Paragraph 68
For regulation 91 (omission of regulation 94A (offences relating to Commission Regulation 2016/161)) substitute—
“Amendment of regulation 94A (offences relating to Commission Regulation 2016/161)
91.In regulation 94A—
(a)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).”;
(b)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).”.”.