Selling a marketing authorization from one company to another not only involves the transfer of money but also needs the transfer of regulatory files. Not an easy job when this is about old products which have been registered for decades and which have undergone massive variations throughout this period. And usually during this period the product has been in the hands of various successive RA-managers who may have had inconsistert archiving methods. So, before such files can be transferred they sometimes need a “refurbishment” to orderly re-archive the regulatory history of decades. One of our consultants has been busy this quarter peparing a handful of such files to be transferred for one of our regular customers.
Talking about data transfer, starting this month new pharmacovigilance regulations came into force and one of the elements was the uploading of product data of all registered medicinal products available in the EU into the EudraVigilance Medicinal Product Dictionary (EVMPD). Big Pharma companies may easily have control of hundreds of marketing authorization and therefore this uploading is a time-consuming project. One of these companies therefore called in our assistance to finish this job in time and thanks to this the project could be finalized in Week 22, just before the critical deadline of 1 July.
Projects related to community pharmacies not often are dealt with by our group but this quarter such a project came in involving the provision of secretarial and organizational support to two groups of pharmacies. These groups include not just common-type community pharmacies but specialized pharmacies providing services to other pharmacies. These services regard the central filling of prescriptions or the combining of several medicines into one time-dedicated single pack (also known as “baxtering”). Due to the fact that such specialized pharmacies still have the regulatory status of a pharmacy but have more industry-like operations in place, various typical regulatory problems appear on the table which need to be taken care. And due to our vast experience with all kinds of pharmaceutical regulatory issues we feel particularly qualified to deliver such support.