49. Federal Law, with which a federal law on setting standards of quality and safety for the collection, processing, storage and distribution of human cells and tissues for use in humans (tissue safety law-GSG) , and amended the Medicines Act, the Reproductive Medicine Act, the Health and Nutrition Security Act and the Federal Act on hospitals and health care institutions

The National Council has decided:

Article 1

Federal law on setting standards of quality and safety for the collection, processing, storage and distribution of human cells and tissues for use in humans (tissue safety law-GSG)

Scope

§ 1. (1) This federal law regulates the extraction of human cells and tissues for use in humans. Furthermore, it regulates the processing, storage and distribution of human cells and tissues for use in humans, provided that they are not used for the production of proprietary medicinal products, investigational medicinal products or medical devices.

(2) In the production, processing, storage and distribution of human cells and tissues, the state of the sciences and technology must be observed.

(3) This federal law shall not apply to:

1.		cells and tissues used as an autologous transplant within one and the same medical intervention,
2.		Blood and blood components according to § 3 Blood Safety Act 1999, BGBl. I No 44/1999, and
3.		human organs and parts of organs, if they are to be used for the same purpose as the organ in the human body.

Definitions

§ 2. In the sense of this federal law means

1.		cells: individual human cells or accumulations of cells that are not held together by any kind of connective tissue;
2.		Tissue: all components of the human body consisting of cells;
3.		Donors: any person who expresses the will to donate cells or tissues for use in humans in relation to the personnel involved in the operation of a removal facility, as well as any deceased person, cells or tissues for use in the People are taken;
4.		Donation: the delivery of human cells or tissues intended for use in humans;
5.		Organ: all parts of the human body, other than the skin, consisting of different tissues, which form a functional unit with respect to structure, blood vessel supply and ability to perform physiological functions;
6.		Extraction: the removal of cells or tissues, including the determination of the health of a donor, as well as the donor protection and quality assurance measures associated with these operations;
7.		Processing: all activities relating to the preparation, handling, preservation, reproduction and packaging of cells or tissues intended for human use;
8.		Conservation: the use of chemical substances, modified environmental conditions or other means during processing, with the aim of preventing or delaying biological or physical impairment of cells or tissues;
9.		Storage: the storage of the product up to distribution;
10.		Distribution: the transport and delivery of cells or tissues intended for human use, including export to third countries;
11.		Use in humans: the medical use of cells or tissues in or on a human recipient as well as extracorporeal applications;
12.		Serious incident: any adverse event related to the collection, testing, processing, storage and distribution, and use of tissues and cells, which is the transmission of a contagious disease, death or may result in a life-threatening condition, disability or loss of ability of donors or recipients, may require or extend a hospital stay, or may cause or prolong a disease;
13.		serious adverse reaction: an unintended reaction, including a communicable disease, in the donor or recipient in connection with the extraction or use of cells and tissues that are fatal or life-threatening is a disability or a loss of ability, or if hospitalization is required or extended, or is leading to a disease or prolongs it;
14.		Removal equipment: any device, including mobile pick-up teams, in which activities related to the production of human cells and tissues are carried out for human use;
15.		Tissue bank: means any institution in which activities relating to the processing, storage or distribution of human cells and tissues are carried out for human use;
16.		Allogeneic use: the removal of cells or tissues from one person and their transfer to another person;
17.		autologous use: the removal of cells or tissues and their retransmission to one person and the same person;
18.		Users: hospitals and professional doctors and dentists who are responsible for the use of human cells or tissues in humans;
19.		Quality system: the organisational structure, defined responsibilities, procedures, processes and resources for the implementation of quality management, including all activities that contribute directly or indirectly to quality;
20.		Validation (or "qualification" in relation to installations or environments): providing a documented proof that proves to be highly secure that a specific process, standard procedure, equipment item or environment is without exception manufactures a product that meets the specifications and quality characteristics set out in advance; a process is validated to assess how effectively the performance of a system is for the purpose of use;
21.		Traceability: the possibility of the tissue or to locate and identify the cell at each stage from removal, processing, testing and storage, to its use in the recipient or for disposal, including the possibility of the donor and the tissue bank, which Tissue or Cells are obtained, processed or stored, as well as the possibility to identify the recipient (s) to the user; traceability also means the possibility of all relevant data relating to the products and to locate and determine the materials used in these tissues and/or Cells come into contact;
22.		Advanced therapy medicinal products: medicinal products referred to in Part IV of Annex I to Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to medicinal products for human use, as last amended by the Directive 2004 /27/EC.

Recovery

§ 3. (1) The collection of cells and tissues may only be carried out by means of removal facilities, which have been reported to the Federal Office for Health in accordance with § 19.

(2) Each removal device must have the personnel, spatial, operational and technical equipment required according to the respective state of the art and technology. The personnel involved in the extraction or testing must be brought to the latest state of the art and technology in good time and regularly by means of appropriate training measures.

(3) Organizing forms in which the production of cells and tissues are carried out in part or exclusively by mobile pick-up teams outside of their own premises shall also be considered as a removal device in accordance with paragraph 1.

(4) The equipment must be designed in such a way that the respective state of the sciences and technology is ensured in accordance with an uninterrupted organisational sequence, the necessary hygiene standards are maintained and living donors are guaranteed at all times an emergency medical first supply can be provided.

(5) Each removal device must operate a functional quality system according to the state of the art and technology, which provides for the active participation of the management and the staff.

(6) Each sampling device shall ensure that, within the framework of the quality system, at least standard operating procedures (SOPs), guidelines, training and reference manuals, and self-inspection in accordance with paragraph 7, Records of donors and information on the transmission of the cells and tissues obtained are documented.

(7) Each withdrawal facility shall regularly carry out self-inspections in order to monitor the application and observance of the state of the art and technology and to make proposals for any necessary corrective measures. The self-inspection is a part of the quality system.

(8) Each sampling device shall ensure that the documents are fully available at all times during inspections in the framework of the quality system.

(9) It is prohibited for the withdrawal facility to apply for the donation of human tissues and cells, even or by other physical or legal persons, for the donation of a financial gain or a comparable advantage to the donation of human tissues and cells. View is provided.

Donors

§ 4. (1) The assessment and selection of donors shall be carried out in accordance with the state of the sciences.

