0A4F4F9BD490A749D5437F821CF06DF1
Law on Quality and Safety of Human Tissue and Cells (2013)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20005698
http://leaux.net/URLS/ConvertAPI Text Files/617FFB9ABAD6C9227298690E6E739BC9.en.txt
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
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p.(None): pursuant to section 9 subsection 2 or violates the reporting obligation pursuant to section 9 subsection 4,
p.(None): 8. does not meet the requirements for a quality system in accordance with section 10 subsections 1 to 3 or violates the obligation in section 10 subsection 4,
p.(None): 9. Contrary to Section 11 (1) as a tissue bank, no written agreements with removal facilities for removal or contrary to Section 11 (7) as
p.(None): Tissue bank with a license to import from third countries does not conclude any written agreements with third country suppliers or against § 11
p.(None): 2 to 6 or 8 violates,
p.(None): 10. accepts or imports or exports cells or tissue contrary to the provisions of Section 12 or does not meet the other requirements of Section 12,
p.(None): 11. in processing the requirements in accordance with § 13, in storage the requirements in accordance with § 14, in distribution the requirements in accordance with § 15, in the
p.(None): Labeling does not meet the requirements of Section 15a or, in terms of documentation, the requirements of Section 16,
p.(None): 12. does not meet the reporting obligations in accordance with Section 17 or Section 17a,
p.(None): 13. violates the duty of confidentiality according to § 18,
p.(None): 14. does not immediately notify the Federal Office for Safety in Health Care of the change of person of the holder in accordance with section 21 or section 25,
p.(None): 15. as the person in charge of a hospital or as a freelance doctor or dentist of his documentation obligation in accordance with section 32 (1) or his
p.(None): Does not comply with the reporting obligation pursuant to Section 32 (2), or
p.(None): 16. contravenes regulations on the basis of this Federal Act,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Fine up to 7,270 euros.
p.(None): (2) Who
p.(None): 1. contrary to Section 3 (1), the cells and tissues are extracted from the withdrawal facilities by the Federal Office for Safety in Health Care
p.(None): were not reported
p.(None): 2. violates the prohibition of Section 3 (9),
p.(None): 3. takes a sample even though there is a serious risk to the life or health of the donor or the obligation to check it
p.(None): fails to comply with Section 4 (2),
p.(None): 4. performs the removal without medical information within the meaning of Section 4 (3) or without the consent of the living donor in accordance with Section 4 (3),
p.(None): 5. contrary to Section 4 (4), cells or tissues taken from a living person as part of medical treatment, without clarification and
p.(None): Patient's consent continues to be used
p.(None): 6. violates the obligations according to § 4 paragraph 5 or 5a,
p.(None): 7. Donors of cells or tissues or third parties for a donation contrary to Section 4 Paragraph 6 a fi nancial gain or comparable advantage
p.(None): sends or promises
p.(None): 8. as a removal facility before the first extraction of cells or tissues the commencement of this activity, the Federal Office for Security in
p.(None): Healthcare does not report in accordance with Section 19 (1),
p.(None): 9. makes changes to the operation as a removal facility without these changes to the Federal Office for Safety in Health Care in accordance with § 19
p.(None): 2, or fail to comply with conditions or requirements pursuant to Section 20,
p.(None): 10. operates a tissue bank without a license pursuant to Section 22 or uses a processing procedure without authorization,
p.(None): 11. as a tissue bank, makes changes with regard to operations in accordance with section 22 (2) or significant changes in import activities in accordance with section 3,
p.(None): without obtaining an approval from the Federal Office for Health Safety,
p.(None): 12. The Federal Office for Safety in Health Care does not stop the operation of a withdrawal facility or tissue bank in accordance with § 25a
p.(None): reports immediately,
p.(None): 13. as a tissue bank, does not comply with the conditions and requirements pursuant to Section 23 subsection 2, Section 24 or Section 27 subsection 1,
p.(None): 14. does not grant access to the monitoring bodies within the meaning of section 26, prevents their activity or the necessary inspection of files or the taking of samples
p.(None): makes impossible
p.(None): 15. as a removal facility violates the obligation under Section 26 (4), or
p.(None): 16. as a tapping facility, does not comply with the conditions or requirements set out in section 27 (1),
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 36,340 euros. The same applies if an act in accordance with paragraph 1 poses a serious risk to the life and health of a person
p.(None): emerged or the perpetrator has already been punished twice in accordance with paragraph 1.
p.(None): (3) Who
p.(None): 1. as the responsible person violates his obligations pursuant to Section 9 (3),
p.(None): 2. performs the activity of a responsible person without fulfilling the requirements of Section 9 (2),
p.(None): 3. as the responsible person does not meet the reporting obligations pursuant to section 17 (3), or
p.(None): 4. as the responsible person who violates his obligations under an ordinance pursuant to Section 30,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Fine up to 7,270 euros.
p.(None): (3a) Anyone who, as the person responsible for the distribution of cells or tissue, does not comply with the requirements of Section 15 (2) commits, unless the deed does
p.(None): A criminal offense falling within the jurisdiction of the courts constitutes an administrative offense and is subject to a fine of up to EUR 7,270
p.(None): punish.
p.(None): (4) The attempt is punishable.
p.(None): Involvement of organs of the public security service
p.(None): § 36. The organs of the public security service have to the Federal Office for security in the health care over its requests to secure the
p.(None): Exercise the powers pursuant to sections 26, 27 (2) and (3) and 37 (3) to provide help within the scope of their statutory scope.
p.(None): EU Compendium of Tissue Facilities
p.(None): Section 36a. (1) The Federal Office for Safety in Health Care is obliged to provide all information on approved tissue banks in accordance with Annex VIII of the
p.(None): Directive (EU) 2015/565 in the EU Compendium of Tissue Facilities. This data is to be updated when a new tissue bank
p.(None): is approved, information about an approved tissue bank changes or proves to be incorrect, or changes to a tissue bank are approved.
p.(None): These updates must be made immediately, at the latest within ten working days if there are significant changes in accordance with Section 22.
p.(None): (2) The Federal Office for Safety in Health Care has the competent authorities in another Member State if they are included in the EU Compendium of
p.(None): Tissue facilities see false information regarding a tissue facility in that Member State, or if they are found to be in material breach of the
p.(None): Warn about the provisions of the Single European Code related to the other Member State.
p.(None): (3) The Federal Office for Safety in Health Care must notify the Commission and the other competent authorities if this
p.(None): EU compendium of tissue and cell products, in his opinion, needs to be updated.
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Political / political affiliation
Searching for indicator party:
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p.(None): Donation number;
p.(None): 25. "EU tissue establishment code": the unique identification number for approved, named, approved or licensed tissue establishments in the
p.(None): European economic area. The tissue establishment code consists of an ISO country code and the tissue establishment number in the EU
p.(None): Compendium of Tissue Facilities;
p.(None): 26. "unique donation number": the unique number as set out in Appendix A.
p.(None): 27. "Product identification sequence": the second part of the Single European Code, consisting of the product code, the split number and the
p.(None): Expiration date;
p.(None): 28. “Product code”: the identifier of the speci fi c type of the tissues and cells concerned. According to Appendix A, the product code consists of the identifier of the
p.(None): Systems for the product coding, which the tissue device uses ('E' for EUTC, 'A' for ISBT 128, 'B' for Eurocode) and from the product number for
p.(None): Tissues and cells in the relevant coding system for the product type;
p.(None): 29. "Split number": the number in Annex A used to distinguish and uniquely identify tissues and cells associated with the same
p.(None): unique donation number and product code are identified and come from the same tissue facility;
p.(None): 30. "expiry date" means the date in Annex A by which the tissues and cells can be used;
p.(None): 31. "EU Coding Platform": the IT platform operated by the Commission with the EU Compendium of Tissue Facilities and the EU Compendium
p.(None): tissue and cell products;
p.(None): 32. "EU Compendium of Tissue Facilities": the register of all of the competent authorities of a Party to the Agreement on the
p.(None): European Economic Area approved, licensed, designated or approved tissue establishment that provides information about this
p.(None): Contains tissue devices in accordance with Annex VIII of Directive (EU) 2015/565;
p.(None): 33. "EU Compendium of Tissue and Cell Products": the register of all tissue and cell types in circulation in the European Economic Area
p.(None): the respective product codes of the three permitted coding systems (EUTC, ISBT 128 and Eurocode);
p.(None): 34. “EUTC”: the product coding system for tissues and cells developed by the Union, which is available from a register of all in the Union
p.(None): Tissue and cell types with the respective product codes;
p.(None): 35. “Open to traffic”: distribution for human use or transfer to another actor, for example for
p.(None): Further processing with or without return;
p.(None): 36. "within the same facility": all steps from extraction to use in humans are carried out by the same responsible person and
p.(None): carried out in the same system for quality management and traceability in a hospital in which the
p.(None): Removal device and the approved tissue bank are located;
p.(None): 37. "Pooling": one and the same container contains or mixes tissues or cells from more than one extraction from the same
p.(None): Donors or from two or more donors;
p.(None): 38. "third country supplier" means a tissue bank, sampling facility or other body in a third country which is responsible for the export of cells and tissues which
p.(None): delivers them to an introductory tissue bank responsible for the European Economic Area. A third country supplier can also use one or more of the
p.(None): activities outside the European Economic Area in connection with donation, extraction, testing, processing,
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p.(None): (2) The documentation according to Paragraph 1 has complete traceability according to the state of medical science, insofar as this is in the
p.(None): It is the responsibility of the extraction facility to ensure. The removal facility also has traceability for all required data
p.(None): Ensure products and materials that come into contact with these cells and tissues. Tissues and cells used in the manufacture of medicines
p.(None): used for novel therapies must also meet these requirements.
p.(None): (3) The documentation must be in writing, electronically or on another data carrier, provided that it is ensured that the necessary information is given during the
p.(None): Duration of the retention period are available to be made.
p.(None): (4) The documentation has been through at least ten years - those parts that are essential for complete traceability through at least 30 years -
p.(None): to be kept and available for inspection at any time by the supervisory bodies responsible under this federal law.
p.(None): (Note: Paragraph 5 repealed by Art. 45 no. 3, Federal Law Gazette I No. 37/2018)
p.(None): (6) Cells or tissue obtained must be packaged in accordance with the state of the art in science and technology.
p.(None): Relationship of withdrawal facilities with tissue banks and with third parties
p.(None): § 6. (1) Each sampling facility must conclude written agreements with tissue banks to which cells or tissue are passed on
p.(None): clearly define the responsibilities of each side.
p.(None): (2) Each removal facility is obliged to undertake all activities outside the removal facility by third parties and the effects on the
p.(None): Quality and safety of cells and tissues can have to make written agreements. This in particular
p.(None): 1. if a sampling facility transfers the testing of the donor to a third party, or
p.(None): 2. if a third party delivers goods or services that affect the guarantee of the quality and safety of tissues or cells.
p.(None): (3) The assessment and selection of third parties is to be carried out by the removal facility according to whether they can comply with the prescribed standards.
p.(None): (4) Each removal facility has a complete list of all agreements concluded with tissue banks or with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The original or a copy of the agreements must always be available in the removal facility and are effective after they have expired
p.(None): keep for at least 10 years.
p.(None): (5) In the agreements between the withdrawal facility and third parties, the responsibilities that are exercised by third parties and the
p.(None): to specify the exact procedure. A contractor may not perform a contractually assigned task without the written consent of the removal facility
p.(None): Pass on to third parties.
p.(None): (6) In the event of extraction outside the company's own premises, the tapping facility has to do so by means of written agreements with the parties involved
p.(None): Institutions to ensure compliance with the quality and safety standards provided in this federal law.
p.(None): (7) At the request of the Federal Office for Safety in Health Care, the withdrawal facility has copies of its agreements with tissue banks and
p.(None): to submit with third parties.
p.(None): Authorization to issue regulations
p.(None): § 7. (1) The Federal Minister of Health, Family and Youth, insofar as this is to protect the donor and the perfect condition of
p.(None): donated cells and tissues is required by regulation for more detailed regulations
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p.(None): If medically assisted reproduction is required, the Federal Minister of Health can provide for deviations from the requirements of Section 6.
p.(None): (3) The Federal Minister of Health has to provide for deviations from Sections 6, 11 and 12 (3) by ordinance for extraction in accordance with Section 3 (1a).
p.(None): tissue banks
p.(None): § 8. (1) The processing, storage or distribution of cells and tissues may only take place in a tissue bank that has a license in accordance with § 22.
p.(None): The processing methods to be used also require approval.
p.(None): (2) Each tissue bank has the personal, spatial, operational and technical equipment required by the state of the art in science and technology
p.(None): exhibit. Before starting work and afterwards, the staff must be regularly and in good time through appropriate training measures
p.(None): the latest state of the art in science and technology. The training measures are to be documented, this documentation is at least
p.(None): to be kept for five years.
p.(None): (3) The equipment must be designed in such a way that the respective state of the art in science and technology ensures a trouble-free organization
p.(None): is guaranteed and the required hygiene standards are observed.
p.(None): (4) Each tissue bank is obliged to have contractual agreements with another tissue bank in order to be able to, in the event of the termination of its
p.(None): Ensure that the stored cells or tissues and the documentation are taken over by them.
p.(None): responsible person
p.(None): § 9. (1) Each tissue bank must have a "responsible person" at all times.
p.(None): (2) This must have a degree in a contracting party to the Agreement on the European Economic Area or the Swiss Confederation
p.(None): Human medicine, dentistry, veterinary medicine, pharmacy or other life sciences or one of another contracting state or the
p.(None): Swiss Confederation successfully recognized as equivalent training and successfully completed one after completing the above training
p.(None): at least two years in a tissue bank in a party to the Agreement on the European Economic Area or in the
p.(None): Swiss Confederation with practical experience in the processing, storage and distribution of human cells and
p.(None): Have acquired tissues.
p.(None): (3) The responsible person must ensure that the human cells and tissues intended for use in humans are in harmony
p.(None): received, tested, processed, stored and with the provisions of this federal law and the regulations issued on the basis thereof
p.(None): be distributed. The responsible person must be given sufficient powers so that they can fulfill their responsibilities.
p.(None): (4) The tissue bank is obligated, the person responsible and any change thereof, with proof of qualification, to the Federal Office immediately
p.(None): for healthcare safety announcement.
p.(None): quality assurance
p.(None): § 10. (1) Each tissue bank must operate a functional quality system according to the state of the art in science and technology, which the active
p.(None): Management and staff involvement.
p.(None): (2) Each tissue bank must ensure that, as part of the quality system, at least standard operating procedures (standard operating procedures
p.(None): SOPs), guidelines, training and reference manuals, self-inspection in accordance with paragraph 3, registration forms, records of donors, distribution and
p.(None): if necessary, information about the final determination of the cells and tissues is documented.
p.(None): (3) Each tissue bank must regularly carry out self-inspections in order to ensure the application and compliance with the state of the art in science and technology
p.(None): monitor and to propose any necessary corrective actions. Self-inspection is part of the quality system.
p.(None): (4) Each tissue bank must ensure that the documents within the framework of the quality system are available at all times during inspections.
p.(None): Relationships between tissue banks and withdrawal facilities, third-country suppliers and other third parties
p.(None): § 11. (1) Each tissue bank has written agreements with the removal facilities from which cells or tissue are accepted
p.(None): complete that clearly define the responsibilities of each side. In particular, there is a procedure for risk assessment by the responsible person
p.(None): regarding donors who do not meet the selection criteria of a regulation according to § 7 and the responsibilities for the transfer of cells or
p.(None): Regulate tissue to the tissue bank.
p.(None): (2) The tissue bank is committed to all activities that are carried out outside the tissue bank by third parties and the effects on quality and
p.(None): Cell and tissue security may have to make written agreements. This in particular
p.(None): 1. if a tissue bank transfers responsibility for a phase of tissue or cell processing to a third party,
p.(None): 2. if a third party delivers goods or provides services that affect the guarantee of the quality and safety of tissues or cells,
p.(None): including their distribution,
p.(None): 3. if a tissue bank provides services for a tissue bank that is not authorized for this,
p.(None): 4. when a tissue bank distributes processed tissue or cells from third parties.
p.(None): (3) A transfer of activities reserved for a tissue bank by the tissue bank is only permitted if the company has a license in accordance with
p.(None): Section 22 or a corresponding license from a competent authority of another party to the Agreement on the European Economic Area
p.(None): or if the company, insofar as this is outside the European Economic Area, in this federal law and on the basis thereof
p.(None): enacted regulations can comply with prescribed standards.
p.(None): (3a) The distribution of cells or tissues can also be transferred to a company that does not have a license pursuant to Section 22. The following applies to this company
p.(None): Section 15 subsection 2 accordingly.
p.(None): (4) Each tissue bank must have a complete list of the agreements concluded with removal facilities and with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The agreements must always be available in the tissue bank in the original or a copy.
p.(None): (5) In the agreements between the tissue bank and a third party, the responsibilities that are performed by third parties and the
p.(None): to specify the exact procedure. A contractor may not contractually assign a task to third parties without the client's written consent
p.(None): pass on.
p.(None): (6) At the request of the Federal Office for Safety in Health Care, the tissue banks have copies of their agreements with them
p.(None): Withdrawal facilities and to be presented with third parties.
p.(None): (7) Tissue banks with an authorization to import from third countries must conclude written agreements with third country suppliers which:
p.(None): in accordance with the state of affairs paragraph 1 or 2. This does not apply to single imports and in connection with imports of hematopoietic
p.(None): StemXcells for the treatment of life-threatening diseases.
p.(None): (8) Tissue banks with a license to import from third countries have the quality and security requirements in a written agreement
p.(None): to be defined, so that the quality and safety standards of the cells and tissues to be introduced are equivalent to the standards
p.(None): of this federal law and the regulations issued on the basis thereof. The written agreement includes at least the one in Appendix E.
p.(None): mentioned requirements. Furthermore, the right of the Federal Office for Safety in Health Care is to be laid down during the term of the
p.(None): written agreement and to inspect the activities and facilities of all third country suppliers for a period of two years after their termination.
p.(None): (9) Notwithstanding paragraph 7 first sentence, an import from a third country supplier with whom there is no written agreement is permitted if
p.(None): unexpectedly, according to the state of medical science, an import to save life or rescue from a serious health risk
p.(None): of a recipient is urgently required. The tissue bank has to document this stating the reasons and the equivalence of the quality and
p.(None): Safety standards for the cells and tissues to be introduced with the standards of this federal law and those based on it
p.(None): To respect regulations.
p.(None): Receiving cells and tissues, import and export
p.(None): § 12. (1) The import and export from or to third countries of donations obtained from human cells and tissues for processing, storage or
p.(None): Distribution may only take place through tissue banks that have been approved and certified for this purpose (Section 26 (1a)).
p.(None): (2) An import from third countries may only take place if the tissue bank ensures that quality and safety standards have been complied with
p.(None): are at least equivalent to the standards of this federal law. The tissue bank must have all documents with regard to assessment and
p.(None): Selection of donors. Traceability to the donor must be ensured at all times.
p.(None): (3) Donations of human cells and tissues intended for processing, storage or distribution may only be made from a tissue bank
p.(None): are accepted if they are received directly from withdrawal facilities, tissue banks or pursuant to Articles 5 or 6 of the Directive
p.(None): 2004/23 / EG corresponding removal facilities of another contracting party to the Agreement on the European Economic Area.
p.(None): (4) For all donations of human cells or tissue, it must be checked whether it is based on the documents required according to the current state of the art
p.(None): their suitability for use in humans is given.
p.(None): (5) The packaging of the human cells or tissues received by the tissue bank must be state of the art
p.(None): correspond. The tissue bank has to check this and discard the cells and tissue in the event of deviations from the state of the art or science.
p.(None): (6) Every acceptance and rejection of received cells or tissues must be documented.
p.(None): (7) Cells and tissues may only be processed or stored for distribution until the results of the test in accordance with paragraph 4 are suitable for
p.(None): Have resulted in human use.
p.(None): Processing cells and tissues
p.(None): § 13. (1) For all processing steps that affect quality and safety, the tissue bank must specify manufacturing instructions. each
p.(None): The manufacturing regulations must be changed through a new edition, the reasons for the change. The previously valid manufacturing regulation is at
p.(None): Indicate the edition of the new edition and mark it as invalid.
p.(None): (2) The manufacturing regulations contain special regulations for the handling of cells or tissues that have to be discarded. It is
p.(None): ensure that contamination of other cells or tissues, the processing environment and personnel is avoided.
p.(None): (3) Processing must be carried out in accordance with the approved processing methods and the manufacturing regulations.
p.(None): (4) The equipment used, the work rooms and the conditions for process development, validation and control are state of the art
p.(None): To match science and technology.
p.(None): Storage of cells and tissues
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p.(None): To impose different or additional requirements on healthcare providers to achieve these goals.
p.(None): Section 25. The change in the identity of the holder of a tissue bank approved in accordance with Section 22 does not affect the effectiveness of this approval. The
p.(None): Legal successors must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Section 25a. The Federal Office for Safety in Health Care is immediately to cease the operation of an extraction facility or tissue bank
p.(None): Report.
p.(None): inspections
p.(None): Section 26. (1) The Federal Office for is responsible for monitoring compliance with this Federal Act through withdrawal facilities and tissue banks
p.(None): Healthcare security. The inspections must take place at regular intervals of no more than two years.
p.(None): (1a) The Federal Office for Safety in Health Care has a certificate of this within 90 days of completing an inspection of the tissue bank
p.(None): to be issued if this has shown that the provisions of this Federal Act and the regulations issued on the basis thereof and the
p.(None): Approval is granted. If this requirement is not met, the Federal Office for Safety in Health Care has it within the mentioned
p.(None): Determine deadline with notice. The certi fi cate is to be withdrawn if it subsequently becomes known that the requirements have not been met. It's closed
p.(None): withdraw if the requirements are no longer met.
