Page 1

New Directory Login Free Directory for 2 weeks

Coronavirus info

Legal library

Existing legislation New legislation Amended legislation Local government decree Laws of a thousand years

Legislation in force Search /

/ XXI 2008 law

✖

Obtaining credit

The current state of the legislation (28.06.2021).
THE symbols indicate past and future changes in paragraphs.
✖

Free Rights Library

I'll open it in the Rights Library

✖

Free Directory

XXI 2008 law
on the protection of human genetic data, human genetic testing and research,
*
and the rules for the operation of biobanks
The National Assembly
Recognizing the need for special and enhanced protection of an individual's innate genetic characteristics for life,
that genetic research on a sample of human biological material by understanding the background of diseases and exploring treatment options
is of great scientific importance, given the need to increase the protection of human dignity in genetic research,
having regard to Annex VI to the 2002 the Council of Europe on the protection of the human rights and dignity of the human being
Convention for the Protection of Human Rights with regard to the Application of Medicine, done at Oviedo on 4 April 1997:
and the Convention on Biomedicine
constitutes the following law:

Chapter I.
PURPOSE AND SCOPE OF THE ACT

The purpose of the law
§ 1 The purpose of this Act is to determine the rules for human genetic testing and human genetic research, genetic
the conditions and purposes of data processing and the rules for biobanks.
Principles
*

1 / A. §

*

(1) Human genetic research that investigates the behavioral characteristics of the person concerned or

only appropriate guarantees, such as a wide range of information, non-genetic
research procedure that respects its characteristics, ensuring the possibility of collective consultation in the case of research involving an ethnic group
- can be performed with.
2. The rights of any person shall not be restricted by reason of the structure of their DNA and the genetic risks which may be inferred from it.
3. The health care of the persons concerned may not be made conditional on the use of their genetic samples or genetic data in research.
consent to the use and archiving of
Scope of the Act
*
§ 2. (1) The
provisions of this Act - with the exception of § 27 (2) - shall be applied in accordance with this Act.

genetic sampling for the purpose of human genetic testing or human genetic research,
genetic data, human genetic testing and genetic research, and biobanks
apply.
(2) This Act shall apply to data management and data processing carried out by fully or partially automated means and by manual means.
apply equally.
*
(3) The
scope of this Act does not cover the system of criminal records and the processing of criminal and law enforcement biometric data.

DNA profile and other judicial, law enforcement and crime prevention
data management.
Interpretative provisions
Section 3* (1) For the purposes of this Act
1. data subject: a natural person providing a genetic sample who has come into contact with or is coming into contact with a data controller under this Act;
2. genetic sample: any human genetic test or human genetic research carried out in accordance with this Act or taken for the purposes of this Act.
a sample of biological material of human origin otherwise intended to be used for that purpose;
3.

*

4. coded genetic sample or data: a genetic sample or data in which all the data relating to the person providing the sample are present
personal identification data has been replaced by a code;
5. pseudonymised genetic sample or data: an encoded genetic sample or data in which the
code has been made available exclusively to the person concerned;
6. anonymised genetic sample or data: a genetic sample or data in respect of which all relevant data are available
personally identifiable information has been rendered inoperable;
7. biobank: a genetic sample and the related genetic and personal identification data in accordance with the Human Genetics Act of this Act.
with an operating or research permit specified by law for the purpose of research or human genetic research
collection, excluding samples taken for healthcare or medical research, or any
biological cells and tissues secondary to the intervention, as well as
a collection of samples containing personal identification and other health data;
8. human genetic research: by the structural structure of the genome (genes, chromosomes) determining the genetic identity of individuals,
disorders and variants of the program, as well as the physical, mental, behavioral characteristics of the gene-encoded program.
the laws of the gene-coded program from parents to offspring,
research on the detection of abnormalities, which uses genetic testing for research purposes in accordance with this Act to achieve its objectives;
9. ‘ archived collection’ means a collection of biological samples for which the original purpose of sampling has already been achieved and in which the
clinical genetic testing or genetic screening of stored samples only with the consent of the person providing the sample,
in addition, genetic testing for research purposes may be carried out in the framework of authorized medical research;
10.