(2) Prior to the removal of cells or tissues, the living donor shall be subjected to the necessary tests to assess the physical and psychological risks to his or her health. A withdrawal must not be carried out if this poses a serious risk to the life or health of the donor. If, according to the state of medical science, this is indicated according to the type of donation for the protection of donors, they shall be subject to regular medical checks after the donation.

(3) The removal may only be carried out if the live donor, prior to the removal by a doctor, is fully informed about the planned withdrawal, its purpose, the risks and consequences associated with it, in particular any further studies necessary after removal, the analytical tests to be carried out and the consequences of abnormal findings, the therapeutic purpose of the cells or tissues taken, and the potential benefits to the recipient, as well as to protective measures to protect the donor and of its data, as well as existing confidentiality obligations, and The donor has given his consent to the removal and testing and to the further use of the cells or tissues. Consent can be revoked at any time. The consent must be recorded in written form and must be documented in accordance with § 5. The consent must be dated and signed by the donor. If the donor is not in a position to receive the signature, consent must be given to a witness who has to confirm his/her consent by signing his/her signature.

(4) Where cells or tissues have been taken from a living person in the course of a medical treatment, their further use shall be permitted where that person is responsible for the therapeutic purpose of the cells and tissues taken and the potential for the treatment of the tissues and tissues. Use for the recipient, any further examinations necessary after removal, the analytical tests to be carried out and the consequences of abnormal findings, as well as protective measures for the protection of the donor and its data, as well as existing Confidentiality requirements have been clarified and the further use of the cells and Tissue for use in humans has consented. With regard to the form of consent and a possible revocation, paragraph 3 shall apply.

(5) In order to save the life of humans or to restore their health, it is permissible to remove dead cells or tissues if these cells or tissues are within the scope of this federal law or as a medicinal product. for novel therapies for use in humans, and the other requirements of § 62a of the Federal Law on hospitals and health care institutions, BGBl. No 1/1957, have been complied with.

(6) It is prohibited to provide donors of cells or tissues or third persons with a financial gain or comparable advantage for a donation or to promise them. Legal transactions which are in breach of this prohibition are void.

(7) (6) provides for the granting of adequate compensation to live donors in respect of earnings and other reasonable expenses incurred as a result of the removal and related medical measures, and the granting of Compensation for damages in the event of damage resulting from the removal and other medical measures associated with it shall not be accepted.

Documentation, labelling, packaging

§ 5. (1) The results of the assessment of the health suitability of the dispensers shall be documented by the sampling device, relevant anomalous findings shall be communicated to the living donor.

(2) The documentation referred to in paragraph 1 shall ensure complete traceability in accordance with the status of medical science, insofar as this falls within the remit of the withdrawal facility. The withdrawal facility shall also ensure traceability of all necessary data on products and materials coming into contact with these cells and tissues.

(3) The documentation shall be made in writing, electronically or on any other data carrier, provided that it is ensured that the necessary information is available during the period of the retention period.

(4) The documentation shall be kept for at least ten years-those parts which are indispensable for the complete traceability, by at least 30 years-and to be taken into account by the competent authorities responsible under this federal law at all times. Control bodies shall be kept ready.

(5) Each withdrawal facility shall take data security measures in accordance with § § 14f Data Protection Act 2000.

(6) The identification code ISBT 128 shall be used to identify cells or tissues obtained. They are to be packed according to the state of science and technology and passed on to the tissue bank or to users for direct use.

Relations with tissue banks and third parties

§ 6. (1) Each withdrawal facility shall conclude written agreements with tissue banks, to which cells or tissues are to be transferred, which clearly define the responsibilities of each side.

(2) Each withdrawal facility shall be obliged to enter into written agreements on all activities carried out by third parties outside the collection facility and the effects on the quality and safety of the cells and tissues. complete. In particular:

1.		if a removal device transfers the test of the donor to a third party, or
2.		where a third party supplies goods or services which affect the quality and safety of the tissues or cells.

(3) The assessment and selection of third parties shall be carried out by the sampling device according to whether they are able to comply with the required standards.

(4) Each withdrawal facility shall have a full list of all agreements concluded with tissue banks or with third parties in accordance with paragraphs 1 and 2 of this Article. The agreements must be kept in the original or in copies in the withdrawal facility and must be kept at the end of their effectiveness by at least 10 years.

(5) The agreements between the withdrawal facility and third parties shall determine the responsibilities of third parties and the detailed procedures. A contractor shall not pass on to third parties without the written authorisation of the removal facility a contract which has been contractually transferred to it.

(6) In the event of extraction outside of its own premises, the withdrawal facility has to comply with the quality and safety standards laid down in this Federal Law by written agreements with the institutions involved. to ensure.

(7) At the request of the Federal Office for Safety in the Health Care, the withdrawal facility shall submit copies of its agreements with tissue banks and with third parties.

Authorisation for a regulation in respect of the production

§ 7. The Federal Minister for Health, Family and Youth may, in so far as this is necessary for the protection of donors and the impeccable nature of donated cells and tissues, more detailed rules

1.		the requirements for the necessary human, spatial, operational and technical equipment, including the quality system to be provided;
2.		the selection criteria for the donor of cells and tissues, including the findings of a temporary or permanent exclusion of health suitability as donors, as well as those criteria in the case of autologous use,
3.		what information, in what form, is to be given to the living donor before the donation, and which relevant anomalous findings are to be reported;
4.		in which form the identity of the donor is to be documented, by whom, in what way and to what extent the collection, processing and dissemination of the data, as well as the documentation, must be carried out and what arrangements for traceability to meeting,
5.		the laboratory tests prescribed for donors and the results of the study, which are limited in time or permanently exclude health suitability as donors,
6.		the method of obtaining cells and tissues,
7.		the packaging, labelling and transfer of cells and tissues to tissue banks or to users for direct use, including the information to be provided and the documents to be transmitted; and
8.		with regard to compulsory insurance for allogeneic donors
.

Tissue banks

§ 8. (1) The processing, storage or distribution of cells and tissues may only be carried out in a tissue bank which has an authorization in accordance with § 22. In doing so, the processing procedures to be applied shall also require authorisation.

