6 regulation of the Federal Minister of health, the haemovigilance regulation 2007 modifies the
On the basis of § 75 d 4 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 146/2009, of the section 21 Z 3 and Z 8 of the blood safety Act 1999, Federal Law Gazette I no. 44, last amended by Federal Law Gazette I no. 107/2009, is prescribed:
The haemovigilance regulation 2007 (HäVO 2007), Federal Law Gazette II No. 155/2007, as last amended by Federal Law Gazette II No. 219/2008, is amended as follows:
1 the following sentence is added to § the 4:
"The Federal Office for security in the health care sector has annually by no later than September 1 to publish a summary report of all reported serious adverse reactions according to § 2 para 3 and all false transfusions of the previous year on his Web site."
2. in paragraph 6, the second sentence reads:
"The Federal Office for security in the health care sector has annually by no later than September 1 to publish a summary report of all reported serious incidents of the previous year on his Web site."
3. According to article 7, the following paragraph 7a with heading is inserted:
"Annual report of the blood establishment
Section 7a. Each blood establishment is required, the Federal Office for security in health care no later than 30 April of the following year an annual report on the collection and distribution of blood and blood components to hospitals, hospital blood banks and companies that produce medicines, check or bring in traffic, to present. 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 banks and hospitals, 4. supplied the total number of unused donations, 5. the number of each manufactured and distributed blood components, 6 incidence and prevalence of transfusion-transmitted infection markers in blood or blood components, 7 the number of product recalls and 8 the number of reported serious incidents and adverse reactions."