*

*
11. human
genetic testing: germ cell-derived disease associated with or predicting adverse health effects

(inherited) or early in fetal life, congenital genome (genes, chromosomes)
laboratory analysis of a genetic sample for the detection of variants
there may be a clinical genetic test, a genetic screening test and a genetic test for research purposes;
*
12. clinical
genetic test: a human genetic test in which the person providing the genetic sample is a disease

(diagnostic genetic test) or in which the blood relative of the asymptomatic person providing the genetic sample
suffers from a genetic disease and is at increased risk for his or her own health or for having children;
*
13. genetic
screening: an unsorted human genetic screening program performed on members of a specified population

testing to identify those at risk from asymptomatic individuals who provide a genetic sample
by exploring their characteristics;
14. "*genetic test for research purposes" means a human genetic test in which the individual providing the genetic sample is asymptomatic;
or a patient whose disease has already been confirmed by a clinical diagnostic genetic test and the approved research plan
to better understand the genetic background or treatment options for human diseases;
*
15. genetic
counseling: a consultation procedure in which a person authorized to do so by law provides information to the clinician

the benefits or risks of genetic testing, the possible consequences of the results of human genetic testing, and
helps to understand the nature of the disease;
16. " third country" means any country which is not an EEA State;
17. EEA State: a Member State of the European Union and another State party to the Agreement on the European Economic Area, as well as
a State of which the European Community and its Member States are nationals and which is not a national of the Agreement on the European Economic Area
a State party to the Agreement on the European Economic Area under an international agreement concluded between States Parties
enjoys the same legal status as its national;
18. close relative: spouse, cousin, brother, registered partner, spouse, cousin
spouse and spouse and descendant of the brother.
(2) In* addition to the provisions of subsection (1), for the purposes of this Act, CLIV. Act (hereinafter:
Eütv.), Act XLVII of 1997 on the handling and protection of health and related personal data. Act (a
hereinafter referred to as "Eüak."), and on the protection of individuals with regard to the processing of personal data and such
European Parliament and of the Council of 27 April 2016 on the free movement of data and repealing Directive 95/46 / EC
the interpretative provisions of this Regulation of the European Parliament and of the Council (hereinafter referred to as the General Data Protection Regulation).
*

(3)

Genetic data as defined in Article 4 (13) of the General Data Protection Regulation for the purposes of this Act a

for human genetic testing and human genetic research.

II. Chapter
GENERAL RULES

Management of genetic data
§ 4 (1)

*

(2) Genetic data if the conditions set out in this Act are met
(a) *for human genetic testing
*
(aa) the
institution performing the human genetic testing,
*
(ab) the
person performing the human genetic test,

ac) a doctor pursuant to § 14,
(b) *for the purpose of human genetic research
(ba) the research institution,
(bb) any other person involved in the conduct of the research
can handle.
Section 5 (1) Genetic data
a) the responsible person pursuant to § 25 in the scope of duties under this Act,
(b) *the Data Protection Officer shall be the Euak. acting in accordance with its responsibilities under
(2) The person named by the data subject pursuant to Section 7 (2) and the close data subject of the data subject are entitled to access the genetic data.
subject to Section 7 (3) and Section 10 (3).
RIGHTS OF THE PERSON CONCERNED
Right to information

§ 6. (1) The data subject is entitled to get acquainted with his or her genetic data generated during human genetic testing.
Prior* to sampling for human genetic testing, the person concerned shall be informed in the context of genetic counseling by:
the purpose of sampling, the benefits and risks of carrying out or not carrying out the test, the
close relatives, the ways in which the genetic sample and data are stored, the
genetic samples as well as the possibilities of data identification.
2a. In*addition to paragraph 2, depending on the type of genetic testing, the data subject shall be informed of:

*
(a) in
the case of a clinical genetic test, the result of the genetic test carried out, its possible consequences, and

the genetic risk to the person concerned and his or her close relatives and the nature of the disease;
(b) in the case of a genetic screening test, the nature of the disease, the meaning of the positive and negative results and the
the importance of a confirmatory test;
(c) in the case of a genetic test for research purposes, the nature of the research and the fact that the data subject may request the result of the research
getting to know each other.
(3) If the genetic sample is used for research purposes, the person concerned shall, before signing the consent statement pursuant to Section 8 (1),
shall be informed of the Eütv. 159 (3), the methods of storage of the genetic sample and data, the various
genetic samples or data stored in the form of data and, in the absence of any other
the inclusion of a genetic sample in an archived collection, the possible transfer of stored genetic samples.
*
4. The
data subject shall have the right to receive the results of the clinical genetic testing in a personalized form, genetic counseling.