(2) Each tissue bank shall have the personnel, spatial, operational and technical equipment required in accordance with the state of the art and technology. Staff must be kept up-to-date with the latest developments in science and technology in good time and on a regular basis before taking up their duties and thereafter on an ongoing basis. The training measures must be documented, and this documentation must be kept for at least five years.

(3) The equipment must be designed in such a way that the respective state of the sciences and technology is ensured in accordance with a trouble-free organisation procedure and that the necessary hygiene standards are maintained.

(4) Each tissue bank is obliged to have contractual arrangements with another tissue bank in order to ensure, in the case of the cessation of its activity, that the stored cells or tissues and the documentation of these .

Person responsible

§ 9. (1) Each tissue bank shall have an uninterrupted possession of a "responsible person".

(2) In a Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation, it must study human medicine, dentistry, veterinary medicine, pharmacy or other bioscience or any of the an equivalent recognised training to another Contracting State or the Swiss Confederation, and after completion of the above-mentioned training, an activity of at least two years in a tissue bank in a Contracting Party to the Agreement on the European Economic Area or to of the Swiss Confederation and have acquired practical experience in the processing, storage and distribution of human cells and tissues.

(3) The responsible person shall ensure that human cells and tissues intended for human use are in accordance with the provisions of this Federal Law and of the Regulations adopted on its basis. will be tested, tested, processed, stored and distributed. The person responsible shall be given sufficient powers to enable them to fulfil their responsibilities.

(4) The tissue bank shall be obligated to announce the responsible person and any change of the same, with proof of qualification, immediately to the Federal Office for Safety in the Health Care.

Quality assurance

§ 10. (1) Each tissue bank must operate a functional quality system according to the state of the art and technology, which provides for the active participation of the management and the staff.

(2) Each tissue bank shall ensure that, within the framework of the quality system, at least standard operating procedures (SOPs), guidelines, training and reference manuals, self-inspection in accordance with paragraph 3, notification forms, Records of donors, distribution and, at best, information about the final determination of cells and tissues.

(3) Each tissue bank shall carry out regular self-inspections in order to monitor the application and observance of the state of science and technology and to propose proposals for any necessary corrective measures. The self-inspection is part of the quality system.

(4) Each tissue bank shall ensure that the documentation within the framework of the quality system is at all times fully available for inspections.

Relations with removal facilities and third parties

§ 11. (1) Each tissue bank shall conclude written agreements with the withdrawal facilities, from which cells or tissues are accepted, which clearly define the responsibilities of each site. In particular, a risk assessment procedure by the responsible person in relation to donors who do not comply with the selection criteria of a Regulation in accordance with § 7 and the responsibilities for the transfer of cells or tissues shall be to the tissue bank.

(2) The tissue bank shall be obliged to conclude written agreements on all activities carried out outside the tissue bank by third parties and the effects on the quality and safety of the cells and tissues. In particular:

1.		if a tissue bank transfers to a third party the responsibility for a phase of tissue or cell processing,
2.		where a third party supplies goods or services which affect the quality and safety of the tissues or cells, including their distribution,
3.		if a tissue bank provides services for a tissue bank that is not approved for that purpose,
4.		if a tissue bank distributes tissue or cells processed by third parties.

(3) A transfer from a tissue bank reserved activities by the tissue bank shall be permitted only if the holding is subject to an authorisation in accordance with § 22 or a corresponding authorization by a competent authority of another contracting party to the , or if the holding is situated outside the European Economic Area, the standards laid down in this Federal Law and by the Regulations adopted on its basis can be observed.

(4) Each tissue bank shall have a complete list of its agreements concluded with the withdrawal facilities and with third parties in accordance with paragraphs 1 and 2 of this Article. The agreements must be permanently in the tissue bank in the original or in the copy.

(5) In the agreements between the tissue bank and a third party, the responsibilities of third parties and the precise procedures shall be laid down. A contractor shall not pass on to third parties without the written consent of the contracting authority a contract entrusted to it.

(6) At the request of the Federal Office for Health Security, the tissue banks shall submit to this copy of their agreements with removal facilities and with third parties.

Acceptance of cells and tissues, import and export

§ 12. (1) The import and export of or to third countries of the donations of human cells and tissues obtained for processing, storage or distribution shall only be made by tissue banks.

(2) Imports from third countries may only be imported if the tissue bank ensures that quality and safety standards have been complied with, which are at least equivalent to the standards of this federal law. The tissue bank shall have all the documents relating to the assessment and selection of donors on any import. Traceability to the donor must be ensured at all times.

(3) Donations of human cells and tissues intended for processing, storage or distribution shall only be accepted by a tissue bank if the tissue bank is directly responsible for the collection of tissue banks, tissue banks or the tissue banks reported in accordance with § 19. Articles 5 or 6 of Directive 2004 /23/EC shall be adopted by another Contracting Party to the Agreement on the European Economic Area.

(4) In the case of all donations of human cells or tissues, it is necessary to consider whether, due to the documents required in accordance with the state of the sciences, their suitability for use in humans is given.

(5) The packaging of the human cells or tissues received by the tissue bank shall correspond to the state of the sciences and technology. The tissue bank has to examine this and to discard the cells and tissues in the event of deviations from the state of the sciences or technology.

(6) Each reception and each disconnection of received cells or tissues shall be documented.

(7) Occupied cells or tissues shall be labelled according to the state of science and technology. Each donation and any product resulting from it must be marked with the identification code ISBT 128.

(8) Cells and tissues may not be processed or stored for distribution until the results of the examination referred to in paragraph 4 have resulted in the suitability for use in humans.

Processing of cells and tissues

§ 13. (1) For all processing steps that affect quality and safety, the tissue bank shall lay down manufacturing rules. Any modification of the manufacturing rules shall be effected by reprinting, and the amendment shall be justified. The previously valid production method must be drawn into the new edition and be marked as invalid.

(2) The manufacturing rules shall be subject to specific rules for dealing with cells or tissues which must be discarded. In doing so, it is necessary to ensure that contamination of other cells or tissues, the processing environment and the personnel is avoided.

(3) Processing shall be carried out in accordance with the approved processing procedures and the manufacturing rules.

(4) The equipment used, the working spaces and the conditions for process development, validation and control shall be in accordance with the state of the sciences and technology.

