Status of the legislation in force today (14/04/2020). THE ! "signs past and future changes in paragraphs represent. This document contains website 1 of the legislation. To print the entire legislation, select it in the header found print icon! 23/2002. (V. 9.) EüM decree on human medical research CLIV of 1997 on health. § (hereinafter: Eütv.) Pursuant to Article VI (2) (o) and (p), in accordance with promulgated by law, to the Council of Europe on the human rights and dignity of the human being in biology and medicine the Oviedo Convention for the Protection of Human Rights and Fundamental Freedoms Additional Protocol to the Convention on the Prohibition of the Cloning of Human Beings and in accordance with the Declaration of Helsinki adopted by the World Medical Association, I order the following: § 1 (1) * The provisions of this Regulation shall apply to min (dhetntpe: m // blearenndivnéggz.ewttolte medical research (Section 157 of the Eütv., hereinafter: research). test In the case of a clinical trial of a medicinal product and a medical device, the provisions of this Regulation shall apply to prevail. It qualifies as medical research in particular utm_source = netjogta (a) to improve diagnostic, therapeutic, preventive and rehabilitative procedures, new procedures and a better understanding of the pathology and course of diseases, b) genetic, (c) cells, cell constituents, tissues, organs removed from a living human or dead body, done with a body part, d) epidemiological, (e) in the public health and epidemiological interest, f) * g) research on gametes and embryos. (2) - (3) * § 2. (1) For the purposes of this Decree the) * statement of consent: the person participating in the investigation has legal capacity person in the Eütv. 159 (1) e), or to a limited extent the legal capacity of a minor and the exercise of health care rights in his or her capacity to act and in respect of a class of property of a limited nature or in the case of an incapacitated person, the Eütv. A statement pursuant to Section 159 (4) (d); (b) research plan: the objectives, planned course, methods, statistical aspects of the research and documentation on its organizational issues prepared in advance in accordance with this Regulation; including further versions and modifications thereof; c) * (d) undesirable event: an adverse event in the research subject's state of health a change that does not necessarily result from the treatment applied; (e) "serious adverse event" means an adverse event that is life-threatening; requires or prolongs hospital treatment, is permanent causes damage to health, disability, congenital anomaly, birth defect or death; f) * (g) research coordinator: in the case of multi-center research, the researcher responsible for coordinating the research; h) * non-commercial research: industrial, commercial, service provider research carried out by researchers independent of business, which does not even indirectly serve the material of the sponsor profit and (ha) commissioned by an independent researcher or non-profit organization, in particular an educational organization institution, funded health care provider, publicly funded research institute, social organization, (hb) the research is planned and carried out by the sponsor in accordance with point (ha), (hc) the data resulting from the research become the property of the sponsor in accordance with point (ha), (hd) the results of the research are communicated by the sponsor in accordance with point (ha). i) * (2) * In addition to the provisions of paragraph 1, for the purposes of this Regulation, and the authorization procedure for medical research on human beings definitions contained in a separate legal act on the rules of taking into account. Protection of the person involved in the research § 3. (1) A person with legal capacity may be involved in research if the Eütv. Section 159 (1) - (3) compliance with the conditions laid down in paragraphs 1 and 2 and with the requirements of this Regulation. (2) The research may not replace for the participant what is necessary from a medical-professional point of view, a examinations and interventions for the prevention, early detection and treatment of diseases. 3. Where research is intended to involve persons of reproductive age, the planning, authorization, in informing participants, special attention should be paid to research on fertility and fertility, pregnancy, embryonal / fetal health, which may occur at the time of inclusion in the research, impact. (4) Research should be designed and conducted in a manner that minimizes the person involved in the research possible damage, pain, fear and anxiety. The age of the person involved, health any foreseeable risks associated with the condition should be considered in the research planning and control. (5) The health status of the participant before the start of the research, continuously during the research and should then be carefully monitored and documented. (6) * As a participant in the research, primarily in the health care institution patients can be involved. A call to recruit participants - healthy with the exception of volunteers - can only be referred to doctors, according to the purpose and methods of the research, the with a precise indication of the number of participants to be selected. Recruiting healthy volunteers by means of a communication to the public, the invitation to recruit must clearly state that the involving healthy volunteers. The recruitment call may not be for advertising purposes. The call for recruitment the proposed text and a description of the recruitment method for the official approval of the research, or be accompanied by a request for a professional-ethical opinion. In the published recruitment notice, the reference to the existence of an official permit. In the event of a deviation from the permitted method and text of recruitment, the an amendment to the permit shall be initiated. (7) The loss of income related to the participation in the research and the travel expenses of the participant actually incurred and justified in this context - not covered by social security reimbursement is payable. Other benefits or fees for the participant - with the exception of research on healthy volunteers. Informing the participant, consent to the research § 4. (1) The person with legal capacity to be involved in the research shall be the head of the research or the person appointed by him / her. The doctor participating in the research shall inform the patient orally and in writing in Hungarian in a way that is comprehensible to the patient AH. 159 (3). 2. The person providing the information shall pay particular attention to verifying that he or she wishes to be involved whether the person is capable of acting. The findings in this regard are recorded in the medical records. (3) The information and consent shall be recorded in writing on a separate sheet. The written information and the a copy of the consent form shall be kept in the participant's medical records, and one copy shall be given to the participant. 