Dáil Éireann Debate, Tuesday - 24 July 2018
1753. Deputy Jim O'Callaghan asked the Minister for Health the details of the EU directives that fall under his remit not yet transposed into law; the deadline imposed by the EU for the transposition of same; and the estimated date for the transposition of those directives into law. [34712/18]
Amharc ar fhreagraAccording to the European Commission's Internal Market Scoreboard for Summer 2018, there are three EU Directives for which the Department of Health has lead responsibility that are due for transposition:
Directive 2015/565 as regards certain technical requirements for the coding of human tissues and cells
This Directive was due to be transposed by 29 October 2016. The Statutory Instrument being prepared to give effect to the Directive is at an advanced stage of drafting and this work will continue over the coming weeks. It is hoped to be in a position to formally notify the Commission of the transposition of the Directive in the near future.
Directive 2015/566 as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells
This Directive was due to be transposed by 29 October 2016. The Statutory Instrument being prepared to give effect to the Directive is at an advanced stage of drafting and this work will continue over the coming weeks. It is hoped to be in a position to formally notify the Commission of the transposition of the Directive in the near future.
Commission Directive (EU) 2017/1572 as regards the principles and guidelines for good manufacturing practice for medicinal products for human use
The provisions of the Directive shall only apply 6 months after certain elements of the new Clinical Trial Regulation (Regulation (EU) 536/2014) come into force, which is not envisaged until 2020 at the earliest.
My Department is committed to ensuring that the transposition of all Directives is completed in a timely manner.
