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.
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.