Regulation 4 Amendment of regulation 7 of the principal Regulations

in sub-paragraph (b), for “good practice”, substitute “good practice, which complies with the Community standards and requirements set out in the Annex to Commission Directive 2005/62/EC^f1;”;

omit sub-paragraph (e);

in sub-paragraph (f), at the end, insert “; and”; and

after sub-paragraph (f), insert the following paragraph—

“(g)

retain, for a period of at least 15 years, a record of any serious adverse events which may affect the quality or safety of blood and blood components.”.