79C3C34C52B45572883A05D425EB0F82

Decree No. 235/2009 (X.20.) from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices

https://net.jogtar.hu/jogszabaly?docid=A0900235.KOR&celpara=#xcelparam

http://leaux.net/URLS/ConvertAPI Text Files/EEC1D38554367AC6579C9653EBFC47B8.en.txt

Examining the file media/Synopses/EEC1D38554367AC6579C9653EBFC47B8.html:

This file was generated: 2020-12-01 05:55:25

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	6
Health	Drug Usage	drug	2
Health	Drug Usage	substance	2
Health	Drug Usage	usage	2
Health	Mentally Disabled	disabled	1
Health	Pregnant	pregnant	2
Health	visual impairment	blind	1
Social	Access to Social Goods	access	1
Social	Age	age	8
Social	Child	child	1
Social	Incarcerated	restricted	7
Social	Linguistic Proficiency	language	2
Social	Marital Status	single	1
Social	Occupation	job	1
Social	Police Officer	officer	44
Social	Property Ownership	property	1
Social	Trade Union Membership	union	1
Social	Youth/Minors	minor	6
Social	embryo	embryo	1
Social	gender	gender	1
Social	philosophical differences/differences of opinion	opinion	22
General/Other	Incapacitated	incapacitated	10
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	24
General/Other	declaration of helsinki	helsinki	1
General/Other	participants in a control group	control group	1
General/Other	participants in a control group	placebo	1

Political / political affiliation

Searching for indicator party:

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p.(None): provide the investigator with a marketing authorization as a medicinal product free of charge, but the
p.(None): does not otherwise participate in or otherwise support the investigation.
p.(None): Authorization of a clinical trial
p.(None): Article 23 (1) * The clinical trial shall be evaluated by the OGYÉI (hereinafter referred to as the licensor) for the evaluation of the submitted documents and the
p.(None): subject to the authority's opinion.
p.(None): (1a) * The conditions laid down in the decision authorizing the clinical trial and the specifications of the approved protocol and
p.(None): the requirements for the commencement and control of a clinical trial shall constitute a code of conduct.
p.(None): 2. The application for authorization may be downloaded from the sponsor in duplicate on the European Medicines Agency (EMEA) website.
p.(None): sheet, accompanied by the documents specified therein.
p.(None): 3. During the licensing procedure, the licensor shall examine it in accordance with the nature of the study in question
p.(None): (a) the completion and adequacy of the pre-clinical tests,
p.(None): (b) clinical trials carried out with the investigational product up to the time of application;
p.(None): (c) the technical feasibility of the proposed study and the suitability of the test methods were included in the objectives of the protocol.
p.(None): answer,
p.(None): (d) the adequacy of the test plan to professional requirements,
p.(None): (e) the expected risks and the expected therapeutic benefit,
p.(None): (f) the suitability of the investigational medicinal product for human use in terms of drug quality;
p.(None): (g) the adequacy of third party liability insurance.
p.(None): (4) * The proposed text of the recruitment notice and the method of recruitment shall be provided by the official approval of the clinical trial and
p.(None): request for ethical review. The published recruitment notice shall include a reference to the existence of an official authorization. The recruitment
p.(None): in the event of a deviation from its authorized method and text, an amendment to the authorization shall be initiated.
p.(None): Section 24 (1) *
p.(None): (2) The Ethics Committee shall formulate the position of the Authority in the composition specified in separate legislation on the following matters:
p.(None): (a) providing opinions on bioequivalence studies,
p.(None): b) IV. review of phase I clinical trials,
p.(None): (c) technical issues related to substantial modification of the protocol;
p.(None): (d) in the case of extraordinary reasons justifying the extraordinary procedure indicated by the licensor, as decided by the chairman of the Ethics Committee;
p.(None): procedures.
p.(None): (3) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial planned to involve a partially restricted person, the Ethics Committee shall be competent
p.(None): In developing its position, it examines whether the Whether Article 159 (4) and (5) are fully implemented,
p.(None): that its capacity to act in the exercise of rights relating to health care is partially or totally restricted
p.(None): minors, and Section 2: 9 of Act V of 2013 on the Civil Code. Of the Act, the question in question is that of incapacitated minors
p.(None): and in the clinical trial in minors with specialist examination of the disease and the patient population concerned,
p.(None): and a specialist in pediatrics and, if necessary, a teacher or psychiatrist.
p.(None): (4) * Ethics Committee declares in professional statement on professional and ethical adequacy of clinical trial
p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
p.(None): to the licensor - at least the justification of the study, the number of subjects to be involved, the planned time of the study and the recruitment methods
p.(None): a simplified study plan shall be submitted.
p.(None): Article 26 (1) The decision of the authorizing officer shall include, in accordance with the nature of the investigation in question:
p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
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p.(None): 6. In matters not covered by paragraphs 2 to 5, Articles 23 to 26 shall apply to the application for amendment. Of the Act
p.(None): apply mutatis mutandis.
p.(None): 27 / A. § * When new, relevant information about a clinical trial becomes known that affects the written information,
p.(None): an amendment to the permit shall be requested. Subject to the amended written information, the subject shall be re - informed and
p.(None): consent to the continuation of the clinical trial.
p.(None): Inspection of the test
p.(None): Section 28 (1) The licensor may carry out controls before, during and after clinical trials.
p.(None): follow-up to applications for import authorizations. The authorizing officer shall keep records of the checks.
p.(None): 2. During the authorized clinical trial, the licensor shall verify:
p.(None): (a) compliance with the provisions concerning the manufacture, labeling and dispatch of the investigational medicinal product to a health establishment,
p.(None): in particular, certificates of compliance with good manufacturing practice for medicinal products,
p.(None): (b) appropriate documentation of the data in the clinical trial,
p.(None): (c) adherence to GCP principles; and
p.(None): (d) the continuation of the clinical trial as provided for in the authorization and the protocol.
p.(None): 3. After verification, the authorizing officer shall draw up an inspection report and make it available to the sponsor. Upon request, the
p.(None): the authorizing officer shall make the report available to the Ethics Committee, to the States party to the EEA Agreement and to the EMEA.
p.(None): 4. If the inspection reveals that the conduct of the clinical trial does not comply with the authorization or this Title,
p.(None): or the clinical trial poses a serious risk to the life or health of the subjects,
p.(None): it shall immediately send the minutes to the sponsor and to the Ethics Committee and proceed as provided in Article 29 (1) - (2).
p.(None): 5. If the deficiencies found during the inspection are of minor importance, the safety of the subjects shall not be endangered.
p.(None): calls on those concerned to remedy these shortcomings and suggests ways of overcoming them;
p.(None): notify the sponsor and the study director.
p.(None): Suspension and termination of the clinical trial
p.(None): Article 29 (1) If it is found during the inspection that
p.(None): (a) the continuation of the study does not comply with the authorization, the protocol, or this Title, and the clinical investigation of the IMP
p.(None): the conditions laid down in separate legislation,
p.(None): (b) the study endangers the life, health or safety of the subjects; or
p.(None): (c) the scientific validity of the study is in doubt,
p.(None): the licensor shall immediately suspend the study and send the report to the sponsor and to the Ethics Committee.
p.(None): 2. Except in the case of imminent danger to the subjects, following the suspension, before the termination decision is taken:
p.(None): the licensor shall seek the opinion of the sponsor, the investigators and those involved in the investigation within a seven-day time limit, and shall
...

