Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells (Text with EEA relevance) (c. 39)

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ANNEX U.K.

Annexes II and III to Directive 2006/17/EC are amended as follows:

(1)

in Annex II, point 1.2 is replaced by the following:

‘1.2. HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’;

(2)

Annex III is amended as follows:

(a)

point 2.4 is replaced by the following:

‘2.4.

HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’;

(b)

point 3.3 is replaced by the following:

‘3.3.

HTLV-I antibody testing must be performed for donors living in, or originating from, high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’;

(c)

point 4.2 is replaced by the following:

‘4.2. For donations other than by partners, blood samples must be obtained at the time of each donation.

For donation by partners (not for direct use), blood samples must be obtained within three months before the first donation. For further partner donations by the same donor, further blood samples must be obtained according to national legislation, but no later than 24 months from the previous sampling.’.