Explanatory note

These Regulations amend the Blood Safety and Quality Regulations 2005 (S.I. 2005/50) (“the 2005 Regulations”) in order to implement Commission Directive 2014/110/EU amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations and Commission Implementing Directive 2011/38/EU amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life.

Regulation 2(2) amends Part 3 of the Schedule to the 2005 Regulations in order to transpose the changes made to Annex III to Directive 2004/33/EC by Directive 2014/110/EU. This allows testing for West Nile Virus as an alternative to a 28 day deferral period for blood donors returning from West Nile Virus affected areas.

Regulation 2(3) amends Part 5 of the Schedule to the 2005 Regulations in order to transpose the changes made to Annex V to Directive 2004/33/EC by Directive 2011/38/EU. This relaxes the quality control requirements for maximum pH values for units of platelets at the end of the shelf life.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public or voluntary sectors is foreseen. A Transposition Note in relation to the implementation of the Directives is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk. Copies may also be obtained from the Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ.