Tissue Extraction Facility Regulation

Original Language Title: Änderung der Gewebeentnahmeeinrichtungsverordnung

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168. Ordinance of the Federal Minister of Health, amending the Regulation on tissue removal regulations

On the basis of § 7 of the tissue safety law-GSG, BGBl. I n ° 49/2008, as last amended by the Federal Law BGBl. I No 162/2013, shall be assigned:

The Tissue Collection Regulation-GEEVO, BGBl. II No 191/2008, as amended by the BGBl Regulation. II No 87/2014, shall be amended as follows:

1. At the end of Section 1, Section 3, Z 5, the point shall be replaced by a line-point and the following Z 6 and 7 shall be added:

" 6.

Quarantine shall mean the status of tissues or cells taken from, or tissue isolated from physical or other effective means, pending a decision on acceptance or rejection;

7.

critical: with a possible influence on quality and/or safety, or with the cells and tissues in contact. "

2. In accordance with Section 3 (3), the following paragraphs 3a and 3b are inserted:

" (3a) Deceased children whose mothers are infected with HIV, hepatitis B, hepatitis C or HTLV or where there is a risk of such infection shall be excluded from donation if during the preceding twelve months they are excluded from the Mother was breastfed.

(3b) Late children, whose mothers are infected with HIV, shall be excluded from donation if the risk of infection transmission cannot be definitively excluded. "

3. In Section 11 (10), the following Z 6 is added:

" 6.

Persons with a risk of transmission for hereditary diseases known in the family shall be excluded from the donation. "

4. § 12 reads:

" Reference to acts of the European Union

§ 12. This Regulation implements the following Directives:

1.

Directive 2004 /23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 206, 22.7.2004, p. No. OJ L 102, 07.04.2004 p. 48,

2.

Directive 2006 /17/EC on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards technical requirements for the donation, procurement and testing of human tissues and cells, OJ L 175, 5.7.2006, p. No. OJ L 38, 09.02.2006 p. 40,

3.

Directive 2006 /86/EC transposing Directive 2004 /23/EC of the European Parliament and of the Council as regards requirements for traceability, reporting of serious incidents and adverse reactions, and certain technical requirements relating to the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L 327, 30.4.2004, p. No. OJ L 294, 25.10.2006 p. 32, and

4.

Directive 2012/39/EU amending Directive 2006 /17/EC as regards certain technical requirements for the testing of human tissues and cells, OJ L 175, 5.7.2006, p. No. OJ L 327, 26.11.2012 p. 24.

Stöger