p.(None): (2) In the event of a serious undesirable reaction or a serious incident, the Federal Office for Security in
p.(None): To initiate appropriate inspections if necessary. In such cases, such inspections are sufficient for one
p.(None): reasoned request by the competent authority (ies) of another party to the Agreement on the European Economic Area. On
p.(None): If requested by another contracting party to the Agreement on the European Economic Area or the Commission, the Federal Office for Security
p.(None): Healthcare with the results of the inspections carried out in relation to the requirements of this federal law.
p.(None): (3) The organs of the Federal Office for Safety in Health Care and the experts consulted by it
p.(None): 1. to grant access to all rooms,
p.(None): 2. to give the opportunity to carry out the activities and procedures carried out in accordance with this Federal Act and the regulations issued on the basis thereof
p.(None): to review and assess and, if this is necessary to preserve evidence, take photographs and video recordings in the company,
p.(None): 3. to grant the required inspection of all documents and records at their request, and to make copies or photographs thereof, and
p.(None): 4. to enable the removal of samples in the amount required for an analysis.
p.(None): (3a) The powers of the organs of the Federal Office for Safety in Health Care listed in paragraph 3 also exist with regard to facilities or
p.(None): Means of transport for companies that have been commissioned by tissue banks to distribute cells or tissue.
p.(None): (4) If the extraction takes place outside the operating rooms, the removal facility has in agreement with the relevant institutions
p.(None): to ensure that the premises in which the extraction takes place can also be checked in the course of inspections and the organs of the
p.(None): Federal Office for Safety in Health Care and the experts consulted by it have all rights under paragraph 3.
p.(None): (5) The inspections are in arrears except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce beforehand.
p.(None): (6) Care must be taken to avoid any disruption or obstruction of the business that is not absolutely necessary.
p.(None): (7) The samples taken, insofar as this is possible in their nature and this does not prevent their perfect assessment, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence purposes. About the sampling is the
p.(None): To confirm the removal device or the tissue bank.
p.(None): (8) No compensation is due for the samples taken in accordance with paragraph 3 no. 4 in conjunction with paragraph 7.
p.(None): (9) The Federal Office for Safety in Health Care is entitled to inspect third-country suppliers of importing tissue banks in third countries
p.(None): to verify that the quality and safety standards of the third country supplier for the cells or tissues to be imported are compatible with the
p.(None): Standards of this federal law are at least equivalent.
p.(None): (10) Upon a reasoned request from another member state of the European Economic Area or the European Commission, the Federal Office for
p.(None): Healthcare safety Information on the results of the inspections and other control measures related to the import
p.(None): Tissue banks and third country suppliers are available.
p.(None): (11) If cells or tissues are imported to Austria that are to be distributed to another Member State, the Federal Office for Security in
p.(None): Healthcare, on a reasoned request from the Member State where the imported cells or tissues are subsequently distributed, to carry out
p.(None): Carry out inspections or other control measures related to the importing tissue bank and the activities of third country suppliers. The
p.(None): The Federal Office for Safety in Health Care, after consultation with the Member State that submitted the application, has to decide on the measures to be taken
p.(None): decide on.
p.(None): (12) If an inspection is carried out on such an application, the Federal Office for Safety in Health Care has to contact the person responsible
p.(None): The authority (ies) of the Member State that made the request whether and, if so, in what form the latter Member State takes part in the inspection,
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Health / Cognitive Impairment
Searching for indicator impairment:
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p.(None): 1. cells and tissues used as an autologous graft within the same medical procedure,
p.(None): 2. Blood and blood components according to § 3 Blood Safety Act 1999, Federal Law Gazette I No. 44/1999, and
p.(None): 3. Human organs and parts of organs if they are to be used for the same purpose as the organ in the human body.
p.(None): definitions
p.(None): § 2. In the sense of this federal law means
p.(None): 1. Cells: individual human cells or collections of cells that are not held together by any type of connective tissue;
p.(None): 2. Tissue: all parts of the human body consisting of cells;
p.(None): 3. Donor: Any person who has the will to donate cells or tissues for use in humans versus that in running one
p.(None): Personnel involved in the removal facility, as well as each deceased from whom cells or tissues are removed for use in humans;
p.(None): 4. Donation: the delivery of human cells or tissues for human use;
p.(None): 5th organ: all - with the exception of the skin - parts of the human body consisting of different tissues and living, which in terms of structure,
p.(None): Blood vessel supply and the ability to perform physiological functions form a functional unit;
p.(None): 6. Collection: the removal of cells or tissues including the determination of the health suitability of a donor and with them
p.(None): Donor protection and quality assurance measures related to operations;
p.(None): 7. Processing: all activities in connection with the preparation, handling, preservation, multiplication and packaging of for
p.(None): Use in human cells or tissues;
p.(None): 8. Preservation: the use of chemical substances, changed environmental conditions or other means during processing with the aim of achieving a
p.(None): prevent or delay biological or physical impairment of cells or tissues;
p.(None): 9. Storage: the storage of the product until distribution;
p.(None): 10. Distribution: the transport and delivery of cells or tissues intended for human use, including exports to third countries;
p.(None): 11. Use in humans: the medical use of cells or tissues in or on a human recipient and extracorporeal
p.(None): applications;
p.(None): 12. serious incident: any undesirable event related to the extraction, testing, processing, storage and distribution as well
p.(None): Use of tissues and cells that transmit an infectious disease, death or life-threatening condition, a
p.(None): Disability or loss of ability of donors or recipients could result in hospitalization or
p.(None): could prolong or lead to or could prolong an illness;
p.(None): 13. Serious adverse reaction: an unintended reaction, including a communicable disease, at the donor or recipient in the
p.(None): Associated with the extraction or use of cells and tissues that are fatal or life-threatening, a disability or a disability
p.(None): Results in loss of capacity or necessitates or prolongs hospitalization or leads to or prolongs an illness;
p.(None): 14. Withdrawal facility: any facility, including mobile harvesting teams, involved in activities related to the extraction of human beings
p.(None): Cells and tissues for human use are exported;
p.(None): 15. Tissue bank: any facility in which activities related to the processing, storage or distribution of human cells and tissues are used
p.(None): Application to be carried out in humans;
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): Personnel involved in the removal facility, as well as each deceased from whom cells or tissues are removed for use in humans;
p.(None): 4. Donation: the delivery of human cells or tissues for human use;
p.(None): 5th organ: all - with the exception of the skin - parts of the human body consisting of different tissues and living, which in terms of structure,
p.(None): Blood vessel supply and the ability to perform physiological functions form a functional unit;
p.(None): 6. Collection: the removal of cells or tissues including the determination of the health suitability of a donor and with them
p.(None): Donor protection and quality assurance measures related to operations;
p.(None): 7. Processing: all activities in connection with the preparation, handling, preservation, multiplication and packaging of for
p.(None): Use in human cells or tissues;
p.(None): 8. Preservation: the use of chemical substances, changed environmental conditions or other means during processing with the aim of achieving a
p.(None): prevent or delay biological or physical impairment of cells or tissues;
p.(None): 9. Storage: the storage of the product until distribution;
p.(None): 10. Distribution: the transport and delivery of cells or tissues intended for human use, including exports to third countries;
p.(None): 11. Use in humans: the medical use of cells or tissues in or on a human recipient and extracorporeal
p.(None): applications;
p.(None): 12. serious incident: any undesirable event related to the extraction, testing, processing, storage and distribution as well
p.(None): Use of tissues and cells that transmit an infectious disease, death or life-threatening condition, a
p.(None): Disability or loss of ability of donors or recipients could result in hospitalization or
p.(None): could prolong or lead to or could prolong an illness;
p.(None): 13. Serious adverse reaction: an unintended reaction, including a communicable disease, at the donor or recipient in the
p.(None): Associated with the extraction or use of cells and tissues that are fatal or life-threatening, a disability or a disability
p.(None): Results in loss of capacity or necessitates or prolongs hospitalization or leads to or prolongs an illness;
p.(None): 14. Withdrawal facility: any facility, including mobile harvesting teams, involved in activities related to the extraction of human beings
p.(None): Cells and tissues for human use are exported;
p.(None): 15. Tissue bank: any facility in which activities related to the processing, storage or distribution of human cells and tissues are used
p.(None): Application to be carried out in humans;
p.(None): 16. allogeneic use: the removal of cells or tissues from one person and their transfer to another person;
p.(None): 17. autologous use: the removal of cells or tissues and their transfer back to the same person;
p.(None): 18. User: Hospitals and self-employed doctors and dentists who are responsible for the use of human cells or tissues in humans
p.(None): are responsible;
p.(None): 19. Quality system: the organizational structure, defined responsibilities, procedures, processes and resources for the implementation of the
p.(None): Quality management, including all activities that contribute directly or indirectly to quality;
p.(None): 20. Validation (or "qualification" in relation to plants or environments): Providing documented evidence that proves with high certainty,
p.(None): that a speci fi c process, standard process, piece of equipment, or an environment, without exception, creates a product that does the job
p.(None): corresponds to specified speci fi cations and quality characteristics; A process is validated to evaluate how e ff ectively the performance of a system for the
p.(None): Intended use is;
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): 1. if a sampling facility transfers the testing of the donor to a third party, or
p.(None): 2. if a third party delivers goods or services that affect the guarantee of the quality and safety of tissues or cells.
p.(None): (3) The assessment and selection of third parties is to be carried out by the removal facility according to whether they can comply with the prescribed standards.
p.(None): (4) Each removal facility has a complete list of all agreements concluded with tissue banks or with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The original or a copy of the agreements must always be available in the removal facility and are effective after they have expired
p.(None): keep for at least 10 years.
p.(None): (5) In the agreements between the withdrawal facility and third parties, the responsibilities that are exercised by third parties and the
p.(None): to specify the exact procedure. A contractor may not perform a contractually assigned task without the written consent of the removal facility
p.(None): Pass on to third parties.
p.(None): (6) In the event of extraction outside the company's own premises, the tapping facility has to do so by means of written agreements with the parties involved
p.(None): Institutions to ensure compliance with the quality and safety standards provided in this federal law.
p.(None): (7) At the request of the Federal Office for Safety in Health Care, the withdrawal facility has copies of its agreements with tissue banks and
p.(None): to submit with third parties.
p.(None): Authorization to issue regulations
p.(None): § 7. (1) The Federal Minister of Health, Family and Youth, insofar as this is to protect the donor and the perfect condition of
p.(None): donated cells and tissues is required by regulation for more detailed regulations
p.(None): 1. The requirements for the necessary personnel, spatial, operational and technical equipment including the one to be provided
p.(None): Quality Systems,
p.(None): 2. The selection criteria for the donors of cells and tissues including which findings are limited in time or permanent health suitability
p.(None): Exclude donors, as well as these criteria in the case of autologous use,
p.(None): 3. what information and in what form the living donor has to be given before the donation and what relevant abnormal findings have to be communicated,
p.(None): 4. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the collection, processing and
p.(None): The transmission of the data and the documentation must be carried out and the precautions to be taken regarding traceability,
p.(None): 5. the laboratory tests prescribed for donors and which test results are temporary or permanent are suitable for health
p.(None): exclude as donor,
p.(None): 6. the processes for obtaining cells and tissues,
p.(None): 7. The packaging, labeling and transfer of cells and tissues to tissue banks or to users for direct use, including the
p.(None): the information and documents to be provided, and
p.(None): 8. regarding an obligation to insure for allogeneic donors
p.(None): adopted.
p.(None): (2) Provided that this is compatible with the protection of the donor and the perfect condition of donated cells and with regard to the special features
...
p.(None): Withdrawal of the certificate and authorization
p.(None): Section 28. (1) The Federal Office for Safety in Health Care must withdraw the certificate or the tissue bank from a withdrawal facility,
p.(None): if
p.(None): 1. a requirement for the issuance of the certi fi cate in accordance with §§ 19ff or the granting of the license in accordance with §§ 22ff has ceased to apply or
p.(None): Orders to remedy defects within the meaning of Section 27 (1) have not been complied with twice,
p.(None): 2. it emerges that such a requirement was not met when the certificate was issued or the license was granted,
p.(None): 3. the holder of a certi fi cate or an authorization for violation of the provisions of this Federal Act pursuant to Section 35 (1) within five
p.(None): Years has been punished at least three times, or
p.(None): 4. at least the holder of a certi fi cate or a license for violations of the provisions of this Federal Act pursuant to Section 35 (2)
p.(None): has been punished twice.
p.(None): (2) The Federal Office for Safety in Health Care may temporarily or permanently grant a responsible person the right to exercise
p.(None): Prohibit the work of a responsible person if they are punished at least three times for violations of the provisions of this Federal Act
p.(None): has been.
p.(None): Registers of withdrawal devices and tissue banks
p.(None): Section 29. (1) The Federal Office for Safety in Health Care has a register of all certified withdrawal facilities and approved tissue banks, in
p.(None): which in any case must also contain information about the activities for which the certi fi cation or approval was granted. This is in the
p.(None): Make the Internet publicly available on the homepage of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Minister of Health, Family and Youth may, by ordinance, provide more detailed regulations regarding the maintenance of this register and the type and
p.(None): Extent of entries.
p.(None): (3) The Federal Office for Safety in Health Care must assign a unique tissue establishment number to each tissue bank approved, provided that
p.(None): this does not result from the chosen Single European Code. If a tissue bank has several locations, it can with regard to the
p.(None): Tissue device number can be treated as a single tissue device.
p.(None): Authorization to issue regulations on tissue banks
p.(None): Section 30. The Federal Minister of Health, Family and Youth may, by ordinance, issue more detailed provisions on:
p.(None): 1. What are the requirements for the necessary spatial and technical equipment as well as for the hygiene standards to be observed?
p.(None): Adequate quality system and the organizational scheme must be set up
p.(None): 2. What minimum staffing levels a tissue bank must have, what special knowledge and skills the staff must have
p.(None): and in which schooling, further education and further training measures these people have to take,
p.(None): 3. how cells and tissues are to be labeled,
p.(None): 4. Which requirements are to be met for products for autologous use?
p.(None): 5. which procedures are to be followed when receiving cells or tissues,
p.(None): 6. Which conditions are to be observed during processing, storage and distribution, can also be more detailed regulations regarding the requirements
p.(None): processing methods are taken,
p.(None): 7. Which packaging requirements have to be met?
p.(None): 8. Which requirements are to be made of the documentation and its type and scope,
p.(None): 9. what precautions are to be taken regarding traceability,
p.(None): 10. Which procedures for reporting serious incidents and serious undesirable reactions have to be followed as well as with regard to type and
p.(None): Scope of such reports,
p.(None): 11.When equivalent quality and safety standards within the meaning of Section 12 (2) can be assumed for imports from third countries,
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
p.(None): 1. processed, stored and distributed by a removal facility without this facility having to have an authorization in accordance with § 22, and
p.(None): 2. Irrespective of § 12, the user can directly insert or receive it or it can be carried out by a removal facility.
p.(None): Regulations for users
p.(None): Section 32. (1) Users have any use of cells and tissues in humans according to the state of the art in a data archive
p.(None): document and keep it for at least 30 years. In any case, this documentation must contain:
p.(None): 1.Identification of the tissue bank or the removal device for direct use from which the cells or tissue were obtained,
p.(None): 2. identification of the user,
p.(None): 3. cell or tissue type,
p.(None): 4. Product identifier,
p.(None): 5. Recipient identification,
p.(None): 6. date of application,
p.(None): 7. Single European Code (if available).
p.(None): (1a) The legibility of the documentation must be ensured for the retention period. The access authorization for the individual users is individual
p.(None): assign and document. The persons authorized to access are to be informed about the requirements according to Art. 32 Para. 4 General Data Protection Regulation. There are
p.(None): Take data security measures in accordance with Art. 32 General Data Protection Regulation.
p.(None): (2) Doctors and dentists
p.(None): 1. any serious adverse reaction that has been observed during or after clinical use of cells or tissues and with quality
p.(None): and could be related to cell or tissue security, and
p.(None): 2. any lack of quality or safety that arises in connection with a serious undesirable incident in the extraction, processing,
p.(None): Storage or distribution,
p.(None): immediately the tissue bank from which they received the cells or the tissue or, in the case of direct use of the withdrawal device, the
p.(None): affected cells or tissues, report and pass on all relevant information in order to facilitate traceability and the
p.(None): To ensure quality and safety control. In the case of direct use, the user must also report to the Federal Office of
p.(None): Reimburse healthcare security.
p.(None): (3) The Federal Minister of Health, Family and Youth can, by ordinance, specify the content of the documentation in accordance with paragraph 1
p.(None): as well as the type, scope and form of reports and information in accordance with paragraph 2.
p.(None): Vigilanzregister
p.(None): Section 33. (1) The Federal Office for Safety in Health Care has all reported serious undesirable reactions and all serious ones
p.(None): Record incidents in a register. This register is used for tissue vigilance and market surveillance. Processing data from donors and
p.(None): Receiver takes place without personal reference. Data security measures in accordance with Art. 32 General Data Protection Regulation must be taken.
p.(None): (2) The Federal Office for Safety in Health Care has a report to the Federal Minister of Health, Family and Youth by June 30 each year
p.(None): submit reports of serious incidents and serious adverse reactions in the previous calendar year.
p.(None): Automation-supported data traffic
p.(None): Section 34. The Federal Office for Safety in Health Care is authorized to store data in or for automation-supported data traffic in accordance with section 33 (1)
p.(None): collect and transmit them to
p.(None): 1. the Federal Ministry of Health, Family and Youth,
p.(None): 2. the European Commission and
p.(None): 3. competent authorities of other contracting parties to the Agreement on the European Economic Area.
p.(None): administrative Penalties
p.(None): Section 35. (1) Who
p.(None): 1. in the extraction, processing, storage and distribution of human cells and tissue contrary to § 1 paragraph 2 the state of the art and
p.(None): Technology does not comply
p.(None): 2. does not meet or guarantee the requirements of section 3 (2) or (4) to (8) for extraction facilities,
p.(None): 3. performs the removal of cells or tissues from the living donor contrary to Section 4 (2) without previous examinations,
p.(None): 4. violates the documentation requirements according to § 5 paragraphs 1 to 4 or the packaging requirements of § 5 paragraph 6,
p.(None): 5. violates the obligations under § 6,
p.(None): 6. violates the obligations under § 8 paragraphs 2 to 4,
p.(None): 7. operates a tissue bank without having a responsible person or employing a responsible person who does not have the quali fi cation
p.(None): pursuant to section 9 subsection 2 or violates the reporting obligation pursuant to section 9 subsection 4,
p.(None): 8. does not meet the requirements for a quality system in accordance with section 10 subsections 1 to 3 or violates the obligation in section 10 subsection 4,
p.(None): 9. Contrary to Section 11 (1) as a tissue bank, no written agreements with removal facilities for removal or contrary to Section 11 (7) as
p.(None): Tissue bank with a license to import from third countries does not conclude any written agreements with third country suppliers or against § 11
p.(None): 2 to 6 or 8 violates,
p.(None): 10. accepts or imports or exports cells or tissue contrary to the provisions of Section 12 or does not meet the other requirements of Section 12,
...
p.(None): Paragraph 3, Section 32 Paragraphs 1 and 1a, the changes in Section 35, Section 36a and Section 37a Paragraphs 2 and 3 in the version of the Federal Law BGBl. I № 105/2016 take effect on April 29
p.(None): 2017 in force.
p.(None): (2) The obligation to attach the Single European Code does not apply to cells or tissues that are already stored on October 29, 2016
p.(None): provided that the tissues and cells are released for traffic no later than five years after this time and their traceability otherwise
p.(None): is guaranteed. For cells and tissues that are stored beyond this point in time and only released for traffic after the five-year period
p.(None): and to which the Single European Code cannot be applied, in particular because they are stored frozen, Section 15a (5) applies
p.(None): Sentence.
p.(None): (3) Tissue banks that received a license for import from third countries before April 29, 2017 must be approved by the Federal Office of
p.(None): Healthcare safety to issue a certificate in accordance with Appendix C.
p.(None): (4) Sections 2 (21), 4 (5a), 7 (1), 16 (4), 18 (3), 32 (1a) and 33 (1), § 5 no longer applies Paragraph 5 and Section 16 Paragraph 4, as well as Appendix D
p.(None): Section B in the version of the 2nd Matter Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, comes into force on May 25, 2018.
p.(None): § 38. Insofar as other federal laws are referred to in this federal law, these are to be applied in their respectively applicable version.
p.(None): § 39. With the enforcement of this federal law, the Federal Minister of Health, Family and Youth is in agreement with § 36
p.(None): Federal Minister of the Interior.
p.(None): Section 40. (1) The Federal Office for Safety in Health Care has the Federal Minister of Health, Family and Youth and that of Health
p.(None): Österreich GesmbH set up an advisory board for advice on transplantation issues based on the annual reports of the tissue banks
p.(None): Activities of the withdrawal facilities and tissue banks within the framework of this federal law and the enforcement of this federal law.
p.(None): (2) The advisory council referred to in paragraph 1 may submit an opinion to the Federal Minister of Health, Family and Youth on the basis of the annual report
p.(None): transmit, especially with regard to the ratio of the need for organs and parts of organs of the deceased for the purpose of transplantation and
p.(None): Removal of cells and tissues for use in humans.
p.(None): (3) The Federal Office for Safety in Health Care has through the Federal Ministry of Health, Family and Youth of the European
p.(None): Commission by April 7, 2009 and thereafter every three years a report on the activities of the extraction facilities and tissue banks in the context of this
p.(None): Federal law and on the enforcement of this federal law in the previous reporting period.