Storage of cells and tissues

§ 14. (1) All procedures relating to the storage of cells and tissues shall be defined in SOPs. The storage has to correspond to the state of science and technology.

(2) All storage processes have to be carried out under controlled conditions. Ongoing controls shall ensure that no situation occurs which could affect the function or integrity of the cells or tissues.

Distribution of cells and tissues, recall

§ 15. (1) Processed cells or tissues may not be released for distribution until all the requirements and the state of the sciences and technology laid down pursuant to this Federal Act and the Regulations adopted on its basis are fulfilled. The release has to be made by the person responsible according to § 9.

(2) The tissue banks shall ensure the quality of the cells or tissues during the distribution according to the state of the art and technology.

(3) tissue banks shall ensure that an accurate, rapid and verifiable procedure is established with which each distributed product, associated with a serious incident or serious adverse reaction, is established: can be called back.

Documentation

§ 16. (1) tissue banks shall have a documentation relating to their activities which corresponds to the state of the sciences. In any case, the nature and quantity of the cells and tissues which have been received, tested, processed, stored and distributed or otherwise used and discarded shall be retained, the origin and destination of which shall be recorded.

(2) The documentation shall ensure complete traceability in accordance with the state of the sciences. Traceability shall also be ensured for all necessary data on products and materials which come into contact with these cells and tissues.

(3) The documentation shall be made in writing, electronically or on any other data carrier, provided that it is ensured that the necessary information is available during the period of the retention period.

(4) Each tissue bank shall take data security measures in accordance with § § 14f Data Protection Act 2000.

(5) The documentation shall be kept for at least ten years-those parts which are indispensable for the complete traceability, by at least 30 years-and to be taken into account by the competent authorities responsible under this federal law at all times. Control bodies shall be kept ready.

(6) tissue banks shall be obliged to submit a report to the Federal Office for Health Security (Bundesamt für Sicherheit im healthcare) by 30 June each year on their activities during the previous calendar year.

Reporting of serious adverse events and serious adverse reactions

§ 17. (1) Tissue banks shall have

1.		All serious incidents that may affect the quality and safety of cells and tissues must be immediately sent to the Federal Office for Health and Safety in the Health and Safety Authority, and
2.		all serious incidents which may be attributed to the quality and safety of the cells and tissues shall be immediately followed by those withdrawal or tissue banks from which they have been given the cells or tissues;
and to pass on all relevant information in order to facilitate traceability and to ensure quality and safety control.

(2) Pick-up facilities shall have all serious incidents which may affect the quality and safety of the cells or tissues and all serious adverse reactions occurring during the extraction process and which may result in the quality and safety of the cells or tissues. and the safety of cells or tissues, to report to that tissue bank for which the cells and tissues are intended.

(3) The responsible person pursuant to § 9 has to ensure that the Federal Office for Safety in the Health Care (Bundesamt für Sicherheit im Healthcare) reports any serious incident and any serious adverse reaction pursuant to paragraphs 1 and 2 as well as in accordance with § 32 (2) and a Report on the causes and consequences of this report.

(4) Pick-up facilities and tissue banks shall have all the information necessary for the investigation of all the extraction, processing, storage or distribution of the cells or tissues concerned, or tissue banks, of serious adverse reactions and serious adverse reactions.

Confidentiality of Obligations

§ 18. (1) Any person in a withdrawal facility and any person working or working in a tissue bank shall be bound to secrecy over all the secrets entrusted to her in the performance of his or her duties, provided that she does not already have: is subject to such a duty of confidentiality in accordance with other statutory or service law provisions.

(2) The duty of confidentiality shall not apply if:

1.		the person threatened by the revelation of the mystery, who is in the withdrawal facility or person who has been involved in a tissue bank or who has been employed by a tissue bank, has not been kept secret;
2.		the disclosure of the secret of the nature and content of the protection of higher-value interests of public health care or of the administration of justice is strictly necessary; or
3.		Reporting obligations with regard to communicable diseases are complied with.

(3) Data on the person of the donor and the recipient are excluded from the right of information pursuant to Section 26 of the Data Protection Act 2000. § 20 Reproductive Medicine Act, BGBl. No 275/1992, remains unaffected.

Reporting of the extraction of cells and tissues

§ 19. (1) Before the initial collection of cells or tissues, each withdrawal facility shall notify the Federal Office for Safety in the Health Care of the activity of this activity.

(2) If, after the notification referred to in paragraph 1, a change is to be made in respect of the holding which may have an effect on the quality of the cells or tissues or the protection of the donors, this amendment shall also require a notification to be made to the Federal Office for Health Security.

(3) The Federal Office for Safety in Health Care has to prohibit the production of cells or tissues if:

1.		do not have the necessary permits under other legislation, or the plant and all the medical and technical facilities required for the operation, comply with the provisions in force in the field of health care; do not comply,
2.		the human, spatial, operational or technical equipment required for the collection is not provided;
3.		the tasks and responsibilities of the persons involved are not established and are not included in an organizational plan,
4.		the necessary facilities for documentation and quality assurance corresponding to the state of the sciences and technology are not available, or
5.		the extraction otherwise does not correspond to the state of science and technology.

(4) The notification shall be accompanied by the following documents:

1.		the name and address of the holder;
2.		an operating description, including a list of essential medical equipment and other facilities,
3.		the necessary plans,
4.		a list of the staffing equipment envisaged, including the qualification and the organisation chart of the tasks and responsibilities of the staff ,
5.		the essential information relating to the quality system to be provided, including SOPs for the selection of donors, the examination and testing of donors, the packaging and transmission of cells or tissues;
6.		the type of cells and tissues obtained,
7.		where appropriate, information on the extraction outside of its own premises, including all places of extraction, subject to the relevant agreements with the relevant institutions,
8.		Information on the selection and recruitment of donors and
9.		a list of tissue banks to be supplied.

(5) The Federal Office for Health Security has to issue a certificate within six months of complete notification of suitability for the production of cells or tissues, if the conditions are fulfilled.

§ 20. (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to grant, in accordance with § 19 notified removal facilities, conditions and conditions corresponding to the state of the sciences and technology, provided that such conditions for the protection of the health of the Donors, ensuring the proper quality of the cells or tissues obtained, or in order to comply with the state of the art.