receive information. The information should help the data subject to consider the possible long-term consequences of the outcome
processing and selection of optimal treatment options.
5. In addition to paragraphs 2 and 4, genetic counseling may be provided at the individual request of the data subject.
(6) In the case of automated data processing and coding, the data subject shall be informed of the applied IT method upon request.
(7) The person concerned may waive the knowledge of his or her genetic data in his or her declaration. The declaration may be withdrawn at any time without restriction. The
the data subject shall be informed of this right.
§ 7. (1) Genetic data may be communicated to the data subject, to a person pursuant to subsection (2) or to a person who, on the basis of this Act,
entitled to know.
2. In the authentic instrument concerned, in a private instrument of full probative value or, in the event of incapacity, in the presence of two witnesses,
by oral declaration, you can name the person who is entitled to know your genetic data.
(3) If the prevention of the illness of a close relative, the knowledge of the nature of his illness, the treatment and the treatment of his offspring
If it is necessary to assess the relevant disease risk, the genetic data may also be disclosed to a close relative. Of this
in the context of genetic counseling of a close relative, at the request of the
The right to self - determination

§ 8. (1) Prior to the genetic sampling, regardless of the purpose of the processing of the genetic data, the detailed
informed written consent is required.
(2) A* minor with limited legal capacity and an adult whose legal capacity has been partially restricted by a court in such a way that
that the restriction covers the exercise of your healthcare rights and personal rights, your legal representative
may give its consent pursuant to paragraph 1 with its consent or with its subsequent approval. Subsequent approval
genetic sampling may not take place until Instead of an incapacitated person, his legal representative may declare
subject to Section 13 (3) and (4).
3. The declaration of consent referred to in paragraph 1 shall include:
(a) the consent of the data subject to:
(aa) a genetic sample is taken from him for a predetermined purpose,
ab) the genetic sample or the genetic data derived therefrom are placed in a biobank and it is transferred to another bank in accordance with Section 26 (5).
be transferred to a biobank,
(ac) the genetic sample and the resulting genetic data are placed in an archived collection;
(b) a statement by the data subject that the genetic sample or data
(ba) only for the primary purpose of sampling,
(bb) for any purpose under this Act, or
(bc) for research use only
contributes;
c) a statement by the data subject that, subject to the provisions of Section 23 (2) and Section 24, the genetic sample,
or to store data together with personally identifiable data, encrypted or, in the case of point (b) ( bc) ,
contributes to the storage of pseudonymised or anonymised forms;
d) a statement by the data subject that he or she has received and taken note of the information contained in Section 6 (2) and (3) and (7).
(4) During the storage of a coded genetic sample or data, the identification of the data subject shall, in accordance with this Act, only
for the benefit of his relative.
5. In the absence of a declaration under paragraph 3 ( c) , unless the data subject expressly refuses, the genetic samples and
data can be placed in an anonymized form in an archived collection.
6. In the cases referred to in points ( bb) and ( bc ) of paragraph 3 ( b) , in the case of use for medical research purposes, the consent
The declaration is also subject to the requirements of a separate legal act on medical research.
7. The data subject may withdraw his or her consent pursuant to paragraphs 1 to 3. In the case of consent withdrawn after sampling, the
shall be carried out in accordance with
(8) A* minor with limited legal capacity and an adult whose legal capacity has been partially restricted by a court in such a way that
that the restriction covers the exercise of your healthcare rights and personal rights, your legal representative
may withdraw its consent with its consent or with its subsequent approval. It is legal instead of an incapacitated person
representative may make a statement.
§ 9. (1) For the taking of a genetic sample from a deceased person, the genetic material taken or stored together with the personal identification data
for the examination of a sample, the use of human genetic research or the use of genetic data
may take place if the deceased has not made a protest against it in his or her lifetime.
(2) The deceased may, even in his lifetime, order the use of a genetic sample taken from him after his death to be restricted.
3. A statement of objection or restriction pursuant to paragraphs 1 and 2 shall be made by a person capable of acting in an authentic instrument of full probative value.
private document or, if he could make a written statement with no or only significant difficulty, two witnesses
in the presence of the ensemble.
(4) A* minor with limited legal capacity and an adult whose legal capacity has been partially restricted by a court in such a way that
that the restriction covers the exercise of his healthcare rights and personal rights, his own genetic patterns
may, without the assistance of its legal representative, declare
as set out in paragraph
(5) Instead of the incapacitated person, his or her legal representative may make a declaration in accordance with paragraph (3).
(6) In the case of an oral statement, it shall be recorded in writing, in which the two witnesses shall certify that the oral statement has been made. THE
oral statement from the attending physician, signed by two witnesses, or a statement otherwise
recorded by the attending physician in the medical records.
§ 10. (1) Data provided for the management of genetic data stored, coded or pseudonymised together with the personal identification data of the data subject
you can withdraw your consent at any time. In the case of a withdrawal statement, the data subject may request the genetic sample and its derivative
destruction of all genetic data.
(2) Destruction of a genetic sample and data in the case of a sample and data used exclusively for human genetic research purposes
without delay, no later than 8 days after the submission of the application in the case of samples and data stored for genetic testing
After 30 days, it shall be carried out within 45 days of the request, taking into account the provisions of paragraph 3. The application
genetic samples and data may only be processed for the benefit of a close relative.
*
(3) The
prevention of the illness of a close relative, the knowledge of the nature of the illness, the treatment of

