Paragraph 5 Amendment of the Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001

omit the definitions of “free circulation in member States” and “third country”; and

insert at the appropriate place—

• ““approved country for import” has the meaning given in regulation 8(1) of the Human Medicines Regulations 2012;”.

for paragraph (3) substitute—

“(3)

The prohibition imposed by articles 2 and 3 does not apply where the medicinal product—

(a)

is imported from an approved country for import; and

(b)

is being, or is to be, exported to a country other than the United Kingdom.”; and

in paragraph (4), for “marketing authorisation, certificate of registration, traditional herbal registration or Article 126a authorisation” substitute “UK marketing authorisation, certificate of registration or traditional herbal registration”.