Regulation extending the rules on state batch testing for blood preparations (Article 1 of the Regulation on the introduction of state batch testing for blood preparations)Non-official Table of Contents
Date of expiry: 15.07.1994
" Regulation extending the rules on state batch testing for blood preparations (Article 1 of the Regulation on the introduction of the State batch testing for blood preparations) of 15. July 1994 (BGBl. 1614), as defined by Article 1 of the Regulation of 26 June 2008. June 1995 (BGBl. I p. 854) "
|:||Modified by Art. 1 V v. 26.6.1995 I 854|
For details, see Notes
(+ + + Text evidence: 24.7.1994 + + +)
(+ + + For application). cf. § 4 para. 1 + + +)
This V was issued by the Federal Ministry of Health in agreement with the Federal Ministry of Economics 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. Non-official table of contents
The rules on state batch testing are extended to blood preparations made from mixtures of human blood plasma, and containing the blood components as active substances. Non-official table of contents
The competent federal authority has a decision on the release of the batch within a period of two months after receipt of the batch sample to be tested. Article 27 (2) of the Medicines Act shall apply accordingly. Non-official table of contents
The competent federal authority has to release the batch even if the competent authority of another The Member State of the European Union or of another Contracting State of the Agreement on the European Economic Area, after an experimental investigation, has established that the batch shall be based on the methods of production and control, which shall: the corresponding state of scientific knowledge, has been prepared and tested, and has the necessary quality, efficacy and safety. Non-official table of contents
(1) For blood preparations under this Regulation, which do not have blood clotting factor IX or In the case of prothrombin complex preparations, the Regulation shall apply from 1 January 2008 onwards. January 1996. On batches of these blood preparations, which are on the 1. The Regulation shall not be applicable on the basis of the Regulation on the market in January 1996.(2) The Regulation shall not apply to such batches which are already on the market at the date of entry into force of this Regulation.