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Manufacturing Sites of Formulated Product

Where a registered/licensed product is no longer being manufactured by the manufacturer currently approved for that product, notification must be made to the relevant Board as soon as possible. The proprietor/licensee must then apply for a Type C2 – Change in manufacturing process (including new or additional manufactuer of the formulated product) within six months from the date of the notification.

A registered/licensed product cannot ‘sit’ indefinitely without an approved manufacturer. Failure to gain approval for a new manufacturer for a product within the six month deadline will result in compliance action being taken.