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Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life Text with EEA relevance

Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life Text with EEA relevance

Directive 2011/38/EU · Directive · 5 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

Annex V to Directive 2004/33/EC is amended in accordance with the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. 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

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

Article 4

This Directive is addressed to the Member States.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX In point 2.4 of Annex V to Directive 2004/33/EC, for the entries: — ‘Platelets, apheresis’, — ‘Platelets, aphaeresis, leucocyte-depleted’, — ‘Platelets, recovered, pooled’, — ‘Platelets, recovered, pooled, leucocyte-depleted’, — ‘Platelets, recovered, single unit’, and — ‘Platelets, recovered, single unit, leucocyte-depleted’, the acceptable results for quality measurements for pH are replaced by the following: ‘Minimum 6,4 corrected for 22 °C, at the end of the shelf life’.

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

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