p.(None): Section 41. The following guidelines are implemented by this Federal Act:
p.(None): 1. Directive 2004/23 / EG for the definition of quality and safety standards for donation, procurement, testing, processing, preservation,
p.(None): Storage and distribution of human tissues and cells, OJ. No.L 102 of April 7, 2004 p. 48,
p.(None): 2. Directive 2006/17 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to technical regulations for the
p.(None): Donation, procurement and testing of human tissues and cells, OJ. No.L 38 of February 9, 2006 p. 40,
p.(None): 3. Directive 2006/86 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to the requirements for
p.(None): Traceability, reporting serious incidents and undesirable reactions, and certain technical requirements for
p.(None): Coding, processing, preservation, storage and distribution of human tissues and cells, OJ. L 294 of October 25, 2006 S 32,
p.(None): 4. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human tissues
p.(None): and cells, OJ. No.L 93 from 04/09/2015 S 43,
p.(None): 5. Directive (EU) 2015/566 implementing Directive 2004/23 / EC with regard to the procedures for checking the equivalence of quality and
p.(None): Safety standards for imported tissues and cells, OJ. No.L 93 from 04/09/2015 S 56.
p.(None): Appendix A
p.(None): Composition of the Single European Code
...
p.(None): Want to import tissue from third countries
p.(None): The applicant importing tissue bank must have the current version of the following documents relating to the applicant and his / her third-country supplier
p.(None): provide and - if not already done in the context of previous applications for authorization as an introductory tissue bank - upon request to the
p.(None): Submit to the Federal Office. This does not apply to one-off imports within the meaning of Section 2 no. 39 of this Federal Act, which are subject to these documentation requirements
p.(None): with exception of. When importing hematopoietic stem cells for the treatment of life-threatening diseases, only the documentation on A. for
p.(None): Will be provided.
p.(None): A. Documentation on the introductory tissue bank
p.(None): 1. Job description of the responsible person and precise information on their relevant qualifications and training in accordance with § 9;
p.(None): 2. Copy of the original label, the outer packaging label as well as the documents for the outer packaging and the transport container;
p.(None): 3. List of relevant, current standard operating instructions (SOP) for the institution's import activities, including the SOP for the application of the
p.(None): Uniform European codes, the reception and storage of imported cells and tissues in the introductory tissue bank, the management
p.(None): serious incidents and serious undesirable reactions, management of recalls and traceability from donor to
p.(None): Receiver.
p.(None): B. Documentation of the third country supplier (s)
p.(None): 1. Detailed description of the criteria for the identification and assessment of donors, details of the donors or the donor family
p.(None): Information, description of the procedure for obtaining the consent of the donor or the donor family as well as information on whether it is a
p.(None): voluntary and free donation;
p.(None): 2. detailed information about the test centers used by the third country suppliers and the tests carried out by these centers;
p.(None): 3. detailed information on the methods used in the processing of cells and tissues, including precise information on the validation of the
p.(None): Critical processing procedure;
p.(None): 4. Detailed information about the facilities, important equipment and materials as well as the criteria for quality control and environmental control in
p.(None): Relating to any activity performed by the third country supplier;
p.(None): 5. detailed information on the conditions for the release of tissues and cells by the third country supplier (s);
p.(None): 6. Information about each subcontractor of the third country suppliers, including the name, address and the activity carried out;
p.(None): 7. Summary of the most recent inspection by the competent third country authority (ies) at the third country supplier, including the inspection date of the
p.(None): Type of inspection and main conclusions;
p.(None): 8. Summary of the most recent third country supplier audit performed by or on behalf of the importing tissue bank;
p.(None): 9. relevant national or international approvals, if available.
p.(None): Attachments
p.(None): Minimum requirements regarding the content of written agreements between importing tissue banks and their third country suppliers
p.(None): Except for one-off imports within the meaning of Section 2 No. 39 of this Federal Act and imports of hematopoietic stem cells for treatment
p.(None): Life-threatening diseases that are exempt from these requirements must be the written agreement between the introductory tissue bank
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): 4. Donation: the delivery of human cells or tissues for human use;
p.(None): 5th organ: all - with the exception of the skin - parts of the human body consisting of different tissues and living, which in terms of structure,
p.(None): Blood vessel supply and the ability to perform physiological functions form a functional unit;
p.(None): 6. Collection: the removal of cells or tissues including the determination of the health suitability of a donor and with them
p.(None): Donor protection and quality assurance measures related to operations;
p.(None): 7. Processing: all activities in connection with the preparation, handling, preservation, multiplication and packaging of for
p.(None): Use in human cells or tissues;
p.(None): 8. Preservation: the use of chemical substances, changed environmental conditions or other means during processing with the aim of achieving a
p.(None): prevent or delay biological or physical impairment of cells or tissues;
p.(None): 9. Storage: the storage of the product until distribution;
p.(None): 10. Distribution: the transport and delivery of cells or tissues intended for human use, including exports to third countries;
p.(None): 11. Use in humans: the medical use of cells or tissues in or on a human recipient and extracorporeal
p.(None): applications;
p.(None): 12. serious incident: any undesirable event related to the extraction, testing, processing, storage and distribution as well
p.(None): Use of tissues and cells that transmit an infectious disease, death or life-threatening condition, a
p.(None): Disability or loss of ability of donors or recipients could result in hospitalization or
p.(None): could prolong or lead to or could prolong an illness;
p.(None): 13. Serious adverse reaction: an unintended reaction, including a communicable disease, at the donor or recipient in the
p.(None): Associated with the extraction or use of cells and tissues that are fatal or life-threatening, a disability or a disability
p.(None): Results in loss of capacity or necessitates or prolongs hospitalization or leads to or prolongs an illness;
p.(None): 14. Withdrawal facility: any facility, including mobile harvesting teams, involved in activities related to the extraction of human beings
p.(None): Cells and tissues for human use are exported;
p.(None): 15. Tissue bank: any facility in which activities related to the processing, storage or distribution of human cells and tissues are used
p.(None): Application to be carried out in humans;
p.(None): 16. allogeneic use: the removal of cells or tissues from one person and their transfer to another person;
p.(None): 17. autologous use: the removal of cells or tissues and their transfer back to the same person;
p.(None): 18. User: Hospitals and self-employed doctors and dentists who are responsible for the use of human cells or tissues in humans
p.(None): are responsible;
p.(None): 19. Quality system: the organizational structure, defined responsibilities, procedures, processes and resources for the implementation of the
p.(None): Quality management, including all activities that contribute directly or indirectly to quality;
p.(None): 20. Validation (or "qualification" in relation to plants or environments): Providing documented evidence that proves with high certainty,
p.(None): that a speci fi c process, standard process, piece of equipment, or an environment, without exception, creates a product that does the job
p.(None): corresponds to specified speci fi cations and quality characteristics; A process is validated to evaluate how e ff ectively the performance of a system for the
p.(None): Intended use is;
p.(None): 21. Traceability: the possibility of the tissue or the cell at every stage from the extraction, processing, testing and storage to
p.(None): Localize and identify use at recipient or for disposal, including the ability to identify the donor and tissue bank,
...
Health / stem cells
Searching for indicator stem cells:
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p.(None): or if the company, insofar as this is outside the European Economic Area, in this federal law and on the basis thereof
p.(None): enacted regulations can comply with prescribed standards.
p.(None): (3a) The distribution of cells or tissues can also be transferred to a company that does not have a license pursuant to Section 22. The following applies to this company
p.(None): Section 15 subsection 2 accordingly.
p.(None): (4) Each tissue bank must have a complete list of the agreements concluded with removal facilities and with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The agreements must always be available in the tissue bank in the original or a copy.
p.(None): (5) In the agreements between the tissue bank and a third party, the responsibilities that are performed by third parties and the
p.(None): to specify the exact procedure. A contractor may not contractually assign a task to third parties without the client's written consent
p.(None): pass on.
p.(None): (6) At the request of the Federal Office for Safety in Health Care, the tissue banks have copies of their agreements with them
p.(None): Withdrawal facilities and to be presented with third parties.
p.(None): (7) Tissue banks with an authorization to import from third countries must conclude written agreements with third country suppliers which:
p.(None): in accordance with the state of affairs paragraph 1 or 2. This does not apply to single imports and in connection with imports of hematopoietic
p.(None): StemXcells for the treatment of life-threatening diseases.
p.(None): (8) Tissue banks with a license to import from third countries have the quality and security requirements in a written agreement
p.(None): to be defined, so that the quality and safety standards of the cells and tissues to be introduced are equivalent to the standards
p.(None): of this federal law and the regulations issued on the basis thereof. The written agreement includes at least the one in Appendix E.
p.(None): mentioned requirements. Furthermore, the right of the Federal Office for Safety in Health Care is to be laid down during the term of the
p.(None): written agreement and to inspect the activities and facilities of all third country suppliers for a period of two years after their termination.
p.(None): (9) Notwithstanding paragraph 7 first sentence, an import from a third country supplier with whom there is no written agreement is permitted if
p.(None): unexpectedly, according to the state of medical science, an import to save life or rescue from a serious health risk
p.(None): of a recipient is urgently required. The tissue bank has to document this stating the reasons and the equivalence of the quality and
p.(None): Safety standards for the cells and tissues to be introduced with the standards of this federal law and those based on it
p.(None): To respect regulations.
p.(None): Receiving cells and tissues, import and export
p.(None): § 12. (1) The import and export from or to third countries of donations obtained from human cells and tissues for processing, storage or
p.(None): Distribution may only take place through tissue banks that have been approved and certified for this purpose (Section 26 (1a)).
p.(None): (2) An import from third countries may only take place if the tissue bank ensures that quality and safety standards have been complied with
...
p.(None): 7. The tissue bank has an accurate, quick, and verifiable process to deal with any distributed product that has a serious problem
p.(None): Incident or a serious adverse reaction could be recalled.
p.(None): (2) The license is to be tied to conditions and requirements in accordance with the state of the art in science and technology, insofar as they are to guarantee
p.(None): the flawless nature of the products, to protect the health of the recipient or to maintain the state of the art in science.
p.(None): (3) The following documents must be attached to the application for the authorization:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the operation, including a list of essential equipment and other operating equipment,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the staffing options envisaged, including the quali fi cation and the organizational scheme for the
p.(None): Tasks and area of responsibility of the staff including the responsible person,
p.(None): 5. the essential information on the quality system to be provided, including SOPs and the documentation,
p.(None): 6. Type and scope of the envisaged processing, testing, storage and distribution including the intended processing methods.
p.(None): (4) If a tissue bank applies for a license to import from third countries, the requests are the information and documents in accordance with Annex B.
p.(None): and to make the documentation according to Appendix D available and, on request, to the Federal Office for Safety in Health Care
p.(None): to transfer. Copies of their written agreements with third-country suppliers must also be submitted.
p.(None): (5) Is a permit for single imports or for the import of hematopoietic stem cells for the treatment of life-threatening diseases
p.(None): the documentation provided for in Annex B Part F and the documentation in Annex D Part B need not be submitted.
p.(None): (6) The Federal Office for Safety in Health Care has a tissue bank that has (also) received a license for import from third countries
p.(None): Issue certificate in accordance with Appendix C.
p.(None): § 24. If an authorization is issued, it follows that, despite compliance with the requirements stipulated in the notification, the guarantee of flawlessness
p.(None): The quality of the products or the protection of the health of the recipient is not adequately ensured, the Federal Office for Safety in
p.(None): To impose different or additional requirements on healthcare providers to achieve these goals.
p.(None): Section 25. The change in the identity of the holder of a tissue bank approved in accordance with Section 22 does not affect the effectiveness of this approval. The
p.(None): Legal successors must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Section 25a. The Federal Office for Safety in Health Care is immediately to cease the operation of an extraction facility or tissue bank
p.(None): Report.
p.(None): inspections
p.(None): Section 26. (1) The Federal Office for is responsible for monitoring compliance with this Federal Act through withdrawal facilities and tissue banks
p.(None): Healthcare security. The inspections must take place at regular intervals of no more than two years.
p.(None): (1a) The Federal Office for Safety in Health Care has a certificate of this within 90 days of completing an inspection of the tissue bank
p.(None): to be issued if this has shown that the provisions of this Federal Act and the regulations issued on the basis thereof and the
...
p.(None): 7. Email address.
p.(None): F. Documentation to accompany the application
p.(None): 1. A copy of the written agreement with the third country supplier (s).
p.(None): 2. A detailed description of the route of the imported cells and tissues from procurement to their arrival at the importing tissue bank.
p.(None): 3. A copy of the third-country supplier's export license or, if no special export license has been issued, one
p.(None): Certificate from the relevant third country authority (s) approving the activities of the third country supplier in the cells and tissues sector, including
p.(None): To run. These documents must also contain the contact details of the competent authority (ies) of the third country. In third countries where such documents
p.(None): other documents are not available, such as reports on audits at the third-country supplier.
p.(None): Appendix C.
p.(None): Certificate of approval as an introductory tissue bank
p.(None): Appendix D.
p.(None): Minimum requirements with regard to the documentation submitted to the Federal Office for Safety in Health Care of tissue banks, the cells and
p.(None): Want to import tissue from third countries
p.(None): The applicant importing tissue bank must have the current version of the following documents relating to the applicant and his / her third-country supplier
p.(None): provide and - if not already done in the context of previous applications for authorization as an introductory tissue bank - upon request to the
p.(None): Submit to the Federal Office. This does not apply to one-off imports within the meaning of Section 2 no. 39 of this Federal Act, which are subject to these documentation requirements
p.(None): with exception of. When importing hematopoietic stem cells for the treatment of life-threatening diseases, only the documentation on A. for
p.(None): Will be provided.
p.(None): A. Documentation on the introductory tissue bank
p.(None): 1. Job description of the responsible person and precise information on their relevant qualifications and training in accordance with § 9;
p.(None): 2. Copy of the original label, the outer packaging label as well as the documents for the outer packaging and the transport container;
p.(None): 3. List of relevant, current standard operating instructions (SOP) for the institution's import activities, including the SOP for the application of the
p.(None): Uniform European codes, the reception and storage of imported cells and tissues in the introductory tissue bank, the management
p.(None): serious incidents and serious undesirable reactions, management of recalls and traceability from donor to
p.(None): Receiver.
p.(None): B. Documentation of the third country supplier (s)
p.(None): 1. Detailed description of the criteria for the identification and assessment of donors, details of the donors or the donor family
p.(None): Information, description of the procedure for obtaining the consent of the donor or the donor family as well as information on whether it is a
p.(None): voluntary and free donation;
p.(None): 2. detailed information about the test centers used by the third country suppliers and the tests carried out by these centers;
p.(None): 3. detailed information on the methods used in the processing of cells and tissues, including precise information on the validation of the
p.(None): Critical processing procedure;
p.(None): 4. Detailed information about the facilities, important equipment and materials as well as the criteria for quality control and environmental control in
p.(None): Relating to any activity performed by the third country supplier;
p.(None): 5. detailed information on the conditions for the release of tissues and cells by the third country supplier (s);
p.(None): 6. Information about each subcontractor of the third country suppliers, including the name, address and the activity carried out;
p.(None): 7. Summary of the most recent inspection by the competent third country authority (ies) at the third country supplier, including the inspection date of the
p.(None): Type of inspection and main conclusions;
p.(None): 8. Summary of the most recent third country supplier audit performed by or on behalf of the importing tissue bank;
p.(None): 9. relevant national or international approvals, if available.
p.(None): Attachments
p.(None): Minimum requirements regarding the content of written agreements between importing tissue banks and their third country suppliers
p.(None): Except for one-off imports within the meaning of Section 2 No. 39 of this Federal Act and imports of hematopoietic stem cells for treatment
p.(None): Life-threatening diseases that are exempt from these requirements must be the written agreement between the introductory tissue bank
p.(None): and contain the third country supplier at least the following requirements.
p.(None): 1. Detailed information on the speci fi cations of the importing tissue bank, with which the compliance with those laid down in Directive 2004/23 / EC
p.(None): Quality and safety standards should be ensured, and with regard to the mutually agreed tasks and responsibilities of the two parties
p.(None): to ensure that the quality and safety standards of the imported cells and tissues are equivalent;
p.(None): 2. Clause which ensures that the third country supplier provides the information on the importing tissue bank as set out in Section B of Annex III to this Directive
p.(None): transmitted;
p.(None): 3. Clause which ensures that the third country supplier informs the importing tissue bank of any suspected or actual serious incident or
p.(None): informed of serious adverse reactions that affect the quality and safety of the or imported from the introductory tissue bank
p.(None): cells and tissues to be introduced;
p.(None): 4. Clause that ensures that the third country supplier informs the importing tissue bank of any significant change in its activities that affect the
p.(None): Quality and safety of the cells and tissues introduced or to be introduced by the importing tissue bank; this also applies to one
p.(None): Withdrawal or suspension - in whole or in part - of its authorization for the export of cells and tissues and any other decisions that
p.(None): were taken by the responsible third country authority (ies) for non-compliance with the provisions;
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Social / Access to Social Goods
Searching for indicator access:
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p.(None): is established, has been taken and may be relevant to the quality and safety of the imported tissues and cells,
p.(None): Report to.
p.(None): § 17a. Tissue banks are required to report to the Federal Office for Health Safety if
p.(None): 1. Information in the EU Compendium of Tissue Facilities needs to be updated or corrected,
p.(None): 2. the EU Compendium of Tissue and Cell Products needs to be updated, or
p.(None): 3. The tissue bank in cells or tissue that it receives from other tissue banks in the European Economic Area, a significant violation
p.(None): against the provisions of the Single European Code.
p.(None): confidentiality
p.(None): § 18. (1) Every person working or who has worked in a withdrawal facility and in a tissue bank is in secrecy about all of them
p.(None): Committed to the performance of their activities or secrets which have become known, provided that they are not already based on other legal or official law
p.(None): Regulations such a duty of confidentiality is imposed.
p.(None): (2) There is no duty of confidentiality if
p.(None): 1. The person threatened by the disclosure of the secret is the person who worked or was active in the removal facility or in the tissue bank
p.(None): released from secrecy,
p.(None): 2. the disclosure of the type and content of the secret in order to protect the higher interests of public health care or the administration of justice
p.(None): is absolutely necessary, or
p.(None): 3. Reporting obligations regarding communicable diseases are met.
p.(None): (3) Information about the person of the donor and recipient is exempt from the right of access according to Art. 15 General Data Protection Regulation. § 20
p.(None): Reproductive Medicine Act, Federal Law Gazette No. 275/1992, remains unaffected.
p.(None): Notification of cell and tissue extraction
p.(None): § 19. (1) Before the first extraction of cells or tissues, each removal facility has to start this activity with the Federal Office for Security
p.(None): to report in healthcare.
p.(None): (2) If, after the notification in accordance with paragraph 1, a change is to be made with regard to the operation, the effects on the quality of the cells or
p.(None): Tissue or the protection of donors, this change also requires notification to the Federal Office for Safety in Health Care.
p.(None): (3) The Federal Office for Safety in Health Care must prohibit the extraction of cells or tissues if
p.(None): 1. the approvals required under other legal provisions are not available or the plant and all necessary for the operation
p.(None): medical and technical facilities do not comply with the applicable regulations in the field of health care,
p.(None): 2. the personnel, spatial, operational or technical equipment required for the extraction is not available,
p.(None): 3. the tasks and areas of responsibility of the active persons are not defined and are not shown in an organizational plan,
p.(None): 4. the necessary facilities for documentation and quality assurance that is in line with the state of the art in science and technology
p.(None): are present, or
p.(None): 5. otherwise the extraction does not correspond to the state of the art in science and technology.
p.(None): (4) The following documents must be attached to the notification:
p.(None): 1. name and address of the holder,
p.(None): 2. a description of the company including a list of essential medical devices and other company facilities,
...
p.(None): Report.
p.(None): inspections
p.(None): Section 26. (1) The Federal Office for is responsible for monitoring compliance with this Federal Act through withdrawal facilities and tissue banks
p.(None): Healthcare security. The inspections must take place at regular intervals of no more than two years.
p.(None): (1a) The Federal Office for Safety in Health Care has a certificate of this within 90 days of completing an inspection of the tissue bank
p.(None): to be issued if this has shown that the provisions of this Federal Act and the regulations issued on the basis thereof and the
p.(None): Approval is granted. If this requirement is not met, the Federal Office for Safety in Health Care has it within the mentioned
p.(None): Determine deadline with notice. The certi fi cate is to be withdrawn if it subsequently becomes known that the requirements have not been met. It's closed
p.(None): withdraw if the requirements are no longer met.
p.(None): (2) In the event of a serious undesirable reaction or a serious incident, the Federal Office for Security in
p.(None): To initiate appropriate inspections if necessary. In such cases, such inspections are sufficient for one
p.(None): reasoned request by the competent authority (ies) of another party to the Agreement on the European Economic Area. On
p.(None): If requested by another contracting party to the Agreement on the European Economic Area or the Commission, the Federal Office for Security
p.(None): Healthcare with the results of the inspections carried out in relation to the requirements of this federal law.
p.(None): (3) The organs of the Federal Office for Safety in Health Care and the experts consulted by it
p.(None): 1. to grant access to all rooms,
p.(None): 2. to give the opportunity to carry out the activities and procedures carried out in accordance with this Federal Act and the regulations issued on the basis thereof
p.(None): to review and assess and, if this is necessary to preserve evidence, take photographs and video recordings in the company,
p.(None): 3. to grant the required inspection of all documents and records at their request, and to make copies or photographs thereof, and
p.(None): 4. to enable the removal of samples in the amount required for an analysis.
p.(None): (3a) The powers of the organs of the Federal Office for Safety in Health Care listed in paragraph 3 also exist with regard to facilities or
p.(None): Means of transport for companies that have been commissioned by tissue banks to distribute cells or tissue.
p.(None): (4) If the extraction takes place outside the operating rooms, the removal facility has in agreement with the relevant institutions
p.(None): to ensure that the premises in which the extraction takes place can also be checked in the course of inspections and the organs of the
p.(None): Federal Office for Safety in Health Care and the experts consulted by it have all rights under paragraph 3.
p.(None): (5) The inspections are in arrears except in the event of danger or if there is a reasonable assumption that the effectiveness of the official act thereby
p.(None): could be affected to announce beforehand.
p.(None): (6) Care must be taken to avoid any disruption or obstruction of the business that is not absolutely necessary.
p.(None): (7) The samples taken, insofar as this is possible in their nature and this does not prevent their perfect assessment, are divided into three equal parts
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence purposes. About the sampling is the
...
