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Dáil Question to Dept of Health on outstanding EU Directives

QUESTION NO: 211

for WRITTEN ANSWER on 11/12/2013

* To ask the Minister for Health the number of EU directives related to his Department that have yet to be transposed into Irish law despite the deadline date having passed; when is it proposed that these Directives will be transposed; and if he will make a statement on the matter.

– Anthony Lawlor T.D.

REPLY.

There are four EU Directives, where the deadline has passed and have yet to be transposed into Irish law:

1. Directive 2011/62/EU on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.

The Directive was due to be fully transposed by the 02/01/13. On 23 May 2013, the Minister for Health signed four statutory instruments which transposed into Irish law all of the Falsified Medicines Directive, with the exception of one article – Article 85c regarding the sale of medicines over the internet. It is expected that the transposition with be completed in the near future.

2. Directive 2011/24/EU of 9 March 2011 on the application of patients’ rights in cross-border healthcare.

This Directive was due to be transposed by 25/10/13. Partial compliance has been achieved. Work is underway to achieve full compliance as soon as possible.

3. Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State

This Directive was due to be transposed by 25/10/2013. It is anticipated that transposition will be complete shortly.

4. Directive 2012/26/EU of the European Parliament and of the Council of 25 October, 2012 amending Directive 2001/83/EC as regards pharmacovigilance

This Directive was due to be transposed by 28/10/2013. It is anticipated that transposition will be complete shortly.

My Department is committed to ensuring that the transposition of all Directives is completed as soon as possible.