Wednesday 15 February 2017

Good Practice Guidelines for Blood Establishments

EU directive integrates Council of Europe Good Practice Guidelines for blood establishments

Good Practice Guidelines have been prepared through co-operation between the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM) and the Commission of the European Union (EU). The elaboration of the Good Practice Guidelines included substantial public consultations giving stakeholders an opportunity to comment on the draft version.

The Good Practice Guidelines were adopted by the European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS) of the Council of Europe during its plenary session in November 2016. The document is an integral part of the 19th Edition of the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components, Appendix to Recommendation No. R (95) 15 of the Committee of Ministers, referred to below as the “Guide”.

Following adoption of the Good Practice Guidelines by the European Commission, European Union and European Economic Area Member States shall ensure that Blood Establishments take fully into account the standards and specifications set out in those Guidelines when implementing their quality system, in line with the new Commission Directive (EU) 2016/1214. In order to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2018, some member states need to translate the text of the Good Practice Guidelines into their national language. To expedite this process, a verbatim copy of the text of the Good Practice Guidelines that will be published in the Guide is downloadable as a document here.

Posted by Dr. Tim Sandle

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