Change product authorisation

Changes in the product authorisation can be major and minor changes.

Major changes

Do you apply for a major change in the product authorisation, such as:

  • amendment of uses
  • extension of uses
  • change in restriction sentences
  • change in the legal instructions for use – WG(GA)
  • major change in product composition

These major changes require an amendment of the existing authorisation (PPPR 1107/2009, art 33) and will be processed following the zonal procedure. Non-significant changes are evaluated at the national level. Changes in a derived authorisation follow the process of 'derived authorisation'.

Minor and administrative changes

Do you apply for other changes, such as minor changes:

  • changing the production proces (including new/additional production location
  • minor change in product composition
  • changing labelling
  • changing packaging
  • changing shelf life
  • changing the name of an authorised product
  • changing the name or adress of the authorisation holder
  • transferring ownership of an authorised product to another company
  • minor changes in legal instructions for use  WG(GA)