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
p.(None): 1. processed, stored and distributed by a removal facility without this facility having to have an authorization in accordance with § 22, and
p.(None): 2. Irrespective of § 12, the user can directly insert or receive it or it can be carried out by a removal facility.
p.(None): Regulations for users
p.(None): Section 32. (1) Users have any use of cells and tissues in humans according to the state of the art in a data archive
p.(None): document and keep it for at least 30 years. In any case, this documentation must contain:
p.(None): 1.Identification of the tissue bank or the removal device for direct use from which the cells or tissue were obtained,
p.(None): 2. identification of the user,
p.(None): 3. cell or tissue type,
p.(None): 4. Product identifier,
p.(None): 5. Recipient identification,
p.(None): 6. date of application,
p.(None): 7. Single European Code (if available).
p.(None): (1a) The legibility of the documentation must be ensured for the retention period. The access authorization for the individual users is individual
p.(None): assign and document. The persons authorized to access are to be informed about the requirements according to Art. 32 Para. 4 General Data Protection Regulation. There are
p.(None): Take data security measures in accordance with Art. 32 General Data Protection Regulation.
p.(None): (2) Doctors and dentists
p.(None): 1. any serious adverse reaction that has been observed during or after clinical use of cells or tissues and with quality
p.(None): and could be related to cell or tissue security, and
p.(None): 2. any lack of quality or safety that arises in connection with a serious undesirable incident in the extraction, processing,
p.(None): Storage or distribution,
p.(None): immediately the tissue bank from which they received the cells or the tissue or, in the case of direct use of the withdrawal device, the
p.(None): affected cells or tissues, report and pass on all relevant information in order to facilitate traceability and the
p.(None): To ensure quality and safety control. In the case of direct use, the user must also report to the Federal Office of
p.(None): Reimburse healthcare security.
p.(None): (3) The Federal Minister of Health, Family and Youth can, by ordinance, specify the content of the documentation in accordance with paragraph 1
p.(None): as well as the type, scope and form of reports and information in accordance with paragraph 2.
p.(None): Vigilanzregister
p.(None): Section 33. (1) The Federal Office for Safety in Health Care has all reported serious undesirable reactions and all serious ones
p.(None): Record incidents in a register. This register is used for tissue vigilance and market surveillance. Processing data from donors and
...
p.(None): 5. contrary to Section 4 (4), cells or tissues taken from a living person as part of medical treatment, without clarification and
p.(None): Patient's consent continues to be used
p.(None): 6. violates the obligations according to § 4 paragraph 5 or 5a,
p.(None): 7. Donors of cells or tissues or third parties for a donation contrary to Section 4 Paragraph 6 a fi nancial gain or comparable advantage
p.(None): sends or promises
p.(None): 8. as a removal facility before the first extraction of cells or tissues the commencement of this activity, the Federal Office for Security in
p.(None): Healthcare does not report in accordance with Section 19 (1),
p.(None): 9. makes changes to the operation as a removal facility without these changes to the Federal Office for Safety in Health Care in accordance with § 19
p.(None): 2, or fail to comply with conditions or requirements pursuant to Section 20,
p.(None): 10. operates a tissue bank without a license pursuant to Section 22 or uses a processing procedure without authorization,
p.(None): 11. as a tissue bank, makes changes with regard to operations in accordance with section 22 (2) or significant changes in import activities in accordance with section 3,
p.(None): without obtaining an approval from the Federal Office for Health Safety,
p.(None): 12. The Federal Office for Safety in Health Care does not stop the operation of a withdrawal facility or tissue bank in accordance with § 25a
p.(None): reports immediately,
p.(None): 13. as a tissue bank, does not comply with the conditions and requirements pursuant to Section 23 subsection 2, Section 24 or Section 27 subsection 1,
p.(None): 14. does not grant access to the monitoring bodies within the meaning of section 26, prevents their activity or the necessary inspection of files or the taking of samples
p.(None): makes impossible
p.(None): 15. as a removal facility violates the obligation under Section 26 (4), or
p.(None): 16. as a tapping facility, does not comply with the conditions or requirements set out in section 27 (1),
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Punish a fine of up to 36,340 euros. The same applies if an act in accordance with paragraph 1 poses a serious risk to the life and health of a person
p.(None): emerged or the perpetrator has already been punished twice in accordance with paragraph 1.
p.(None): (3) Who
p.(None): 1. as the responsible person violates his obligations pursuant to Section 9 (3),
p.(None): 2. performs the activity of a responsible person without fulfilling the requirements of Section 9 (2),
p.(None): 3. as the responsible person does not meet the reporting obligations pursuant to section 17 (3), or
p.(None): 4. as the responsible person who violates his obligations under an ordinance pursuant to Section 30,
p.(None): commits an administrative offense, unless the offense fulfills the offense of a criminal act falling within the jurisdiction of the courts, and is with
p.(None): Fine up to 7,270 euros.
p.(None): (3a) Anyone who, as the person responsible for the distribution of cells or tissue, does not comply with the requirements of Section 15 (2) commits, unless the deed does
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Social / Marital Status
Searching for indicator single:
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p.(None): Intended use is;
p.(None): 21. Traceability: the possibility of the tissue or the cell at every stage from the extraction, processing, testing and storage to
p.(None): Localize and identify use at recipient or for disposal, including the ability to identify the donor and tissue bank,
p.(None): who receives, processes or stores the tissues or cells, as well as the possibility to collect the respective recipient (s) from the user;
p.(None): Traceability also means the ability to locate and locate all relevant data related to the products and materials
p.(None): raise that come into contact with these tissues or cells;
p.(None): 22. Medicinal products for novel therapies: gene therapeutics and somatic cell therapeutics according to Part IV of Annex I to Directive 2001/83 / EC of the European Union
p.(None): Parliament and of the Council of 6 November 2001 adopting a Community code for medicinal products for human use, as last amended by the Directive
p.(None): 2004/27 / EG as well as biotechnologically processed tissue products according to Article 2 Paragraph 1 lit. b of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on medicinal products for advanced therapies and amending Directive 2001/83 / EC and the
p.(None): Regulation (EC) No. 726/2004;
p.(None): 23. "Uniform European Code" or "SEC": the unique identification number for tissues and cells distributed in the European Economic Area. The
p.(None): Uniform European Code consists of a donation identification sequence and a product identification sequence according to Appendix A;
p.(None): 24. “Donation identification sequence”: the first part of the Single European Code, consisting of the EU Tissue Establishment Code and the unique one
p.(None): Donation number;
p.(None): 25. "EU tissue establishment code": the unique identification number for approved, named, approved or licensed tissue establishments in the
p.(None): European economic area. The tissue establishment code consists of an ISO country code and the tissue establishment number in the EU
p.(None): Compendium of Tissue Facilities;
p.(None): 26. "unique donation number": the unique number as set out in Appendix A.
p.(None): 27. "Product identification sequence": the second part of the Single European Code, consisting of the product code, the split number and the
p.(None): Expiration date;
p.(None): 28. “Product code”: the identifier of the speci fi c type of the tissues and cells concerned. According to Appendix A, the product code consists of the identifier of the
p.(None): Systems for the product coding, which the tissue device uses ('E' for EUTC, 'A' for ISBT 128, 'B' for Eurocode) and from the product number for
p.(None): Tissues and cells in the relevant coding system for the product type;
p.(None): 29. "Split number": the number in Annex A used to distinguish and uniquely identify tissues and cells associated with the same
p.(None): unique donation number and product code are identified and come from the same tissue facility;
p.(None): 30. "expiry date" means the date in Annex A by which the tissues and cells can be used;
p.(None): 31. "EU Coding Platform": the IT platform operated by the Commission with the EU Compendium of Tissue Facilities and the EU Compendium
p.(None): tissue and cell products;
p.(None): 32. "EU Compendium of Tissue Facilities": the register of all of the competent authorities of a Party to the Agreement on the
p.(None): European Economic Area approved, licensed, designated or approved tissue establishment that provides information about this
p.(None): Contains tissue devices in accordance with Annex VIII of Directive (EU) 2015/565;
p.(None): 33. "EU Compendium of Tissue and Cell Products": the register of all tissue and cell types in circulation in the European Economic Area
p.(None): the respective product codes of the three permitted coding systems (EUTC, ISBT 128 and Eurocode);
p.(None): 34. “EUTC”: the product coding system for tissues and cells developed by the Union, which is available from a register of all in the Union
p.(None): Tissue and cell types with the respective product codes;
p.(None): 35. “Open to traffic”: distribution for human use or transfer to another actor, for example for
p.(None): Further processing with or without return;
p.(None): 36. "within the same facility": all steps from extraction to use in humans are carried out by the same responsible person and
p.(None): carried out in the same system for quality management and traceability in a hospital in which the
p.(None): Removal device and the approved tissue bank are located;
p.(None): 37. "Pooling": one and the same container contains or mixes tissues or cells from more than one extraction from the same
p.(None): Donors or from two or more donors;
p.(None): 38. "third country supplier" means a tissue bank, sampling facility or other body in a third country which is responsible for the export of cells and tissues which
p.(None): delivers them to an introductory tissue bank responsible for the European Economic Area. A third country supplier can also use one or more of the
p.(None): activities outside the European Economic Area in connection with donation, extraction, testing, processing,
p.(None): Maintain, store or distribute cells and tissues imported into the European Economic Area;
p.(None): 39. "Single import" means the import of a specific type of cells or tissues for use by an intended recipient or recipients
p.(None): Recipients who / have stored these cells or tissues with a third country supplier for future use and therefore the
p.(None): importing tissue bank and is known to the third country supplier before import. This is normally allowed for a specific recipient
p.(None): occur at most once. Regular or repeated importation through the same third country supplier is not considered to be a "single import".
p.(None): recovery
p.(None): Section 3
p.(None): were reported in accordance with § 19.
p.(None): (1a) Deviating from Paragraph 1, cells and tissues may also be obtained from unreported sampling facilities if there are any
p.(None): a medical intervention unforeseen according to the state of medical science the need for later autologous use
p.(None): of these cells and tissues.
p.(None): (2) Each extraction facility has the personnel, spatial, operational and
p.(None): to have technical equipment. The personnel involved in the extraction or testing must take appropriate further training measures in good time
p.(None): and are regularly brought up to date with the latest science and technology.
p.(None): (3) Organizational forms in which the extraction of cells and tissues are partially or exclusively also count as withdrawal devices according to Paragraph 1
p.(None): done by mobile removal teams outside of their own premises.
p.(None): (4) The equipment must be designed in such a way that the respective state of the art in science and technology ensures a trouble-free organizational process
p.(None): is guaranteed, the required hygiene standards are maintained and living donors can receive emergency medical care at any time.
p.(None): (5) Each extraction facility must operate a functional quality system in accordance with the state of the art in science and technology, which the active
p.(None): Management and staff involvement.
p.(None): (6) Every removal facility must ensure that at least standard operating instructions (standard operating
p.(None): Procedures-SOPs), guidelines, training and reference manuals, self-inspection according to paragraph 7, records of donors and information about
p.(None): the transfer of the cells and tissues obtained are documented.
...
p.(None): Section 22 or a corresponding license from a competent authority of another party to the Agreement on the European Economic Area
p.(None): or if the company, insofar as this is outside the European Economic Area, in this federal law and on the basis thereof
p.(None): enacted regulations can comply with prescribed standards.
p.(None): (3a) The distribution of cells or tissues can also be transferred to a company that does not have a license pursuant to Section 22. The following applies to this company
p.(None): Section 15 subsection 2 accordingly.
p.(None): (4) Each tissue bank must have a complete list of the agreements concluded with removal facilities and with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The agreements must always be available in the tissue bank in the original or a copy.
p.(None): (5) In the agreements between the tissue bank and a third party, the responsibilities that are performed by third parties and the
p.(None): to specify the exact procedure. A contractor may not contractually assign a task to third parties without the client's written consent
p.(None): pass on.
p.(None): (6) At the request of the Federal Office for Safety in Health Care, the tissue banks have copies of their agreements with them
p.(None): Withdrawal facilities and to be presented with third parties.
p.(None): (7) Tissue banks with an authorization to import from third countries must conclude written agreements with third country suppliers which:
p.(None): in accordance with the state of affairs paragraph 1 or 2. This does not apply to single imports and in connection with imports of hematopoietic
p.(None): StemXcells for the treatment of life-threatening diseases.
p.(None): (8) Tissue banks with a license to import from third countries have the quality and security requirements in a written agreement
p.(None): to be defined, so that the quality and safety standards of the cells and tissues to be introduced are equivalent to the standards
p.(None): of this federal law and the regulations issued on the basis thereof. The written agreement includes at least the one in Appendix E.
p.(None): mentioned requirements. Furthermore, the right of the Federal Office for Safety in Health Care is to be laid down during the term of the
p.(None): written agreement and to inspect the activities and facilities of all third country suppliers for a period of two years after their termination.
p.(None): (9) Notwithstanding paragraph 7 first sentence, an import from a third country supplier with whom there is no written agreement is permitted if
p.(None): unexpectedly, according to the state of medical science, an import to save life or rescue from a serious health risk
p.(None): of a recipient is urgently required. The tissue bank has to document this stating the reasons and the equivalence of the quality and
p.(None): Safety standards for the cells and tissues to be introduced with the standards of this federal law and those based on it
p.(None): To respect regulations.
p.(None): Receiving cells and tissues, import and export
p.(None): § 12. (1) The import and export from or to third countries of donations obtained from human cells and tissues for processing, storage or
p.(None): Distribution may only take place through tissue banks that have been approved and certified for this purpose (Section 26 (1a)).
...
p.(None): Indicate the edition of the new edition and mark it as invalid.
p.(None): (2) The manufacturing regulations contain special regulations for the handling of cells or tissues that have to be discarded. It is
p.(None): ensure that contamination of other cells or tissues, the processing environment and personnel is avoided.
p.(None): (3) Processing must be carried out in accordance with the approved processing methods and the manufacturing regulations.
p.(None): (4) The equipment used, the work rooms and the conditions for process development, validation and control are state of the art
p.(None): To match science and technology.
p.(None): Storage of cells and tissues
p.(None): § 14. (1) All procedures in connection with the storage of cells and tissues are to be specified in SOPs. The storage has the state of
p.(None): To match science and technology.
p.(None): (2) All storage processes must take place under controlled conditions. Regular checks ensure that there is no situation
p.(None): occurs that could impair the function or integrity of the cells or tissues.
p.(None): Distribution of cells and tissues, recall
p.(None): § 15. (1) Processed cells or tissues may only be released for distribution if all according to this federal law and the one on it
p.(None): The enacted regulations and the state of the art in science and technology are met. The release has been made through the
p.(None): responsible person according to § 9.
p.(None): (2) The tissue banks have to ensure the quality of the cells or tissues during the distribution according to the state of the art in science and technology.
p.(None): (3) The tissue banks must ensure that an accurate, quick and verifiable procedure is established with which each distributed product that
p.(None): a serious incident or serious adverse reaction may be recalled.
p.(None): (4) In the case of single imports, the tissue bank must ensure that the imported cells or tissue are used by persons other than the
p.(None): intended recipients is excluded.
p.(None): Labelling
p.(None): § 15a. (1) Cells and tissues released for use in humans are through the tissue bank with the Single European
p.(None): Label the code in accordance with Appendix A.
p.(None): (2) In other cases, in which cells or tissues are released for traffic by the tissue bank, at least the
p.(None): Donor identification sequence must be documented.
p.(None): (3) Paragraph 1 does not apply to
p.(None): 1. Germ cells from partner donations,
p.(None): 2. cells and tissues remaining in the same facility,
p.(None): 3. cells or tissues imported from third countries, provided that the import takes place via a tissue bank with a license to import from third countries, the
p.(None): is located in the hospital where the application is made and
p.(None): 4. cells or tissues distributed directly to users for direct use.
p.(None): (4) As a system for the allocation of unique donation numbers, tissue banks must either use their own system or a system that is unique worldwide
p.(None): Number according to the coding system ISBT 128.
p.(None): (5) The Single European Code must be put on a label on the packaging in a legible form; to him the acronym 'SEC'
p.(None): preceded. The attachment must be permanent and permanent. Furthermore, the uniform European code must be documented in the accompanying documents.
p.(None): If the Single European Code cannot be attached to a label due to lack of space, the code is clearly the same as the accompanying documents
p.(None): assigned to packaged cells or tissues.
p.(None): (6) The Single European Code is with the donation identification sequence and the product identification sequence, separated by a space, or in two
p.(None): to print consecutive lines.
p.(None): (7) Tissue banks must take all necessary measures if the Single European Code on the label is not in accordance with the regulations
p.(None): is appropriate.
p.(None): documentation
p.(None): § 16. (1) Tissue banks have to keep a documentation of their activity corresponding to the state of the art. In any case, Art
p.(None): and amount of cells and tissues received, tested, processed, stored and distributed or otherwise used and rejected,
p.(None): to record their origin and destination. This also applies to tissue banks with a license to import from third countries.
p.(None): (2) The documentation must ensure complete traceability according to the state of the art in science. Traceability is also for everyone
p.(None): ensure necessary data about products and materials that come into contact with these cells and tissues. This also applies to tissue banks
p.(None): with a license to import from third countries and must also be guaranteed for one-off imports.
p.(None): (3) The documentation must be in writing, electronically or on another data carrier, provided that it is ensured that the necessary information is given during the
p.(None): Duration of the retention period are available to be made.
p.(None): (Note: Paragraph 4 repealed by Art. 45 no. 5, Federal Law Gazette I No. 37/2018)
p.(None): (5) The documentation is through at least ten years - those parts that are essential for complete traceability, at least 30 years -
p.(None): to be kept and available for inspection at any time by the supervisory bodies responsible under this federal law.
p.(None): (6) Tissue banks are obliged to report annually to the Federal Office for Safety in Health Care by April 30th about their work in the
p.(None): to submit the previous calendar year. The Federal Office is obliged to publish these reports on the website of the Federal Office for Security at
p.(None): Make healthcare accessible to the public.
