Question regarding CTAs

Special Interest Networks Regulatory Operations SPIN
#1

For CTAs, can anyone submit a CTA? Meaning can a US company submit a CTA to different countries without having in-country representation? (i.e. can a US only company submit CTAs to the Netherlands, Spain, Germany and UK without having an EU contact sign off?)

Any guidance would be extremely helpful.

thank you!

#2

The simple answer is no, you will need a legal representative based in the EU.
Happy to discuss further
Dianne

#3

This is the exact confirmation I needed - thank you so much!!!