This post was written by John Wilkinson, Nicola Maguire and Adam Lewington.
In November 2013, the Human Medicines (Amendment) (No.2) Regulations 2013 (the “Amendment”) came into effect, amending the Human Medicines Regulations 2012, which set out a “comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance.” The Amendment implements Directive 2012/26/EU and Regulation (EU) No 1027/2012 setting out changes to the licence notifications that holders of marketing authorisations must give and changes to pharmacovigilance monitoring systems. The Amendment allows General Sale List (“GSL”) medicines (often referred to as over-the-counter medicines) to be sold on trains and aeroplanes in the United Kingdom.
To learn more about the recent amendments, read the full alert.