...
p.(None): the withdrawal facilities or tissue banks involved provide all the relevant information to clarify serious incidents and
p.(None): to provide serious adverse reactions.
p.(None): (5) Tissue banks with a license to import from third countries are required, all suspected by the Federal Office for Safety in Health Care
p.(None): or actual serious incidents or serious adverse reactions reported to you by third country suppliers and
p.(None): report the quality and safety of the cells or tissues they have imported. Such notifications must be made in accordance with Annex III
p.(None): and IV of Directive 2006/86 / EC.
p.(None): (6) Tissue banks with a license to import from third countries are obliged to inform the Federal Office for Safety in Health Care immediately
p.(None): 1. Any revocation and any suspension - in whole or in part - of a third country supplier's approval for the export of tissues and cells and
p.(None): 2. Any other decision taken because of non-compliance by the competent authority (ies) of the state in which the third country supplier
p.(None): is established, has been taken and may be relevant to the quality and safety of the imported tissues and cells,
p.(None): Report to.
p.(None): § 17a. Tissue banks are required to report to the Federal Office for Health Safety if
p.(None): 1. Information in the EU Compendium of Tissue Facilities needs to be updated or corrected,
p.(None): 2. the EU Compendium of Tissue and Cell Products needs to be updated, or
p.(None): 3. The tissue bank in cells or tissue that it receives from other tissue banks in the European Economic Area, a significant violation
p.(None): against the provisions of the Single European Code.
p.(None): confidentiality
p.(None): § 18. (1) Every person working or who has worked in a withdrawal facility and in a tissue bank is in secrecy about all of them
p.(None): Committed to the performance of their activities or secrets which have become known, provided that they are not already based on other legal or official law
p.(None): Regulations such a duty of confidentiality is imposed.
p.(None): (2) There is no duty of confidentiality if
p.(None): 1. The person threatened by the disclosure of the secret is the person who worked or was active in the removal facility or in the tissue bank
p.(None): released from secrecy,
p.(None): 2. the disclosure of the type and content of the secret in order to protect the higher interests of public health care or the administration of justice
p.(None): is absolutely necessary, or
p.(None): 3. Reporting obligations regarding communicable diseases are met.
p.(None): (3) Information about the person of the donor and recipient is exempt from the right of access according to Art. 15 General Data Protection Regulation. § 20
p.(None): Reproductive Medicine Act, Federal Law Gazette No. 275/1992, remains unaffected.
p.(None): Notification of cell and tissue extraction
p.(None): § 19. (1) Before the first extraction of cells or tissues, each removal facility has to start this activity with the Federal Office for Security
p.(None): to report in healthcare.
p.(None): (2) If, after the notification in accordance with paragraph 1, a change is to be made with regard to the operation, the effects on the quality of the cells or
...
p.(None): are,
p.(None): 6. the proposed processing methods correspond to the state of the art in science and technology, and
p.(None): 7. The tissue bank has an accurate, quick, and verifiable process to deal with any distributed product that has a serious problem
p.(None): Incident or a serious adverse reaction could be recalled.
p.(None): (2) The license is to be tied to conditions and requirements in accordance with the state of the art in science and technology, insofar as they are to guarantee
p.(None): the flawless nature of the products, to protect the health of the recipient or to maintain the state of the art in science.
p.(None): (3) The following documents must be attached to the application for the authorization:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the operation, including a list of essential equipment and other operating equipment,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the staffing options envisaged, including the quali fi cation and the organizational scheme for the
p.(None): Tasks and area of responsibility of the staff including the responsible person,
p.(None): 5. the essential information on the quality system to be provided, including SOPs and the documentation,
p.(None): 6. Type and scope of the envisaged processing, testing, storage and distribution including the intended processing methods.
p.(None): (4) If a tissue bank applies for a license to import from third countries, the requests are the information and documents in accordance with Annex B.
p.(None): and to make the documentation according to Appendix D available and, on request, to the Federal Office for Safety in Health Care
p.(None): to transfer. Copies of their written agreements with third-country suppliers must also be submitted.
p.(None): (5) Is a permit for single imports or for the import of hematopoietic stem cells for the treatment of life-threatening diseases
p.(None): the documentation provided for in Annex B Part F and the documentation in Annex D Part B need not be submitted.
p.(None): (6) The Federal Office for Safety in Health Care has a tissue bank that has (also) received a license for import from third countries
p.(None): Issue certificate in accordance with Appendix C.
p.(None): § 24. If an authorization is issued, it follows that, despite compliance with the requirements stipulated in the notification, the guarantee of flawlessness
p.(None): The quality of the products or the protection of the health of the recipient is not adequately ensured, the Federal Office for Safety in
p.(None): To impose different or additional requirements on healthcare providers to achieve these goals.
p.(None): Section 25. The change in the identity of the holder of a tissue bank approved in accordance with Section 22 does not affect the effectiveness of this approval. The
p.(None): Legal successors must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Section 25a. The Federal Office for Safety in Health Care is immediately to cease the operation of an extraction facility or tissue bank
p.(None): Report.
p.(None): inspections
p.(None): Section 26. (1) The Federal Office for is responsible for monitoring compliance with this Federal Act through withdrawal facilities and tissue banks
p.(None): Healthcare security. The inspections must take place at regular intervals of no more than two years.
p.(None): (1a) The Federal Office for Safety in Health Care has a certificate of this within 90 days of completing an inspection of the tissue bank
...
p.(None): 2. it emerges that such a requirement was not met when the certificate was issued or the license was granted,
p.(None): 3. the holder of a certi fi cate or an authorization for violation of the provisions of this Federal Act pursuant to Section 35 (1) within five
p.(None): Years has been punished at least three times, or
p.(None): 4. at least the holder of a certi fi cate or a license for violations of the provisions of this Federal Act pursuant to Section 35 (2)
p.(None): has been punished twice.
p.(None): (2) The Federal Office for Safety in Health Care may temporarily or permanently grant a responsible person the right to exercise
p.(None): Prohibit the work of a responsible person if they are punished at least three times for violations of the provisions of this Federal Act
p.(None): has been.
p.(None): Registers of withdrawal devices and tissue banks
p.(None): Section 29. (1) The Federal Office for Safety in Health Care has a register of all certified withdrawal facilities and approved tissue banks, in
p.(None): which in any case must also contain information about the activities for which the certi fi cation or approval was granted. This is in the
p.(None): Make the Internet publicly available on the homepage of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Minister of Health, Family and Youth may, by ordinance, provide more detailed regulations regarding the maintenance of this register and the type and
p.(None): Extent of entries.
p.(None): (3) The Federal Office for Safety in Health Care must assign a unique tissue establishment number to each tissue bank approved, provided that
p.(None): this does not result from the chosen Single European Code. If a tissue bank has several locations, it can with regard to the
p.(None): Tissue device number can be treated as a single tissue device.
p.(None): Authorization to issue regulations on tissue banks
p.(None): Section 30. The Federal Minister of Health, Family and Youth may, by ordinance, issue more detailed provisions on:
p.(None): 1. What are the requirements for the necessary spatial and technical equipment as well as for the hygiene standards to be observed?
p.(None): Adequate quality system and the organizational scheme must be set up
p.(None): 2. What minimum staffing levels a tissue bank must have, what special knowledge and skills the staff must have
p.(None): and in which schooling, further education and further training measures these people have to take,
p.(None): 3. how cells and tissues are to be labeled,
p.(None): 4. Which requirements are to be met for products for autologous use?
p.(None): 5. which procedures are to be followed when receiving cells or tissues,
p.(None): 6. Which conditions are to be observed during processing, storage and distribution, can also be more detailed regulations regarding the requirements
p.(None): processing methods are taken,
p.(None): 7. Which packaging requirements have to be met?
p.(None): 8. Which requirements are to be made of the documentation and its type and scope,
p.(None): 9. what precautions are to be taken regarding traceability,
p.(None): 10. Which procedures for reporting serious incidents and serious undesirable reactions have to be followed as well as with regard to type and
p.(None): Scope of such reports,
p.(None): 11.When equivalent quality and safety standards within the meaning of Section 12 (2) can be assumed for imports from third countries,
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
p.(None): 1. processed, stored and distributed by a removal facility without this facility having to have an authorization in accordance with § 22, and
p.(None): 2. Irrespective of § 12, the user can directly insert or receive it or it can be carried out by a removal facility.
p.(None): Regulations for users
p.(None): Section 32. (1) Users have any use of cells and tissues in humans according to the state of the art in a data archive
p.(None): document and keep it for at least 30 years. In any case, this documentation must contain:
p.(None): 1.Identification of the tissue bank or the removal device for direct use from which the cells or tissue were obtained,
p.(None): 2. identification of the user,
p.(None): 3. cell or tissue type,
p.(None): 4. Product identifier,
p.(None): 5. Recipient identification,
p.(None): 6. date of application,
p.(None): 7. Single European Code (if available).
p.(None): (1a) The legibility of the documentation must be ensured for the retention period. The access authorization for the individual users is individual
p.(None): assign and document. The persons authorized to access are to be informed about the requirements according to Art. 32 Para. 4 General Data Protection Regulation. There are
p.(None): Take data security measures in accordance with Art. 32 General Data Protection Regulation.
p.(None): (2) Doctors and dentists
p.(None): 1. any serious adverse reaction that has been observed during or after clinical use of cells or tissues and with quality
p.(None): and could be related to cell or tissue security, and
p.(None): 2. any lack of quality or safety that arises in connection with a serious undesirable incident in the extraction, processing,
p.(None): Storage or distribution,
p.(None): immediately the tissue bank from which they received the cells or the tissue or, in the case of direct use of the withdrawal device, the
p.(None): affected cells or tissues, report and pass on all relevant information in order to facilitate traceability and the
p.(None): To ensure quality and safety control. In the case of direct use, the user must also report to the Federal Office of
p.(None): Reimburse healthcare security.
p.(None): (3) The Federal Minister of Health, Family and Youth can, by ordinance, specify the content of the documentation in accordance with paragraph 1
p.(None): as well as the type, scope and form of reports and information in accordance with paragraph 2.
p.(None): Vigilanzregister
...
p.(None): Fine up to 7,270 euros.
p.(None): (3a) Anyone who, as the person responsible for the distribution of cells or tissue, does not comply with the requirements of Section 15 (2) commits, unless the deed does
p.(None): A criminal offense falling within the jurisdiction of the courts constitutes an administrative offense and is subject to a fine of up to EUR 7,270
p.(None): punish.
p.(None): (4) The attempt is punishable.
p.(None): Involvement of organs of the public security service
p.(None): § 36. The organs of the public security service have to the Federal Office for security in the health care over its requests to secure the
p.(None): Exercise the powers pursuant to sections 26, 27 (2) and (3) and 37 (3) to provide help within the scope of their statutory scope.
p.(None): EU Compendium of Tissue Facilities
p.(None): Section 36a. (1) The Federal Office for Safety in Health Care is obliged to provide all information on approved tissue banks in accordance with Annex VIII of the
p.(None): Directive (EU) 2015/565 in the EU Compendium of Tissue Facilities. This data is to be updated when a new tissue bank
p.(None): is approved, information about an approved tissue bank changes or proves to be incorrect, or changes to a tissue bank are approved.
p.(None): These updates must be made immediately, at the latest within ten working days if there are significant changes in accordance with Section 22.
p.(None): (2) The Federal Office for Safety in Health Care has the competent authorities in another Member State if they are included in the EU Compendium of
p.(None): Tissue facilities see false information regarding a tissue facility in that Member State, or if they are found to be in material breach of the
p.(None): Warn about the provisions of the Single European Code related to the other Member State.
p.(None): (3) The Federal Office for Safety in Health Care must notify the Commission and the other competent authorities if this
p.(None): EU compendium of tissue and cell products, in his opinion, needs to be updated.
p.(None): Transitional and final provisions
p.(None): Section 37. (1) Anyone who obtains cells or tissue or operates a tissue bank at the time this federal law comes into force and this company
p.(None): wants to continue, has one within six months after the entry into force of this federal law at the Federal Office for Safety in Health Care
p.(None): To report in accordance with § 19 or to apply for a license in accordance with § 22.
p.(None): (2) Existing tissue banks may continue to be operated until a decision is made on the application made in accordance with paragraph 1, provided that they are in perfect condition
p.(None): The quality of the products and the protection of the health of the recipient are guaranteed.
p.(None): (3) The Federal Office for Safety in Health Care must have the remedial action taken immediately before the decision is made on the application made under paragraph 1
p.(None): order with grievances, which are suitable to ensure the perfect condition of the products and the protection of the health of the recipient
p.(None): guarantee. In the event of imminent danger, the withdrawal facility or tissue bank must be closed by the Federal Office for Safety in Health Care.
p.(None): (4) If the operator of a removal facility fails to notify the registration office or a tissue bank to apply for an authorization to the Federal Office of
p.(None): Healthcare safety within the specified period, or if the operator does not comply with the instructions in Paragraph 3, this has
p.(None): Federal Office for Safety in Health Care to prohibit the operation with notice.
p.(None): (5) The obligation under Section 16 (6) second sentence concerns the reports for the calendar year 2012 for the first time.
p.(None): Section 37a. (1) Section 1 (3) (1), Section 2 (23) to (39), the heading before Section 5, Section 5 (2) and (6), the heading before Section 6 and 11, Section 11 (7) and (8), Section 12 Paras. 1 and 7 to 9,
p.(None): Section 15 subsection 4, Section 15a including the heading, Section 16 subsection 1, 2, 6 and 7, Section 17 subsection 5 and 6, Section 17a, Section 22 subsection 3 and 4, Section 23 subsection 4 to 6, § 25a, § 26 paragraph 1a and 9 to 12, § 29
p.(None): Paragraph 3, Section 32 Paragraphs 1 and 1a, the changes in Section 35, Section 36a and Section 37a Paragraphs 2 and 3 in the version of the Federal Law BGBl. I № 105/2016 take effect on April 29
p.(None): 2017 in force.
p.(None): (2) The obligation to attach the Single European Code does not apply to cells or tissues that are already stored on October 29, 2016
p.(None): provided that the tissues and cells are released for traffic no later than five years after this time and their traceability otherwise
p.(None): is guaranteed. For cells and tissues that are stored beyond this point in time and only released for traffic after the five-year period
p.(None): and to which the Single European Code cannot be applied, in particular because they are stored frozen, Section 15a (5) applies
p.(None): Sentence.
p.(None): (3) Tissue banks that received a license for import from third countries before April 29, 2017 must be approved by the Federal Office of
p.(None): Healthcare safety to issue a certificate in accordance with Appendix C.
p.(None): (4) Sections 2 (21), 4 (5a), 7 (1), 16 (4), 18 (3), 32 (1a) and 33 (1), § 5 no longer applies Paragraph 5 and Section 16 Paragraph 4, as well as Appendix D
p.(None): Section B in the version of the 2nd Matter Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, comes into force on May 25, 2018.
p.(None): § 38. Insofar as other federal laws are referred to in this federal law, these are to be applied in their respectively applicable version.
p.(None): § 39. With the enforcement of this federal law, the Federal Minister of Health, Family and Youth is in agreement with § 36
p.(None): Federal Minister of the Interior.
p.(None): Section 40. (1) The Federal Office for Safety in Health Care has the Federal Minister of Health, Family and Youth and that of Health
p.(None): Österreich GesmbH set up an advisory board for advice on transplantation issues based on the annual reports of the tissue banks
p.(None): Activities of the withdrawal facilities and tissue banks within the framework of this federal law and the enforcement of this federal law.
...
p.(None): Commission by April 7, 2009 and thereafter every three years a report on the activities of the extraction facilities and tissue banks in the context of this
p.(None): Federal law and on the enforcement of this federal law in the previous reporting period.
p.(None): Section 41. The following guidelines are implemented by this Federal Act:
p.(None): 1. Directive 2004/23 / EG for the definition of quality and safety standards for donation, procurement, testing, processing, preservation,
p.(None): Storage and distribution of human tissues and cells, OJ. No.L 102 of April 7, 2004 p. 48,
p.(None): 2. Directive 2006/17 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to technical regulations for the
p.(None): Donation, procurement and testing of human tissues and cells, OJ. No.L 38 of February 9, 2006 p. 40,
p.(None): 3. Directive 2006/86 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to the requirements for
p.(None): Traceability, reporting serious incidents and undesirable reactions, and certain technical requirements for
p.(None): Coding, processing, preservation, storage and distribution of human tissues and cells, OJ. L 294 of October 25, 2006 S 32,
p.(None): 4. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human tissues
p.(None): and cells, OJ. No.L 93 from 04/09/2015 S 43,
p.(None): 5. Directive (EU) 2015/566 implementing Directive 2004/23 / EC with regard to the procedures for checking the equivalence of quality and
p.(None): Safety standards for imported tissues and cells, OJ. No.L 93 from 04/09/2015 S 56.
p.(None): Appendix A
p.(None): Composition of the Single European Code
p.(None): Donation identification sequence Product identification sequence
p.(None): EU tissue bank code Unique product code Split number Expiry date
p.(None): Donation number * (YYYYMMDD)
p.(None): ****
p.(None): ISO tissue bank number Identification of the product number ***
p.(None): Country code product coding system **
p.(None): 2 6 alphanumeric 13 1 characters 7 3 8 digits
p.(None): Character characters alphanumeric alphanumeric alphanumeric
p.(None): Sign sign sign
p.(None): * Allocation through tissue bank or using ISBT 128
p.(None): ** E (for EUTC), or A (for ISBT 128) or B (for Eurocode)
p.(None): *** Product number in the permitted coding systems (EUTC; ISBT 128 or Eurocode) for the product type
p.(None): **** If no expiry date has been set, 00000000 must be specified as the expiry date.
p.(None): Appendix B
p.(None): Information and documents to be attached to an application for a license for import activities from third countries
p.(None): When applying for a license, the introductory tissue bank must - if not already done in the context of previous applications for a license - be the most current
p.(None): Provide information and (for Part F) documents on the following points:
p.(None): A. General information about the introductory tissue bank (EGB)
p.(None): 1. Name of the EGB (company name).
p.(None): 2. Visit address of the EGB.
p.(None): 3. Postal address of the ETUC (if different).
p.(None): 4. Status of the applying ETUC: It must be stated whether this is the first application for authorization as an ETUC or whether it is an application for an extension
p.(None): is. If the applicant is already approved as a tissue bank, the EU tissue establishment code must be provided.
p.(None): 5. Name of the applicant unit (if not identical to the company name).
p.(None): 6. Visiting address of the applicant unit.
p.(None): 7. Postal address of the applicant unit (if different).
...
Social / Occupation
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p.(None): Associated with the extraction or use of cells and tissues that are fatal or life-threatening, a disability or a disability
p.(None): Results in loss of capacity or necessitates or prolongs hospitalization or leads to or prolongs an illness;
p.(None): 14. Withdrawal facility: any facility, including mobile harvesting teams, involved in activities related to the extraction of human beings
p.(None): Cells and tissues for human use are exported;
p.(None): 15. Tissue bank: any facility in which activities related to the processing, storage or distribution of human cells and tissues are used
p.(None): Application to be carried out in humans;
p.(None): 16. allogeneic use: the removal of cells or tissues from one person and their transfer to another person;
p.(None): 17. autologous use: the removal of cells or tissues and their transfer back to the same person;
p.(None): 18. User: Hospitals and self-employed doctors and dentists who are responsible for the use of human cells or tissues in humans
p.(None): are responsible;
p.(None): 19. Quality system: the organizational structure, defined responsibilities, procedures, processes and resources for the implementation of the
p.(None): Quality management, including all activities that contribute directly or indirectly to quality;
p.(None): 20. Validation (or "qualification" in relation to plants or environments): Providing documented evidence that proves with high certainty,
p.(None): that a speci fi c process, standard process, piece of equipment, or an environment, without exception, creates a product that does the job
p.(None): corresponds to specified speci fi cations and quality characteristics; A process is validated to evaluate how e ff ectively the performance of a system for the
p.(None): Intended use is;
p.(None): 21. Traceability: the possibility of the tissue or the cell at every stage from the extraction, processing, testing and storage to
p.(None): Localize and identify use at recipient or for disposal, including the ability to identify the donor and tissue bank,
p.(None): who receives, processes or stores the tissues or cells, as well as the possibility to collect the respective recipient (s) from the user;
p.(None): Traceability also means the ability to locate and locate all relevant data related to the products and materials
p.(None): raise that come into contact with these tissues or cells;
p.(None): 22. Medicinal products for novel therapies: gene therapeutics and somatic cell therapeutics according to Part IV of Annex I to Directive 2001/83 / EC of the European Union
p.(None): Parliament and of the Council of 6 November 2001 adopting a Community code for medicinal products for human use, as last amended by the Directive
p.(None): 2004/27 / EG as well as biotechnologically processed tissue products according to Article 2 Paragraph 1 lit. b of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on medicinal products for advanced therapies and amending Directive 2001/83 / EC and the
p.(None): Regulation (EC) No. 726/2004;
p.(None): 23. "Uniform European Code" or "SEC": the unique identification number for tissues and cells distributed in the European Economic Area. The
p.(None): Uniform European Code consists of a donation identification sequence and a product identification sequence according to Appendix A;
...
p.(None): 3. A copy of the third-country supplier's export license or, if no special export license has been issued, one
p.(None): Certificate from the relevant third country authority (s) approving the activities of the third country supplier in the cells and tissues sector, including
p.(None): To run. These documents must also contain the contact details of the competent authority (ies) of the third country. In third countries where such documents
p.(None): other documents are not available, such as reports on audits at the third-country supplier.
p.(None): Appendix C.
p.(None): Certificate of approval as an introductory tissue bank
p.(None): Appendix D.
p.(None): Minimum requirements with regard to the documentation submitted to the Federal Office for Safety in Health Care of tissue banks, the cells and
p.(None): Want to import tissue from third countries
p.(None): The applicant importing tissue bank must have the current version of the following documents relating to the applicant and his / her third-country supplier
p.(None): provide and - if not already done in the context of previous applications for authorization as an introductory tissue bank - upon request to the
p.(None): Submit to the Federal Office. This does not apply to one-off imports within the meaning of Section 2 no. 39 of this Federal Act, which are subject to these documentation requirements
p.(None): with exception of. When importing hematopoietic stem cells for the treatment of life-threatening diseases, only the documentation on A. for
p.(None): Will be provided.
p.(None): A. Documentation on the introductory tissue bank
p.(None): 1. Job description of the responsible person and precise information on their relevant qualifications and training in accordance with § 9;
p.(None): 2. Copy of the original label, the outer packaging label as well as the documents for the outer packaging and the transport container;
p.(None): 3. List of relevant, current standard operating instructions (SOP) for the institution's import activities, including the SOP for the application of the
p.(None): Uniform European codes, the reception and storage of imported cells and tissues in the introductory tissue bank, the management
p.(None): serious incidents and serious undesirable reactions, management of recalls and traceability from donor to
p.(None): Receiver.
p.(None): B. Documentation of the third country supplier (s)
p.(None): 1. Detailed description of the criteria for the identification and assessment of donors, details of the donors or the donor family
p.(None): Information, description of the procedure for obtaining the consent of the donor or the donor family as well as information on whether it is a
p.(None): voluntary and free donation;
p.(None): 2. detailed information about the test centers used by the third country suppliers and the tests carried out by these centers;
p.(None): 3. detailed information on the methods used in the processing of cells and tissues, including precise information on the validation of the
p.(None): Critical processing procedure;
p.(None): 4. Detailed information about the facilities, important equipment and materials as well as the criteria for quality control and environmental control in
p.(None): Relating to any activity performed by the third country supplier;
...
