Regulation 130 Insertion of regulation 148A (urgent safety restrictions)I1

After regulation 148 (obligation to ensure appropriate and continued supplies) insert—

“Urgent safety restrictions

148A

(1)

Where, in the event of a risk to public health, the holder of a traditional herbal registration takes urgent safety restrictions on its own initiative, it must inform the licensing authority immediately.

(2)

If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted by the licensing authority.

(3)

In the event of a risk to public health, the licensing authority may impose urgent safety restrictions.

(4)

Where an urgent safety restriction is taken by the holder of a traditional herbal registration, or imposed by the licensing authority, the holder must submit an application for variation of that registration in relation to that restriction within 15 days beginning with the date of the initiation of that restriction.”.