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The Blood Safety and Quality (Amendment) Regulations 2006

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Amendment of regulation 7 of the principal Regulations

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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(1);”;

(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..

(1)

OJ L 256, 1.10.2005, p 41.

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