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

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BERV

Date of completion: 20.12.2007

Full quote:

" Blood stem cell unit register ordinance of 20 December 2007 (BGBl. I p. 3081) "

Footnote

(+ + + Text proof: 23.12.2007 + + +) 

  

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Input formula

Pursuant to Section 9 (3) of the Transfusion Act, as amended by the Notice of 28 August 2007 (BGBl. 2169), the Federal Ministry of Health is responsible for: Unofficial table of contents

§ 1 Type of register

The Federal Office for Medical Documentation and Information (Registry Authority) establishes and operates the register in the form of a database in accordance with Section 9 (2) sentence 1 of the Transfusion Act. Unofficial table of contents

§ 2 Content of the register

Only the following information is stored in the register:

1.

Name, address, telephone number, fax number and address of the electronic mail of the institution which has the permission within the meaning of the second sentence of section 9 (2) of the Transfusion Act,

2.

the nature and name of the blood stem cell preparations produced and placed on the market or imported, in accordance with the manufacturing or import authorisation,

3.

the activities of the establishment in accordance with the manufacturing or import licence;

4.

the date on which the authorisation was granted,

5.

the number of the approval certificate;

6.

the name, address, telephone number, fax number and address of the electronic mail of the notifying competent authority;

7.

Name of the notifying person of the competent authority.

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§ 3 Transmission of the data to the register authority

(1) The competent authority shall send the information in accordance with section 2 of the register authority electronically or in writing. For this purpose, the register authority shall designate a form and 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 have any modification of the data submitted by the competent authorities. (3) The register authority has to check the data in accordance with § 2 for the correctness and completeness of the transfer to the register and to correct the incorrect data. Unofficial table of contents

§ 4 Transmission of data by the register authority

(1) The information stored in the register in accordance with § 2 (1) to (3) must be generally accessible via the Internet by means of automated retrieval. The information according to § 2 nos. 4 to 6 is accessible only to the register authority and to the competent authorities of the federal government and the countries. The data in accordance with § 2 no. 7 are only accessible to the register authority. (2) The register authority shall send the information stored in the register to the competent authorities of the federal and state governments as well as to the European Commission, insofar as this is the case. To fulfil the duties and obligations under national law or under the law of the European Union. The establishment of an automated procedure allowing automated retrieval of the information referred to in the first sentence shall be permitted where this is appropriate because of the frequency or the vulnerability of the requests for transmission of information; (3) The use of the register is free of charge for the competent authorities of the federal and state governments, as well as for the European Commission. All other users of the register pay a fee in accordance with the registration catalogue of the register authority. Unofficial table of contents

§ 5 Data Security

The register authority shall take appropriate measures in respect of data security, in particular the integrity of the information stored in the register and the information provided by the register authority, in accordance with the state of the art. . Unofficial table of contents

§ 6 Deletion of information

The register authority shall immediately delete 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. Unofficial table of contents

Section 7 Entry into force

This Regulation shall enter into force on the day following the date of delivery. Unofficial table of contents

Final formula

The Federal Council has agreed.