Safety features

Medicines placed on the market from February 2019 will have the following ‘safety features’:

1.     An anti-tamper device (similar to what you would see on a milk carton) so the person supplying it be sure it hasn’t been interfered with. Such devices are already common on many medicines but will be mandatory for most medicines in future. 

2.     A special 2D barcode containing information about the medicine, known as unique identifiers. Embedded in this barcode will be a product code, serial number, batch number and expiry. In some countries, reimbursement codes will be included in the barcode but this is not required in Ireland. 

Detailed technical requirements for unique identifiers and the databases or ‘repositories’ where they will be stored are set out the Commission Delegated Regulation (EU) 2016/161, also known as the ‘Delegated Regulation).  

The Delegated Regulation set an implementation deadline of 9th February 2019 and manufacturers must ensure medicines released to the market after this date have the required safety features.