4. The written information shall contain at least the following: a) identification of the research, (b) an indication of the experimental nature of the research, the purpose of the research, its expected duration, the number of persons to be involved, the course of the research, the nature and frequency of the planned interventions, (c) other agreed treatment options available to the participant and information thereon that research may mean the interruption of treatment that has already begun and that it has begun the consequences for the participant of the interruption of treatment, (d) a detailed description of the possible and expected consequences, risks and inconveniences, and an indication that the research may involve undesirable events which are unforeseeable, (e) a description of the reasonably foreseeable benefits or, if no benefit is expected from the research for the participant communication of the fact, f) the percentage probability of random assignment to each treatment group, g) * the occurrence of research - related damage to the participant, or treatment, compensation and damages to be provided in case of violation of the right to privacy [Eütv. § 164 (2)] and compensation [Eütv. 164 (1)], the Eütv. Section 164 (2) the name and contact details of the liability insurer referred to in (h) the reimbursement, if any, of the costs incurred by the participant for participating in the research; (i) a warning that the consent is voluntary and unaffected, it may be withdrawn at any time, either orally or in writing, without giving any reason, without disadvantage, j) the rules for handling and accessing the participant's data, k) * giving the opinion of the competent authority necessary for the commencement of the research the name of the ethics committee, as well as the name of the chairman of IKEB and the independent doctor pursuant to Section 12 (5), and contact information. (5) The participant shall give his or her consent in writing. The statement of consent shall include at least: includes: a) identification of the research, (b) the name of the healthcare institution where the research is to be carried out, c) the name, position and position of the head of the research or the person providing the information Name, d) * identification data of the participant (name, mother 's name, place and time of birth, TAJ number, address), a minor with limited legal capacity and the exercise of related rights and a group of assets of a property nature in the case of a partially restricted or incapacitated participant, the legal representative giving the consent identification data, e) * a statement that the participant has limited legal capacity minors and their capacity to act in relation to the exercise of healthcare rights, and is partially restricted or in the case of an incapacitated participant, also the legal representative - in the research following the information provided for in paragraph 1, without influence, knowing that at any time, orally or in writing, without giving any reason revocable, f) the date of signature of the statement of consent, g) the signature of the research leader or information provider, (h) the signature of the person giving his consent and, in the case referred to in paragraph 7, of the witness. (6) * The person providing the information and the participant - to a limited extent the legal capacity of a minor and the exercise of health care rights in his or her capacity to act and in respect of a class of property of a limited nature or in the case of an incapacitated participant, the legal representative - also the written information pursuant to paragraph 4 sign. (7) * If you want to be involved in the research, or to a limited extent the legal capacity of a minor and the exercise of health care rights in his or her capacity to act and in respect of a class of property of a limited nature or in the case of an incapacitated person, the legal representative cannot read the consent form the joint presence of two independent witnesses shall be ensured when providing the necessary information. Witnesses a by signing a statement of consent, they certify that the person to be included in the investigation is lawful provided with all possible information and the person and / or legal representative of the person to be involved gave its consent voluntarily and without interference. (8) If, in the course of the research, new relevant information becomes available in connection with the research, which affects the contents of the written prospectus, an amendment to the permit shall be initiated in Section 13 in accordance with In accordance with the amended written information you must be informed again and your written consent must be sought to continue the research. 4 / A. § * (1) If specified in the special legislation during the research samples are taken for human genetic testing, the participant shall be informed separately. THE the information shall also include the right of the participant to be sampled separately in this case, the genetic data relating to him may no longer be anonymous to use. Rejection of sampling does not constitute a barrier to participant participation in further research section. Information on and agreement to sampling in a separate document must be booked. (2) Prior to sampling for human genetic testing, the participant shall be subjected to genetic counseling must be informed within (a) the purpose, quantitative and qualitative details of the sampling, (b) the benefits and risks of performing or not performing the study, (c) any possible outcome for the data subject and his or her close relatives consequences, (d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms samples and the possibilities for identifying data, (e) unless otherwise stated by the participant, the genetic sample is in an archived collection the possible transfer of stored genetic samples, (f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and (g) whether it may decide to place the sample it provides in a biobank; placement method so that a sample is possible (ga) storage of personal data, gb) in encrypted form, gc) pseudonymised, ie in a form in which the the replacement code has been made available to the subject exclusively, (gd) anonymised, ie in a form where all the data relating to the subject are available personally identifiable information has been rendered inoperable. (3) The participant shall also be informed that it may decide to add a sample to the biobank participation in research. In this case, the participant must declare that: for the primary purpose of sampling, for diagnostic purposes only, or whether it contributes to its use, ie for diagnostic and research purposes. 