a

for paragraph (1)(b) substitute—

b

establish and maintain a quality system for blood establishments—

i

in relation to Great Britain, that is based on the principles of good practice, which meets the standards and requirements set out in the Annex to Commission Directive 2005/62/EC and which gives effect to the Good Practice Guidelines for Blood Establishments Required to Comply with Directive 2005/62/EC published in the 20th edition of the Guide to the preparation, use and quality assurance of blood components4;

ii

in relation to Northern Ireland, that is based on the principles of good practice, which complies with the Community standards and requirements set out in the Annex to Commission Directive 2005/62/EC and which gives effect to the requirements in respect of the use of good practice guidelines set out in Article 2.2 of that Directive;