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.
