Derived authorisation

A derived authorisation is based on an existing, fully assessed authorisation in the Netherlands (the original product). The product authorised by a derived authorisation is completely identical to the original product, but is being marketed under a different name.

This derived authorisation process is valid for:

  • new derived authorisations;
  • renewals of derived authorisations;
  • expanding the field of use of a derived authorisation;
  • restriction  of the field of use of a derived authorisation.

Note:

For renewal of derived authorisations some relevant information can be found under 'Product renewals (NL=zRMS and NL=CMS / Instructions for submission'.

The application costs are specified in the Tariffs Decree.