4 / B. § * (1) If the research is due to a human genetic test a separate statement of consent shall be drawn up. 2. The participant's statement of consent shall include at least the following: (a) the identity of the research; (b) the name of the healthcare provider where the research is to be performed; c) the name, position and position of the head of the research or the person providing the information designation; d) * identification of the participant (name, place and date of birth), a minor with limited legal capacity and rights related to health care in his or her capacity to act and partially limited to a group of property cases or in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a hereinafter referred to as the "person entitled to make a declaration"); e) * a statement that the participant has limited legal capacity minors and their capacity to act in relation to the exercise of healthcare rights, and is partially restricted or in the case of an incapacitated subject, the person entitled to make a statement - in the genetic test consent to participate in Article 4 / A. § or the information contained therein voluntarily, without influence, after resignation, in the knowledge that at any time, may be revoked orally or in writing without giving reasons; (f) the consent to the taking of a sample of the quantity and quality indicated in the prospectus and the identity of the participant use; (g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided biobank and the method of disposal, so that a sample is possible (ga) storage of personal data, gb) in encrypted form, gc) pseudonymised, ie in a form in which the the replacement code has been made available to the subject exclusively, (gd) anonymised, ie in a form where all the data relating to the subject are available personally identifiable information has been rendered unfit for identification; (h) a statement by the participant that the sample placed in the biobank is participating in further research; in this In this case, the participant must declare that his sample is the primary purpose of sampling diagnostic, for research purposes only, or any, ie diagnostic and research contributes to its use for its intended purpose; (i) the manner in which the result is to be communicated, even if the subject does not have access to it; (j) consenting to or excluding any future request; (k) the date of signature of the statement of consent; (l) the signature of the research leader or information provider; (m) the signature of the person giving his consent. Exercising a minor with limited legal capacity and rights related to health care in her capacity to act partially limited and incapacitated involvement of a person in research * § 5 (1) * If the research - the Eütv. Section 159 (4) and (5) subject to certain conditions - a minor with limited legal capacity and the exercise of rights relating to healthcare and of a pecuniary nature involving a partially restricted person in respect of a case group, both a minor with limited legal capacity and rights related to health care in his or her capacity to act and in respect of a group of property-type matters both the restricted person and his legal representative shall be informed in accordance with Section 4. (2) * Research can only be conducted on a minor with limited legal capacity and the exercise of rights relating to healthcare, and in the case of a group of property of a partially limited nature, if both the a minor with limited legal capacity and rights related to health care in his or her capacity to act and a group of assets of a property nature the consent of both a partially restricted person and his or her legal representative. The consent statement of both the minor with limited legal capacity and the capacity of the minor the exercise of rights relating to healthcare and of a pecuniary nature must be signed by both the person who is partially restricted in respect of the case and his or her legal representative. § 6 (1) * If the research - the Eütv. Section 159 (4) and (5) in accordance with the conditions laid down in paragraph 2, it is intended to involve an incapacitated person shall be in accordance with the provisions of (2) The Eütv. A person pursuant to Section 16 (1) - (2) shall comply with the provisions of Section 4 be properly informed. In addition, a person who is incapacitated shall, in accordance with his or her judgment, be informed of all the research important circumstance, its risk and its positive or negative impact. A person with pedagogical experience should also be involved in informing the minor. (3) If the incapacitated person has understood the information, he or she can assess it and explicitly refuses to participate in the research or intends to withdraw from the research, this should be done to the research leader, or fully taken into account by the person conducting the research. (4) If the incapacitated person becomes able to act, as soon as possible be informed of the research and seek its consent to continue it. Failing this, the research may not be carried out on the person concerned. (5) Research may not be carried out with the involvement of an incapacitated person who, in his or her legal capacity, has excluded participation in research. (6) * A minor with limited legal capacity and capacity for action is the exercise of rights relating to healthcare and of a pecuniary nature partially limited and incapacitated person as a healthy volunteer for research cannot be involved. § 7 * § 8 * § 9 * § 10 * § 11 * The Institutional Research Ethics Committee and the Regional Research Ethics Committee § 12. (1) * All healthcare institutions where research is conducted use IKEB operate. In the healthcare institutions defined in Annex 1, the Regional Research Ethics Committee (a hereinafter referred to as RKEB). (2) Establishment of IKEB and RKEB, determination of their number - provisions of paragraph (4) the head of the health care institution. (3) In the health care institution where RKEB operates, it may also perform the tasks of IKEB. (4) IKEB and RKEB are listed in the Eütv. Shall be compiled in accordance with the provisions of Section 159 (6) provided that the number of members of the committee may not be less than five. (5) The protection of the interests of the participants in the research carried out in the institution by the President of IKEB shall be members of IKEB provided by an independent doctor not involved in the research. The designated doctor continuously monitors the progress of the research and maintains regular contact with the with the persons involved in the investigation, provides them with information and professional assistance. (6) * (7) * The task of the RKEB is to carry out the research specified in a separate legal act forming an ethical opinion in the case of. ! (8) * In the case of IKEB, it contains the composition and operating rules rules of procedure shall be approved by the territorially competent RKEB. The composition of the RKEB is the Health Scientific Council Committee under the Ministerial Decree on the Health Scientific Council approve. § 13. * § 14. (1) * It is funded at least in part by the Health Fund the head of the health care institution shall declare to the health insurer before the start of the research additional costs. (2) * About the date of commencement of the research by the health care institution the head shall notify the ethics committee. Exemption from payment of procedural fees * § 15. * Non-commercial research as well as Eütv. Section 159 (5) The authorization procedure for research under this Regulation shall be free of charge. § 16 * § 17 * § 18 * § 19. (1) * The National Health Insurance Fund Manager (hereinafter: NEAK) verifies that the additional costs recorded in the