Wednesday, 23 January 2019

Ceisteanna (143, 151)

Catherine Murphy


143. Deputy Catherine Murphy asked the Minister for Health the consultation he has had with pharmacy representative groups in advance of the implementation of the falsified medicines EU directive; if his attention has been drawn to the fact the directive may impact on the day to day work of the dispensing pharmacist; if he has consulted with all points of the supply chain of pharmaceutical drugs on same; and if he will make a statement on the matter. [3202/19]

Amharc ar fhreagra

John Brassil


151. Deputy John Brassil asked the Minister for Health the liability arising for hospital pharmacists in the implementation of the European Union falsified medicines directive; and if he will make a statement on the matter. [3246/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

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.