PSUR – Periodic Safety Update Reports

Shall PSURs be submitted, if the active substance is not included in the EURD list?

Is it necessary to apply for the MA variation to discharge the obligation submitting of the PSUR for MPs authorised according to Section 27, Sub-sect. 1 or 7, homeopathics products or trad. herbal MP according to Sect. 30 of AoP?

Is it necessary to submit the PSUR for hybrid medicinal products?

Is it necessary to submit the PSUR for medicinal products with marketing authorisation based on a combination of generic and hybrid applications (e.g. one strength has been authorised as generic, the other one as hybrid)?

Is it necessary to submit the PSUR, if the EURD list does not specify a fixed combination, but only individual substances?

What is the maximum period for submitting the PSUR after the DLP?

Who is the PSUR to be submitted to?