OpenLegislation

Article 1

United Kingdom

Original text. Later amendments are not shown.

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 Europef1.’

Annotations

Footnotes

f1

Good Practice Guidelines, included in the Guide to the preparation, use and quality assurance of blood components, Appendix to Recommendation No. R (95) 15 of the Committee of Minsters on the preparation, use and quality assurance of blood components adopted on 12 October 1995.’