p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
p.(None): (g) the registration number of the test.
p.(None): 2. The authorizing officer shall send his decision:
p.(None): (a) the applicant,
p.(None): (b) the competent authority acting,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The decision of the authorizing officer shall be a condition for the opening of the investigation.
p.(None): 4. Where the licensor has notified the applicant of an Annex III, as notified by the applicant, Class IIa and IIa or IIb implantable, durable
...

p.(None): If it does not intend to comply with these conditions, it shall continue the investigation in accordance with the original protocol and notify the licensor thereof. THE
p.(None): the applicant shall continue the examination in accordance with the original protocol if the application is rejected. In the case of multiple modifications, the licensor shall:
p.(None): provided separately in the application.
p.(None): 6. In matters not covered by paragraphs 2 to 5, Articles 32 to 34 shall apply to the request for amendment. Of the Act
p.(None): apply mutatis mutandis.
p.(None): Inspection of the test
p.(None): Article 36 (1) The licensor may carry out inspections before, during and after the commencement of investigations.
p.(None): license. The authorizing officer shall keep records of the checks.
p.(None): 2. The licensing inspector may be the person who has the creditor's credentials relating to him. The
p.(None): prior to commencement of the inspection, the inspector shall present the credential issued by the licensor.
p.(None): 3. During an authorized examination, the licensor may verify:
p.(None): (a) the intended use of the test device,
p.(None): (b) the documentation of the data as required during the investigation,
p.(None): (c) compliance with the safety requirements for the device; and
p.(None): (d) the continuation of the study as required by the permit and the protocol.
p.(None): 4. The authorizing officer shall keep a record of the checks carried out in accordance with paragraph 3, with a copy to the applicant. The
p.(None): in the case of an application for authorization, the Protocol shall be made available to the specialized authority and the authorities of the States party to the EEA Agreement
p.(None): provide.
p.(None): 5. Subject to authorized investigations, subjects and persons entitled to make statements, investigators,
p.(None): the head of the investigating service provider may apply a signal to the licensor if they consider that the investigator in the license or
p.(None): Contrary to the protocol.
p.(None): 6. If the deficiencies found during the inspection are of minor importance, the authorizing officer shall call upon the applicant to remedy the deficiencies.
p.(None): eliminate them.
p.(None): Suspension and termination of the clinical trial
p.(None): Section 37 (1) * If it is found that
p.(None): (a) the continuation of the study does not comply with the authorization, the research plan or this Title and the medical devices;
p.(None): the conditions laid down in specific legislation on clinical trials,
p.(None): (b) the life, health or safety of the subjects or staff is endangered by the investigation,
p.(None): (c) the examination is contrary to public policy or public health; or
p.(None): d) the applicant has not complied with the notice under Section 36 (6),
p.(None): the authorizing officer shall immediately suspend the examination and send the inspection report to the applicant and to the competent authority.
p.(None): 2. Following suspension, before the termination decision, except in case of imminent danger to the participants in the research:
p.(None): - the authorizing officer shall request the opinion of the applicant, the investigators and the investigators by setting a time-limit of seven days,
...