declaration pursuant to Section 14 (1) and that health insurance is provided exclusively for research are not used at their expense. (2) * (3) * If the audit finds that it is exclusively research the NEAK initiates the research suspension. Reporting obligation § 20 * The research leader is every second from the start of the research at the end of the year and within 15 days of the completion of the research, send a report to the licensor on ethical Committee and IKEB. The report reports on the research experiences of the patients actually involved the number of adverse events and serious adverse events that have occurred. The research is considered complete when if the last observation of each patient, according to the research plan It happened. For non - interventional studies provisions * 20 / A. § * Medicinal products for human use and other, Act XCV of 2005 amending the laws regulating the pharmaceutical market. Act (hereinafter: Gytv.) Non-interventional tests in accordance with Section 1 (8) and performed on humans intervention as defined in the legislation on the rules for the authorization of medical research in the case of non - interventional medical research (hereinafter together: non - interventional study) a 20 / B-20 / S. §. 20 / B. § * For the purposes of this Chapter: the) * sponsor: any natural or legal person who you are which initiates, conducts or finances a non-interventional investigation. The investigator and the principal may be the same person; (b) subject: a person participating in a non-interventional study who or to whom the data is used to continue the investigation or who participates in the investigation as a control person; (c) ‘investigator’ means a person charged with carrying out a non-interventional investigation in a test site; (d) principal investigator: the responsible leader of the team at a particular investigation site if the a non-interventional study is performed by a group of several investigators; (e) recruitment: the recruitment of a non-interventional study by the person who authorized the study; an authorized public call for the purpose of involving subjects in an investigation; f) non-commercial trial: from industrial, commercial, service companies research carried out by independent investigators which does not even indirectly serve the financial gain of the sponsor; and (fa) commissioned by an independent investigator or non-profit organization, in particular an educational organization institution, funded health care provider, publicly funded research institute, social organization, (fb) the investigation is planned and continued by the sponsor in accordance with point (fa), fc) the data resulting from the investigation become the property of the principal referred to in point (fa), (fd) the results of the test are communicated by the sponsor in accordance with point (fa); g) * coordinating study director: in the case of a multicenter study, the study responsible for the whole. h) * 20 / C. § * The following, in particular, shall be considered as non - interventional investigations: a) security, b) pharmacoeconomic, c) quality of life, d) epidemiological, e) compliance / persistence, f) observation cohort, g) retrospective case control, (h) other observational tests. 20 / D. § * 20 / E. § * 20 / F. § * (1) * The sponsor, the study director and the investigator, if the the purpose of the test cannot be achieved without recruitment or only with disproportionate difficulty, test you can recruit subjects in the press or on your own website by means of a published call. The text of the invitation to participate must state the purpose of the investigation, methods, marking the range of subjects to be selected, with the candidates any reimbursement to be made to the elected and the rules for processing the data of applicants. The call cannot be for advertising purposes. The published call must refer to the existence of a supporting professional ethics license. THE In the event of a deviation from the permitted method and text of recruitment, an amendment to the license shall be initiated. (2) The subject and the Eütv. The person entitled to make a declaration pursuant to § 16 (a hereinafter referred to as "the person entitled to make a declaration") loss of income and costs related to participation in the investigation, in particular Reimbursement may be made for expenses actually incurred and justified in connection with the journey. No other benefits or fees may be granted to the subject and the person entitled to make a statement. 20 / G. § * (1) Non-interventional investigation of a person with legal capacity improvement of diagnostic, therapeutic, prevention and rehabilitation procedures only, development and evaluation of procedures, as well as the pathogenesis and pathogenesis of diseases and epidemiological and public health contexts. (2) A non-interventional investigation shall be performed on a minor or a person with incapacitated its capacity to exercise its rights in relation to healthcare, and in respect of a group of property of a partially limited nature, 20 / I-20 / J. §-in subject only to the coexistence of the following conditions can be performed in case of: * (a) the investigation may not be carried out on a person of comparable efficiency; b) * the Eütv. Person pursuant to Section 16, Paragraphs (1) - (2) - subject to the provisions of Art. 16th § (5) - or with limited legal capacity over the age of 16 in respect of the exercise of rights in relation to a minor or a person with legal capacity, and a subject of partial investigation limited to a group of property - related matters gave his consent. 20 / Mon. § * 1. The subject of a non-interventional study shall be included in the study prior to the consent of the investigator or the investigator, orally and in writing in Hungarian - or in the subject's mother tongue or in another language indicated by the subject - known to the lay person orally and in writing (a) the voluntary nature of the participation in the study and the fact that the consent may be given at any time; (2) may be revoked orally or in writing without giving any reason and without adverse consequences; b) the essence, purpose, expected duration and place of the planned investigation, the persons to be involved the number or scope of the (c) the expected benefits and reimbursement to the subject of the investigation or to others, if It happens; (d) rules on the handling of, and access to, subject data; e) the name, position and job title of the person (s) responsible for the investigation; (f) the identity of the non-interventional study; g) the name and registered office of the applicant. 2. The subject shall obtain the written consent of the subject following the information referred to in paragraph 1 add to the test. If the subject is unable to write in writing, or due to illiteracy, is not interested in two non-interventional oral consent in the joint presence of a witness is required for the investigation. In the case of oral consent a a statement must be made in writing certifying the verbal consent signed by the two witnesses took place. In the event of the subject's ability to recover, the statement of consent shall be issued by the confirm the written statement of consent before proceeding with the investigation, failing which shall be deemed to be withdrawn and the investigation may not be continued on the person concerned. 3. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 1. and the statement of consent referred to in paragraph 4 has been communicated to him and orally agreed. In addition to paragraph 1, the subject 's statement of consent shall in particular: shall include, as appropriate: (a) where the non - interventional examination is carried out by a health care provider, its health the name of the service provider where the test is to be performed; b) * the identity of the subject (name, place and date of birth), in the case of an incapacitated minor with limited legal capacity under the age of 16 a also the identification data of the person entitled to make a declaration; c) * a statement that the subject is incapacitated or in the case of a minor subject with limited legal capacity under the age of authorized person - his consent to participate in the investigation is set out in paragraph 1 after giving information voluntarily, without influence, knowing that it is at any time, orally can be revoked in writing without giving reasons; (d) the date of signature of the statement of consent; (e) the signature of the study director or informant; (f) the signature of the person giving his consent. (5) * The person providing the information and the subject - are incapacitated In the case of a minor subject with limited legal capacity under the age of 16, to make a statement authorized person - also signs the written prospectus referred to in paragraph 1. (6) The information and consent shall be recorded in a separate sheet. The consent form and one original of each written information document shall be kept in the test documentation, and one original shall be handed over to the subject. (7) * If, in connection with a non-interventional investigation, such new relevant information becomes known which affects the contents of the written prospectus, the license modification should be initiated for human medical research, human clinical trials of the investigational medicinal products to be used and in humans clinical investigation of medical devices intended for clinical use 235/2009 on the rules for the authorization procedure (X. 20.) Government Decree 19. §. The subject of the amended written information shall be re-examined be informed and consent must be sought for the investigation to continue. In the absence of this investigation, the cannot be continued on the person concerned. 20 / I. § * Non-interventional study in minors is described in 20 / G-20 / H. §-in may be carried out only if all of the following conditions are met: (a) the study is directly related to the clinical condition in which the minor suffers or is of a nature which can only be performed on minors; (b) in the case of a minor under the age of 16, the consent of the person entitled to make the declaration contains the probable will of a minor capable of forming an opinion and assessing the situation, and this a the declaration may be withdrawn at any time without the minor being adversely affected; (c) an investigator with experience in relation to minors shall, depending on his or her intellectual level, properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him; (d) the investigator or study director takes full account of the a minor under the age of 16 who is able to assess the situation explicitly refuses to participate in the study, or that you wish to withdraw from the investigation at any time; e) * 20 / J. § * (1) * A non-interventional study shall not be included in a incapacitated or disabled minor; and the exercise of rights relating to healthcare, and a person who is partially restricted in the case of a group of property in its possession, it expressly excluded its participation in such investigations. Not for a particular study nor may he be involved who has previously refused consent in possession of his capacity to act for that study. (2) * Incapacitated or incapacitated with health care the exercise of related rights and a group of assets of a property nature partially restricted in adults 20 / G-20 / H. § only with proper application a non - interventional test may be carried out if - in paragraph 1 all of the following conditions are met: (a) in the case of a person who is incapacitated, the consent of the person entitled to make the declaration it must contain the presumed will of the subject and this statement at any time can be withdrawn without prejudice to the subject; (b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and adverse effects; (c) in the case of an incapacitated person, the investigator and the investigator-in-charge shall take full the subject, who is able to form an opinion and assess the situation, expressly excludes from the study participation or wish to withdraw from the investigation at any time; d) * human medical research for human use clinical trials of investigational medicinal products and laying down rules for the authorization procedure for clinical trials on medical devices intended for clinical investigations 235/2009 (X. 20.) Government Decree [hereinafter: 235/2009. (X. 20.) Government Decree] Section 17 (1) (hereinafter referred to as the licensing authority) shall be the appropriate specialist for the disease in question decide on the authorization in the light of its opinion. (3) If the subject is able to act during the non-interventional investigation shall be informed of the test as soon as possible and 20 / H. With the appropriate application of the provisions of § your consent must be obtained to proceed. Failure to do so will result in an investigation of the person concerned cannot be continued. 20 / Tues § * 20 / L. § * 20 / M. § * 20 / N. § * During an approved non - interventional test: subjects and persons entitled to make a statement, investigators, study directors, the head of the health care provider conducting the examination or the sponsor may file a complaint with the to the licensing authority if they consider the test in the license or test continue as provided for in the plan. 20 / O. § * 1. Except as provided in paragraph 2, no intervention Within 90 days of the completion of the investigation, the sponsor shall notify the licensing authority of the investigation completion, the number of patients involved, within one hundred and eighty days of the completion of the investigation given answer. In the case of a post - authorization pharmacovigilance study: reporting on the pharmacovigilance of medicinal products for human use shall be complied with in accordance with a ministerial decree. (3) * The National Institute of Pharmacy and Food Health (a hereinafter referred to as ‘OGYÉI’) shall send copies of the non-interventional For ETT TUKEB. 20 / Fri. § * (1) A non-interventional test is an authorized test the provisions of the plan are considered to be an occupational rule. (2) * (3) * If the principal is related to some or all of the investigation entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable for compliance with the provisions on testing laid down in this Regulation and in specific legislation. 