU, the possibility of a “country-specific” secondary packaging process is a valuable asset for any logistic service provider.

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This quarter, as well as the next one, a significant amount of our time will have to be devoted to the removal of our agency to new offices which expectedly will take place in July of this year. Our current location has been lodging us ever since 1990 and it currently no longer meets the requirements of a modern office. Luckily for us, most of the paperwork of the early years has now been replaced by electronic submissions and archiving, reducing the size of our archives, but still significant piles of binders can be found everywhere in our premises. It will give us a hard time to think of a new destiny for all those “residues” of so many clients, but possibly the current location may stay empty for another couple of months which leaves us some extra time to find an appropriate solution.

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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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