Regulation on the extension of the rules on state batch testing for blood preparations (Article 1 of the Regulation on the introduction of state-level batch testing in the case of blood preparations)

Unofficial table of contents

Blood ZV

Date of completion: 15.07.1994

Full quote:

" Regulation extending the rules on state batch testing for blood preparations (Article 1 of the Regulation on the introduction of state batch testing in the case of blood preparations) of 15 July 1994 (BGBl. 1614), as defined by Article 1 of the Regulation of 26 June 1995 (BGBl). I p. 854).

Status:

Amended by Art. 1 V v. 26.6.1995 I 854

For more details, please refer to the menu under Notes

Footnote

(+ + + Proof of text: 24.7.1994 + + +) 
(+ + + For application cf.  Section 4 (1) + + +) 

  

This V was issued by the Federal Ministry of Health in agreement with the Federal Ministry for Economic Affairs with the approval of the Federal Council. She's gem. Art. 3 G v. 15.7.1994 I 1614 entered into force on 24.7.1994. Unofficial table of contents

§ 1

The rules on state batch testing are extended to include blood preparations made from mixtures of human blood plasma and containing the blood components as active substances. Unofficial table of contents

§ 2

The competent federal authority shall take a decision on the release of the batch within a period of two months from the receipt of the batch sample to be tested. Article 27 (2) of the Medicines Act shall apply accordingly. Unofficial table of contents

§ 3

The competent federal authority shall also release the charge if the competent authority of another Member State of the European Union or of another Contracting State of the Agreement on the European Economic Area shall, in accordance with a it has been found that the batch has been manufactured and tested in accordance with the methods of production and control which correspond to the state of the scientific findings and that they are of the required quality, Efficacy and safety. Unofficial table of contents

§ 4

(1) For blood preparations under this Regulation, which are not blood clotting factor IX or prothrombin complex preparations, the Regulation shall apply from 1 January 1996. The Regulation does not apply to batches of these blood preparations which are already on the market on 1 January 1996. (2) The Regulation shall not apply to such batches which are applicable at the date of entry into force of this Regulation. are already on the market.