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Amendment of regulation 7 of the principal Regulations
This section has no associated Explanatory Memorandum
4.—(1) In regulation 7 of the principal Regulations (blood establishment requirements), in paragraph (1)—
(a)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();”;
(b)omit sub-paragraph (e);
(c)in sub-paragraph (f), at the end, insert “; and”; and
(d)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.”.
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