(2) If the protection of the health of the donor or the guarantee of the flawless nature of the desired cells or tissues cannot be achieved even by means of an amortiation of conditions or conditions, the Federal Office for Security prohibit the production of cells and tissues in the health care sector in accordance with § 19 of the notified removal facilities.

(3) It is established that, in spite of compliance with the requirements laid down in the communication, the avoidance of adverse effects on the protection of the health of the donor, the quality of the cells or tissues obtained, or the state of the sciences, In order to achieve these goals, the Federal Office for Health Security (Bundesamt für Sicherheit im Sicherheit) has to prescribe other or additional requirements in order to achieve these goals.

§ 21. If a change takes place in the person of the holder of a withdrawal facility reported in accordance with § 19, the legal successor shall immediately disclose this to the Federal Office for Safety in the Health Care.

Issue of authorisation for tissue banks

§ 22. (1) A permit issued by the Federal Office for Health Security is required for the operation of a tissue bank.

(2) If a change in the operation of a tissue bank, which may have an effect on the quality of the cells or tissues, is to be made after the granting of the authorization, this amendment shall also require the approval of the Federal Office for Safety in the health sector.

Conditions for authorization

§ 23. (1) The authorization shall be granted if:

1.		the requirements laid down in other legislation are available, and the plant and all the medical and technical facilities required for the operation are subject to the applicable rules in the field of health care corresponding to
2.		a person responsible for that law has been appointed and reputable to the authority,
3.		the human, spatial, operational and technical equipment necessary for the nature and scope of the intended processing, testing, storage and distribution is given,
4.		the tasks and responsibilities of persons working in the tissue bank are defined and identified in an organizational plan,
5.		the necessary facilities for a documentation and a quality assurance corresponding to the state of the sciences and technology are available,
6.		the processing procedures provided for are in accordance with the state of the art and technology; and
7.		the tissue bank shall have a precise, rapid and verifiable procedure to recall any distributed product which might be associated with a serious adverse event or reaction can.

(2) The authorization shall be subject to the state of the sciences and technology in accordance with conditions and conditions, provided that such conditions are to be met in order to ensure the proper nature of the products, to protect the health of the recipient or to protect the health of the recipient. Observance of the state of the sciences is necessary.

(3) The following documents shall be attached to the request for the grant of the authorization:

1.		the name and address of the advertiser,
2.		an operating description, including a list of essential equipment and other facilities,
3.		the necessary plans,
4.		a list of the staffing equipment envisaged, including the qualification and organisation scheme of the tasks and responsibilities of the staff, including the person responsible. ,
5.		the essential information relating to the quality system to be provided, including SOPs and documentation;
6.		The nature and extent of the processing, testing, storage and distribution envisaged, including the processing procedures provided for.

§ 24. If, after the granting of an authorization, the guarantee is not sufficiently secured, in spite of compliance with the conditions laid down in the communication, the guarantee of the correct nature of the products or the protection of the health of the recipient is not sufficiently ensured, the Federal Office of Public Health Security has to impose other or additional requirements in order to achieve these objectives.

§ 25. The change in the person of the holder of a tissue bank approved in accordance with § 22 shall not affect the validity of this authorization. The legal successor shall immediately inform the Federal Office for Safety in the Health Care of the change in the person of the holder.

Inspections

§ 26. (1) Monitoring compliance with this Federal Act by means of removal facilities and by tissue banks is the responsibility of the Federal Office for Safety in the Health Care Sector. The inspections shall be carried out at regular intervals of no more than two years.

(2) In the event of a serious adverse reaction or a serious incident, the Federal Office for Health Security shall, if necessary, arrange for such inspections to be carried out. Such inspections shall also be carried out in such cases on a duly substantiated request from the competent authority (s) of another Party to the Agreement on the European Economic Area. At the request of another Contracting Party to the Agreement on the European Economic Area or the Commission, the Federal Office for Health and Safety shall inform the public of the results of the requirements of this Federal Law. inspections carried out.

(3) The institutions of the Federal Office for Health and Safety and the experts it has drawn up shall be:

1.		to be granted access to all premises,
2.		the possibility to review and assess the activities and procedures carried out under this Federal Act and the Regulations adopted on its basis, and to the extent necessary to ensure the protection of evidence, photographs and to make video recordings in operation,
3.		to provide the necessary insight into all documents and records, and to make copies or photographs thereof; and
4.		to enable samples to be taken in the quantity required for an examination.

(4) In the case of extraction outside the premises, the withdrawal facility shall, in its agreement with the institutions concerned, ensure that the premises in which the extraction takes place are also carried out in the course of inspections. the institutions of the Federal Office for Health and Safety and the experts it has drawn up shall be able to exercise all the rights referred to in paragraph 3.

(5) The inspections shall be terminated in advance, except where there is a risk or if there is a reasoned assumption that the effectiveness of the official act could be adversely affected by the prior announcement.

(6) It should be taken into consideration that any disturbance or obstruction of the holding which is not strictly necessary is avoided.

(7) The samples taken are to be divided into three equal parts, in so far as it is possible to do so by their nature, and in this way it is not foiled up to their proper judgement. Two parts of it shall be officially closed, a part shall be left to the party for evidence. The sampling device, or, respectively, the sampling device, is a The tissue bank shall be followed by a confirmation.

(8) No compensation is due for the samples taken pursuant to paragraph 3 Z 4 in conjunction with paragraph 7.

§ 27. (1) The Federal Office for Health and Safety has the right to apply the best possible disposal of cases of maladministration in a modest way to the removal and removal of tissue banks. If these are not removed within a period to be set, the Federal Office for Health and Safety in the health sector shall inform the establishment of the necessary extent, if necessary also entirely, until the defect removal order has been completed. for the time being.

(2) In cases of imminent danger to human health, the Federal Office for Health Security has, after prior agreement of the holder, or if it is not possible, in the case of tissue banks of the responsible persons. (a) to suspend the operation on the spot, even without prior procedure and prior to the release of a date, but to issue a written communication within two weeks, if the measures taken are not in force; step.

(3) If it is clear that a withdrawal facility is operated without a notification or a tissue bank without an authorization, the Federal Office for Safety in Health shall have without prior procedure and prior to the release of a certificate, the To block the operation on the spot. A written communication shall be issued without delay.