is entitled to inspect the genetic data in order to assess the risk of disease. To this end, with the consent of the data subject
- the attending physician initiates the involvement of close relatives in genetic counseling.
§ 11. In applying the provisions of this chapter, the Eütv. 13 and 14 of the right to information and § 16 a
its rules of consent also apply mutatis mutandis.

III. Chapter
RULES FOR HUMAN GENETIC EXAMINATION
*
§ 12. (1)
Human genetic testing is only about the minimum professional conditions necessary for the provision of health services

may be performed by a health care provider equipped with a qualified personal background and operating license in accordance with this Regulation.
(2) A health care provider performing human genetic testing shall comply with the provisions of this Act and the storage of genetic samples and data.
the conditions of the Regulation on the minimum professional conditions for the provision of health services. Healthcare
the Human Reproduction Committee of the Scientific Council of Health (hereinafter: ETT HRB)
act as an expert when seconded.
*
§ 13. (1) Human
genetic testing for prevention, diagnostic, therapeutic, rehabilitation or research purposes and exclusively for medical purposes

interest.
(2) The consent of the person concerned pursuant to Section 8 (1) is required for the performance of a human genetic examination.
3. A *human genetic test shall not be performed on an incapacitated person unless, in the knowledge of the results of the test,
a measure may be taken to prevent the onset of the disease of the person under investigation, to delay its onset,
limits its severity, prevents disability, helps to restore its health, and
necessary to determine the direction of its continuation.
*
4. Exceptionally,
a human genetic test may be performed for the benefit of a close relative for the purposes of paragraph 3.

in the case of an incapacitated person, if the performance of the test cannot be replaced by another test, the benefits of the test outweigh the
the possible risks and disadvantages involved or the nature of the investigation necessarily justifies
carried out.
§ 14 The result of the human genetic examination shall be communicated to the treating doctor who initiated the examination.
Section 15 The information pursuant to Section 6 (2) prior to sampling for the purpose of human genetic testing shall include:
for the exact purpose of human genetic testing. Further investigation beyond the scope of the information, in particular
Further investigation made necessary as a result of human genetic testing - to § 8 (3), b) point bb) in Subpart
in the absence of a declaration to that effect, only with the re-consent of the data subject. The
the provisions of Section 8 shall apply to the making of a repeated consent.

ARC. Chapter
USE OF GENETIC SAMPLES AND DATA FOR RESEARCH PURPOSES
§ 16. (1) Genetic samples or data may be used for the purpose of human genetic research in accordance with the provisions of this Act.
*
(2) In
the case of human genetic research, the Eütv. 157-164 / D. § shall also apply.

(3) Human genetic research may be carried out only in an institution where the storage of genetic samples and data is subject to this Act and special regulations.
statutory conditions are available. Failing this, the research plan cannot be approved.
§ 17. (1) Human genetic research performed on a population includes individuals belonging to a given group or individuals belonging to different groups.
to determine the distribution of genetic variations existing between individuals, to explore their nature and consequences
can be done.
2. The genetic research referred to in paragraph 1 shall be comprehensive information, respecting the non-genetic characteristics of the personality.
procedure. During the research procedure, the purpose of the research, the range and number of subjects involved in the research, the research
information on the duration of the sample and the methods of storing the data may be provided to the entire population involved in the research,
which cannot be a substitute for individual information and consent from data subjects.
3. The genetic sample or data obtained in the course of genetic research referred to in paragraph 1 shall not be personally identifiable,
can also be grouped according to the criteria specific to the group involved in the research.
(4) Human genetic research examining the behavioral characteristics of an individual shall respect the non-genetic characteristics of the personality.
research process.
§ 18 The data subject may at any time during the research request a genetic sample or genetic data derived therefrom for research purposes only.
coding, pseudonymisation or anonymisation.
§ 19. (1) For the use of an anonymised genetic sample or data stored in an archived collection for new research, the
the consent of the person concerned pursuant to Section 8 (1) is required. If the data subject is relevant to the research
does not consent to use, the sample and data may not be used for that purpose.
2. If consent cannot be obtained for any other reason, the genetic sample stored together with the personally identifiable data, or
prior to further use, the coded genetic sample or data shall be
may be stored again together with personally identifiable data with the consent of the Genetic sample or data without coding, separately
in the absence of consent, may be used for human genetic research purposes even if the declaration of the person concerned pursuant to Section 8 (1)
allowed.
§ 20 For the use of a genetic sample taken for the purpose of genetic testing for research purposes in accordance with the rules contained in § 19
shall apply.

