German to English Law/Patents Medical: Pharmaceuticals Arzneimittel/EG-Recht

This is from an objection submitted to a court regarding the 'Zulassung' of an Arzneimittel.

Obviously it is clear what Zulassung means in general. But I am unsure what it's specific meaning is in the context of EU medical regulatory law. Does it mean approval, registration, authorisation or licensing? Is there a difference between those four terms in English when used in this context, or can they be used interchangeably?

Some examples from the document:

'Angesichts dessen überrascht es nicht, dass der der Zulassung für XXXX (name of medicine) zugrunde liegende Beurteilungsbericht ebenfalls nicht den europäischen Standards genügt.'

'Die Zulassung für XXXX (name of medicine) wurde in Tschechien am XX Juli 2005 beantragt.'

etc. etc.

I have been using licence/licensing throughout, but then it struck me that, if 'licence' is what is meant, why didn't the author use Lizenz?

Any thoughts from pharma/EU regulation specialists gratefully received.

Thanks.