Draft paper on new EMA guidance for importers of medicinal products14/07/2015 - Bart Van Acker, Founder/Managing Director at Quality by Design
Because, as time goes by, medicinal products for the European market are being produced increasingly outside Europe, EMA wants to write a new Guidance on this.
The draft paper for this was published in late May. Consultation is set to run until late August.
Europe already sees importers of medicinal products as manufacturers. They are therefore obliged to have a manufacturing authorisation. Consequently, they are already obliged to practise GMP.
However, to EMA it seems useful to offer impacted stakeholders more interpretation and clear expectations. This guidance for importers is drawn up for that reason.