Paragraph 82 I1

In regulation 110 (amendment of regulation 125 (traditional herbal medicinal products)) for “125(5)(b)” to the end substitute—

“125(5) for sub-paragraph (b) substitute—

“(b)

in relation to—

(i)

a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;

(ii)

a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.”.”.