Amendment Of The Regulation On Medicinal Products From Human Blood

Original Language Title: Änderung der Verordnung betreffend Arzneimittel aus menschlichem Blut

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46. Regulation of the Federal Minister for health, modifies the regulation on medicinal products from human blood

On reason of sections 5 and 62B of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 114/2012, is prescribed:

The regulation on medicinal products from human blood, BGBl. II no 187/2005, as last amended by regulation BGBl. II No 311/2011, is amended as follows:

The existing text of § 2 receives the sales designation (1); the following paragraph 2 is added:

"(2) for transfusion for blood or blood components for transfusion, imported from States that are not party to the agreement on the European economic area, are to undergo the in annex IV of Directive 2002/98/EC of designated tests. Furthermore is nonspecific immune activation markers to conduct an investigation."