Amendment Of The Regulation On Medicinal Products From Human Blood

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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month, or Get a Day Pass for only USD$9.99.

46. Regulation of the Federal Minister of Health, amending the Regulation on medicinal products derived from human blood

On the basis of § § 5 and 62b of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 114/2012, shall be arranged:

The Regulation on medicinal products derived from human blood, BGBl. II No 187/2005, as last amended by the BGBl Regulation. II No 311/2011, shall be amended as follows:

The previous text of § 2 is given the sales designation "(1)"; the following paragraph 2 is added:

Blood or blood components intended for transfusion, which are imported from countries not party to the Agreement on the European Economic Area, are those listed in Annex IV to Directive 2002 /98/EC shall be carried out. In addition, an investigation into non-specific immune activation markers is to be carried out. "