The ‘Safety Features’ Delegated Regulation introduces new rules for the supply of medicines from the 9th February 2019. These safety features include a form of an anti-tamper device and unique identifiers embedded in a 2D barcode on the pack.
The purpose of the Regulation is to benefit patient safety and maintain confidence in the safety of medicines supplied to them.
A Statutory Instrument will provide that the Irish legislative system is consistent with the requirements of the Regulation. Nothing in the new Regulations seeks to alter the existing legal and regulatory responsibilities of persons authorised to place medicinal products on the market or to supply them to the public. It will apply to manufacturers, wholesalers and pharmacy owners and pharmacists equally.
The Regulation provided a 3-year transition period, starting in 2016, to facilitate preparation for its introduction. Details of the requirements of the Delegated Regulation have been communicated to all sectors throughout this period by the Irish Medicines Verification Office, the Health Products Regulatory Authority, the Pharmaceutical Society of Ireland and the Irish Pharmaceutical Union.
I recognise concerns raised by stakeholders regarding the practical implementation of the Regulation. I also want to ensure that, above all, the normal supply of medicines to patients is maintained. I therefore intend to implement the system in a pragmatic manner and defer operating the offences provisions in the legislation for an initial period.
This will allow everyone involved to develop familiarity with the new arrangements and overcome any teething issues before we proceed to introduction of the provisions that deal with offences.