Haemovigilance Regulation 2007

Original Language Title: Änderung der Hämovigilanz-Verordnung 2007

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173. Regulation of the Federal Minister of Health, amending the hemovigilance regulation 2007

On the basis of § 75n (4) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 48/2013, and § 21 Z 3 and Z 8 of the Blood Safety Act 1999-BSG 1999, BGBl. I n ° 44/1999, as last amended by the Federal Law BGBl. I No 107/2009, shall be:

Haemovigilance-Regulation 2007, BGBl. II No 155/2007, as last amended by the BGBl Regulation. II No 6/2012, shall be amended as follows:

1. § 1 reads:

" § 1. This Regulation shall apply to reports of serious adverse reactions or serious incidents in connection with the collection, testing, transfusion, processing, storage or distribution of blood or blood components or in the Related to product-related deficiencies in blood or blood components, but not to the collection and testing of blood or blood components of persons to whom blood or blood components are intended for diagnostic purposes within the framework of their medical Treatment is taken. "

2. § 3 (1) reads:

" (1) Reporting requirements

1.

The medical director of a hospital blood depot, where there is no such person, the medical director of a hospital,

2.

physicians, including group practices, and

3.

the medical director of a blood donation establishment. "

3. In Section 3 (4), the phrase "The head of a hospital blood depot where such a hospital does not exist, the medical director of a hospital, has the Federal Office for Safety in Health" through the phrase " The head of a hospital blood depot, where such a hospital does not exist, the medical director of a hospital, and established physicians, including group practices, have the Federal Office for Security in the Healthcare " replaced.

4. In accordance with § 4, first sentence, the following sentence shall be inserted:

" The annual report has the following in Annex II, Part D of Directive 2005 /61/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards requirements for traceability and notification of serious incidents and serious adverse reactions, OJ C No. OJ L 256, 01.10.2005, p. 32. '

5. § 5 (1) reads:

" (1) Reporting requirements

1.

the responsible person of a holding who processes, stores or distributes human blood or blood components, provided that they are intended for transfusion,

2.

the medical director of a blood donation establishment,

3.

The medical director of a hospital blood depot, where there is no such person, the medical director of a hospital, and

4.

physicians including group practices. "

6. In accordance with § 6, first sentence, the following sentence shall be inserted:

"The annual report shall include the content provided for in Part C of Annex III to Directive 2005 /61/EC."

7. § 8 reads:

" § 8. This Regulation implements Directive 2005 /61/EC. "

8. The text of the previous § 9 receives the sales designation "(1)" ; the following paragraph 2 is added:

" (2) The annual reports in accordance with § § 4 and 6 shall, for the first time, have the requirements of § § 4 and 6 in the version of the BGBl Regulation for the year 2012. II No 173/2013. '

Stöger