p.(None): details of any tests carried out to assess its safety, quality and usefulness, taking into account the intended purpose of the device;
p.(None): (f) where the device is manufactured utilizing tissue of animal origin in order to reduce the risk of infection
p.(None): the risk management measures taken;
p.(None): (g) results of design calculations made, examinations carried out and technical tests carried out.
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are
p.(None): the documentation referred to in this point. The manufacturer must authorize the assessment of the effectiveness of these measures and, where appropriate,
p.(None): control.
p.(None): 10. Method, surface, time of contact of the parts that are in direct contact with the test subject or the operator, the material (s) used
p.(None): confirmation of biocompatibility, safety data sheet
p.(None): 11. Requirements for sterility and sterilization process and how to ensure it
p.(None): 12. Draft label
p.(None): 13. Draft instruction manual
p.(None): 14. Declaration that the device (s) intended for the clinical trial, in addition to the aspects being investigated,
p.(None): the essential requirements contained in Annex 1 to the Separate Medical Device Act and the manufacturer has done everything in its power
p.(None): protecting the health and safety of participants in a trial
p.(None): Clinical trial data and documentation
p.(None): 15. * In the case of a multicentre investigation, the opinion of the Ethics Committee of the State Party to the EEA Agreement, if any
p.(None): 16. Clinical trial design, including:
p.(None): (a) the purpose of the study (in terms of efficacy),
p.(None): (b) a precise, objective determination of the achievement of the test objective;
p.(None): (c) a description of the test method used (eg double-blind, randomized, etc.),
p.(None): (d) a description of the test procedure,
p.(None): (e) factors affecting the outcome of the test (eg other disease),
p.(None): f) a sample data sheet, algorithm, written instruction needed to evaluate the study,
p.(None): (g) a follow-up plan,
p.(None): (h) the scientific, medical and technical justification for the study,
p.(None): (i) the criteria for the selection of subjects to be investigated,
p.(None): (j) identification and justification of the number of subjects to be included in the study,
p.(None): (k) the identification of the items under examination,
p.(None): (l) identification of any other device which is not covered by the CE marking and is not involved in the test,
p.(None): (m) the identification of the other devices which are not covered by the CE marking and which are not subject to the test;
p.(None): showing how the safety of the test can be guaranteed,
p.(None): (n) risk analysis and risk assessment, a detailed assessment of the likely risks and adverse reactions, or their elimination; or
p.(None): how to reduce them,
p.(None): (o) an analysis and justification of the acceptability of the intended performance and the proportion of the risks and adverse reactions likely to occur,
p.(None): (p) a copy of the evidence of formal qualifications of the investigating staff,
p.(None): (q) patient information and consent,
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Health / Drug Usage

Searching for indicator drug:

Searching for indicator substance:

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p.(None): investigations.
p.(None): Section 31 (1) For the purposes of this Title:
p.(None): (a) * sponsor: any natural or legal person who, under his own name, is preparing a clinical trial device for a clinical trial,
p.(None): particularly
p.(None): (aa) assemble, package, process, refurbish, label, and label the device intended for clinical investigation, unless already
p.(None): assembles or adapts devices placed on the market to a specific patient in the course of medical treatment for their intended purpose
p.(None): according to individual needs,
p.(None): (ab) designs, manufactures, packages, labels, on its own responsibility, a device intended for clinical investigation, whether or not such operations are performed by itself;
p.(None): or is commissioned by or on behalf of another;
p.(None): (b) * Authorized representative: the natural or legal person responsible for the preparation of the device intended for clinical investigation by the sponsor.
p.(None): a legal entity which, subject to the agreement of the sponsor with the sponsor during the authorization and conduct of the clinical trial,
p.(None): act on behalf of;
p.(None): (c) subject: a person participating in the clinical trial who is using the clinical trial device or who is in the clinical trial.
p.(None): participates as a control person;
p.(None): d) *
p.(None): (2) * For the purposes of this title, the provisions of the Ministerial Decree on Medical Devices
p.(None): and the Ministerial Decree on the Clinical Trial of Medical Devices
p.(None): to take into account.
p.(None): Authorization of a clinical trial
p.(None): Article 32 (1) * The investigation shall be authorized and registered by OGYÉI (hereinafter referred to as "licensor").
p.(None): (2) * OGYÉI examines whether a substance intended to be used in a clinical trial is an integral part of a device which, when used alone, is licensed under Gytv.
p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
...

p.(None): (ae) a description of the intended use,
p.(None): (af) a list of factors affecting the intended use,
p.(None): (ag) contraindications / exclusion factors for use,
p.(None): (ah) warnings on application, precautions to be taken, description of principle of operation,
p.(None): (ai) a general description of the proposed variants, identifying them;
p.(None): (b) design drawings, methods of manufacture envisaged, in particular as regards sterilization, and drawings of components, sub-assemblies and circuits:
p.(None): (ba) its physical description,
p.(None): (bb) its technical data,
p.(None): (bc) Schematic / schematic drawing, picture / photograph;
p.(None): (c) descriptions and explanations necessary for the understanding of said plans and the operation of the instrument:
p.(None): (ca) a list of the standards used in the design of the device,
p.(None): (c b) a list of standards for the device which have not been applied and a description of the solutions by which they are essential
p.(None): compliance with the relevant requirements of the requirements can be achieved by deviating from the standard,
p.(None): (cc) verification and approval of the design and construction documentation for the device,
p.(None): (cd) the conditions, technical and safety requirements for the intended connection of the device to another device,
p.(None): conditions and limits;
p.(None): (d) the results of the risk analysis and a list of the harmonized standards applied in whole or in part, and
p.(None): a description of the solutions adopted to meet the requirements of Title 3 of this Regulation, provided that:
p.(None): nationalized harmonized standards have not been applied;
p.(None): (e) where a device, drug substance or human blood derivative is an integral part of the device,
p.(None): details of any tests carried out to assess its safety, quality and usefulness, taking into account the intended purpose of the device;
p.(None): (f) where the device is manufactured utilizing tissue of animal origin in order to reduce the risk of infection
p.(None): the risk management measures taken;
p.(None): (g) results of design calculations made, examinations carried out and technical tests carried out.
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are
p.(None): the documentation referred to in this point. The manufacturer must authorize the assessment of the effectiveness of these measures and, where appropriate,
p.(None): control.
p.(None): 10. Method, surface, time of contact of the parts that are in direct contact with the test subject or the operator, the material (s) used
p.(None): confirmation of biocompatibility, safety data sheet
p.(None): 11. Requirements for sterility and sterilization process and how to ensure it
p.(None): 12. Draft label
p.(None): 13. Draft instruction manual
p.(None): 14. Declaration that the device (s) intended for the clinical trial, in addition to the aspects being investigated,
p.(None): the essential requirements contained in Annex 1 to the Separate Medical Device Act and the manufacturer has done everything in its power
p.(None): protecting the health and safety of participants in a trial
p.(None): Clinical trial data and documentation
...

Searching for indicator usage:

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p.(None): I'll open it in the Jurisprudence
p.(None): ads.
p.(None): FUNCTIONAL COOKIES
p.(None): These cookies allow us to show you ads that are relevant to your interests.
p.(None): COMFORTABLE COOKIE-K
p.(None): 235/2009. (X. 20.) Government Decree
p.(None): Recommended setting. These cookies provide an opportunity for you to analyze your use of the site for personalized content and
p.(None): or send you ads, or use our analytics to improve our services.
p.(None): human medical research, human research
p.(None): clinical trials of medicinal products; and clinical use in humans
p.(None): intended for testingSave
p.(None): the rules for the authorization procedure for the clinical trial of medical devices
p.(None): CLIV of 1997 on Health § 246 (b) and § 247 (1) (u) of the Act and the administrative procedure
p.(None): With this option, you enable:
p.(None): CXL of 2004 on the General Rules of Services and Services. 174 / A. (1) a) of the Constitution, the Constitution
p.(None): Secure login, remember login details
p.(None): Acting within the scope of its responsibilities under Article 35 (1) (b), Article 35 (2) of the Constitution shall
p.(None): Memorizing the process of tasks and transactions
p.(None): Web analytics measurements for statistical purposes
p.(None): of the Constitution, in the exercise of its powers under Article 40 (3) of the Constitution, and
p.(None): Send a reminder about the items in your cart
p.(None): Hirdetésekés
p.(None): health official display
p.(None): igazgatásiaztevékenységről
p.(None): page XI of 1991 Pursuant to the authorization contained in Article 15 (4) of the Act, the Government a
p.(None): Showing ads that are relevant to your interests (remarketing) a
p.(None): orders: outside (eg social networking sites)
p.(None): website
p.(None): Page Usage Analysis in order to customize your content
p.(None): Section 1 (1) The provisions of this Decree
p.(None): should be applied to all CLIV 1997 Health Regulations. (hereinafter referred to as: “Eutv.”)
p.(None): your website
p.(None): Page Usage Analysis of Wolters Kluwer Hungary Kft.
p.(None): human medicine
p.(None): activities use research (hereinafter:
p.(None): order research)
p.(None): to personalize it.
p.(None): with offers
p.(None): search for it at the contact details you provided (if you have one
p.(None): 2. The provisions of Title 1 shall apply
p.(None): contact information eg. registration for the authorization of all non-paragraph 3 medical research.
p.(None): in)
p.(None): (3) * The Az
p.(None): for human use
p.(None): pages are complete, all bypassed
p.(None): convenience drugs and other things called "Comfort
p.(None): XCV of 2005 amending the laws governing the pharmaceutical market for the provision of such a function.
p.(None): cookie "setting. You can change your cookie settings at any time
p.(None): 1 of the Act on Companies Act (hereinafter: Gytv.)
p.(None): browser (Firefox, § 7)
p.(None): Chrome by Explorer,
p.(None): Safari, Internet clinical trial
p.(None): Microsoft licensing
p.(None): Edge). Title 2, Clinical Devices
p.(None): for testingAWolters
p.(None): Address 3Kluwer Hungary Ltd.'s data management information can be found here.
p.(None): shall be governed by its provisions.
p.(None): TITLE 1
p.(None): AUTHORIZING HUMAN RESEARCH
p.(None): § 2. For the purposes of this title
p.(None): (a) multi-center research: research based on the same research plan but carried out at more than one research site;
p.(None): (b) participant: a person who participates in the research as a subject, including a member of the control group;
p.(None): (c) "research supervisor" means a person who conducts research professionally;
p.(None): d) * Principal: any natural or legal person who initiates, directs or finances a research, provided that:
p.(None): the principal investigator and the principal may be the same person;
...