Social / Property Ownership
Searching for indicator home:
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p.(None): Home Contact Sitemap Imprint Deutsch
p.(None): [Federal law] State law Municipal law Judiciary Other announcements, decrees Total query
p.(None): Federal law consolidated: Entire legal provision for tissue safety law, version dated February 18, 2020 Print view
p.(None): Other formats:
p.(None): long Title
p.(None): Federal law on the definition of quality and safety standards for the extraction, processing, storage and distribution of human cells
p.(None): and tissues for use in humans (Tissue Safety Act-GSG)
p.(None): StF: BGBl. I No. 49/2008 (NR: GP XXIII RV 261 AB 343 p. 40. BR: AB 7823 p. 751.)
p.(None): [CELEX-No: 32004L0023, 32006L0017, 32006L0086]
p.(None): modification
p.(None): BGBl. I No. 63/2009 (NR: GP XXIV RV 155 AB 184 p. 26. BR: 8115 AB: 8123 p. 772.)
p.(None): BGBl. I No. 108/2012 (NR: GP XXIV RV 1935 AB 1980 p. 179. BR: 8814 AB 8819 p. 815.)
p.(None): [CELEX No .: 32010L0053]
p.(None): BGBl. I No. 162/2013 (NR: GP XXIV RV 2446 AB 2560 p. 213. BR: AB 9071 p. 823.)
p.(None): [CELEX-No .: 32011L0024, 32012L0026]
p.(None): BGBl. I No. 105/2016 (NR GP XXV RV 1293 AB 1309 p. 152. BR: AB 9660 p. 860.)
p.(None): [CELEX-No .: 32015L0565, 32015L0566]
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 S. 23. BR: 9967 AB 9970 S. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): text
p.(None): scope
p.(None): § 1. (1) This federal law regulates the extraction of human cells and tissues for use in humans. It also regulates the
p.(None): Processing, storage and distribution of human cells and tissues for use in humans, if not for the production of
p.(None): Medicines that are always prepared in advance in the same composition and under the same name in a for delivery to the consumer or
p.(None): Certain form can be placed on the market, used by investigational medicinal products or by medical devices.
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): 17. autologous use: the removal of cells or tissues and their transfer back to the same person;
p.(None): 18. User: Hospitals and self-employed doctors and dentists who are responsible for the use of human cells or tissues in humans
p.(None): are responsible;
p.(None): 19. Quality system: the organizational structure, defined responsibilities, procedures, processes and resources for the implementation of the
p.(None): Quality management, including all activities that contribute directly or indirectly to quality;
p.(None): 20. Validation (or "qualification" in relation to plants or environments): Providing documented evidence that proves with high certainty,
p.(None): that a speci fi c process, standard process, piece of equipment, or an environment, without exception, creates a product that does the job
p.(None): corresponds to specified speci fi cations and quality characteristics; A process is validated to evaluate how e ff ectively the performance of a system for the
p.(None): Intended use is;
p.(None): 21. Traceability: the possibility of the tissue or the cell at every stage from the extraction, processing, testing and storage to
p.(None): Localize and identify use at recipient or for disposal, including the ability to identify the donor and tissue bank,
p.(None): who receives, processes or stores the tissues or cells, as well as the possibility to collect the respective recipient (s) from the user;
p.(None): Traceability also means the ability to locate and locate all relevant data related to the products and materials
p.(None): raise that come into contact with these tissues or cells;
p.(None): 22. Medicinal products for novel therapies: gene therapeutics and somatic cell therapeutics according to Part IV of Annex I to Directive 2001/83 / EC of the European Union
p.(None): Parliament and of the Council of 6 November 2001 adopting a Community code for medicinal products for human use, as last amended by the Directive
p.(None): 2004/27 / EG as well as biotechnologically processed tissue products according to Article 2 Paragraph 1 lit. b of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on medicinal products for advanced therapies and amending Directive 2001/83 / EC and the
p.(None): Regulation (EC) No. 726/2004;
p.(None): 23. "Uniform European Code" or "SEC": the unique identification number for tissues and cells distributed in the European Economic Area. The
p.(None): Uniform European Code consists of a donation identification sequence and a product identification sequence according to Appendix A;
p.(None): 24. “Donation identification sequence”: the first part of the Single European Code, consisting of the EU Tissue Establishment Code and the unique one
p.(None): Donation number;
p.(None): 25. "EU tissue establishment code": the unique identification number for approved, named, approved or licensed tissue establishments in the
p.(None): European economic area. The tissue establishment code consists of an ISO country code and the tissue establishment number in the EU
p.(None): Compendium of Tissue Facilities;
p.(None): 26. "unique donation number": the unique number as set out in Appendix A.
p.(None): 27. "Product identification sequence": the second part of the Single European Code, consisting of the product code, the split number and the
p.(None): Expiration date;
p.(None): 28. “Product code”: the identifier of the speci fi c type of the tissues and cells concerned. According to Appendix A, the product code consists of the identifier of the
p.(None): Systems for the product coding, which the tissue device uses ('E' for EUTC, 'A' for ISBT 128, 'B' for Eurocode) and from the product number for
p.(None): Tissues and cells in the relevant coding system for the product type;
p.(None): 29. "Split number": the number in Annex A used to distinguish and uniquely identify tissues and cells associated with the same
p.(None): unique donation number and product code are identified and come from the same tissue facility;
p.(None): 30. "expiry date" means the date in Annex A by which the tissues and cells can be used;
p.(None): 31. "EU Coding Platform": the IT platform operated by the Commission with the EU Compendium of Tissue Facilities and the EU Compendium
p.(None): tissue and cell products;
p.(None): 32. "EU Compendium of Tissue Facilities": the register of all of the competent authorities of a Party to the Agreement on the
p.(None): European Economic Area approved, licensed, designated or approved tissue establishment that provides information about this
p.(None): Contains tissue devices in accordance with Annex VIII of Directive (EU) 2015/565;
p.(None): 33. "EU Compendium of Tissue and Cell Products": the register of all tissue and cell types in circulation in the European Economic Area
p.(None): the respective product codes of the three permitted coding systems (EUTC, ISBT 128 and Eurocode);
p.(None): 34. “EUTC”: the product coding system for tissues and cells developed by the Union, which is available from a register of all in the Union
p.(None): Tissue and cell types with the respective product codes;
p.(None): 35. “Open to traffic”: distribution for human use or transfer to another actor, for example for
p.(None): Further processing with or without return;
p.(None): 36. "within the same facility": all steps from extraction to use in humans are carried out by the same responsible person and
p.(None): carried out in the same system for quality management and traceability in a hospital in which the
p.(None): Removal device and the approved tissue bank are located;
p.(None): 37. "Pooling": one and the same container contains or mixes tissues or cells from more than one extraction from the same
p.(None): Donors or from two or more donors;
p.(None): 38. "third country supplier" means a tissue bank, sampling facility or other body in a third country which is responsible for the export of cells and tissues which
p.(None): delivers them to an introductory tissue bank responsible for the European Economic Area. A third country supplier can also use one or more of the
p.(None): activities outside the European Economic Area in connection with donation, extraction, testing, processing,
p.(None): Maintain, store or distribute cells and tissues imported into the European Economic Area;
p.(None): 39. "Single import" means the import of a specific type of cells or tissues for use by an intended recipient or recipients
p.(None): Recipients who / have stored these cells or tissues with a third country supplier for future use and therefore the
p.(None): importing tissue bank and is known to the third country supplier before import. This is normally allowed for a specific recipient
p.(None): occur at most once. Regular or repeated importation through the same third country supplier is not considered to be a "single import".
p.(None): recovery
...
Social / Youth/Minors
Searching for indicator youth:
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p.(None): 1. if a sampling facility transfers the testing of the donor to a third party, or
p.(None): 2. if a third party delivers goods or services that affect the guarantee of the quality and safety of tissues or cells.
p.(None): (3) The assessment and selection of third parties is to be carried out by the removal facility according to whether they can comply with the prescribed standards.
p.(None): (4) Each removal facility has a complete list of all agreements concluded with tissue banks or with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The original or a copy of the agreements must always be available in the removal facility and are effective after they have expired
p.(None): keep for at least 10 years.
p.(None): (5) In the agreements between the withdrawal facility and third parties, the responsibilities that are exercised by third parties and the
p.(None): to specify the exact procedure. A contractor may not perform a contractually assigned task without the written consent of the removal facility
p.(None): Pass on to third parties.
p.(None): (6) In the event of extraction outside the company's own premises, the tapping facility has to do so by means of written agreements with the parties involved
p.(None): Institutions to ensure compliance with the quality and safety standards provided in this federal law.
p.(None): (7) At the request of the Federal Office for Safety in Health Care, the withdrawal facility has copies of its agreements with tissue banks and
p.(None): to submit with third parties.
p.(None): Authorization to issue regulations
p.(None): § 7. (1) The Federal Minister of Health, Family and Youth, insofar as this is to protect the donor and the perfect condition of
p.(None): donated cells and tissues is required by regulation for more detailed regulations
p.(None): 1. The requirements for the necessary personnel, spatial, operational and technical equipment including the one to be provided
p.(None): Quality Systems,
p.(None): 2. The selection criteria for the donors of cells and tissues including which findings are limited in time or permanent health suitability
p.(None): Exclude donors, as well as these criteria in the case of autologous use,
p.(None): 3. what information and in what form the living donor has to be given before the donation and what relevant abnormal findings have to be communicated,
p.(None): 4. In what form the identity of the donor is to be documented, by whom, in what way and to what extent the collection, processing and
p.(None): The transmission of the data and the documentation must be carried out and the precautions to be taken regarding traceability,
p.(None): 5. the laboratory tests prescribed for donors and which test results are temporary or permanent are suitable for health
p.(None): exclude as donor,
p.(None): 6. the processes for obtaining cells and tissues,
p.(None): 7. The packaging, labeling and transfer of cells and tissues to tissue banks or to users for direct use, including the
p.(None): the information and documents to be provided, and
p.(None): 8. regarding an obligation to insure for allogeneic donors
p.(None): adopted.
p.(None): (2) Provided that this is compatible with the protection of the donor and the perfect condition of donated cells and with regard to the special features
p.(None): If medically assisted reproduction is required, the Federal Minister of Health can provide for deviations from the requirements of Section 6.
...
p.(None): Section 28. (1) The Federal Office for Safety in Health Care must withdraw the certificate or the tissue bank from a withdrawal facility,
p.(None): if
p.(None): 1. a requirement for the issuance of the certi fi cate in accordance with §§ 19ff or the granting of the license in accordance with §§ 22ff has ceased to apply or
p.(None): Orders to remedy defects within the meaning of Section 27 (1) have not been complied with twice,
p.(None): 2. it emerges that such a requirement was not met when the certificate was issued or the license was granted,
p.(None): 3. the holder of a certi fi cate or an authorization for violation of the provisions of this Federal Act pursuant to Section 35 (1) within five
p.(None): Years has been punished at least three times, or
p.(None): 4. at least the holder of a certi fi cate or a license for violations of the provisions of this Federal Act pursuant to Section 35 (2)
p.(None): has been punished twice.
p.(None): (2) The Federal Office for Safety in Health Care may temporarily or permanently grant a responsible person the right to exercise
p.(None): Prohibit the work of a responsible person if they are punished at least three times for violations of the provisions of this Federal Act
p.(None): has been.
p.(None): Registers of withdrawal devices and tissue banks
p.(None): Section 29. (1) The Federal Office for Safety in Health Care has a register of all certified withdrawal facilities and approved tissue banks, in
p.(None): which in any case must also contain information about the activities for which the certi fi cation or approval was granted. This is in the
p.(None): Make the Internet publicly available on the homepage of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Minister of Health, Family and Youth may, by ordinance, provide more detailed regulations regarding the maintenance of this register and the type and
p.(None): Extent of entries.
p.(None): (3) The Federal Office for Safety in Health Care must assign a unique tissue establishment number to each tissue bank approved, provided that
p.(None): this does not result from the chosen Single European Code. If a tissue bank has several locations, it can with regard to the
p.(None): Tissue device number can be treated as a single tissue device.
p.(None): Authorization to issue regulations on tissue banks
p.(None): Section 30. The Federal Minister of Health, Family and Youth may, by ordinance, issue more detailed provisions on:
p.(None): 1. What are the requirements for the necessary spatial and technical equipment as well as for the hygiene standards to be observed?
p.(None): Adequate quality system and the organizational scheme must be set up
p.(None): 2. What minimum staffing levels a tissue bank must have, what special knowledge and skills the staff must have
p.(None): and in which schooling, further education and further training measures these people have to take,
p.(None): 3. how cells and tissues are to be labeled,
p.(None): 4. Which requirements are to be met for products for autologous use?
p.(None): 5. which procedures are to be followed when receiving cells or tissues,
p.(None): 6. Which conditions are to be observed during processing, storage and distribution, can also be more detailed regulations regarding the requirements
p.(None): processing methods are taken,
p.(None): 7. Which packaging requirements have to be met?
p.(None): 8. Which requirements are to be made of the documentation and its type and scope,
p.(None): 9. what precautions are to be taken regarding traceability,
p.(None): 10. Which procedures for reporting serious incidents and serious undesirable reactions have to be followed as well as with regard to type and
p.(None): Scope of such reports,
p.(None): 11.When equivalent quality and safety standards within the meaning of Section 12 (2) can be assumed for imports from third countries,
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
p.(None): 1. processed, stored and distributed by a removal facility without this facility having to have an authorization in accordance with § 22, and
p.(None): 2. Irrespective of § 12, the user can directly insert or receive it or it can be carried out by a removal facility.
p.(None): Regulations for users
p.(None): Section 32. (1) Users have any use of cells and tissues in humans according to the state of the art in a data archive
p.(None): document and keep it for at least 30 years. In any case, this documentation must contain:
p.(None): 1.Identification of the tissue bank or the removal device for direct use from which the cells or tissue were obtained,
p.(None): 2. identification of the user,
p.(None): 3. cell or tissue type,
p.(None): 4. Product identifier,
p.(None): 5. Recipient identification,
p.(None): 6. date of application,
p.(None): 7. Single European Code (if available).
p.(None): (1a) The legibility of the documentation must be ensured for the retention period. The access authorization for the individual users is individual
p.(None): assign and document. The persons authorized to access are to be informed about the requirements according to Art. 32 Para. 4 General Data Protection Regulation. There are
p.(None): Take data security measures in accordance with Art. 32 General Data Protection Regulation.
p.(None): (2) Doctors and dentists
p.(None): 1. any serious adverse reaction that has been observed during or after clinical use of cells or tissues and with quality
p.(None): and could be related to cell or tissue security, and
p.(None): 2. any lack of quality or safety that arises in connection with a serious undesirable incident in the extraction, processing,
p.(None): Storage or distribution,
p.(None): immediately the tissue bank from which they received the cells or the tissue or, in the case of direct use of the withdrawal device, the
p.(None): affected cells or tissues, report and pass on all relevant information in order to facilitate traceability and the
p.(None): To ensure quality and safety control. In the case of direct use, the user must also report to the Federal Office of
p.(None): Reimburse healthcare security.
p.(None): (3) The Federal Minister of Health, Family and Youth can, by ordinance, specify the content of the documentation in accordance with paragraph 1
p.(None): as well as the type, scope and form of reports and information in accordance with paragraph 2.
p.(None): Vigilanzregister
p.(None): Section 33. (1) The Federal Office for Safety in Health Care has all reported serious undesirable reactions and all serious ones
p.(None): Record incidents in a register. This register is used for tissue vigilance and market surveillance. Processing data from donors and
p.(None): Receiver takes place without personal reference. Data security measures in accordance with Art. 32 General Data Protection Regulation must be taken.
p.(None): (2) The Federal Office for Safety in Health Care has a report to the Federal Minister of Health, Family and Youth by June 30 each year
p.(None): submit reports of serious incidents and serious adverse reactions in the previous calendar year.
p.(None): Automation-supported data traffic
p.(None): Section 34. The Federal Office for Safety in Health Care is authorized to store data in or for automation-supported data traffic in accordance with section 33 (1)
p.(None): collect and transmit them to
p.(None): 1. the Federal Ministry of Health, Family and Youth,
p.(None): 2. the European Commission and
p.(None): 3. competent authorities of other contracting parties to the Agreement on the European Economic Area.
p.(None): administrative Penalties
p.(None): Section 35. (1) Who
p.(None): 1. in the extraction, processing, storage and distribution of human cells and tissue contrary to § 1 paragraph 2 the state of the art and
p.(None): Technology does not comply
p.(None): 2. does not meet or guarantee the requirements of section 3 (2) or (4) to (8) for extraction facilities,
p.(None): 3. performs the removal of cells or tissues from the living donor contrary to Section 4 (2) without previous examinations,
p.(None): 4. violates the documentation requirements according to § 5 paragraphs 1 to 4 or the packaging requirements of § 5 paragraph 6,
p.(None): 5. violates the obligations under § 6,
p.(None): 6. violates the obligations under § 8 paragraphs 2 to 4,
p.(None): 7. operates a tissue bank without having a responsible person or employing a responsible person who does not have the quali fi cation
p.(None): pursuant to section 9 subsection 2 or violates the reporting obligation pursuant to section 9 subsection 4,
p.(None): 8. does not meet the requirements for a quality system in accordance with section 10 subsections 1 to 3 or violates the obligation in section 10 subsection 4,
p.(None): 9. Contrary to Section 11 (1) as a tissue bank, no written agreements with removal facilities for removal or contrary to Section 11 (7) as
p.(None): Tissue bank with a license to import from third countries does not conclude any written agreements with third country suppliers or against § 11
p.(None): 2 to 6 or 8 violates,
p.(None): 10. accepts or imports or exports cells or tissue contrary to the provisions of Section 12 or does not meet the other requirements of Section 12,
...
p.(None): Paragraph 3, Section 32 Paragraphs 1 and 1a, the changes in Section 35, Section 36a and Section 37a Paragraphs 2 and 3 in the version of the Federal Law BGBl. I № 105/2016 take effect on April 29
p.(None): 2017 in force.
p.(None): (2) The obligation to attach the Single European Code does not apply to cells or tissues that are already stored on October 29, 2016
p.(None): provided that the tissues and cells are released for traffic no later than five years after this time and their traceability otherwise
p.(None): is guaranteed. For cells and tissues that are stored beyond this point in time and only released for traffic after the five-year period
p.(None): and to which the Single European Code cannot be applied, in particular because they are stored frozen, Section 15a (5) applies
p.(None): Sentence.
p.(None): (3) Tissue banks that received a license for import from third countries before April 29, 2017 must be approved by the Federal Office of
p.(None): Healthcare safety to issue a certificate in accordance with Appendix C.
p.(None): (4) Sections 2 (21), 4 (5a), 7 (1), 16 (4), 18 (3), 32 (1a) and 33 (1), § 5 no longer applies Paragraph 5 and Section 16 Paragraph 4, as well as Appendix D
p.(None): Section B in the version of the 2nd Matter Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, comes into force on May 25, 2018.
p.(None): § 38. Insofar as other federal laws are referred to in this federal law, these are to be applied in their respectively applicable version.
p.(None): § 39. With the enforcement of this federal law, the Federal Minister of Health, Family and Youth is in agreement with § 36
p.(None): Federal Minister of the Interior.
p.(None): Section 40. (1) The Federal Office for Safety in Health Care has the Federal Minister of Health, Family and Youth and that of Health
p.(None): Österreich GesmbH set up an advisory board for advice on transplantation issues based on the annual reports of the tissue banks
p.(None): Activities of the withdrawal facilities and tissue banks within the framework of this federal law and the enforcement of this federal law.
p.(None): (2) The advisory council referred to in paragraph 1 may submit an opinion to the Federal Minister of Health, Family and Youth on the basis of the annual report
p.(None): transmit, especially with regard to the ratio of the need for organs and parts of organs of the deceased for the purpose of transplantation and
p.(None): Removal of cells and tissues for use in humans.
p.(None): (3) The Federal Office for Safety in Health Care has through the Federal Ministry of Health, Family and Youth of the European
p.(None): Commission by April 7, 2009 and thereafter every three years a report on the activities of the extraction facilities and tissue banks in the context of this
p.(None): Federal law and on the enforcement of this federal law in the previous reporting period.
p.(None): Section 41. The following guidelines are implemented by this Federal Act:
p.(None): 1. Directive 2004/23 / EG for the definition of quality and safety standards for donation, procurement, testing, processing, preservation,
p.(None): Storage and distribution of human tissues and cells, OJ. No.L 102 of April 7, 2004 p. 48,
p.(None): 2. Directive 2006/17 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to technical regulations for the
p.(None): Donation, procurement and testing of human tissues and cells, OJ. No.L 38 of February 9, 2006 p. 40,
p.(None): 3. Directive 2006/86 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to the requirements for
p.(None): Traceability, reporting serious incidents and undesirable reactions, and certain technical requirements for
p.(None): Coding, processing, preservation, storage and distribution of human tissues and cells, OJ. L 294 of October 25, 2006 S 32,
p.(None): 4. Directive (EU) 2015/565 amending Directive 2006/86 / EC with regard to certain technical regulations for the coding of human tissues
p.(None): and cells, OJ. No.L 93 from 04/09/2015 S 43,
p.(None): 5. Directive (EU) 2015/566 implementing Directive 2004/23 / EC with regard to the procedures for checking the equivalence of quality and
p.(None): Safety standards for imported tissues and cells, OJ. No.L 93 from 04/09/2015 S 56.
p.(None): Appendix A
p.(None): Composition of the Single European Code
p.(None): Donation identification sequence Product identification sequence
...
Social / education
Searching for indicator education:
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p.(None): which in any case must also contain information about the activities for which the certi fi cation or approval was granted. This is in the
p.(None): Make the Internet publicly available on the homepage of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Minister of Health, Family and Youth may, by ordinance, provide more detailed regulations regarding the maintenance of this register and the type and
p.(None): Extent of entries.
p.(None): (3) The Federal Office for Safety in Health Care must assign a unique tissue establishment number to each tissue bank approved, provided that
p.(None): this does not result from the chosen Single European Code. If a tissue bank has several locations, it can with regard to the
p.(None): Tissue device number can be treated as a single tissue device.
p.(None): Authorization to issue regulations on tissue banks
p.(None): Section 30. The Federal Minister of Health, Family and Youth may, by ordinance, issue more detailed provisions on:
p.(None): 1. What are the requirements for the necessary spatial and technical equipment as well as for the hygiene standards to be observed?
p.(None): Adequate quality system and the organizational scheme must be set up
p.(None): 2. What minimum staffing levels a tissue bank must have, what special knowledge and skills the staff must have
p.(None): and in which schooling, further education and further training measures these people have to take,
p.(None): 3. how cells and tissues are to be labeled,
p.(None): 4. Which requirements are to be met for products for autologous use?
p.(None): 5. which procedures are to be followed when receiving cells or tissues,
p.(None): 6. Which conditions are to be observed during processing, storage and distribution, can also be more detailed regulations regarding the requirements
p.(None): processing methods are taken,
p.(None): 7. Which packaging requirements have to be met?
p.(None): 8. Which requirements are to be made of the documentation and its type and scope,
p.(None): 9. what precautions are to be taken regarding traceability,
p.(None): 10. Which procedures for reporting serious incidents and serious undesirable reactions have to be followed as well as with regard to type and
p.(None): Scope of such reports,
p.(None): 11.When equivalent quality and safety standards within the meaning of Section 12 (2) can be assumed for imports from third countries,
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
p.(None): 1. processed, stored and distributed by a removal facility without this facility having to have an authorization in accordance with § 22, and
...
