Regulation 91 Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)F1I1

for paragraph (1) substitute—

“(1)

A person who is—

(a)

the holder of a UKMA(NI), UKMA(UK) or parallel import licence, or

(b)

a parallel distributor,

is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).”;

for paragraph (3) substitute—

“(3)

In this regulation “parallel distributor” means a person who imports into Northern Ireland from an EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of a UKMA(NI), UKMA(UK), Article 126a authorisation, COR(NI), COR(UK), THR(NI) or THR(UK).”.