Health / Mentally Disabled

Searching for indicator disabled:

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p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
...

Health / Pregnant

Searching for indicator pregnant:

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p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
...

p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
p.(None): (c) information of particular importance to the radiation protection of participants and assistants and supporters:
p.(None): (ca) their sex,
p.(None): (cb) their age,
p.(None): (cc) the fact that they are pregnant or have a child,
p.(None): (cd) measures taken to optimize their exposure,
p.(None): (ce) the fact that they have participated in previous radiation exposure research programs,
p.(None): (d) information concerning the researchers and the institution carrying out the research:
p.(None): (da) if research is carried out by a holder of a license for the use of nuclear energy, the use of radioactive material or ionizing radiation;
p.(None): a copy of the permit for the operation of equipment that generates but does not contain radioactive material and
p.(None): regulations and description of the workplace radiation protection,
p.(None): d (b) evidence of professional qualifications for radiation protection designers, approvers and contractors in the field of research and radiation protection
p.(None): copy of the document,
p.(None): (e) the expected exposure of participants, workers, carers and assistants and the general public during the research;
p.(None): risk analysis describing the estimation of radiation exposure.
p.(None): TITLE 4
p.(None): ON PUBLIC HEALTH AND MEDICAL SERVICE AND PHARMACEUTICAL
p.(None): ON THE DESIGNATION OF A PUBLIC ADMINISTRATION (XII. 28.) KORM. REGULATION AND IT
p.(None): 295/2004 ON THE HEALTH AUTHORIZATION AND ADMINISTRATION OFFICE (X. 28.) KORM.
p.(None): AMENDMENT OF THE REGULATION
p.(None): 38-39. § *
p.(None): Article 40 (1) This Decree on medicinal products for pediatric use, as well as Decree 1768/92, 2001/2001
p.(None): Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Directive 2001/83 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
...

Health / visual impairment

Searching for indicator blind:

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p.(None): the risk management measures taken;
p.(None): (g) results of design calculations made, examinations carried out and technical tests carried out.
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are
p.(None): the documentation referred to in this point. The manufacturer must authorize the assessment of the effectiveness of these measures and, where appropriate,
p.(None): control.
p.(None): 10. Method, surface, time of contact of the parts that are in direct contact with the test subject or the operator, the material (s) used
p.(None): confirmation of biocompatibility, safety data sheet
p.(None): 11. Requirements for sterility and sterilization process and how to ensure it
p.(None): 12. Draft label
p.(None): 13. Draft instruction manual
p.(None): 14. Declaration that the device (s) intended for the clinical trial, in addition to the aspects being investigated,
p.(None): the essential requirements contained in Annex 1 to the Separate Medical Device Act and the manufacturer has done everything in its power
p.(None): protecting the health and safety of participants in a trial
p.(None): Clinical trial data and documentation
p.(None): 15. * In the case of a multicentre investigation, the opinion of the Ethics Committee of the State Party to the EEA Agreement, if any
p.(None): 16. Clinical trial design, including:
p.(None): (a) the purpose of the study (in terms of efficacy),
p.(None): (b) a precise, objective determination of the achievement of the test objective;
p.(None): (c) a description of the test method used (eg double-blind, randomized, etc.),
p.(None): (d) a description of the test procedure,
p.(None): (e) factors affecting the outcome of the test (eg other disease),
p.(None): f) a sample data sheet, algorithm, written instruction needed to evaluate the study,
p.(None): (g) a follow-up plan,
p.(None): (h) the scientific, medical and technical justification for the study,
p.(None): (i) the criteria for the selection of subjects to be investigated,
p.(None): (j) identification and justification of the number of subjects to be included in the study,
p.(None): (k) the identification of the items under examination,
p.(None): (l) identification of any other device which is not covered by the CE marking and is not involved in the test,
p.(None): (m) the identification of the other devices which are not covered by the CE marking and which are not subject to the test;
p.(None): showing how the safety of the test can be guaranteed,
p.(None): (n) risk analysis and risk assessment, a detailed assessment of the likely risks and adverse reactions, or their elimination; or
p.(None): how to reduce them,
p.(None): (o) an analysis and justification of the acceptability of the intended performance and the proportion of the risks and adverse reactions likely to occur,
p.(None): (p) a copy of the evidence of formal qualifications of the investigating staff,
p.(None): (q) patient information and consent,
p.(None): (r) procedure to be followed in the event of an unexpected event, list of notifiers, time limit for notification;
p.(None): (s) the criteria for stopping the clinical trial,
p.(None): t) * commencement of research activity by the clinical trial health care provider to cover compensation and damages
...