Searching for indicator schooling:
(return to top)
p.(None): Section 29. (1) The Federal Office for Safety in Health Care has a register of all certified withdrawal facilities and approved tissue banks, in
p.(None): which in any case must also contain information about the activities for which the certi fi cation or approval was granted. This is in the
p.(None): Make the Internet publicly available on the homepage of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Minister of Health, Family and Youth may, by ordinance, provide more detailed regulations regarding the maintenance of this register and the type and
p.(None): Extent of entries.
p.(None): (3) The Federal Office for Safety in Health Care must assign a unique tissue establishment number to each tissue bank approved, provided that
p.(None): this does not result from the chosen Single European Code. If a tissue bank has several locations, it can with regard to the
p.(None): Tissue device number can be treated as a single tissue device.
p.(None): Authorization to issue regulations on tissue banks
p.(None): Section 30. The Federal Minister of Health, Family and Youth may, by ordinance, issue more detailed provisions on:
p.(None): 1. What are the requirements for the necessary spatial and technical equipment as well as for the hygiene standards to be observed?
p.(None): Adequate quality system and the organizational scheme must be set up
p.(None): 2. What minimum staffing levels a tissue bank must have, what special knowledge and skills the staff must have
p.(None): and in which schooling, further education and further training measures these people have to take,
p.(None): 3. how cells and tissues are to be labeled,
p.(None): 4. Which requirements are to be met for products for autologous use?
p.(None): 5. which procedures are to be followed when receiving cells or tissues,
p.(None): 6. Which conditions are to be observed during processing, storage and distribution, can also be more detailed regulations regarding the requirements
p.(None): processing methods are taken,
p.(None): 7. Which packaging requirements have to be met?
p.(None): 8. Which requirements are to be made of the documentation and its type and scope,
p.(None): 9. what precautions are to be taken regarding traceability,
p.(None): 10. Which procedures for reporting serious incidents and serious undesirable reactions have to be followed as well as with regard to type and
p.(None): Scope of such reports,
p.(None): 11.When equivalent quality and safety standards within the meaning of Section 12 (2) can be assumed for imports from third countries,
p.(None): 12. What content the annual activity report of the tissue bank has to show.
p.(None): direct use
p.(None): § 31. (1) The Federal Minister of Health, Family and Youth may, by ordinance, designate specific types of cells and tissues in which it
p.(None): According to the state of the art, it is permissible that these are used directly in the patient after extraction, without entering a tissue bank
p.(None): to be included. This regulation can also specify the conditions for their direct exchange.
p.(None): (2) If a regulation according to paragraph 1 applies to cells and tissues, these can
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): punish.
p.(None): (4) The attempt is punishable.
p.(None): Involvement of organs of the public security service
p.(None): § 36. The organs of the public security service have to the Federal Office for security in the health care over its requests to secure the
p.(None): Exercise the powers pursuant to sections 26, 27 (2) and (3) and 37 (3) to provide help within the scope of their statutory scope.
p.(None): EU Compendium of Tissue Facilities
p.(None): Section 36a. (1) The Federal Office for Safety in Health Care is obliged to provide all information on approved tissue banks in accordance with Annex VIII of the
p.(None): Directive (EU) 2015/565 in the EU Compendium of Tissue Facilities. This data is to be updated when a new tissue bank
p.(None): is approved, information about an approved tissue bank changes or proves to be incorrect, or changes to a tissue bank are approved.
p.(None): These updates must be made immediately, at the latest within ten working days if there are significant changes in accordance with Section 22.
p.(None): (2) The Federal Office for Safety in Health Care has the competent authorities in another Member State if they are included in the EU Compendium of
p.(None): Tissue facilities see false information regarding a tissue facility in that Member State, or if they are found to be in material breach of the
p.(None): Warn about the provisions of the Single European Code related to the other Member State.
p.(None): (3) The Federal Office for Safety in Health Care must notify the Commission and the other competent authorities if this
p.(None): EU compendium of tissue and cell products, in his opinion, needs to be updated.
p.(None): Transitional and final provisions
p.(None): Section 37. (1) Anyone who obtains cells or tissue or operates a tissue bank at the time this federal law comes into force and this company
p.(None): wants to continue, has one within six months after the entry into force of this federal law at the Federal Office for Safety in Health Care
p.(None): To report in accordance with § 19 or to apply for a license in accordance with § 22.
p.(None): (2) Existing tissue banks may continue to be operated until a decision is made on the application made in accordance with paragraph 1, provided that they are in perfect condition
p.(None): The quality of the products and the protection of the health of the recipient are guaranteed.
p.(None): (3) The Federal Office for Safety in Health Care must have the remedial action taken immediately before the decision is made on the application made under paragraph 1
p.(None): order with grievances, which are suitable to ensure the perfect condition of the products and the protection of the health of the recipient
p.(None): guarantee. In the event of imminent danger, the withdrawal facility or tissue bank must be closed by the Federal Office for Safety in Health Care.
p.(None): (4) If the operator of a removal facility fails to notify the registration office or a tissue bank to apply for an authorization to the Federal Office of
p.(None): Healthcare safety within the specified period, or if the operator does not comply with the instructions in Paragraph 3, this has
p.(None): Federal Office for Safety in Health Care to prohibit the operation with notice.
p.(None): (5) The obligation under Section 16 (6) second sentence concerns the reports for the calendar year 2012 for the first time.
...
p.(None): and to which the Single European Code cannot be applied, in particular because they are stored frozen, Section 15a (5) applies
p.(None): Sentence.
p.(None): (3) Tissue banks that received a license for import from third countries before April 29, 2017 must be approved by the Federal Office of
p.(None): Healthcare safety to issue a certificate in accordance with Appendix C.
p.(None): (4) Sections 2 (21), 4 (5a), 7 (1), 16 (4), 18 (3), 32 (1a) and 33 (1), § 5 no longer applies Paragraph 5 and Section 16 Paragraph 4, as well as Appendix D
p.(None): Section B in the version of the 2nd Matter Data Protection Adjustment Act, Federal Law Gazette I No. 37/2018, comes into force on May 25, 2018.
p.(None): § 38. Insofar as other federal laws are referred to in this federal law, these are to be applied in their respectively applicable version.
p.(None): § 39. With the enforcement of this federal law, the Federal Minister of Health, Family and Youth is in agreement with § 36
p.(None): Federal Minister of the Interior.
p.(None): Section 40. (1) The Federal Office for Safety in Health Care has the Federal Minister of Health, Family and Youth and that of Health
p.(None): Österreich GesmbH set up an advisory board for advice on transplantation issues based on the annual reports of the tissue banks
p.(None): Activities of the withdrawal facilities and tissue banks within the framework of this federal law and the enforcement of this federal law.
p.(None): (2) The advisory council referred to in paragraph 1 may submit an opinion to the Federal Minister of Health, Family and Youth on the basis of the annual report
p.(None): transmit, especially with regard to the ratio of the need for organs and parts of organs of the deceased for the purpose of transplantation and
p.(None): Removal of cells and tissues for use in humans.
p.(None): (3) The Federal Office for Safety in Health Care has through the Federal Ministry of Health, Family and Youth of the European
p.(None): Commission by April 7, 2009 and thereafter every three years a report on the activities of the extraction facilities and tissue banks in the context of this
p.(None): Federal law and on the enforcement of this federal law in the previous reporting period.
p.(None): Section 41. The following guidelines are implemented by this Federal Act:
p.(None): 1. Directive 2004/23 / EG for the definition of quality and safety standards for donation, procurement, testing, processing, preservation,
p.(None): Storage and distribution of human tissues and cells, OJ. No.L 102 of April 7, 2004 p. 48,
p.(None): 2. Directive 2006/17 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to technical regulations for the
p.(None): Donation, procurement and testing of human tissues and cells, OJ. No.L 38 of February 9, 2006 p. 40,
p.(None): 3. Directive 2006/86 / EC implementing Directive 2004/23 / EC of the European Parliament and of the Council with regard to the requirements for
p.(None): Traceability, reporting serious incidents and undesirable reactions, and certain technical requirements for
p.(None): Coding, processing, preservation, storage and distribution of human tissues and cells, OJ. L 294 of October 25, 2006 S 32,
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General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): 39. "Single import" means the import of a specific type of cells or tissues for use by an intended recipient or recipients
p.(None): Recipients who / have stored these cells or tissues with a third country supplier for future use and therefore the
p.(None): importing tissue bank and is known to the third country supplier before import. This is normally allowed for a specific recipient
p.(None): occur at most once. Regular or repeated importation through the same third country supplier is not considered to be a "single import".
p.(None): recovery
p.(None): Section 3
p.(None): were reported in accordance with § 19.
p.(None): (1a) Deviating from Paragraph 1, cells and tissues may also be obtained from unreported sampling facilities if there are any
p.(None): a medical intervention unforeseen according to the state of medical science the need for later autologous use
p.(None): of these cells and tissues.
p.(None): (2) Each extraction facility has the personnel, spatial, operational and
p.(None): to have technical equipment. The personnel involved in the extraction or testing must take appropriate further training measures in good time
p.(None): and are regularly brought up to date with the latest science and technology.
p.(None): (3) Organizational forms in which the extraction of cells and tissues are partially or exclusively also count as withdrawal devices according to Paragraph 1
p.(None): done by mobile removal teams outside of their own premises.
p.(None): (4) The equipment must be designed in such a way that the respective state of the art in science and technology ensures a trouble-free organizational process
p.(None): is guaranteed, the required hygiene standards are maintained and living donors can receive emergency medical care at any time.
p.(None): (5) Each extraction facility must operate a functional quality system in accordance with the state of the art in science and technology, which the active
p.(None): Management and staff involvement.
p.(None): (6) Every removal facility must ensure that at least standard operating instructions (standard operating
p.(None): Procedures-SOPs), guidelines, training and reference manuals, self-inspection according to paragraph 7, records of donors and information about
p.(None): the transfer of the cells and tissues obtained are documented.
p.(None): (7) Every sampling facility has to carry out regular self-inspections in order to ensure that the state of the art and the state of the art are applied and observed
p.(None): Monitor technology and make suggestions for any necessary corrective measures. Self-inspection is part of the quality system.
p.(None): (8) Each removal facility must ensure that the documents within the framework of the quality system are available at all times during inspections
p.(None): stand.
p.(None): (9) The donor facility is prohibited from donating human tissues and cells himself or through other physical or legal persons
p.(None): to advertise that there is a prospect of a financial gain or a comparable advantage for the donation.
p.(None): donor
p.(None): § 4. (1) The assessment and selection of donors must be made in accordance with the state of the art in science.
p.(None): (2) Before the removal of cells or tissues, the living donor must undergo the necessary examinations to determine the physical and
p.(None): assess psychological risks to his health. A withdrawal may not be carried out if this poses a serious risk to life or the life
...
p.(None): 2. Telephone number.
p.(None): 3. Email address.
p.(None): 4. Name of the responsible person (if not identical to the contact person).
p.(None): 5. Telephone number.
p.(None): 6. Email address.
p.(None): 7. URL address of the EGB website (if available).
p.(None): C. Information on the cells and tissues to be imported
p.(None): 1. List the types of cells and tissues to be imported, including one-time imports of specific types of cells and tissues.
p.(None): 2. Product name (possibly according to the general EU list) of all types of cells and tissues to be imported.
p.(None): 3. Trade name (if not identical to the product name) of all types of cells and tissues to be imported.
p.(None): 4. Name of the third country supplier for each type of cell and tissue to be imported.
p.(None): D. Place of activity
p.(None): 1. List of activities related to the donation, procurement, testing, processing, preservation or storage prior to the import of the
p.(None): Third-country suppliers are organized by type of cells or tissues.
p.(None): 2. List of activities related to donation, procurement, testing, processing, preservation or storage prior to the import of
p.(None): Subcontractors of the third country supplier are carried out, broken down by type of cells or tissues.
p.(None): 3. List of all activities carried out by the ETUC after import, broken down by type of cells or tissues.
p.(None): 4. Names of third countries in which the activities are carried out before import, broken down by type of cells or tissues.
p.(None): E. Information about third country suppliers
p.(None): 1. Name of the third country supplier (company name).
p.(None): 2. Name of the contact person.
p.(None): 3. Visiting address.
p.(None): 4. Postal address (if different).
p.(None): 5. Telephone number with international area code.
p.(None): 6. Emergency telephone number (if different).
p.(None): 7. Email address.
p.(None): F. Documentation to accompany the application
p.(None): 1. A copy of the written agreement with the third country supplier (s).
p.(None): 2. A detailed description of the route of the imported cells and tissues from procurement to their arrival at the importing tissue bank.
p.(None): 3. A copy of the third-country supplier's export license or, if no special export license has been issued, one
p.(None): Certificate from the relevant third country authority (s) approving the activities of the third country supplier in the cells and tissues sector, including
p.(None): To run. These documents must also contain the contact details of the competent authority (ies) of the third country. In third countries where such documents
p.(None): other documents are not available, such as reports on audits at the third-country supplier.
p.(None): Appendix C.
p.(None): Certificate of approval as an introductory tissue bank
p.(None): Appendix D.
p.(None): Minimum requirements with regard to the documentation submitted to the Federal Office for Safety in Health Care of tissue banks, the cells and
p.(None): Want to import tissue from third countries
p.(None): The applicant importing tissue bank must have the current version of the following documents relating to the applicant and his / her third-country supplier
p.(None): provide and - if not already done in the context of previous applications for authorization as an introductory tissue bank - upon request to the
p.(None): Submit to the Federal Office. This does not apply to one-off imports within the meaning of Section 2 no. 39 of this Federal Act, which are subject to these documentation requirements
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General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): (4) Each tissue bank must ensure that the documents within the framework of the quality system are available at all times during inspections.
p.(None): Relationships between tissue banks and withdrawal facilities, third-country suppliers and other third parties
p.(None): § 11. (1) Each tissue bank has written agreements with the removal facilities from which cells or tissue are accepted
p.(None): complete that clearly define the responsibilities of each side. In particular, there is a procedure for risk assessment by the responsible person
p.(None): regarding donors who do not meet the selection criteria of a regulation according to § 7 and the responsibilities for the transfer of cells or
p.(None): Regulate tissue to the tissue bank.
p.(None): (2) The tissue bank is committed to all activities that are carried out outside the tissue bank by third parties and the effects on quality and
p.(None): Cell and tissue security may have to make written agreements. This in particular
p.(None): 1. if a tissue bank transfers responsibility for a phase of tissue or cell processing to a third party,
p.(None): 2. if a third party delivers goods or provides services that affect the guarantee of the quality and safety of tissues or cells,
p.(None): including their distribution,
p.(None): 3. if a tissue bank provides services for a tissue bank that is not authorized for this,
p.(None): 4. when a tissue bank distributes processed tissue or cells from third parties.
p.(None): (3) A transfer of activities reserved for a tissue bank by the tissue bank is only permitted if the company has a license in accordance with
p.(None): Section 22 or a corresponding license from a competent authority of another party to the Agreement on the European Economic Area
p.(None): or if the company, insofar as this is outside the European Economic Area, in this federal law and on the basis thereof
p.(None): enacted regulations can comply with prescribed standards.
p.(None): (3a) The distribution of cells or tissues can also be transferred to a company that does not have a license pursuant to Section 22. The following applies to this company
p.(None): Section 15 subsection 2 accordingly.
p.(None): (4) Each tissue bank must have a complete list of the agreements concluded with removal facilities and with third parties in accordance with paragraphs 1 and 2
p.(None): to lead. The agreements must always be available in the tissue bank in the original or a copy.
p.(None): (5) In the agreements between the tissue bank and a third party, the responsibilities that are performed by third parties and the
p.(None): to specify the exact procedure. A contractor may not contractually assign a task to third parties without the client's written consent
p.(None): pass on.
p.(None): (6) At the request of the Federal Office for Safety in Health Care, the tissue banks have copies of their agreements with them
p.(None): Withdrawal facilities and to be presented with third parties.
p.(None): (7) Tissue banks with an authorization to import from third countries must conclude written agreements with third country suppliers which:
p.(None): in accordance with the state of affairs paragraph 1 or 2. This does not apply to single imports and in connection with imports of hematopoietic
p.(None): StemXcells for the treatment of life-threatening diseases.
...
p.(None): (2) Withdrawal facilities have all serious incidents that can affect the quality and safety of cells or tissues and
p.(None): all serious undesirable reactions that occur during extraction and that affect the quality and safety of the cells or tissues
p.(None): can report the tissue bank for which the cells and tissues are intended.
p.(None): (3) The responsible person in accordance with § 9 must ensure that the Federal Office for Safety in Health Care has any serious incident
p.(None): and every serious undesirable reaction according to paragraphs 1 and 2 as well as according to § 32 paragraph 2 is reported and a report on the causes and consequences
p.(None): is submitted.
p.(None): (4) Withdrawal facilities and tissue banks are all involved in the extraction, processing, storage or distribution of the cells or tissues concerned
p.(None): the withdrawal facilities or tissue banks involved provide all the relevant information to clarify serious incidents and
p.(None): to provide serious adverse reactions.
p.(None): (5) Tissue banks with a license to import from third countries are required, all suspected by the Federal Office for Safety in Health Care
p.(None): or actual serious incidents or serious adverse reactions reported to you by third country suppliers and
p.(None): report the quality and safety of the cells or tissues they have imported. Such notifications must be made in accordance with Annex III
p.(None): and IV of Directive 2006/86 / EC.
p.(None): (6) Tissue banks with a license to import from third countries are obliged to inform the Federal Office for Safety in Health Care immediately
p.(None): 1. Any revocation and any suspension - in whole or in part - of a third country supplier's approval for the export of tissues and cells and
p.(None): 2. Any other decision taken because of non-compliance by the competent authority (ies) of the state in which the third country supplier
p.(None): is established, has been taken and may be relevant to the quality and safety of the imported tissues and cells,
p.(None): Report to.
p.(None): § 17a. Tissue banks are required to report to the Federal Office for Health Safety if
p.(None): 1. Information in the EU Compendium of Tissue Facilities needs to be updated or corrected,
p.(None): 2. the EU Compendium of Tissue and Cell Products needs to be updated, or
p.(None): 3. The tissue bank in cells or tissue that it receives from other tissue banks in the European Economic Area, a significant violation
p.(None): against the provisions of the Single European Code.
p.(None): confidentiality
p.(None): § 18. (1) Every person working or who has worked in a withdrawal facility and in a tissue bank is in secrecy about all of them
p.(None): Committed to the performance of their activities or secrets which have become known, provided that they are not already based on other legal or official law
p.(None): Regulations such a duty of confidentiality is imposed.
p.(None): (2) There is no duty of confidentiality if
p.(None): 1. The person threatened by the disclosure of the secret is the person who worked or was active in the removal facility or in the tissue bank
p.(None): released from secrecy,
p.(None): 2. the disclosure of the type and content of the secret in order to protect the higher interests of public health care or the administration of justice
p.(None): is absolutely necessary, or
p.(None): 3. Reporting obligations regarding communicable diseases are met.
...
p.(None): Announce healthcare security immediately.
p.(None): Grant of authorization for tissue banks
p.(None): § 22. (1) The operation of a tissue bank requires a license from the Federal Office for Safety in Health Care.
p.(None): (2) If a change in the operation of a tissue bank is to be made after the authorization has been issued, the effects on the quality
p.(None): who may have cells or tissue, this change also requires approval from the Federal Office for Safety in Health Care.
p.(None): (3) The tissue bank may not make any significant change to its import activities without prior authorization. Consider significant changes
p.(None): in particular changes regarding the type of cells or tissues imported, the activities carried out in third countries, which affect quality and safety
p.(None): of the imported cells or tissues, or of the third country suppliers used.
p.(None): 4. An importing tissue bank shall make a one-off import of cells or tissue originating from a third country supplier which is not among them
p.(None): If the applicable authorization falls, such an import is not considered to be a significant change if the importing tissue bank is authorized to use the same type of cells
p.(None): or import tissue from one or more other third country suppliers.
p.(None): Requirements for approval
p.(None): § 23. (1) The license must be granted if
p.(None): 1. The permits required by other legal provisions are available and the operating system and all medical equipment required for the operation
p.(None): and technical facilities comply with the applicable regulations in the field of health care,
p.(None): 2. a responsible person in accordance with this law has been appointed and made known to the authority,
p.(None): 3. The personnel, spatial, operational and necessary for the type and scope of the intended processing, testing, storage and distribution
p.(None): technical equipment is given,
p.(None): 4. the area of responsibility and responsibility of the people working in the tissue bank is defined and shown in an organizational plan,
p.(None): 5. The necessary facilities for documentation and quality assurance in line with the state of the art in science and technology are available
p.(None): are,
p.(None): 6. the proposed processing methods correspond to the state of the art in science and technology, and
p.(None): 7. The tissue bank has an accurate, quick, and verifiable process to deal with any distributed product that has a serious problem
p.(None): Incident or a serious adverse reaction could be recalled.
p.(None): (2) The license is to be tied to conditions and requirements in accordance with the state of the art in science and technology, insofar as they are to guarantee
p.(None): the flawless nature of the products, to protect the health of the recipient or to maintain the state of the art in science.
p.(None): (3) The following documents must be attached to the application for the authorization:
p.(None): 1. Name and address of the applicant,
p.(None): 2. a description of the operation, including a list of essential equipment and other operating equipment,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the staffing options envisaged, including the quali fi cation and the organizational scheme for the
p.(None): Tasks and area of responsibility of the staff including the responsible person,
p.(None): 5. the essential information on the quality system to be provided, including SOPs and the documentation,
p.(None): 6. Type and scope of the envisaged processing, testing, storage and distribution including the intended processing methods.
