Paragraph 170 I1

After regulation 213 (amendment of regulation 281 (duties of authorisation holders and registration holders)) insert—

“Insertion of new regulation 284A (Medicines with differing classification status in Great Britain and Northern Ireland)

213A

After regulation 284, insert—

“Medicines with differing classification status in Great Britain and Northern Ireland

284A

In the case of a medicinal product for sale or supply in Great Britain where the product concerned is not a prescription only medicine in Great Britain but is either—

(a)

a prescription only medicine in Northern Ireland; or

(b)

not authorised for sale or supply in Northern Ireland,

any advertisement to the public must include a statement that the medicinal product is not available without a prescription, or is not available for sale or supply, in Northern Ireland (as the case may be).”.”.