PCN Ready.

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

  1. Check the language the new country requires in ECHA's member-state overview.
  2. Translate the toxicological text and any remarks into that language.
  3. Add the country to the market placement list and submit as an update with the reason "new market".
  4. Check the submission report shows the dossier received by the new country's appointed body.
  5. 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.

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