(4) It shall be immediately enforceable in accordance with paragraphs 1 to 3. A change in the person of the holder does not affect the effectiveness of the fog.

(5) If the conditions for the release of claims pursuant to paragraphs 1 and 2 are no longer available, the Federal Office for Safety in Health shall, upon request, withdraw the measures taken with the foes in a modest way. With the notification in accordance with § 19 or the release of a grant notification in accordance with § 22, the communication in accordance with paragraph 3 repeals the force.

Withdrawal of the certificate and the authorization

§ 28. (1) The Federal Office for Health Security has the certificate or certificate, respectively, of a withdrawal facility. the tissue bank shall withdraw the authorization if:

1.		a prerequisite for issuing the certificate in accordance with § § 19ff or the granting of the authorization pursuant to § § 22ff has been omitted or the removal of defects in the sense of section 27 (1) has not been complied with twice,
2.		is that such a condition already exists when the certificate is issued, or the granting of the authorisation had not been fulfilled,
3.		the holder of a certificate or an authorization for violation of the provisions of this Federal Law has been punished at least three times within five years in accordance with Section 35 (1), or
4.		the holder of a certificate or of an authorization for violations of provisions of this Federal Law has been punished at least twice in accordance with Section 35 (2).

(2) The Federal Office for Health Security may, on time or in the long term, prohibit a responsible person from exercising the duties of a responsible person if he or she is responsible for the activities of a responsible person at least three times for infringements of the Provisions of this federal law have been punished.

Register of removal facilities and tissue banks

§ 29. (1) The Federal Office for Health Security has a register of all certified extraction facilities and approved tissue banks, in which, at any rate, information must also be included for which activities the certification or the authorization has been granted. This is to be made publicly available on the Internet on the homepage of the Federal Office for Health Security.

(2) The Federal Minister for Health, Family and Youth may adopt detailed rules on the management of this register and the nature and extent of the entries by Regulation.

Authorisation for the regulation of tissue banks

§ 30. The Federal Minister for Health, Family and Youth may adopt detailed provisions on this subject by Regulation,

1.		the requirements for the necessary spatial and technical equipment, as well as the hygiene standards to be complied with, a sufficient quality system and the organisation scheme,
2.		the minimum staffing level of a tissue bank, the specific knowledge and skills of the staff, and the training, training and further education activities of these persons,
3.		how cells and tissues are to be identified,
4.		what requirements are to be met for autologous use products,
5.		what procedures are to be followed in the reception of cells or tissues;
6.		the conditions in which the processing, storage and distribution are to be carried out, and more detailed rules on the requirements for processing procedures may be adopted,
7.		what requirements are to be met in packaging,
8.		what requirements should be made of documentation and its type and scope,
9.		what arrangements are to be made with regard to traceability,
10.		what procedures should be followed to report serious incidents and serious adverse reactions, as well as the nature and scope of such notifications;
11.		when equivalent quality and safety standards within the meaning of Article 12 (2) are to be considered on importation from third countries,
12.		the content of the annual activity report of the tissue bank to be refunded.

Direct use

§ 31. (1) The Federal Minister for Health, Family and Youth may by Regulation designate specific types of cells and tissues in which, according to the state of the sciences, it is permissible for them to be used directly in the patient after the extraction. without being included in a tissue bank. This Regulation may also lay down more detailed rules on the conditions for direct exchange of such provisions.

(2) Where a Regulation is applied to cells and tissues in accordance with the provisions of paragraph 1 above, these may

1.		be processed, stored and distributed by a sampling device without the need for such equipment to have an authorization in accordance with section 22, and
2.		, notwithstanding § 12, the user is directly introduced or accepted by the user or carried out by a removal device.

Regulations for users

§ 32. (1) Users have to document any use of cells and tissues according to the state of science. In any case, this documentation shall contain:

1.		the identification of the tissue bank or the withdrawal device in the case of direct use from which the cells or tissues were obtained,
2.		User ID,
3.		cell or tissue type,
4.		product identifier,
5.		recipient identifier,
6.		Date of application.

(2) Physicians and dentists have

1.		any serious adverse reaction which has been observed during or after the clinical use of cells or tissues and could be related to the quality and safety of cells or tissues; and
2.		any lack of quality or safety which could be related to a serious adverse event in the production, processing, storage or distribution of such products,
without delay of the tissue bank from which they have been given the cells or tissue, or to report, in the case of direct use of the withdrawal device which has obtained the cells or tissues concerned, and to pass on all relevant information in order to facilitate traceability and to control quality and safety , In the case of direct use, the user must also report to the Federal Office for Health and Safety in the health care sector.

(3) The Federal Minister for Health, Family and Youth may adopt detailed provisions on the content of the documentation referred to in paragraph 1 above and on the nature, scope and form of the notifications and information referred to in paragraph 2.

Vigilance Register

§ 33. (1) The Federal Office for Health Security has to include all reported serious adverse reactions and all serious incidents in a register. This register shall be used for tissue vigilance and market surveillance. The processing of the data from the donor and the recipient is carried out without reference to any person. Data security measures pursuant to § § 14f Data Protection Act 2000 are to be taken.

(2) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has a report to the Federal Minister for Health, Family and Youth on the reports of serious adverse events and serious adverse reactions in the previous calendar year.

Automation-supported traffic

§ 34. The Federal Office for Health Security is authorized to collect and transmit data according to § 33 (1) in or for the automation-supported data traffic.

1.		the Federal Ministry of Health, Family and Youth,
2.		the European Commission and
3.		competent authorities of other Contracting Parties to the Agreement on the European Economic Area.

