Adding a new country to an existing notification
Direct answer: Submit an update to the existing notification that adds the new member state under market placement and provides the free-text fields in that state's required language. Same UFI, same PCN number. Some countries charge a fee on receipt.
Steps
- Check the language the new country requires in ECHA's member-state overview.
- Translate the toxicological text and any remarks into that language.
- Add the country to the market placement list and submit as an update with the reason "new market".
- Check the submission report shows the dossier received by the new country's appointed body.
- Check the label: the UFI is already there, but label language requirements are separate from the notification.
Fees
A handful of member states charge the notifier a fee per notification. ECHA's overview lists which ones. The ECHA portal itself is free.
Ceasing a market
If you stop selling in a country, you can mark the market as ceased in an update. There is no obligation to do so but it keeps the record clean.