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Human Blood And Transplants Act (Cap. 483) Blood Supply (Temporary Derogations To Eligibilty Criteria) Regulations, 2010 (L.N. 27 Of 2010 )



L.N. 27 of 2010

VERŻJONI ELETTRONIKA

B 187

HUMAN BLOOD AND TRANSPLANTS ACT (CAP. 483)Blood Supply (Temporary Derogations to Eligibility Criteria) Regulations, 2010

IN exercise of the powers conferred by article 16 of the Human Blood and Transplants Act, the Minister for Social Policy, after consultation with the Licensing Authority, has made the following regulations:-

1. The title of these regulations is the Blood Supply

(Temporary Derogations to Eligibility Criteria) Regulations, 2010.

2. 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.

3. (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 7 days after cessation of symptoms of a flu-like illness.
( 2 ) T h e i m p l e m e n t a t i o n o f t h e a f o r e m e n t i o n e d 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.

Title.

Scope.

Derogations.

B 188 VERŻJONI ELETTRONIKA
(3) Any reference, in any other legislation, to the articles in Annex III of Directive 2004/33/EC, shall be construed in the light of the provisions of these regulations.

Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — VallettaMitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper <.. image removed ..>Prezz/Price€0.19


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