20 / Q. § * In the case of a retrospective study, 235/2009. (X. 20.) Government Decree 17 / A. § (1) c) and d) of the 20 / G. § (2) b), the 20 / H. §, a 20 / I. § b) -d), 20 / J. § (1), second sentence, (2) a) -c), and paragraph 3 shall not apply. 20 / R. § * (1) * For the authorization procedures set out in this Chapter, with the exception of non-commercial investigations, to the licensing authority for the administrative services of the applicant is required to pay a fee. (2) * The applicant (a) the authorization referred to in paragraph 3 (a) for the first instance and for the purpose of an amendment the amount specified therein, (b) the appeal referred to in points (b) to (c) of paragraph 3 the same amount as set out therein is required to pay a fee. (3) The amount of the fee: the) * and Gytv. In the case of a non-interventional investigation pursuant to Section 1 (8) aa) * a 235/2009. (X. 20.) Government Decree § 17 (1) (b) (ba) HUF 370,000 in case of approval, HUF 80,000 in case of substantial modification; (ab) Regulation (EC) No 235/2009. (X. 20.) in the examination pursuant to Section 17 (1) (b) (bb) of the Government Decree HUF 200,000 in case of authorization, HUF 80,000 in case of amendment; b) * a 235/2009. (X. 20.) of the Government in the case of the authorization of a non - interventional study and the authorization of a substantial modification of the study plan 000 HUF; c) * in cases not falling under a) -b) HUF 294,000. (4) The fee shall be paid by the applicant in Annex 3 upon submission of the application to the indicated account by postal payment or transfer, or to the cashier of the bank account holder's institution pay. (5) * The fee is the revenue of the licensing authority providing the administrative service. THE 46% of the fee included in paragraph 3 (a) (aa) is OGYÉI, 54% is ETT TUKEB. THE 3) and a substantial modification of the test plan 80% of the fee paid for the licensing is ETT TUKEB, 20% is OGYÉI. Paragraph 3 (a) (aa) The fee for the modification referred to in point (a) shall be shared equally between the licensing authorities acting. The fee paid in appeal proceedings shall be reimbursed to the applicant if: the revised decision or measure to the detriment of the client has been found to be in breach of the law in whole or in part. (7) If, in appeal proceedings, the body acting at second instance is a body which has acted at first instance in whole or in part, unlawful decision (a) annul it at first instance without carrying out any special inquiries necessary to supplement the facts instructs the competent body to conduct a new procedure, it shall be obliged to pay the new procedure without paying a separate fee carried out; (b) by carrying out any special inquiries necessary to supplement the facts (ba) annul and instruct the body at first instance to conduct a new procedure, bb) changes, then the body of first instance to the body of second instance in the proceedings - the separate investigations reimburse the necessary costs incurred in carrying out the (8) * Itv. a) the provisions of Section 28, Paragraphs (2) - (3), the occurrence of the obligation to pay the fee, b) * In the first sentence of Section 31 (1) and in Section 31 (2), (4) - (6), and paragraph 8 to determine the range of persons liable to pay the fees, c) the provisions of Section 32 (1), the refund of the fee, d) the provisions of Section 86 of the statute of limitations shall apply mutatis mutandis by replacing the licensing authority with the licensing authority, a fee shall be construed instead of a fee. (9) For the recording and accounting of fees on the basis of the budget belonging to the general government subsystem existing legal requirements on the reporting and accounting obligations of economic entities apply. (10) * 20 / S. § * (1) * If the licensing authority conducts the investigation in accordance with Eütv. 164 / A. § (2), publishes on its website 235/2009. (X. 20.) Government Decree 17 / A. § Information referred to in points (a) and (c) of paragraph 3. (2) * The licensing authority shall comply with Article 20 / O. § 15 days after notification within its website publishes the 20 / O. § information. 20 / T. § * Miscellaneous and transitional provisions § 21. (1) This Decree shall enter into force on the 15th day following its promulgation. shall apply to authorization procedures initiated after 1 July. (2) * This Regulation shall apply to medicinal products for human use Directive 2001/83 / EC of the European Parliament and of the Council on the pharmacovigilance Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 amending for compliance. (3) * This Regulation is laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council and pharmacovigilance as provided for in Directive 2001/83 / EC of the European Parliament and of the Council Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of lays down the provisions necessary for its implementation. Annex 1 to Decree 23/2002. (V. 9.) EüM decree * Area of ​​competence of regional research ethics committees Name of the researcher or the committee the name of the licensing health institution 1. * Semmelweis University Semmelweis University Regional, and its institutions, the Ministry headed by Pest County and the Minister responsible for health health care institutions under the direct supervision of the capital Institutional Scientific and Research Ethics Committee 2. * Hungarian Armed Forces, Military Hospital-ÁEK Institutional and Health Institutions of the Ministry headed by the Minister responsible for law enforcement, Railway Health institutions 3. Other health care institutions based in Pest 4. Other health care institutions based in Buda 5. Health care institutions in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties 6. Health care institutions in Baranya, Somogy and Tolna counties 7. Csongrád, Bács-Kiskun, Békés and Jász-Nagykun- Regional Research Ethics Committee Metropolitan Municipality Uzsoki Street and Péterffy Sándor Street Hospitals Joint Regional Scientific and Research Ethics Committee Metropolitan Municipality of St. Imre and St. John Hospitals is a joint Regional Scientific and Research Ethics Committee University of Debrecen Medical and Health Sciences Center Regional Scientific and Research Ethics Committee University of Pécs Medical and Health Sciences Coordination Center Regional Science and Research Ethics Committee University of Szeged Szent-Györgyi Albert Medical and Health care institutions in Szolnok county, a With the exception of health care facilities specified in line 2 8. