EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations amend the Blood Safety and Quality Regulations 2005 (“the principal Regulations”) to implement Commission Directive (EU) 2016/1214 (“the 2016 Directive”) which amends Directive 2005/62/EC which contains technical requirements relating to blood establishments.
OJ No L 199, 26.07.2016, p 14.
Regulation 2 amends regulation 7 of the principal Regulations to provide that the quality system maintained by blood establishments must incorporate good practice guidelines of the type mentioned in Article 2.2 of the 2005 Directive, as amended by the 2016 Directive. A model for such guidelines have been jointly developed by the European Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe.
This can be found at: :https://www.edqm.eu/sites/default/files/goodpracticeguidelines-19th_edition_guide_preparation_use_qa_blood_components-december2016.pdf
Regulation 3 makes a similar amendment to regulation 9 of the principal Regulations for hospital blood banks.
A full impact assessment has not been produced for this instrument as no, or no significant impact, on the private, voluntary or public sectors is foreseen.