# The Human Medicines (Amendment) (No. 2) Regulations 2013, Note: Explanatory note


(This note is not part of the Regulations)
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.

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Source: https://www.legislation.gov.uk/uksi/2013/2593/note (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-no-2-regulations-2013/note
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.