Haemovigilance Regulation 2007

Original Language Title: Änderung der Hämovigilanz-Verordnung 2007

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6. Ordinance of the Federal Minister of Health to amend the Hemovigilance Regulation 2007

On the basis of Section 75d (4) of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 146/2009, § 21 Z 3 and Z 8 of the Blood Safety Act 1999, BGBl. I n ° 44, as last amended by the Federal Law BGBl. I No 107/2009, shall be:

Haemovigilance-Regulation 2007 (HäVO 2007), BGBl. II No 155/2007, as last amended by BGBl. II No 219/2008, shall be amended as follows:

(1) The following sentence shall be added to § 4:

" The Federal Office for Health Security has a summary report of all reported serious adverse reactions in accordance with § 2 para. 3 and all mistransfusions of the previous year at the latest by 1 September at the latest. Website to be published. "

2. In § 6 the second sentence reads:

"The Federal Office for Health Security has annually published a summary report of all the serious incidents reported in the previous year on its website by 1 September at the latest."

3. In accordance with § 7, the following § 7a with headline is inserted:

" Activity report of the blood donation institution

§ 7a. Every blood donation establishment is obliged to submit an annual report on the collection and distribution of blood and blood components to hospitals, by 30 April of the following year, to the Federal Office for Health and Safety in the health care sector. hospital blood depots and establishments producing, controlling or placing on the market medicinal products. The annual report shall contain, in particular, the following information:

1.

the total number of donors of blood and blood components,

2.

the total number of donations,

3.

a list of hospital blood depots and hospitals that are supplied,

4.

the total number of donations not used,

5.

the number of blood components produced and distributed,

6.

The incidence and prevalence of transfusions of communicable markers in blood or blood components,

7.

the number of product recalls and

8.

the number of serious adverse events reported and adverse reactions reported. "

Stöger