Regulation For A Register Of Facilities That Produce Blutstammzellzubereitungen And Bring Into Circulation Or Introduce

Original Language Title: Verordnung für ein Register über Einrichtungen, die Blutstammzellzubereitungen herstellen und in den Verkehr bringen oder einführen

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Regulation on a register of establishments producing and placing on the market of blood stem cell preparations (blood stem cell equipment-register regulation-BERV)

unofficial Table of Contents

BERV

Date of issue: 20.12.2007

Full quote:

" Blood stem cell device-register regulation of 20. December 2007 (BGBl. I p. 3081) "

footnote

(+ + + text evidence from: 23.12.2007 + + +)

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input formula

On the basis of § 9 (3) of the Transfusion Act, as amended by the 28. August 2007 (BGBl. 2169), the Federal Ministry of Health is responsible for: Non-official table of contents

§ 1 Type of the register

The information for medical documentation and information in the form of a database in accordance with Section 9 (2) sentence 1 of the Transfusion Act. unofficial table of contents

§ 2 contents of the register

Only the following information is stored in the register:
1.
The name, address, telephone number, fax number and address of the electronic mail service of the institution, which is the permission within the meaning of Section 9 (2) sentence 2 of the Transfusion Act
2.
The type and name of the blood stem cell preparations produced and placed on the market or imported, in accordance with the manufacturing or marketing authorisation procedure; Import permit,
3.
post-manufacturing or import permit activities,
4.
Date of permission granted,
5.
number of the approval certificate,
6.
name, address, telephone number, fax number and address of the electronic mail of the notifying competent authority,
7.
name of the reporting person.
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§ 3 Transmission of the information to the register authority

(1) The competent authority shall forward the information in accordance with § 2 of the register authority electronically or in writing. For this purpose, the register authority shall designate a form and shall make it known in the Federal Gazette.(2) The competent authorities of the Länder shall be responsible for the accuracy and completeness of the data transmitted and shall forward any change to the data without delay to the register authority.(3) The register authority shall check the data in accordance with § 2 for the correctness and completeness of the transfer to the register and correct incorrect data. Non-official table of contents

§ 4 Transmission of information by the register authority

(1) The information stored in the register in accordance with § 2 (1) to (3) shall be generally accessible via the Internet through automated retrieval. The data according to § 2 nos. 4 to 6 are accessible only to the register authority and to the competent authorities of the federal and state governments. The data in accordance with § 2 no. 7 are only accessible to the register authority.2. The register authority shall transmit the information stored in the register to the competent authorities of the federal and state governments and to the European Commission, insofar as this is done in order to fulfil the tasks and obligations under national law or in accordance with the law of the European Union. The establishment of an automated procedure allowing automated retrieval of the information referred to in the first sentence of this Article shall be permitted, where appropriate, because of the frequency or the vulnerability of the requests for transmission of information; is required under EC law.(3) The use of the register is free of charge for the competent authorities of the federal and state governments and for the European Commission. All other users of the register pay a fee in accordance with the registration catalogue of the register authority. Non-official table of contents

§ 5 Data security

The register authority has appropriate data security measures for the respective state of the art. shall, in particular, ensure the integrity of the information stored in the register and the information provided by the Registry. Non-official table of contents

§ 6 Deletion of information

The register authority immediately has the information stored in the register for a facility. if the competent authority of the country has informed the institution that the establishment has ceased the activities notified. Non-official table of contents

§ 7 Entry into force

This Regulation will enter into force the day after the announcement. Non-official table of contents

Final formula

The Bundesrat has agreed.