Adaptation of the Guidance document Variations and extensions HMV4


Inclusion of an additional case for issuing a new authorisation number (section 9.1), further details in section 5 (incl. in respect of the CMDh list with unforeseen variations) and section 6.6 (changes to the PMF can be submitted together with the Annual Update of the PMF as a multiple application).

The new version of the affected document enter into force as of 09.05.2019.