2nd Quarterly Update 2010

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.

A similar coincidence occurred with analgesic projects coming in this quarter. One project was about the design of the clinical development program for a new fixed-combination of analgesics. Fixed combinations of active ingredients need to be clinically tested in accordance with the EU Fixed Combination Guideline requesting the added value of each active ingredient to be clearly demonstrated. A second project concerned a Pricing & Reimbursement application for a new parenteral analgesic. Such new products need a detailed pharmacoeconomic analysis of the cost-benefit ratio. Unless we are dealing with an orphan drug as in this case. The third analgesic project was about an OTC switch of a prescription-only analgesic. Such a switch application requires an extensive justification in which safety details are pivotal. Again the rules for such a change of  classification for the supply of a medicinal product have been detailed in an EU guideline specifying 4 criteria which apply and which deal with direct and indirect safety, the need for additional investigation and the dosage form, as parenteral products normally should be subject to a medical prescription.

Talking about prescriptions, these are necessary to get medicinal products dispensed to you by a licensed pharmacist but up to this moment medical oxygen, being a medicinal product for a couple of years now, has escaped this obligation when delivered to home care patients. Usually the oxygen cylinders are delivered to patients by some gas depot – with or without a pharmaceutical wholesale license – but surely without any intervention of a pharmacy as required by EU-regulations. But that will have to change as new rules will be implemented shortly requiring the gas depot  to act as subcontractor for a licensed pharmacy. Surely, this will create a new bureaucratic burden for some of our clients while insurance companies cry blue murder as they will have to pay the additional dispensing fee for the pharmacies. If you want to get updated about these new rules for medical oxygen, just let us know.