Searching for indicator access:

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p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
p.(None): Section 5 *
p.(None): Section 6 In the case of research where licensing is not carried out by the ETT TUKEB or the ETT HRB,
p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
...

Searching for indicator age:

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p.(None): (c) the name and address of the healthcare provider (s) participating in the research,
p.(None): (d) the name and function of the principal investigator and the research personnel,
p.(None): (e) the purpose of the research,
p.(None): (f) the date and expected duration of the research,
p.(None): (g) an indication of the intended research in one or more centers, the proposed research in the case of multi-center research;
p.(None): a list of locations.
p.(None): 2. The application shall be presented
p.(None): (a) the research plan,
p.(None): (b) the curriculum vitae of the principal investigator,
p.(None): (c) subject to the provisions of the Ministerial Decree on human medical research;
p.(None): a draft written briefing,
p.(None): (d) draft statements of consent of persons participating in the research,
p.(None): (e) an estimate of the additional costs incurred in the research,
p.(None): f. 164 (2) of the Liability Insurance contract issued by the insurer
p.(None): certificate
p.(None): (g) a draft specific data sheet, which must include all data, facts, events and information relevant to the research;
p.(None): can affect your outcome,
p.(None): (h) a statement of the remuneration of the principal investigator and the research contributor.
p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
p.(None): c) a set of criteria for the recruitment, selection and exclusion of participants,
p.(None): (d) number of participants (total and per research site), gender, age, to be included in the research;
p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
...

p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
p.(None): (f) the number, sex, age of participants planned to be included in the research, in the case of multi-center research, and per research site
p.(None): separately.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant,
p.(None): (b) the acting Ethics Committee or Regional Ethics Committee,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The applicant shall notify the decision to the competent IKEB, the head of the research establishment and, if the applicant is not the same,
p.(None): research leader - the research leader.
p.(None): remedy
p.(None): Section 10 *
p.(None): Modification of the authorization
p.(None): Article 11 (1) * After the exploration permit becomes final, the applicant may modify the exploration plan. Modification of the Research Plan -
p.(None): with the exception of paragraphs 2 to 5, the applicant shall notify the authorizing officer.
p.(None): 2. In the event of a major modification to the research plan pursuant to paragraph 3, the applicant shall request the amendment of the authorization.
p.(None): engedélyezőnél. The application shall state the reasons on which the changes are based and shall state the exact content of the amendments. If the change could affect the participants
p.(None): In the interest of safety, the draft modified version of the package leaflet and consent should be attached to the application.
p.(None): (3) A substantial modification of a research plan shall be deemed to be particularly if:
p.(None): a) the modification may affect the safety of the research participants,
...

p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any document used in the conduct of the investigation.
p.(None): 17 / A. § * (1) The application for authorization shall be substantiated by the administrative service fee and shall be presented in the application.
p.(None): (a) the protocol,
p.(None): (b) the curriculum vitae of the coordinating investigator;
p.(None): (c) draft information for subjects (except for retrospective studies),
p.(None): (d) the draft statement of consent of subjects (except for retrospective studies),
p.(None): (e) in the case of recruitment, a draft recruitment plan,
p.(None): (f) in the case of a non-interventional study with a healthcare provider, a statement by the applicant that:
p.(None): has made a notification under the Ministerial Decree on medical research.
p.(None): 2. The request shall include a statement of intent from the investigator or coordinating investigator to the effect that the investigator shall:
p.(None): shall, if approved, implement the study plan known to it in accordance with its terms and the terms of the permit decision.
p.(None): 3. The test plan referred to in paragraph 1 (a) shall be included
p.(None): (a) the purpose, layout, methodology, organization and publication principles of the study;
p.(None): (b) the criteria for inclusion and exclusion of subjects and the manner of recruitment,
p.(None): (c) number or range, sex, age of subjects to be included in the study,
p.(None): (d) the method of statistical processing of data obtained during the study,
p.(None): (e) the planned time and place for the examination,
p.(None): (f) the source of the research funding,
p.(None): g) the name and seat of the applicant.
p.(None): 4. Where the non-interventional investigation is carried out by a healthcare provider, the examination site referred to in paragraph 3 (e) shall be the following:
p.(None): the name and address of the healthcare provider shall be included in the test plan referred to in paragraph 1 (a).
p.(None): (5) In the case of Article 17 (1) (b) p o n t b b), the draft study plan shall not entail any intervention after authorization.
p.(None): in the case of a pharmacovigilance investigation, the Gytv. Pharmacovigilance Risk Assessment Committee referred to in Section 1 point 31 (hereinafter PRAC)
p.(None): must be submitted to.
p.(None): 6. In the case of a non-post-authorization safety study, the study plan shall be subject to the procedure set out in European Directive 726/2004 / EC.
p.(None): pharmacovigilance activities required by Regulation (EC) No 45/2001 of the European Parliament and of the Council and Directive 2001/83 / EC of the European Parliament and of the Council
p.(None): shall comply with Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of this Regulation.
p.(None): 7. Where the sponsor submits the final results of the non-post-authorization safety study
p.(None): requesting a deferral, the information listed in paragraph 1 shall be accompanied by a statement of the reasons therefor.
p.(None): 8. For the purposes of this Regulation, the PRAC shall not be considered as a licensing authority.
...

