Seán Fleming
Ceist:403. Deputy Sean Fleming asked the Minister for Health the position regarding the falsified medicines directive; and if he will make a statement on the matter. [17733/19]
Amharc ar fhreagraTuesday, 16 April 2019
Ceisteanna (403)
Freagraí scríofa
The ‘Safety Features’ Delegated Regulation introduced new rules for the supply of medicines from 9 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.
S.I. No. 36 of 2019 provides that the Irish legislative system is consistent with the requirements of the Regulation. Nothing in the new national 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. These obligations of the Delegated Regulation and Statutory Instrument are legal requirements for legal persons authorised to supply medication. As such legal responsibility lies with the business owner and the individual authorised to supply the medication.
The Regulation provided a 3-year transition period, which commenced 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.
Recognising the concerns raised by stakeholders, and to ensure that above all, the normal supply of medicines to patients is maintained, it was decided to implement the system in a pragmatic manner and defer operating the offences provisions in the legislation for an initial period. This was to allow everyone involved to develop familiarity with the new arrangements and overcome any teething issues before we proceed to commencement of the enforcement provisions that deal with offences. However, it should be noted that this approach will be reviewed three months post implementation to consider commencement of enforcement provisions at that time.