173. Regulation of the Federal Minister of health, the haemovigilance regulation 2007 modifies the
On the basis of 75n para 4 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by the Federal Act Federal Law Gazette I no. 48/2013, and of section 21 Z 3 and Z 8 of the blood safety Act 1999 - BSG 1999, Federal Law Gazette I no. 44/1999, as last amended by Federal Law Gazette I no. 107/2009, is prescribed:
The haemovigilance regulation 2007, BGBl. II No 155/2007, as last amended by regulation BGBl. II No 6/2012, is amended as follows:
1. paragraph 1:
„§ 1. This Regulation shall apply to reports of serious adverse reactions or serious incidents relating to the production, testing, transfusion, processing, storage or distribution of blood or blood components or in connection with product-related defects in blood or blood components, but not on the collection and testing of blood or blood components by persons to whom blood or blood components be removed for diagnostic purposes in the course of their medical treatment."
2. paragraph 3 section 1:
"(1) the Medical Director / the Medical Director of a hospital blood banks, where such a medical director / the Medical Director of a hospital, 2. established physicians and group practices 3. are reportable 1 Medical Director / Medical Director of blood establishment."
3. in article 3, paragraph 4, the phrase is "the Federal Office for security in healthcare has the head of a hospital blood banks, where one does not exist in the Medical Director / Medical Director of a hospital," replaced by the phrase "the head and the head of a hospital blood banks, where one does not exist in the Medical Director / Medical Director of a hospital, established physicians including group practices have the Federal Office for security in the health care sector".
4. after paragraph 4 first sentence is inserted the following sentence:
"The message of the year has 2005/61/EC in annex II, part D of the directive on the implementation of Directive 2002/98/EC of the European Parliament and of the Council as regards the requirements for traceability and the reporting of serious adverse events and serious adverse reactions, OJ "No. L 256 of the 1 October 2005 p. 32, provided content to cover."
5. paragraph 5 paragraph 1:
"(1) 1 are subject the person in a business that handles human blood or blood components, when intended for transfusion, stores or distributed, 2. the Medical Director / Medical Director of a blood establishment, 3. the Medical Director and the Medical Director of a hospital blood banks, where one does not exist in the Medical Director / Medical Director of a hospital, 4. established physicians including group practices."
6 according to § 6, first sentence, the following sentence is inserted:
'The year message has to include the content that is provided for in annex III, part C of the Directive 2005/61/EC.'
7 paragraph 8:
„§ 8. By this regulation, the directive is implemented 2005/61/EC.'
8. the text of the previous article 9 receives the sales designation (1); the following paragraph 2 is added:
"(2) the annual reports after the sections 4 and 6 have for the first time for the year 2012 the requirements of sections 4 and 6 as amended the regulation Federal Law Gazette II No. 173/2013 to match."