Monthly Archives: April 2018

Annoying Mistake in Annex IV Template

There is an annoying mistake in the Finnish QRD PSUR Annex IV template, whose heading is ‘Scientific conclusion and grounds for the variation to the terms of the marketing authorisation(s)’.

In the English template, there is the following phrase: ‘The CMPH recommends that the terms of the Marketing Authorisation(s) should be varied.’ The FI version is ‘Lääkevalmistekomitea suosittelee myyntiluvan/myyntiluvan muuttamista.’

The word corresponding to ‘terms’ is missing in the Finnish template : the latter part of the template should read ‘… myyntiluvan/myyntilupien ehtojen muuttamista.’  (italics are mine).  Now the Finnish phrase claims that the CMPH would recommend varying the marketing authorisation(s).

The current FI template thus reads : ‘The CHMP recommends that the marketing authorisation(s) should be varied.’

The templates can be found here