This last quarter of 2014 proved particularly productive as we finalized two rounds of questions related to separate marketing authorization applications, one for a centralized procedure and one of a decentralized procedure. The former is about to end in mid 2015 representing the end of a 4-year period of processing this submission starting with the application for an SME – status of our client in 2011. That is, if they will accept our responses contained in a 120 pages response document…… However, getting this highly sought-after EU-number, will not allow us to enjoy a well deserved period of rest for long as shortly we might have to prepare a similar application for this product in other countries such as the USA, Turkey, Australia and Brasil.
Talking about countries we should not forget India which nowadays is one of the major suppliers of medicinal products and active pharmaceutical ingredients (API’s) for Europe. So once you’ll need to go there it is easy to find some additional destinations which might be visited for your clients. And this is what happened in November when one of our colleagues went there to be able to deliver the QP-approval of an API-manufacturer as required as part of a marketing authorization application for a new generic for an Asian client of ours. He simply made it a “triple trip” by visiting the Indian mother companies of two Dutch generic companies whom we serve as Qualified Person for their European imports. This saves us lots of time and our clients lots of travel costs.
However, there still remains a lot of work to do in Europe as well since we got involved in a biocide application for a German company. Although regulations for these products are rather new this does not mean that the requirements are still in their childhood. On the contrary, there is quite a lot of environmental data and efficacy data to be submitted before getting recognized as a biocide. And while for medicinal products European procedures with fixed timelines are in place now, that is not yet the case for these biocides. Let’s hope this will not turn-out to become another 4-years project.