...
p.(None): To impose different or additional requirements on healthcare providers to achieve these goals.
p.(None): Section 25. The change in the identity of the holder of a tissue bank approved in accordance with Section 22 does not affect the effectiveness of this approval. The
p.(None): Legal successors must immediately notify the Federal Office for Safety in Health Care of the change in the person of the holder.
p.(None): Section 25a. The Federal Office for Safety in Health Care is immediately to cease the operation of an extraction facility or tissue bank
p.(None): Report.
p.(None): inspections
p.(None): Section 26. (1) The Federal Office for is responsible for monitoring compliance with this Federal Act through withdrawal facilities and tissue banks
p.(None): Healthcare security. The inspections must take place at regular intervals of no more than two years.
p.(None): (1a) The Federal Office for Safety in Health Care has a certificate of this within 90 days of completing an inspection of the tissue bank
p.(None): to be issued if this has shown that the provisions of this Federal Act and the regulations issued on the basis thereof and the
p.(None): Approval is granted. If this requirement is not met, the Federal Office for Safety in Health Care has it within the mentioned
p.(None): Determine deadline with notice. The certi fi cate is to be withdrawn if it subsequently becomes known that the requirements have not been met. It's closed
p.(None): withdraw if the requirements are no longer met.
p.(None): (2) In the event of a serious undesirable reaction or a serious incident, the Federal Office for Security in
p.(None): To initiate appropriate inspections if necessary. In such cases, such inspections are sufficient for one
p.(None): reasoned request by the competent authority (ies) of another party to the Agreement on the European Economic Area. On
p.(None): If requested by another contracting party to the Agreement on the European Economic Area or the Commission, the Federal Office for Security
p.(None): Healthcare with the results of the inspections carried out in relation to the requirements of this federal law.
p.(None): (3) The organs of the Federal Office for Safety in Health Care and the experts consulted by it
p.(None): 1. to grant access to all rooms,
p.(None): 2. to give the opportunity to carry out the activities and procedures carried out in accordance with this Federal Act and the regulations issued on the basis thereof
p.(None): to review and assess and, if this is necessary to preserve evidence, take photographs and video recordings in the company,
p.(None): 3. to grant the required inspection of all documents and records at their request, and to make copies or photographs thereof, and
p.(None): 4. to enable the removal of samples in the amount required for an analysis.
p.(None): (3a) The powers of the organs of the Federal Office for Safety in Health Care listed in paragraph 3 also exist with regard to facilities or
p.(None): Means of transport for companies that have been commissioned by tissue banks to distribute cells or tissue.
p.(None): (4) If the extraction takes place outside the operating rooms, the removal facility has in agreement with the relevant institutions
p.(None): to ensure that the premises in which the extraction takes place can also be checked in the course of inspections and the organs of the
p.(None): Federal Office for Safety in Health Care and the experts consulted by it have all rights under paragraph 3.
...
p.(None): to share. Two parts of it are to be officially closed, one part is to be left to the party for evidence purposes. About the sampling is the
p.(None): To confirm the removal device or the tissue bank.
p.(None): (8) No compensation is due for the samples taken in accordance with paragraph 3 no. 4 in conjunction with paragraph 7.
p.(None): (9) The Federal Office for Safety in Health Care is entitled to inspect third-country suppliers of importing tissue banks in third countries
p.(None): to verify that the quality and safety standards of the third country supplier for the cells or tissues to be imported are compatible with the
p.(None): Standards of this federal law are at least equivalent.
p.(None): (10) Upon a reasoned request from another member state of the European Economic Area or the European Commission, the Federal Office for
p.(None): Healthcare safety Information on the results of the inspections and other control measures related to the import
p.(None): Tissue banks and third country suppliers are available.
p.(None): (11) If cells or tissues are imported to Austria that are to be distributed to another Member State, the Federal Office for Security in
p.(None): Healthcare, on a reasoned request from the Member State where the imported cells or tissues are subsequently distributed, to carry out
p.(None): Carry out inspections or other control measures related to the importing tissue bank and the activities of third country suppliers. The
p.(None): The Federal Office for Safety in Health Care, after consultation with the Member State that submitted the application, has to decide on the measures to be taken
p.(None): decide on.
p.(None): (12) If an inspection is carried out on such an application, the Federal Office for Safety in Health Care has to contact the person responsible
p.(None): The authority (ies) of the Member State that made the request whether and, if so, in what form the latter Member State takes part in the inspection,
p.(None): vote. The Federal Office for Safety in Health Care has to make the final decision about such participation. Will attend
p.(None): refused, the reasons for this must be communicated to the Member State that made the request.
p.(None): Section 27. (1) The Federal Office for Safety in Health Care has removal facilities and tissue banks to remedy abuses as soon as possible
p.(None): to be applied by decision. If these are not removed within a period to be set, the Federal Office for Safety in Health Care has the
p.(None): Operation until the fulfillment of the defect remediation order to the required extent, if necessary completely, to be temporarily prohibited with a decision.
p.(None): (2) In cases of imminent danger to human health, the Federal Office for Safety in Health Care has preceded
p.(None): Notification of the holder, or if such is not possible, at the tissue banks of the person responsible, even without a previous procedure and
p.(None): to block operations on the spot before issuing a decision; however, written notification of this must be issued within two weeks,
p.(None): otherwise the measures taken will lapse.
p.(None): (3) If it is known that a withdrawal device is operated without notification or a tissue bank without a license, the Federal Office for
p.(None): Healthcare security without prior procedure and before operation is blocked to block operations on the spot. A written one
p.(None): Notification of this must be issued immediately.
p.(None): (4) Notices in accordance with paragraphs 1 to 3 are immediately enforceable. The effectiveness of the notices is not affected by a change in the person of the holder.
p.(None): (5) If the requirements for issuing notices in accordance with Paragraphs 1 and 2 no longer exist, the Federal Office for Security in
...
p.(None): 3. Trade name (if not identical to the product name) of all types of cells and tissues to be imported.
p.(None): 4. Name of the third country supplier for each type of cell and tissue to be imported.
p.(None): D. Place of activity
p.(None): 1. List of activities related to the donation, procurement, testing, processing, preservation or storage prior to the import of the
p.(None): Third-country suppliers are organized by type of cells or tissues.
p.(None): 2. List of activities related to donation, procurement, testing, processing, preservation or storage prior to the import of
p.(None): Subcontractors of the third country supplier are carried out, broken down by type of cells or tissues.
p.(None): 3. List of all activities carried out by the ETUC after import, broken down by type of cells or tissues.
p.(None): 4. Names of third countries in which the activities are carried out before import, broken down by type of cells or tissues.
p.(None): E. Information about third country suppliers
p.(None): 1. Name of the third country supplier (company name).
p.(None): 2. Name of the contact person.
p.(None): 3. Visiting address.
p.(None): 4. Postal address (if different).
p.(None): 5. Telephone number with international area code.
p.(None): 6. Emergency telephone number (if different).
p.(None): 7. Email address.
p.(None): F. Documentation to accompany the application
p.(None): 1. A copy of the written agreement with the third country supplier (s).
p.(None): 2. A detailed description of the route of the imported cells and tissues from procurement to their arrival at the importing tissue bank.
p.(None): 3. A copy of the third-country supplier's export license or, if no special export license has been issued, one
p.(None): Certificate from the relevant third country authority (s) approving the activities of the third country supplier in the cells and tissues sector, including
p.(None): To run. These documents must also contain the contact details of the competent authority (ies) of the third country. In third countries where such documents
p.(None): other documents are not available, such as reports on audits at the third-country supplier.
p.(None): Appendix C.
p.(None): Certificate of approval as an introductory tissue bank
p.(None): Appendix D.
p.(None): Minimum requirements with regard to the documentation submitted to the Federal Office for Safety in Health Care of tissue banks, the cells and
p.(None): Want to import tissue from third countries
p.(None): The applicant importing tissue bank must have the current version of the following documents relating to the applicant and his / her third-country supplier
p.(None): provide and - if not already done in the context of previous applications for authorization as an introductory tissue bank - upon request to the
p.(None): Submit to the Federal Office. This does not apply to one-off imports within the meaning of Section 2 no. 39 of this Federal Act, which are subject to these documentation requirements
p.(None): with exception of. When importing hematopoietic stem cells for the treatment of life-threatening diseases, only the documentation on A. for
p.(None): Will be provided.
p.(None): A. Documentation on the introductory tissue bank
p.(None): 1. Job description of the responsible person and precise information on their relevant qualifications and training in accordance with § 9;
p.(None): 2. Copy of the original label, the outer packaging label as well as the documents for the outer packaging and the transport container;
p.(None): 3. List of relevant, current standard operating instructions (SOP) for the institution's import activities, including the SOP for the application of the
p.(None): Uniform European codes, the reception and storage of imported cells and tissues in the introductory tissue bank, the management
p.(None): serious incidents and serious undesirable reactions, management of recalls and traceability from donor to
p.(None): Receiver.
p.(None): B. Documentation of the third country supplier (s)
p.(None): 1. Detailed description of the criteria for the identification and assessment of donors, details of the donors or the donor family
p.(None): Information, description of the procedure for obtaining the consent of the donor or the donor family as well as information on whether it is a
p.(None): voluntary and free donation;
p.(None): 2. detailed information about the test centers used by the third country suppliers and the tests carried out by these centers;
p.(None): 3. detailed information on the methods used in the processing of cells and tissues, including precise information on the validation of the
p.(None): Critical processing procedure;
p.(None): 4. Detailed information about the facilities, important equipment and materials as well as the criteria for quality control and environmental control in
p.(None): Relating to any activity performed by the third country supplier;
p.(None): 5. detailed information on the conditions for the release of tissues and cells by the third country supplier (s);
p.(None): 6. Information about each subcontractor of the third country suppliers, including the name, address and the activity carried out;
p.(None): 7. Summary of the most recent inspection by the competent third country authority (ies) at the third country supplier, including the inspection date of the
p.(None): Type of inspection and main conclusions;
p.(None): 8. Summary of the most recent third country supplier audit performed by or on behalf of the importing tissue bank;
p.(None): 9. relevant national or international approvals, if available.
p.(None): Attachments
p.(None): Minimum requirements regarding the content of written agreements between importing tissue banks and their third country suppliers
p.(None): Except for one-off imports within the meaning of Section 2 No. 39 of this Federal Act and imports of hematopoietic stem cells for treatment
p.(None): Life-threatening diseases that are exempt from these requirements must be the written agreement between the introductory tissue bank
p.(None): and contain the third country supplier at least the following requirements.
p.(None): 1. Detailed information on the speci fi cations of the importing tissue bank, with which the compliance with those laid down in Directive 2004/23 / EC
p.(None): Quality and safety standards should be ensured, and with regard to the mutually agreed tasks and responsibilities of the two parties
p.(None): to ensure that the quality and safety standards of the imported cells and tissues are equivalent;
p.(None): 2. Clause which ensures that the third country supplier provides the information on the importing tissue bank as set out in Section B of Annex III to this Directive
p.(None): transmitted;
p.(None): 3. Clause which ensures that the third country supplier informs the importing tissue bank of any suspected or actual serious incident or
p.(None): informed of serious adverse reactions that affect the quality and safety of the or imported from the introductory tissue bank
p.(None): cells and tissues to be introduced;
p.(None): 4. Clause that ensures that the third country supplier informs the importing tissue bank of any significant change in its activities that affect the
p.(None): Quality and safety of the cells and tissues introduced or to be introduced by the importing tissue bank; this also applies to one
p.(None): Withdrawal or suspension - in whole or in part - of its authorization for the export of cells and tissues and any other decisions that
p.(None): were taken by the responsible third country authority (ies) for non-compliance with the provisions;
p.(None): 5. Clause that specifies the right of the competent authority (ies), in the context of its inspection of the importing tissue bank, also the activities of the
p.(None): Control third country suppliers, including on-site inspections; this clause also stipulates the right of the introductory tissue bank to
p.(None): be to conduct regular audits at their third country supplier;
p.(None): 6. Conditions for the transport of cells and tissues from the third country supplier to the importing tissue bank;
p.(None): 7. Clause which ensures that the third country supplier or its subcontractor provides the donor data for the imported cells and tissues in accordance with the
p.(None): Data protection regulations of the EU stores for 30 years after the acquisition and that suitable precautions are taken for their whereabouts if the
p.(None): Third country supplier ceases to operate;
p.(None): 8. Agreements on the regular review and, if necessary, the revision of the written agreement if, for example, changes to the
p.(None): Requirements of the EU quality and safety standards laid down in Directive 2004/23 / EC must be taken into account;
p.(None): 9. A list of all standard operating instructions of the third country supplier, which concern the quality and safety of the imported cells and tissues, and the
p.(None): Obligation to transmit this on request.
p.(None): to the top
...
Orphaned Trigger Words
p.(None): (5) Each extraction facility must operate a functional quality system in accordance with the state of the art in science and technology, which the active
p.(None): Management and staff involvement.
p.(None): (6) Every removal facility must ensure that at least standard operating instructions (standard operating
p.(None): Procedures-SOPs), guidelines, training and reference manuals, self-inspection according to paragraph 7, records of donors and information about
p.(None): the transfer of the cells and tissues obtained are documented.
p.(None): (7) Every sampling facility has to carry out regular self-inspections in order to ensure that the state of the art and the state of the art are applied and observed
p.(None): Monitor technology and make suggestions for any necessary corrective measures. Self-inspection is part of the quality system.
p.(None): (8) Each removal facility must ensure that the documents within the framework of the quality system are available at all times during inspections
p.(None): stand.
p.(None): (9) The donor facility is prohibited from donating human tissues and cells himself or through other physical or legal persons
p.(None): to advertise that there is a prospect of a financial gain or a comparable advantage for the donation.
p.(None): donor
p.(None): § 4. (1) The assessment and selection of donors must be made in accordance with the state of the art in science.
p.(None): (2) Before the removal of cells or tissues, the living donor must undergo the necessary examinations to determine the physical and
p.(None): assess psychological risks to his health. A withdrawal may not be carried out if this poses a serious risk to life or the life
p.(None): Donor health exists. If this is according to the state of medical science according to the type of donation to protect the donor
p.(None): is indicated, they must be subjected to regular medical checks after the donation.
p.(None): (3) The removal may only be carried out if the living donor prior to the removal by a doctor comprehensively about the planned removal, the
p.(None): Purpose, the associated risks and consequences, in particular any further examinations that may be necessary after removal, the ones to be performed
p.(None): analytical tests and consequences of abnormal findings, the therapeutic purpose of the removed cells or tissues and the potential benefit for the
p.(None): Recipient as well as protective measures to protect the donor and his data as well as existing confidentiality obligations has been informed and the
p.(None): Donor has given his consent to the removal and testing as well as the further use of the cells or tissue. Consent can be given at any time
p.(None): be revoked. The consent must be recorded in writing and must be documented in accordance with § 5. The consent must be dated and dated
p.(None): Donors to be signed. If the donor is unable to provide the signature, the consent must be given to a witness who
p.(None): has to confirm the consent by his signature.
p.(None): (4) If cells or tissues from a living person have been removed as part of medical treatment, their further use is
p.(None): Permitted if this person is concerned about the therapeutic purpose of the cells and tissues extracted and the potential benefit to the recipient, possibly
p.(None): necessary further examinations after the removal, the analytical tests to be carried out and the consequences of abnormal findings as well as about
p.(None): Protective measures to protect the donor and his data as well as existing confidentiality obligations have been clarified and in the further use of the
p.(None): Cells and tissues has approved for use in humans. Paragraph 3 applies with regard to the form of consent and any revocation.
p.(None): (5) In order to save the life of people or to restore their health, it is permissible to remove cells or tissue from the deceased,
p.(None): if these cells or tissues are within the scope of this federal law or as medicinal products for novel therapies for use in
p.(None): People are determined and the other requirements of Section 5 of the Organ Transplantation Act, Federal Law Gazette I No. 108/2012 are met.
p.(None): (5a) Removal facilities are required before the cells or tissues are removed from the deceased by submitting an inquiry to Health Austria
p.(None): GmbH to ensure that there is no entry of an objection in the objection register (§ 6 Organ Transplantation Act). § 7 paragraphs 2 and 3
p.(None): Organ Transplantation Act applies.
p.(None): (6) Donating cells or tissues or third parties for a donation is prohibited by a fi nancial gain or comparable benefit
p.(None): to send or promise. Legal transactions that violate this prohibition are void.
p.(None): (7) Paragraph 6 stands for the granting of adequate compensation to living donors for loss of earnings and other reasonable expenses incurred by
p.(None): the withdrawal and the associated medical measures are caused, and the granting of compensation in the event of the occurrence of a
p.(None): Damage as a result of the removal and other related medical measures.
p.(None): Documentation and packaging
p.(None): § 5. (1) The results of the assessment of the health suitability of the donors are to be documented by the removal facility, relevant anomalies
p.(None): Findings are to be communicated to the living donor.
p.(None): (2) The documentation according to Paragraph 1 has complete traceability according to the state of medical science, insofar as this is in the
p.(None): It is the responsibility of the extraction facility to ensure. The removal facility also has traceability for all required data
...
p.(None): 4. the necessary facilities for documentation and quality assurance that is in line with the state of the art in science and technology
p.(None): are present, or
p.(None): 5. otherwise the extraction does not correspond to the state of the art in science and technology.
p.(None): (4) The following documents must be attached to the notification:
p.(None): 1. name and address of the holder,
p.(None): 2. a description of the company including a list of essential medical devices and other company facilities,
p.(None): 3. the necessary plans,
p.(None): 4. a list of the envisaged staffing including qualifications and the organizational plan for the
p.(None): Tasks and the area of responsibility of the personnel,
p.(None): 5. The essential information about the quality system to be provided including SOPs for the selection of donors, the examination and testing
p.(None): the donor, the packaging and the transfer of cells or tissues,
p.(None): 6. type of cells and tissues obtained,
p.(None): 7. Where applicable, information on extraction outside of the company's own premises, including all locations for removal, upon presentation of the corresponding
p.(None): Agreements with the relevant institutions,
p.(None): 8. Information on the selection and recruitment of donors and
p.(None): 9. a list of the tissue banks to be supplied.
p.(None): (5) The Federal Office for Safety in Health Care has the withdrawal facility a certificate within six if the requirements are met
p.(None): To be issued months after complete notification of the suitability for obtaining cells or tissues.
p.(None): Section 20. (1) The Federal Office for Safety in the Health Care System has notified the removal facilities in accordance with Section 19 with the status of
p.(None): Science and technology to issue appropriate terms and conditions, provided they protect the health of the donor, the warranty
p.(None): the flawless nature of the cells or tissues obtained or to maintain the state of the art.
p.(None): (2) Provided that the health of the donor is protected or that the cells or tissues obtained are in perfect condition
p.(None): The Federal Office for Safety in Health Care has registered in accordance with § 19 that requirements or conditions cannot be met
p.(None): To prohibit removal devices from harvesting cells and tissues.
p.(None): (3) It turns out that despite compliance with the requirements stipulated in the decision, the avoidance of negative effects with regard to health protection
p.(None): of the donor, the quality of the cells or tissues obtained, or the state of the art in science and technology is not adequately assured
p.(None): Federal Office for Safety in Health Care to prescribe other or additional requirements to achieve these goals.
p.(None): § 21. If there is a change in the person of the owner of a withdrawal facility reported in accordance with § 19, the legal successor has this to the Federal Office for
p.(None): Announce healthcare security immediately.
p.(None): Grant of authorization for tissue banks
p.(None): § 22. (1) The operation of a tissue bank requires a license from the Federal Office for Safety in Health Care.
p.(None): (2) If a change in the operation of a tissue bank is to be made after the authorization has been issued, the effects on the quality
p.(None): who may have cells or tissue, this change also requires approval from the Federal Office for Safety in Health Care.
p.(None): (3) The tissue bank may not make any significant change to its import activities without prior authorization. Consider significant changes
p.(None): in particular changes regarding the type of cells or tissues imported, the activities carried out in third countries, which affect quality and safety
p.(None): of the imported cells or tissues, or of the third country suppliers used.
p.(None): 4. An importing tissue bank shall make a one-off import of cells or tissue originating from a third country supplier which is not among them
p.(None): If the applicable authorization falls, such an import is not considered to be a significant change if the importing tissue bank is authorized to use the same type of cells
p.(None): or import tissue from one or more other third country suppliers.
p.(None): Requirements for approval
p.(None): § 23. (1) The license must be granted if
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| criminal | criminal |
| disability | Mentally Disabled |
| education | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| home | Property Ownership |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| job | Occupation |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| schooling | education |
| single | Marital Status |
| stem cells | stem cells |
| union | Trade Union Membership |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['schooling'] |
| schooling | ['education'] |
Trigger Words
capacity
consent
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input