Explanatory note

These Regulations amend the Human Medicines Regulations 2012 (the 2012 Regulations) in order to implement Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance.

These Regulations further amend the 2012 Regulations in order to allow general sale medicinal products to be supplied or sold on aircrafts and trains.

Regulations 2 and 4 amend regulations 8 and 82 of the 2012 Regulations in order to ensure that the changes made to Regulation (EC) No 726/2004 by Regulation (EU) No 1027/2012 are enforceable in the United Kingdom.

Regulations 3, 5 and 6 amend regulations 73, 113 and 142 of the 2012 Regulations respectively in order to transpose the changes made to articles 23a and 123 of Directive 2001/83/EC by Directive 2012/26/EU insofar as they apply to marketing authorisations, homeopathic certificates of registration and traditional herbal registrations.

Regulation 7 amends regulation 196 of the 2012 Regulations in order to transpose the changes made to article 107i of Directive 2001/83/EC by Directive 2012/26/EU.

Regulation 8 amends regulation 346 of the 2012 Regulations in order to oblige the Secretary of State to carry out a review of regulations 73, 82, 113 and 142 of the 2012 Regulations.

Regulation 9 amends Schedule 17 to the 2012 Regulations in order that an operator or commander of an aircraft or an operator of a train is able to sell or supply general sale medicinal products.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public or voluntary sectors is foreseen.