Regulation On The Extension Of The Regulation On The State Charge Examination On Blood Preparations (Article 1 Of The Regulation On The Introduction Of The State Batch Testing In Blood Preparations)

Original Language Title: Verordnung zur Ausdehnung der Vorschriften über die staatliche Chargenprüfung auf Blutzubereitungen (Artikel 1 der Verordnung über die Einführung der staatlichen Chargenprüfung bei Blutzubereitungen)

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Regulation on the extension of the regulation on the State charge examination on blood preparations (article 1 of the regulation on the introduction of the State batch testing in blood preparations) BlutZV Ausfertigung date: 15.07.1994 full quotation: "regulation on the extension of the rules on State batch testing on blood preparations (article 1 of the regulation on the introduction of the State batch testing in blood preparations) of 15 July 1994 (BGBl. I p. 1614), by article 1 of the Decree of 26 June 1995 (BGBl. I p. 854) has been changed" stand : Amended by art. 1 V v. 26.6.1995 I 854 for details on the stand number you see in the menu see remarks footnote (+++ text detection from: 24.7.1994 +++) (+++ to the application see § 4 para 1 +++) this V was issued by the Federal Ministry of health in consultation with the Federal Ministry for Economics with the consent of the Federal Council. She is I 1614 in force article 3 G v. 15.7.1994 according to the 24.7.1994.

§ 1 the regulations be extended over State batch testing on blood preparations which are made from blends of human blood plasma and contain the blood components as active ingredients.

Section 2 has the competent federal authority to make a decision on the release of the batch within a period of two months after receipt of the batch sample to be tested. Section 27, paragraph 2, of the German medicines Act finds appropriate application.

§ 3 the competent federal authority has to release the batch, when the competent authority of another Member State of the European Union or another Contracting State to the agreement on the European economic area after an experimental investigation has determined that the batch has been manufactured and tested after manufacturing and control methods that correspond to the current state of scientific knowledge, and that they required quality That has efficacy and safety.

§ 4 (1) for the blood preparations according to this regulation, which are not blood coagulation factor IX or Prothrombinkomplex products, shall apply the regulation from 1 January 1996. On batches of this blood preparations that are already on January 1, 1996 in the transport sector, the regulation does not apply.
(2) the regulation shall not apply to such charges, which are already in circulation at the time of entry into force of this regulation.