Regulation 6 Amendment of regulation 43 (obligations of licence holder)

at the end of sub-paragraph (i), omit “or”;

in sub-paragraph (ii), for “import.” substitute “import; or”; and

at the end insert—

“(iii)

from the United Kingdom to a person in an EEA State, if the distribution is specifically for purposes of placing the product on the market in that State and the medicinal product has—

(aa)

a marketing authorisation,

(bb)

Article 126a authorisation,

(cc)

certificate of registration, or

(dd)

traditional herbal registration for that EEA State.”