Chapter V.
RULES APPLICABLE TO THE BIOBANK
§ 21. With regard to the handling and storage of genetic samples and related personal data placed in a biobank, the relevant § 8 ​(1)
its declaration under paragraph 1 shall apply.
§ 22. (1) A*biobank is authorized to carry out human genetic examinations and to carry out specific medical research.
provider may establish and maintain it with the permission of the state health administration body.
(2) Other institution conducting human genetic research in the absence of a permit pursuant to subsection (1), approved individual research plan
operate a biobank to store the genetic samples and data needed to carry out the research,
for the duration of the research.
3. A research plan may be approved if the human genetic research institution has a biobank or
the conditions for the establishment and maintenance of a biobank in accordance with this Act and special legislation.
(4)

*

§ 23. (1) During the storage of a genetic sample or data, the protection of the genetic sample or data shall be ensured by destruction,
destruction, alteration, damage, disclosure and access by unauthorized persons.
(2) Unless otherwise provided by this Act, genetic samples and data shall be stored in coded form.
(3) The coded genetic sample, data and code keys shall be stored separately, both physically and electronically.
(4) The right to access the code key belongs to the responsible person pursuant to § 25 within the framework of this Act. The code key is separated
during storage, it must be ensured that it cannot be accessed by anyone other than the person authorized to do so.
(5) The code of the pseudonymised sample or data shall be provided to the exclusive disposal of the person providing the sample.
§ 24. (1) A genetic sample or data together with personal identification data may be stored only on the basis of the consent of the data subject.
(2) Register containing genetic samples and data stored together with personal identification data and coded
cannot be linked to a register containing personally identifiable information.
§ 25. (1) Within the biobank for the protection of genetic samples and genetic data, for the registration of genetic samples and data,
the head of the institution operating the biobank and the person appointed by him to supervise the operation of the biobank
person (hereinafter: responsible person) is responsible.
2. The responsible person must have at least the following conditions:
(a) a professional qualification recognized at university level or equivalent in the field of medicine or biological sciences, and
(b) at least two years' professional experience in the field referred to in point ( a) .
(3) In the area of ​responsibility of the responsible person

(3) In the area of ​responsibility of the responsible person
*
(a) enforce
the collection, storage and processing of genetic samples and data, as well as data protection requirements

relevant legal provisions and institutional rules;
(b) regularly assess the legality and professionalism of the biobank's activities within the institution and the assessment
inform the head of the institution of the outcome;
c) in the event of non-compliance with legal or professional rules, initiate legal,
or to take the necessary measures to restore professional functioning, if necessary with stored genetic samples, or
suspension of activities with substances;
*
(d) inform
the authorities supervising the operation of the biobank of the operational information necessary for the inspection

prepares an annual report on the operation of the biobank, which shall be submitted by 15 February of the following year in accordance with Section 26 (7).
report - to the public health administration.
(4) The health care provider and other institution establishing the biobank shall inform the state health administration body of the
the name of the responsible person referred to in paragraph 1, indicating the specific institutional tasks for which he is responsible.
§ 26. (1) All genetic samples and data stored in the biobank, as well as all related procedures, activities,
the transmission of the genetic sample and data shall be recorded for at least 30 years from the date of the data collection, unless the genetic
withdraws its consent to the processing of the data. In this case, after informing the data subject - all the genetic
data records shall be destroyed. After the mandatory registration period, the data are Eüak. can be handled according to. THE
registration may also take place in electronic form.
2. The register shall contain information on genetic material collected, tested, stored, processed and distributed or otherwise used.
the type, quantity, origin and destination of the samples and the genetic data derived from them.
*
2a. The
public health administration shall keep the register referred to in paragraph 1 in a orderly manner and the register referred to in paragraph 2.

