Mattie McGrath (Tipperary, Independent)
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416. To ask the Minister for Health if he will address concerns expressed by pharmacists with respect to the introduction of the false medicines directive and associated statutory instruments (details supplied); and if he will make a statement on the matter. [2675/19]

Tommy Broughan (Dublin Bay North, Independent)
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438. To ask the Minister for Health if his attention has been drawn to the fact that many pharmacists are concerned in relation to the draft legislation which proposes that the responsibility for implementing the falsified medicines directive will transfer from the pharmacy owner as per the EU directive to the dispensing pharmacists; and if he will make a statement on the matter. [2869/19]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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467. To ask the Minister for Health if he is seeking a corporate transfer of responsibility for the provisions of the falsified medicines directive from the pharmacy owner or proprietor and onto the pharmacists and employees; and if he will make a statement on the matter. [3078/19]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 416, 438 and 467 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 09 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, including the query on responsibility raised in this Parliamentary Question, prior to finalising the Statutory Instrument.