The Human Medicines (Amendment) Regulations 2019

Amendment of regulation 42 (conditions for wholesale dealer’s licence)

6.  In regulation 42(1), after paragraph (3) insert—

“(4) The requirements and obligations contained in a provision of Commission Regulation 2016/161 listed in paragraph (5) have effect as if they were provisions of a wholesale dealer’s licence under this Part.

(5) The provisions mentioned in paragraph (4) are—

(a) Article 10 (verification of the safety features) insofar as it relates to wholesalers;

(b) Article 11 (verification of the authenticity of the unique identifier) insofar as it relates to wholesalers;

(c) Article 12 (unique identifiers which have been decommissioned);

(d) Article 13 (reversing the status of a decommissioned unique identifier) insofar as it relates to wholesalers;

(e) Article 20 (verification of the authenticity of the unique identifier), subject to the exemption contained in Article 21 (derogations from Article 20(b));

(f) Article 22 (decommissioning of unique identifiers); and

(g) Article 24 (actions to be taken in case of tampering or suspected falsification).”.

(1)

Regulation 42 was amended by S.I. 2013/1855.