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties 9. Health care institutions in Vas, Zala and Veszprém counties 10. Health care institutions in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties Regional Scientific and Research Ethics Committee of the Center for Pharmaceutical Sciences Borsod-Abaúj-Zemplén County Local Government Hospital Regional Scientific and Research Ethics Committee Vas County Lajos Markusovszky General, Rehabilitation and Spa Hospital, University Teaching Hospital Regional Scientific and Research Ethics Committee, Szombathely Győr-Moson-Sopron County Local Government Petz Aladár Hospital, Győr, Regional Scientific and Research Ethics Committee Annex 2 to Decree 23/2002. (V. 9.) EüM decree * Notification for non - interventional investigation Name of institution, health care provider: 1. Name of the study 2. In the case of a drug study, the name of the drug 3. * Type of test Drug study Retrospective study Non-drug study Prospective study The study is a prescribed pharmacovigilance study 4. Test site (s) Yes No Date: ................................................ .. .................................................. ................ principal's signature Annex 3 to Decree 23/2002. (V. 9.) EüM decree * Organizations involved in the authorization process and their bank account numbers 1. * VENUE OF On the man Name of the body Health Account Number State medical research other than clinical trials with investigational medicinal products non - interventional studies, clinical trials with medical devices and non-interventional tests and Tests 2-11. cases specified in the order Scientific Council, Committees and Bureau of the Scientific Council for Health Health Care Center 10032000- 01490576- 00000000 2. * Semmelweis Semmelweis University 10032000- University and institutions, Pest County and the Minister of Health under the direct supervision of the headed ministry in the territory of the capital health care institutions Regional, Institutional Scientific and Research Ethics Committee 00282819 3. * Hungarian AEK Military Hospital, 10023002- Defense Forces, a health institutions of the Ministry headed by the Minister responsible for law enforcement, health care institutions 4. Other health care institutions based in Pest 5. Other health care institutions based in Buda 6. Located in Hajdú-Bihar and Szabolcs-Szatmár-Bereg counties institutional and Regional Research Ethics Committee Metropolitan Municipality Uzsoki street and Péterffy Sándor Street Hospitals Joint Regional Scientific and Research Ethics Committee Metropolitan Municipality of St. Imre and St. John Hospitals Joint Regional Science and Research Ethics Committee University of Debrecen Medical and Health Sciences 00290469 11784009- 15492674 11784009- 15492564 10034002- 00282981 health care institutions 7. Health care institutions in Baranya, Somogy and Tolna counties 8. Csongrád, Bács- Kiskun, Békés and health care institutions in Jász-Nagykun-Szolnok county, in the 3rd row with the exception of certain healthcare institutions 9. Health care institutions in Borsod-Abaúj-Zemplén, Heves and Nógrád counties 10. Health care institutions in Vas, Zala and Veszprém counties 11. Health care in Győr-Moson-Sopron, Komárom-Esztergom and Fejér counties Regional Scientific and Research Ethics Committee of the Center University of Pécs Medical and Health Sciences Coordination Center Regional Scientific and Research Ethics Committee University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Science Center Regional Scientific and Research Ethics Committee Borsod-Abaúj-Zemplén County Local Government Hospital of Regional Science and Research Ethics Committee Vas County Lajos Markusovszky General, Rehabilitation and Spa Hospital, Regional Teaching and Research Ethics Committee of the University Teaching Hospital, Szombathely Győr-Moson-Sopron County Municipality Petz Aladár Hospital, Győr, Regional 10024003- 00283236 10028007- 00282802 11994002- 06066651 11747006- 15420026 10200249- 33018597 institutions Scientific and Research Ethics Committee 12. * medicine National Pharmaceutical 10032000- non-interventional studies are those for human use clinical trials of medicinal products and clinical trials of medical devices intended for clinical trials licensing in the cases specified in the Government Decree on the Rules of Procedure and Food Health Institute (OGYÉI) 00290050- 00000000 13. * Medical National Pharmaceutical 10032000- clinical trials and non-interventional trials and the Institute of Food Health 00290050- 00000000 Annex 4 to Decree 23/2002. (V. 9.) EüM decree * Documents to be attached to the request for a non-interventional medical examination 1. Basic data of the study: a) title of the study in Hungarian, protocol number (if any), b) type of test, c) details and contact details of the sponsor of the study, d) the name and contact details (telephone, fax) and professional qualifications of the Hungarian leader of the study and academic degree, curriculum vitae, summary of professional work, e) the name and address of the healthcare provider (s) performing the examination, (f) planned date of commencement of the investigation, g) the planned duration of the study, the date of completion, (h) the intended location and address of the study. 2. Documentation of the medical device under investigation: a) the name, fancy name, serial number of the device, (b) documents proving the lawful placing on the market of the medical device (s) under investigation, c) instructions for use of the device (s) in Hungarian, (d) the technical documentation of the device (s). 3. Test plan including: a) a short summary in Hungarian; (b) a detailed test plan consisting of: (ba) the purpose of the investigation, bb) the name of the test device, (bc) a description of the test method (eg double-blind, randomized, etc.), (bd) a description of the test procedure related to the method, (be) determination of the number of participants in the study, (bf) the conditions for selecting or excluding study participants, (bg) the sample data sheet, algorithm, written instructions needed to evaluate the test, (bh) a follow-up plan, (bi) the scientific and medical justification for conducting the study, (bj) any other CE conformity marking not involved in the test documents proving the lawful placing on the market of medical devices (bk) the procedure to be followed in the event of an unforeseen event, (bl) the conditions for stopping the study, (bm) the package leaflet and the statement of consent, (bn) a risk-liability insurance contract concluded by the originator of the investigation Acknowledgment (bo) a statement from the healthcare provider receiving the study of consent to the study, bp) proof of payment of the administrative service fee. The wording of the second sentence was as follows: 35/2005. (VIII. 26.) EüM decree Section 25 (6). Amended by 52/2012. (XII. 27.) EMMI Decree § 4 a). Repealed by: 31/2009. (X. 20.) EüM Section 6 (2) a) of the Decree. Repealed: 21 X 2009. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) b). Repealed: 21 X 2009. Established: 31/2009. (X. 20.) EüM Decree § 1 (1). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) c). Repealed: 21 X 2009. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) c). Repealed: 21 X 2009. Found: 34/2009 (X. 20.) EüM Decree § 3 (1). Effective: XII. 4- from. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) c). Repealed: 21 X 2009. Established: 31/2009. (X. 20.) EüM Decree § 1 (2). Effective from 21 December 2009. Found: 9/2015. (II. 10.) EMMI Decree § 2. Effective: 2015. III. 13 onwards. Modified: 16/2014. (III. 12.) Article 4 b) of the EMMI Decree. Amended by 31/2009 (X. 20.) EüM Decree § 6 (1) a). