Assertion: imp | /r/HasAspect | a marketing authorisation
Facets:
value: in any member state
type: LOCATION
value: in the eu
type: LOCATION
value: in an ich country
type: LOCATION
Source sentences:
text: A SmPC may be submitted if the IMP has a Marketing Authorisation in any EU Member State and is being used in the same form, for the same indication and with a dosing regimen covered by the SmPC.
text: However, in many cases where the IMP has a marketing authorisation, an IMPD is not required.
text: — the IMP has a marketing authorisation in the EU or in an ICH country, is not modified, and is manufactured in the EU, or
text: — the IMP is not manufactured in the EU, but has a marketing authorisation in the EU, and is not modified.
text: The applicant may submit the current version of the SmPC (or, as regards ICH countries, the documentation equivalent to the SmPC) as the IMPD if an IMP has a marketing authorisation in any Member State or in an ICH country.