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Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance)

Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance)

Directive (EU) 2016/1214 · Directive · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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In Article 2 of Directive 2005/62/EC, paragraph 2 is replaced by the following: ‘2.   Member States shall ensure that, in order to implement the standards and specifications set out in the Annex to this Directive, there are good practice guidelines available to and used by all blood establishments, in their quality system, good practice guidelines which take fully into account, where relevant for blood establishments, the detailed principles and guidelines of good manufacturing practice, as referred to in the first subparagraph of Article 47 of Directive 2001/83/EC. In doing so, Member States shall take into account the Good Practice Guidelines jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe  ( *1 ) .

Article 2

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1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2018 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Other acts of the same type
Directive 2009/18/EC of the European Parliament and of the Council of 23 April 2009 establishing the fundamental principles governing the investigation of accidents in the maritime transport sector and amending Council Directive 1999/35/EC and Directive 2002/59/EC of the European Parliament and of the Council (Text with EEA relevance)Directive 2009/20/EC of the European Parliament and of the Council of 23 April 2009 on the insurance of shipowners for maritime claims (Text with EEA relevance)Directive 2009/21/EC of the European Parliament and of the Council of 23 April 2009 on compliance with flag State requirements (Text with EEA relevance)Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (Codified version) (Text with EEA relevance)Directive 2009/29/EC of the European Parliament and of the Council of 23 April 2009 amending Directive 2003/87/EC so as to improve and extend the greenhouse gas emission allowance trading scheme of the Community (Text with EEA relevance)Directive 2009/30/EC of the European Parliament and of the Council of 23 April 2009 amending Directive 98/70/EC as regards the specification of petrol, diesel and gas-oil and introducing a mechanism to monitor and reduce greenhouse gas emissions and amending Council Directive 1999/32/EC as regards the specification of fuel used by inland waterway vessels and repealing Directive 93/12/EEC (Text with EEA relevance)Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (Text with EEA relevance)Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast) (Text with EEA relevance)Directive 2009/33/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of clean and energy-efficient road transport vehicles (Text with EEA relevance)Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (Recast) (Text with EEA relevance)Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance)Directive 2009/3/EC of the European Parliament and of the Council of 11 March 2009 amending Council Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement (Text with EEA relevance )

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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