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Filed: 31/2009. (X. 20.) EüM decree § 2. Effective: X. 21, 2009. It was submitted before, but not judged shall also apply to applications. Filed: 31/2009. (X. 20.) EüM decree § 2. Effective: X. 21, 2009. This shall also apply to applications submitted but not pending before. Modified: 16/2014. (III. 12.) EMMI Section 4 a) of the Decree. Modified: 16/2014. (III. 12.) EMMI Decree § 4 a). Modified: 16/2014. (III. 12.) EMMI Decree § 4 c). Modified: 16/2014. (III. 12.) EMMI Decree § 4 d). Modified: 16/2014. (III. 12.) EMMI Decree § 4 d). Modified: 16/2014. (III. 12.) EMMI Decree § 4 e). Modified: 16/2014. (III. 12.) EMMI Decree § 4 c). Repealed with previous subtitle: 31/2009. (X. 20.) EüM Decree § 6 (2) d). Invalid: X. 2009 21 onwards. Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 a). Repealed: 2018. II. 14 onwards. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) f). Ineffective: From X. 21, 2009. Repealed with previous subtitle: 31/2009. (X. 20.) EüM Decree § 6 (2) f). Invalid: X. 2009 21 onwards. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) f). Repealed: 21 X 2009. Amended by: 1/2007. (I. 24.) EüM Decree § 3 (2) b), 31/2009. (X. 20.) EüM Decree § 6 (1) b). Repealed by: 31/2009. (X. 20.) EüM decree § 6 (2) g). Repealed: 21 X 2009. Established: 31/2009. (X. 20.) EüM decree § 3. Effective: X. 21, 2009. It was submitted before, but not shall also apply to pending applications. Found: 17/2019. (VIII. 5.) EMMI Decree § 11. Effective: 2019. VIII. From 20. Repealed with previous subtitle: 31/2009. (X. 20.) EüM decree § 6 (2) h). Invalid: X. 2009 21 onwards. Amended by 31/2009 (X. 20.) EüM Decree § 6 (1) c). Amended by 31/2009 (X. 20.) EüM Decree § 6 (2) i). Filed: 34/2009. (X. 20.) EüM Decree § 3 (2). Effective: XII. 4 onwards. Found: 34/2009 (X. 20.) EüM Decree § 3 (2). Effective: XII. From 4. Repealed with previous subtitle: 31/2009. (X. 20.) EüM Decree § 6 (2) k). Invalid: X. 2009 21 onwards. Repealed by: 31/2009. (X. 20.) EüM decree § 6 (2) l). Repealed: 21 X 2009. Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 b). Repealed: 2018. II. 14 onwards. Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (1) a), 54/2016. (XII. 30.) Article 23 (1) a) of the EMMI Decree. Repealed by: 31/2009. (X. 20.) EüM decree § 6 (2) m). Repealed: 21 X 2009. Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (1) b), 54/2016. (XII. 30.) Article 23 (1) b) of the EMMI Decree. Amended by 31/2009 (X. 20.) EüM decree § 6 (1) f). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Beiktatta: 1/2007. (I. 24.) EüM decree 1. §. Amended by 31/2009 (X. 20.) EüM decree § 6 (1) g). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Modified: 16/2014. (III. 12.) EMMI Section 5 a) of the Decree. Found: 52/2012. (XII. 27.) EMMI Decree § 1. Effective from 1 January 2013. Repealed by: 31/2009. (X. 20.) Section 6 (2) n) of the EüM Decree. Repealed: 21 X 2009. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Repealed by: 31/2009. (X. 20.) EüM Decree § 6 (2) o). Repealed: 21 X 2009. Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 c). Repealed: 2018. II. 14 onwards. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Amended by: 56/2013. (VII. 31.) EMMI § 3 a) of the Decree. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Modified: 16/2014. (III. 12.) EMMI Section 4 a) of the Decree. Modified: 16/2014. (III. 12.) EMMI Decree § 4 f). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Modified: 16/2014. (III. 12.) EMMI § 4 g) of the Decree. Modified: 16/2014. (III. 12.) EMMI Decree § 4 g). Modified: 16/2014. (III. 12.) EMMI Decree § 4 g). Amended by 52/2012. (XII. 27.) EMMI Decree § 4 d). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Repealed by: 15/2012. (VIII. 22.) Article 26 of the EMMI Decree. Repealed: 2012. VIII. From 23. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Modified: 16/2014. (III. 12.) EMMI Section 4 a) of the Decree. Modified: 16/2014. (III. 12.) EMMI Decree § 4 h). Founded: 15/2012. (VIII. 22.) EMMI Decree § 19. Amended by 8/2018. (II. 13.) EMMI Decree § 9 a). Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 d). Repealed: 2018. II. 14 onwards. Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 e). Repealed: 2018. II. 14 onwards. Repealed by: 31/2009. (X. 20.) EüM decree § 6 (2) q). Repealed: 21 X 2009. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Amended by: 15/2012. (VIII. 22.) EMMI Decree § 25 c). Founded: 15/2012. (VIII. 22.) EMMI Decree § 21. Valid: 2012. VIII. From 23 p.m. Amended by 52/2012. (XII. 27.) EMMI Decree § 4 e), 23/2015. (IV. 28.) EMMI Decree § 40 a). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Repealed by 56/2013. (VII. 31.) EMMI Decree § 3 b). Repealed: 2013. VIII. 1st. Modified: 16/2014. (III. 12.) EMMI Decree § 5 b). Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Amended by 52/2012. (XII. 27.) EMMI Decree § 5, 8/2018. (II. 13.) Article 9 b) of the EMMI Decree. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Found: 8/2018. (II. 13.) EMMI Decree § 8. Valid: 2018. II. 14 onwards. Founded: 15/2012. (VIII. 22.) EMMI Decree § 22 (1). Valid: 2012. IX. 21 onwards. Founded: 15/2012. (VIII. 22.) EMMI Decree § 22 (2). Valid: 2012. IX. 21 onwards. Modified: 3/2014. (I. 16.) EMMI Decree § 2. Found: 57/2012. (XII. 29.) EMMI Decree § 2 (1). Effective from 29 January 2013. Found: 34/2009 (X. 20.) EüM Decree § 3 (3). Effective: XII. From 4. Founded: 23/2015. (IV. 28.) EMMI Decree § 39. Amended by: 54/2016. (XII. 30.) EMMI Decree § 23 (1) c), 18/2018. (VII. 4.) EMMI Decree § 1. Amended by: 15/2012. (VIII. 22.) EMMI Decree § 25 e). Amended by 34/2009 (X. 20.) EüM Decree § 4 (2). Repealed by: 8/2018. (II. 13.) EMMI Decree § 10 f). Repealed: 2018. II. 14 onwards. Beiktatta: 1/2007. (I. 24.) EüM decree § 1. Valid: 2007. III. from 10. Amended by: 15/2012. (VIII. 22.) EMMI Decree 25 § g), 8/2018. (II. 13.) EMMI Decree § 9 c). Amended by: 15/2012. (VIII. 22.) EMMI Decree § 25 h). Repealed with previous subtitle: 8/2018. (II. 13.) EMMI Decree § 10 g). Repealed: 2018. II. 14 onwards. Founded: 15/2012. (VIII. 22.) EMMI Decree § 23. Valid: 2012. VIII. From 23. Filed: 15/2012. (VIII. 22.) EMMI Decree § 23. Valid: 2012. VIII. From 23. Established: 1/2008. (I. 4.) EüM § 1 of the Decree. Effective: 12/1/2008. Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (2), Annex 15 aa). Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (2), Annex 15 b). Beiktatta: 1/2007. (I. 24.) EüM decree § 2 a). Valid: 2007. III. from 10. Found: 3/2014. (I. 16.) EMMI Decree § 1 (1), Annex 1. Applicable: From 26 January 2014. Found: 34/2009 (X. 20.) EüM Decree § 3 (4), Annex. Effective: XII. 4 onwards. Found: 32/2014. (IV. 18.) EMMI Decree § 2, Annex 1 1. Amended by: 23/2015. (IV. 28.) EMMI Decree 40. § b). Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (2), Annex 15 ba). Amended by: 10/2011. (III. 30.) NEFMI Decree § 28 (2), Annex 15 bb). Filed: 15/2012. (VIII. 22.) EMMI Decree § 24 (2), Annex 2. Amended by 23/2015. (IV. 28.) EMMI Decree 40. § c). Found: 54/2016. (XII. 30.) EMMI Decree § 23 (2), Annex 2. Effective from 1 January 2017. Found: 3/2014. (I. 16.) EMMI Decree § 1 (2), Annex 2. Applicable: From 26 January 2014.