I propose to take Questions Nos. 143 and 151 together.
The Safety Features Delegated Regulation (EU 2016/16) provides that from February 2019, most prescription medicines and a very small number of non-prescription medicines will have to carry ‘safety features’ on their outer packaging. These safety features take the form of an anti-tamper device (e.g. foil seal, breakable cap) and a set of unique identifiers embedded in a 2D barcode on the pack.
The Delegated Regulation was finalised and published in 2016. The intervening 3 year transition period allowed time for all concerned parties to prepare well in advance of the legislation coming into full effect on 9th February 2019. Details of the requirements of the Delegated Regulation have been widely communicated to all sectors throughout this 3 year transition period.
The Delegated Regulation is directly applicable across all EU Member States. However, a Statutory Instrument is being prepared to ensure that the Irish legislative system is consistent with the requirements of the new Regulation.
A copy of the draft Instrument was recently circulated as part of a targeted consultation process. The consultation process provides a mechanism for stakeholders and interested parties to express concerns and to make submissions. The Department is considering all points submitted in the consultation, prior to finalising the Statutory Instrument.