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 for a register of facilities that produce Blutstammzellzubereitungen and bring into circulation or introduce (blood stem cell facilities register regulation BERV) BERV Ausfertigung date: 20.12.2007 full quotation: "blood stem cell facilities register regulation by December 20, 2007 (BGBl. I p. 3081)" footnote (+++ text detection from: 23.12.2007 +++) input formula on the basis of § 9 para 3 of the transfusion act as amended by the notice of August 28, 2007 (BGBl. I p. 2169) enacted the Federal Ministry for health : § 1 art of the register for medical documentation and information established federal authority (authority) and operates the register to § 9 para 2 sentence 1 of the transfusion Act in the form of a database.
Article 2 content of the register in the register only the following information is stored: 1. name, address, telephone, fax number and electronic mail address of the institution that owns the permission within the meaning of § 9 para 2 sentence 2 of the transfusion law, 2 and name manufactured and marketed or imported Blutstammzellzubereitungen in accordance with the manufacturing or import authorisation, 3. activities of the institution to the manufacturing or import authorisation , 4. date of permit issuance, 5. number of the permit notification, 6 name, address, telephone, fax number and electronic mail address of the notifying competent authority, 7. name of the reporting person of the competent authority.
§ Delivery of information to the register authority (1) a competent authority has the information according to § 2 of the register authority electronically or in writing to submit 3. For this purpose, the authority to determine a form and makes it known in the Federal Gazette.
(2) the competent authorities of the countries are responsible for the correctness and completeness of the data transferred and have to submit the register authority immediately any modification of the data.
(3) the authority has to verify the data according to § 2 on accuracy and completeness of the transfer in the register and to correct inaccurate data.
§ 4 delivery of information by the Authority (1) No. 1 to 3 need to stored information in the register pursuant to section 2 in the way of automated retrieval over the Internet generally to be accessible. Details no. 4 to 6 are accessible according to § 2 only the register authority and the competent authorities of the Federal and State Governments. The data according to § 2 No. 7 are accessible to only the register authority.
(2) the register authority submits 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 necessary to fulfil the duties and obligations under national law or under the law of the European Union. An automated procedure that allows an automated retrieval of information, the authorities referred to in sentence 1 is permitted, insofar as this is appropriate or required on the basis of EC law due to the frequency or urgency of delivery requests.
(3) the competent authorities of the Federal and State Governments and the European Commission the use of the register is free of charge. All other users of the register pay a fee in accordance with the pay catalog of the register authority.
§ 5 data security the authority is to take appropriate data security measures the respective State of the art, ensuring in particular the integrity of information stored in the register, as well as the information provided by the authority.
§ 6 deletion of data the register authority has to delete the information stored in the register to an institution, if the competent authority of the Member State has communicated that the establishment has discontinued the reported activities immediately.
Article 7 entry into force this regulation enter into force on the day after the announcement.
Concluding formula the Federal Council has approved.
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