187. Federal Minister for Health and Women's Ordinance on Medicinal Products from Human Blood

According to § § 5, 20 and 62a of the Medicines Act, BGBl. No 185/1983, as last amended by BGBl. I n ° 168/2004, as well as § 7 of the Proprietary Medicinal Products Import Act, BGBl. I No 28/2002, as last amended by BGBl. I n ° 35/2004, shall be assigned:

§ 1. Proprietary medicinal products containing human blood or produced from human blood may only be placed on the market by the manufacturer, dealer or wholesaler if a plasma master file (PMF) is used for the plasma used. , which has been certified by the Federal Minister of Health and Women, the European Medicines Agency, or the competent authority of another Party to the Agreement on the European Economic Area. This certificate is to be submitted to the Federal Ministry of Health and Women.

§ 2. Blood components intended for transfusion or blood components intended for transfusion may only be placed on the market if the blood components used in Annex A , the quality and safety requirements are met. In the case of imports from a Contracting Party to the Agreement on the European Economic Area, the Federal Ministry of Health and Women shall submit the authorisations granted by the competent authorities in accordance with Article 5 of Directive 2002/98/EC.

§ 3. Medicinal products containing human blood or produced from human blood and imported from a Contracting Party to the Agreement on the European Economic Area may be imported from a domestic producer, depositary or Medicinal products wholesalers shall be placed on the market or further processed only if:

1.		the authorisations granted by the competent authorities in accordance with Article 5 of Directive 2002/98/EC, or
2.		for the plasma used, a plasma master file (PMF) which is provided by the Federal Minister for Health and Women, the European Medicines Agency or the competent authority of another Contracting Party to the Agreement on the European Union Economic area certified.

§ 4. (1) Medicinal products containing human blood or produced from human blood and imported from a Member State outside the European Economic Area may be imported from a domestic producer, a deposit or a deposit, or Medicinal products wholesalers shall be placed on the market or further processed only if:

1.		equivalent requirements to those within the meaning of § 1, and
2.		In any case, the medicinal product complies with all the requirements of § § 3 and 4 of the Medicines Act

(2) The conditions set out in paragraph 1 shall be maintained if a plasma master file (PMF) is available for the plasma used by the Federal Minister for Health and Women, the European Medicines Agency or the competent authority of a other party to the Agreement on the European Economic Area.

§ 5. Medicinal products containing human blood or produced from human blood imported from a Member State outside the European Economic Area and intended solely for re-export may be provided by a Domestic producers shall be processed only if it is guaranteed that:

1.		the product can be traced back to the individual donors which have been used for the production of the goods,
2.		in the case of the selection of individual donors, the internationally recognised criteria have been taken into account in accordance with the state of the art,
3.		in the case of each individual donor, by means of a detection method corresponding to the respective state of the sciences, an already successful contact with the HI virus, the HB virus, the HC virus or a pathogen which is epidemiologically relevant in the country of origin. has been excluded,
4.		the medicinal product complies with all requirements in accordance with § § 3 and 4 of the Medicines Act, or an authorisation of the importation of the further processed medicinal products by the competent authority of the importing country is available; and
5.		the products are not placed on the market in the European Economic Area.

§ 6. The plasma master file (PMF) does not have to be in the company of the manufacturer, the drug wholesaler or the depositors, if it is ensured by contractual agreement that it is available to the Federal Ministry for Health and Women's , the request may be submitted without delay.

§ 7. Blood and blood components must be in accordance with the Annex B shall be stored, transported and distributed.

§ 8. To the extent that no different regulations are adopted in this Regulation, the Medicines Operating Regulations 2005 shall apply, BGBl. II No 479/2004, including for establishments which process, process, test, store and deliver human blood or blood components, provided that they are intended for transfusion.

§ 9. (1) The label attached to the primary packaging of the blood or blood component intended for transfusion shall include the following information:

1.		Name of blood component
2.		if appropriate, volume, weight or number of cells of the blood component
3.		Uniform numerical or alphanumeric identification of the donation with a uniform code (ISBT 128)
4.		Name of the blood donation establishment
5.		AB0 group (not required for plasma, which is intended for fractionation only)
6.		RhD-group, either RhD-positive or RhD-negative (not required for plasma, which is only intended for fractionation)
7.		where appropriate, expiry date or expiry
8.		Storage Temperature
9.		Name, composition and volume of the anticoagulant and/or additive solution, if present.

(2) In the case of own blood and blood components, in addition to the information given in paragraph 1, the warning "ONLY FOR THE TRANSFUSION OF OWN BLOOD" shall be included.

§ 10. This Regulation implements the following directives of the European Community:

1.		Directive 2002/98/EC of the European Parliament and of the Council of 27 Jänner 2003 (OJ C 327, 28. No. OJ L 033, 8.2.2003, S 0030-0040);
2.		Commission Directive 2004 /33/EC of 22 March 2004 (OJ L 393, 30.4.2004, p. No. OJ L 091, 30.3.2004, S 0025-0039).

§ 11. The designation "Federal Minister for Health and Women, or the Federal Office for Health and Safety," is replaced by the "Bundesamt für Gesundheit und Frauen" (Federal Minister for Health and Women) and the German Federal Office for Health and Safety (F Federal Ministry of Health and Health "the name" Bundesamt für Sicherheit im Healthcare " (Federal Office for Health and Safety).

§ 12. (1) For the identification of donation with the uniform code according to ISBT 128 provided for in § 9 para. 1 Z 3, the donation can be made up to the end of the 31. For organisational reasons, October 2007 will be dismissed.

(2) proprietary medicinal products which have been approved before the entry into force of this Regulation may be placed on the market even if there is no plasma master file (PMF) certificate within the meaning of § 1.

§ 13. The regulation of the Federal Minister of Health and Public Service of 21 September 1989 concerning medicinal products derived from human blood, BGBl, enters into force with the entry into force of this Regulation. No 488/1989, except for force.

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