Veterinary medicines: Changes to distributor and local representatives details
We have changed the way we deal with variations to change distributor and local representative details.
Distributors
If the Marketing Authorisation Holder (MAH) is also the distributor, the wording ‘Same as MAH’ will now appear in the ‘distributor’ section of the memorandum document, which will be updated during the next suitable application procedure for existing products.
Where the MAH and Distributor are the same, and the MAH details change, you no longer need to submit a separate variation to change the distributor. If the distributor is not changing as a result of the MAH change, please state this in your application.
Local Representatives
CMDv has reviewed its positon and agreed that local representative variations for mutually recognised products should be submitted to the RMS and CMS(s) affected by the change.
Further details are available in the full guidance