BLOOD SUPPLY (TEMPORARY DEROGATIONS TO ELIGIBILITY CRITERIA) REGULATIONS

BLOOD SUPPLY (TEMPORARY DEROGATIONS

TO ELIGIBILITY CRITERIA)

SUBSIDIARY LEGISLATION 483.05

BLOOD SUPPLY (TEMPORARY DEROGATIONS

TO ELIGIBILITY CRITERIA) REGULATIONS

12th January, 2010

LEGAL NOTICE 27 of 2010.

The title of these regulations is the Blood Supply

(Temporary Derogations to Eligibility Criteria) Regulations.

The scope of these regulations is to transpose the

Commission Directive 2009/135/EC of 3 November 2009 allowing

temporary derogations to certain eligibility criteria for whole blood

and blood components donors laid down in Annex III to Directive

2004/33/EC in the context of a risk of shortage caused by the

Influenza A(H1N1) pandemic.

(1) When confronted with a serious risk of shortage or

actual shortage in the supply of blood and blood components

directly due to the A (H1N1) pandemic the blood establishment

may temporarily by way of derogation

(a) from point 1.2 of Annex III to Directive 2004/33/EC,

reduce the minimum haemoglobin levels in donors’

blood to no less than 120 g/l for females and 130 g/l

for males;

(b) from point 2.2.1 of Annex III to Directive 2004/33/EC,

apply a deferral period of no less than seven days after

cessation of symptoms of a flu-like illness.

(2) The implementation of the aforementioned derogations

shall apply only

(a) when and after the Licensing Authority declares a state

of serious risk of shortage or an actual shortage of

blood and blood components directly related to the

A(H1N1) pandemic; and

(b) up to the 30th June, 2010.

(3) Any reference, in any other legislation, to the articles in

Annex III of Directive 2004/33/EC, shall be construed i the light of

the provisions of these regulations.