Administrative penalty provisions

§ 35. (1) Who

1.		in the case of the collection, processing, storage and distribution of human cells and tissues, contrary to § 1 (2), the state of the art and technology is not in compliance,
2.		the conditions set out in Section 3 (2) or (4) to (8) for removal facilities are not fulfilled, or ,
3.		carry out the removal of cells or tissues from the living donor contrary to § 4 (2) without previous investigations,
4.		is in breach of the documentation requirements in accordance with § 5 (1) to (4) or against the labelling or packaging obligations of section 5 (6),
5.		is in breach of the obligations laid down in § 6,
6.		in breach of the obligations laid down in Article 8 (2) to (4),
7.		operates a tissue bank without having to have a responsible person or a responsible person who does not have the qualification in accordance with § 9 para. 2 or violates the reporting obligation pursuant to § 9 para. 4,
8.		does not comply with the requirements for a quality system in accordance with § 10 (1) to (3) or is in breach of the obligation under Section 10 (4),
9.		Contrary to Article 11 (1), no written agreements with removal facilities for removal are to be concluded or are contrary to paragraphs 2 to 6,
10.		Contrary to the provisions of § 12 cells or tissues, accept or implement or do not comply with the other requirements of § 12,
11.		in the case of processing, the requirements of § 13, in the case of storage the requirements of § 14, in the distribution the requirements according to § 15, or the requirements to the documentation according to § 16 shall not be fulfilled,
12.		does not comply with the reporting obligations under section 17;
13.		is in breach of the obligation of confidentiality in accordance with § 18,
14.		the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) does not immediately disclose the change of the person of the holder according to § 21 or § 25,
15.		as the person in charge of a hospital or as a freelance practitioner or dentist of his obligation to provide documentation, in accordance with § 32 (1) or his obligation to notify pursuant to § 32 (2), or
16.		Regulations are contrary to this federal law,
if the offence does not comply with the facts of a criminal offence within the jurisdiction of the courts, an administrative surrender and a fine of up to 7,270 euros.

(2) Who

1.		Contrary to Section 3 (1), the collection of cells and tissues is carried out in removal facilities which have not been reported to the Federal Office for Health and Safety in the healthcare sector,
2.		in breach of the prohibition in § 3 (9),
3.		taking a withdrawal, although there is a serious risk to the life or health of the donor or the obligation to carry out the follow-up pursuant to Section 4 (2) does not comply,
4.		carry out the removal without medical information within the meaning of section 4 (3) or without the consent of the living donor in accordance with § 4 (3),
5.		Contrary to § 4 paragraph 4, cells or tissues taken from a living person in the course of a medical treatment continue to be used without the patient's informed consent and consent,
6.		is in breach of the obligations laid down in Article 4 (5),
7.		dispensiation of cells or tissues or third persons for a donation contrary to § 4 (6) provides a financial gain or comparable advantage, or promises to
8.		a tissue bank without authorization in accordance with § 22, or applying a processing procedure without authorization,
9.		makes changes to the company as a withdrawal facility without reporting it to the Federal Office for Health in accordance with Section 19 (2), or does not comply with conditions or requirements in accordance with § 20,
10.		as a tissue bank, make changes with regard to the operation in accordance with section 22 (2) without obtaining a permit issued by the Federal Office for Health and Safety in the healthcare sector,
11.		as a tissue bank, not comply with conditions and obligations pursuant to Section 23 (2), § 24 or § 27 (1),
12.		grants no access to the monitoring bodies within the meaning of section 26, their activities or prevents the necessary inspection of the file or makes sampling impossible,
13.		in the form of a withdrawal facility in breach of the obligation under Section 26 (4), or
14.		conditions or obligations pursuant to section 27 (1) are not fulfilled as a removal facility,
if the offence does not fulfil the facts of a criminal offence within the jurisdiction of the courts, an administrative surrender and a fine of up to EUR 36,340. The same shall apply if, in accordance with paragraph 1 of this Article, a serious risk to the life and health of a person has been created or the offender has already been punished twice in accordance with paragraph 1.

(3) Who

1.		in breach of his obligations pursuant to Section 9 (3),
2.		the activity of a responsible person, without fulfilling the conditions set out in Section 9 (2),
3.		the person responsible is not in compliance with the reporting obligations under Section 17 (3), or
4.		the person responsible shall be responsible for the obligations imposed on her by a regulation in accordance with Section 30;
if the offence does not comply with the facts of a criminal offence within the jurisdiction of the courts, an administrative surrender and a fine of up to 7,270 euros.

(4) The attempt is punishable.

Participation of bodies of the public security service

§ 36. The institutions of the Public Security Service have the Federal Office for Security in the Public Health Service (Bundesamt für Sicherheit im healthcare) on its request to ensure the exercise of the powers pursuant to § § 26, 27 (2) and (3) and 37 (3) within the framework of its statutory provisions Effective range of assistance.

Transitional and final provisions

§ 37. (1) Those who win cells or tissues or operate a tissue bank at the time of the entry into force of this Federal Act and wish to continue this operation shall have within six months of the entry into force of this Federal Act at the Federal Office for security in the health sector to report in accordance with § 19; apply for an authorisation in accordance with § 22.

(2) Until the decision on the application referred to in paragraph 1 above, existing tissue banks may continue to operate, provided that the correct nature of the products and the protection of the health of the recipient are guaranteed.

(3) Even before the decision on the application submitted in accordance with paragraph 1 has been made, the Federal Office for Safety in Health Care shall immediately arrange for the elimination of maladministration, which are suitable for the flawless nature of the products and the protection of the health of the recipient. In the event of danger in default, the removal device or removal device is to close the tissue bank by the Federal Office for Health Security.

(4) The operator of a removal device shall not be notified of the notification or a tissue bank the application for an authorization to the Federal Office for Health Security within the specified period of time, or if the operator does not comply with the instructions in accordance with paragraph 3, the Federal Office of Safety in the health sector to prohibit the operation with communication.

§ 38. Insofar as other federal laws are referred to in this Federal Act, these are to be applied in their respectively applicable version.

§ 39. The Federal Minister for Health, Family and Youth is responsible for § 36 in agreement with the Federal Minister for the Interior with the enforcement of this Federal Act.

§ 40. (1) The Federal Office for Health Security has annually appointed the Federal Minister for Health, Family and Youth and the Advisory Board established at Health Österreich GesmbH for advice on transplantation matters on the basis of annual reports. to submit a report to the tissue banks on the activities of the removal institutions and tissue banks in the framework of this Federal Law and the enforcement of this Federal Law.

(2) The Advisory Council referred to in paragraph 1 may, on the basis of the annual report, submit an opinion to the Federal Minister for Health, Family and Youth, including in particular the relationship between the requirements for organs and organ parts. Deceased for the purpose of transplantation and the removal of cells and tissues for use in humans.