p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
p.(None): to the licensor - at least the justification of the study, the number of subjects to be involved, the planned time of the study and the recruitment methods
p.(None): a simplified study plan shall be submitted.
p.(None): Article 26 (1) The decision of the authorizing officer shall include, in accordance with the nature of the investigation in question:
p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant or the sponsor,
p.(None): (b) the competent administrative authorities,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): (3) * The licensor shall send the decision of the professional-ethical authority together with the decision to the principal.
p.(None): 26 / A. § * Phase I clinical trials may only be performed at a clinical pharmacology site approved by OGYÉI. The certification
p.(None): the procedure shall be carried out at the request of the service provider's manager. The certification process shall be repeated every three years.
p.(None): 26 / B. § * The sponsor shall notify the decision of OGYÉI regarding the authorization of the clinical trial health care provider
p.(None): send the decision of the OGYÉI and the study plan in Hungarian before commencing the investigation and
p.(None): refer to the relevant IKEB. If the healthcare provider is not a healthcare institution, the IKEB of that institution is competent,
p.(None): which is the headquarters of the investigating provider in the emergency medical care area of the healthcare institution.
p.(None): Modification of the authorization
p.(None): Article 27 (1) * After the study permit becomes final, the applicant may modify the study plan. In the test plan
...

p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
p.(None): (g) the registration number of the test.
p.(None): 2. The authorizing officer shall send his decision:
p.(None): (a) the applicant,
p.(None): (b) the competent authority acting,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The decision of the authorizing officer shall be a condition for the opening of the investigation.
p.(None): 4. Where the licensor has notified the applicant of an Annex III, as notified by the applicant, Class IIa and IIa or IIb implantable, durable
p.(None): does not make a decision regarding the clinical investigation of invasive devices for use within the time limit specified in the Health Care Act,
p.(None): on expiry of that period, the manufacturer may commence an investigation. The applicant shall notify the authorizing officer of the investigation so initiated
p.(None): the licensor shall register the investigation in accordance with Article 32 (1).
p.(None): Modification of the authorization
p.(None): Section 35 (1) * After the study permit becomes final, the applicant may modify the study plan. The study design and the study
...