Compliance with the provisions of paragraph 1 shall be verified, if necessary by the EGTC with the involvement of HRB experts.
(3) For the purposes of further genetic testing or human genetic research, the biobank shall only use the relevant section 8 (1) in an anonymised manner.
may transfer genetic data as part of its declaration under
(4) For any further data transfer exceeding the limits of the consent pursuant to Section 8 (1), the data subject shall:
re-obtaining your consent is required.
(5) In addition to the scope of activities of the institution establishing the biobank, the biobank may only be used for the purposes of this Act by another biobank or an appropriate
provide a genetic sample or data to a research licensee.
*
(6) The
state health administration body shall keep a register of biobanks or genetics on the basis of a valid research permit

sample, data storage institutions that are publicly available. The data necessary for the maintenance of the register
or the authorities or persons authorizing the research plan shall, immediately after the authorization has been granted, provide the
register. The register may not contain genetic data.
*
(7) The
state health administration body shall register in accordance with paragraph (6) and in accordance with Section 25 (3) ( d) .

on the basis of the report, it prepares an annual report on the operation of biobanks, which it sends to the EGTC HRB.
§ 27. (1) The rules applicable to biobanks shall be applied to all human genetic testing and human genetic testing prior to the entry into force of this Act.
a collection of cell, tissue samples or other human biological material
and the gamete bank established for the purpose of gamete donation and storage shall apply.
(2) A cell, tissue sample or other sample created before the entry into force of this Act and intended to be used exclusively for the purpose of human genetic research.
collection of human biological material, excluding the tissue bank established for transplantation and the germ cell
a germ cell bank established for the purpose of donation and deposit - the provisions of Section 19 shall apply with the derogation provided for in paragraph (4).
(3)

*

4. If consent pursuant to paragraph 1 cannot be obtained, the genetic sample or data shall be further processed.
shall be anonymised in accordance with the provisions of this Act.
(5) The transformation into a biobank or the establishment of a biobank requires the permission of the state health administration body.
(6)

*

VI. Chapter
TRANSMISSION OF GENETIC DATA AND SAMPLES ABROAD
§ 28. (1) For*the purpose of human genetic research, the transfer of data to the EEA States shall be considered as if Hungary
data would be transferred within its territory.
*
(2) For
the purposes of human genetic research, only an anonymised, coded or pseudonymised genetic sample or data may be transmitted.

to a third country and only if the law of that country is at least in accordance with this Act and the general data protection law.
data protection provided for in Chapter V of this Regulation. Transfer of coded genetic sample and data to a third country
the code key required for identification cannot be transmitted.
3. Only coded genetic samples may be transferred to a third country for the purpose of human genetic testing. Data protection paragraph 2
should also be ensured in this case.
*

(4)

A genetic sample or data may only be imported from a third country where this law or paragraph (2) applies

specific requirements are provided.
*
5. The
transmission of genetic samples and data provided for in paragraphs 2 and 3 to the public health administration shall be

shall be reported in a non-personally identifiable manner prior to transmission. The notification must indicate that the third
the conditions under which the transfer of data to the country is based on the right level of protection of personal data
definition.

VII. Chapter
FINAL AND TRANSITIONAL PROVISIONS
§ 29

*

Section 30 (1) This Act shall enter into force on 1 July 2008.
(2)

*

(3)

*

(4) Genetic samples and data anonymised in accordance with the provisions of this Act before the entry into force of this Act
for research and investigation in accordance with the provisions of this Act.
Section 31 The Minister of Health is authorized to
(a) *detailed rules for human genetic testing,
(b) *minimum conditions for the operation of laboratories performing human genetic testing,
*
c) accreditation
and quality control requirements for laboratories performing human genetic testing,

(d) details of the storage, handling, processing, coding of the genetic sample and genetic data;
rules
e) the minimum professional conditions for the operation of the biobank, the aspects of authorization,
(f) the formal requirements for the statement of consent
Regulation.
§ 32

*

Back to top

About Wolters Kluwer

Informations

Our pages

Company history

F.A.Q

Wolters Kluwer

Our core values

Privacy Policy

Legal library

Sales representatives

Media offer

Trainings

Customer service

Cookie settings

Tax Online

Follow us

Legal world

Because it's important to make the right decision!

Contact Cookie Management Information

Imprint

© Wolters Kluwer

