Renewal

Keeping an eye on renewal dates

Following the amendments to Directive 2001/82/EC (veterinary medicinal products)  and 2001/83/EC (human medicinal products) you now need to renew your marketing authorisations in Europe only once in order to secure their continuance. Nevertheless, caution is called for: the final deadline for the submission of your renewal documents may vary.

Our team in Karlsruhe will closely monitor the renewal requirements - and the relevant deadlines - in countries outside the EU.

Key points:

• When did you submit your last renewal application?
• Which procedure did your marketing authorisation undergo (national only or MRP/DCP/CP)?
• Which countries are affected?

Everything under control

Have you already fixed a common renewal date during the MRP/DCP procedure or for the synchronisation of PSUR dates with the competent authorities? Your personal contact from our Lifecycle Management team keeps track of the renewal dates for your products, contacts the competent authorities and makes all the necessary arrangements to ensure that your documents arrive there in good time.