(3) The Federal Office for Health Security has, by 7 April 2009 and every three years thereafter, a report on the activities of the Federal Ministry of Health, Famlilie and Youth of the European Commission, has been published by the Federal Office for Health and Safety. To submit to the collection and tissue banks under this Federal Act and to the enforcement of this Federal Act in the previous reporting period.

§ 41. The following guidelines are implemented by this federal law:

1.		Directive 2004 /23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L 206, 22.7.2004, p. No. OJ L 102, 7 April 2004, p. 48,
2.		Directive 2006 /17/EC on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards technical requirements for the donation, procurement and testing of human tissues and cells, OJ L 175, 5.7.2006, p. No. OJ L 38, 9 February 2006 p. 40,
3.		Directive 2006 /86/EC on the implementation of Directive 2004 /23/EC of the European Parliament and of the Council as regards requirements for traceability, reporting of serious incidents and adverse reactions, and certain technical requirements relating to the coding, processing, preservation, storage and distribution of human tissues and cells, OJ L 327, 30.4.2004, p. No. OJ L 294, 25. October 2006 S 32.

Article 2

Amendment of the Medicines Act

The Drug Law, BGBl. I n ° 185/1983, as last amended by the Federal Laws BGBl. I n ° 153/2005 and BGBl. I n ° 6/2007, is amended as follows:

1. In accordance with § 57a, the following § 57b is inserted:

" § 57b. This section does not apply to the delivery of human cells and tissues for use in humans, as far as they are under the tissue safety law, BGBl. I n ° 49/2008. '

2. "and" at the end of Section 62 (2) (2) (2), the item in accordance with section 62 (2) (3) shall be replaced by the word "and" is replaced and after Z 3 the following Z 4 is added:

" 4.		Tissue banks, in so far as their activities pursuant to Section 1 of the Tissue Safety Act fall exclusively within the scope of the tissue safety law. "

3. In accordance with § 75d, the following § 75e is inserted:

" § 75e. Excluded from the reporting obligations of § § 75a to § 75c are those cases in which a serious adverse event or incident occurs. a serious adverse reaction has to be reported in accordance with § § 17 or 32 tissue safety law. "

4. In accordance with Section 94c (7), the following paragraph 7a is inserted:

" (7a) Applications for the authorisation of proprietary medicinal products according to § 17a of this Federal Act, as amended before the entry into force of the Federal Law BGBl. I n ° 153/2005, which were pending on 2 January 2006, are in accordance with the legal situation prior to the entry into force of the Federal Law BGBl. I n ° 153/2005. '

Article 94c (8), first sentence reads:

" The approval of proprietary medicinal products which, in accordance with § 17a of this Federal Act, as amended before the entry into force of the Federal Law BGBl. No later than 30 April 2011, and from 1 May 2011, these proprietary medicinal products may no longer be placed on the market. '

6. According to Article 95 (8d), the following paragraph 8e is inserted:

" (8e) § 57b, § 62 para. 2 and § 75e in the version of the Federal Law BGBl. I n ° 49/2008 come into force with the entry into force of the tissue safety law, BGBl. I n ° 49/2008 in force. Section 94c (7a) and (8), first sentence, shall enter into force on 2 January 2006. "

Article 3

Amendment of the Reproductive Medicine Act

The reproductive health care law, BGBl. No 275/1992, as last amended by the Federal Laws BGBl. I n ° 163/2004 and BGBl. I n ° 6/2007, is amended as follows:

In § 5 (2) 2. sentence, after the word "Equipment" the phrase "and the provisions of the legal powers" inserted.

Article 4

Amendment of the Health and Food Safety Act

The Health and Nutrition Security Act, BGBl. I No 63/2002, as last amended by the Federal Law of the Federal Republic of Germany (BGBl) I No 139/2006 and BGBl. I n ° 6/2007, is amended as follows:

1. The point at the end of Section 6a (1) (5) shall be replaced by a dash and the following Z 6 shall be added:

" 6.		Enforcement of the tissue safety law, BGBl. I n ° 49/2008, to the extent that, under this law, the Federal Office for Safety in Health is entitled to the full education. "

2. In Section 6a (4) and (6), the citation shall be "§ 8 (2) Z 13 to 15" by quoting "§ 8 (2) Z 13 to 16" replaced.

3. The point pursuant to Article 8 (2) (15) is replaced by a supplement, the following Z 16 is added:

" 16.		Investigation and evaluation of human cells and tissues according to the tissue safety law. "

4. § 8 (7) last sentence reads:

"In the area of paragraph 2 Z 13, if it is not for the scientific advice of potential applicants, services may not be provided for third parties."

5. In accordance with section 19 (22), the following paragraph 23 is inserted:

" (23) § 6a (1) Z 6, § 6a (4) and (6) and Section 8 (2) Z 16 in the version of the Federal Law BGBl (Federal Law Gazette). I n ° 49/2008 come into force with the entry into force of the tissue safety law, BGBl. I n ° 49/2008 in force. '

Article 5

Amendment of the Federal Act on hospitals and health care institutions

Federal law on hospitals and health care institutions, BGBl. No. 1/1957, as last amended by the Federal Laws BGBl. I No 122/2006 and BGBl. I n ° 6/2007, is amended as follows:

1. (determining the principles) § 10 para. 1 Z 6 reads:

" 6.		on the deprivation of the law pursuant to § 62a and Section 4 (5) of the tissue security law, BGBl. I n ° 49/2008, to include inscriptions on the history of medical history and to keep it in accordance with Z 3; "

2. In accordance with Section 62a (4), the following paragraph 5 is added:

" (5) The removal of organs and organ parts of deceased for the purpose of transplantation shall take precedence over the removal of cells and tissues for use in humans. The need for organs and organ parts of deceased for transplantation must not be impaired by the removal of cells and tissues for use in humans. "

§ 62c reads:

" § 62c. (1) If the offence is contrary to the provisions of Section 62a, if the action does not comply with a criminal offence under the jurisdiction of the courts, it shall be subject to an administrative surrender and shall be punishable by a fine of up to EUR 36,340.

(2) The attempt is punishable. "

4. In accordance with Section 65 (4c), the following paragraph 4d is inserted:

" (4d) The Land legislation has the implementing provisions of § 10 paragraph 1 Z 6 in the version of the Federal Law BGBl. I n ° 49/2008 within six months. '

Fischer

Gusenbauer