The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use.
Measures to counteract to fake medicines include stricter record-keeping of wholesale distributors, tougher inspections of pharmaceutical producers, an EU-wide quality mark to identify online pharmacies and obligatory safety features on packages.
[1] It requires that a unique identifier must be encoded in a two-dimensional Data Matrix code printed on each unit of sale package which is to contain: There must be a Tamper Evident Device.
[4] The Market Pharmacy in Bolton, which is part of the Hollowood Chemists group claimed in December 2018 to be the first compliant pharmacy in the UK when it connected to the UK Medicines Verification System in December 2018.
[5] The directive ceased to apply in Great Britain, except in Northern Ireland, at the end of the Brexit transition period.