p.(None): 487/2015. (XII. 30.) of the Government of the Republic of Hungary shall be taken into consideration.
p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
p.(None): (c) information of particular importance to the radiation protection of participants and assistants and supporters:
p.(None): (ca) their sex,
p.(None): (cb) their age,
p.(None): (cc) the fact that they are pregnant or have a child,
p.(None): (cd) measures taken to optimize their exposure,
p.(None): (ce) the fact that they have participated in previous radiation exposure research programs,
p.(None): (d) information concerning the researchers and the institution carrying out the research:
p.(None): (da) if research is carried out by a holder of a license for the use of nuclear energy, the use of radioactive material or ionizing radiation;
p.(None): a copy of the permit for the operation of equipment that generates but does not contain radioactive material and
p.(None): regulations and description of the workplace radiation protection,
p.(None): d (b) evidence of professional qualifications for radiation protection designers, approvers and contractors in the field of research and radiation protection
p.(None): copy of the document,
p.(None): (e) the expected exposure of participants, workers, carers and assistants and the general public during the research;
p.(None): risk analysis describing the estimation of radiation exposure.
p.(None): TITLE 4
p.(None): ON PUBLIC HEALTH AND MEDICAL SERVICE AND PHARMACEUTICAL
p.(None): ON THE DESIGNATION OF A PUBLIC ADMINISTRATION (XII. 28.) KORM. REGULATION AND IT
p.(None): 295/2004 ON THE HEALTH AUTHORIZATION AND ADMINISTRATION OFFICE (X. 28.) KORM.
p.(None): AMENDMENT OF THE REGULATION
p.(None): 38-39. § *
p.(None): Article 40 (1) This Decree on medicinal products for pediatric use, as well as Decree 1768/92, 2001/2001
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p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
p.(None): (c) information of particular importance to the radiation protection of participants and assistants and supporters:
p.(None): (ca) their sex,
p.(None): (cb) their age,
p.(None): (cc) the fact that they are pregnant or have a child,
p.(None): (cd) measures taken to optimize their exposure,
p.(None): (ce) the fact that they have participated in previous radiation exposure research programs,
p.(None): (d) information concerning the researchers and the institution carrying out the research:
p.(None): (da) if research is carried out by a holder of a license for the use of nuclear energy, the use of radioactive material or ionizing radiation;
p.(None): a copy of the permit for the operation of equipment that generates but does not contain radioactive material and
p.(None): regulations and description of the workplace radiation protection,
p.(None): d (b) evidence of professional qualifications for radiation protection designers, approvers and contractors in the field of research and radiation protection
p.(None): copy of the document,
p.(None): (e) the expected exposure of participants, workers, carers and assistants and the general public during the research;
p.(None): risk analysis describing the estimation of radiation exposure.
p.(None): TITLE 4
p.(None): ON PUBLIC HEALTH AND MEDICAL SERVICE AND PHARMACEUTICAL
p.(None): ON THE DESIGNATION OF A PUBLIC ADMINISTRATION (XII. 28.) KORM. REGULATION AND IT
p.(None): 295/2004 ON THE HEALTH AUTHORIZATION AND ADMINISTRATION OFFICE (X. 28.) KORM.
p.(None): AMENDMENT OF THE REGULATION
p.(None): 38-39. § *
p.(None): Article 40 (1) This Decree on medicinal products for pediatric use, as well as Decree 1768/92, 2001/2001
p.(None): Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Directive 2001/83 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
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p.(None): (ab) in all other cases, the ETSC TUKEB professional ethics license
p.(None): possess it;
p.(None): (b) * in the case of an investigation as referred to in Article 16 (c)
p.(None): ba) * if the test is not the test referred to in point bb), the National Institute of Pharmacy and Food (the
p.(None): hereinafter referred to as "OGYÉI"),
p.(None): bb) * where compliance with an official decision to conduct a non-post-authorization safety study
p.(None): Gytv. Pharmacovigilance Risk Assessment Committee referred to in Article 1 (31) (a
p.(None): hereinafter referred to as "PRAC") and the ETT TUKEB ethical approval,
p.(None): be notified to OGYÉI before commencement;
p.(None): c) * in the case of investigations referred to in Section 16 (b), may be authorized by OGYÉI.
p.(None): (2) In the case of a study involving no intervention in minors, the ETT TUKEB shall, subject to the opinion of a pediatrician
p.(None): decision.
p.(None): (3) Unless the appeal is excluded by law, in the case of the licensing procedure of the ETC TUKEB, the proceedings of the second instance shall be continued by the ETC Bureau.
p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any document used in the conduct of the investigation.
p.(None): 17 / A. § * (1) The application for authorization shall be substantiated by the administrative service fee and shall be presented in the application.
p.(None): (a) the protocol,
p.(None): (b) the curriculum vitae of the coordinating investigator;
p.(None): (c) draft information for subjects (except for retrospective studies),
p.(None): (d) the draft statement of consent of subjects (except for retrospective studies),
p.(None): (e) in the case of recruitment, a draft recruitment plan,
p.(None): (f) in the case of a non-interventional study with a healthcare provider, a statement by the applicant that:
p.(None): has made a notification under the Ministerial Decree on medical research.
p.(None): 2. The request shall include a statement of intent from the investigator or coordinating investigator to the effect that the investigator shall:
p.(None): shall, if approved, implement the study plan known to it in accordance with its terms and the terms of the permit decision.
p.(None): 3. The test plan referred to in paragraph 1 (a) shall be included
p.(None): (a) the purpose, layout, methodology, organization and publication principles of the study;
p.(None): (b) the criteria for inclusion and exclusion of subjects and the manner of recruitment,
p.(None): (c) number or range, sex, age of subjects to be included in the study,
p.(None): (d) the method of statistical processing of data obtained during the study,
p.(None): (e) the planned time and place for the examination,
p.(None): (f) the source of the research funding,
p.(None): g) the name and seat of the applicant.
p.(None): 4. Where the non-interventional investigation is carried out by a healthcare provider, the examination site referred to in paragraph 3 (e) shall be the following:
...

p.(None): b) a
p.(None): ba) * In the case of an investigation as referred to in Article 16 (b) and Article 17 (1) (b) (ba), you must apply for an amendment of the authorization
p.(None): at OGYÉI,
p.(None): bb) * In the case of the investigation referred to in Section 17 (1) (b) (bb), the PRAC must approve the change and the ETT TUKEB ethical approval
p.(None): you should ask. If approved by the PRAC and approved by ETT TUKEB, it must be submitted at the latest by the time the change is implemented.
p.(None): report to OGYÉI;
p.(None): c) *
p.(None): (1a) * A minor change to the protocol shall be notified by the applicant to the licensor.
p.(None): 2. A substantial modification of the protocol shall in particular be considered as:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation supporting the non-interventional study,
p.(None): c) the amendment concerns the prospectus for investigators,
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (3) * In the course of the procedure of the OGYÉI for the approval of the modification, the EWC TUKEB shall request the opinion of the competent authority in Section 18 (6) a) -c)
p.(None): above.
p.(None): 4. The following documents shall be sent in connection with the notification pursuant to paragraph 1 (b) (bb):
p.(None): (a) the PRAC approval document,
p.(None): (b) an amended protocol approved by the PRAC, indicating any parts modified,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any altered document used in the conduct of the investigation.
p.(None): (5) * In the case referred to in paragraph (1) (c), OGYÉI shall request the opinion of the ETT TUKEB in accordance with Article 18 (2c).
p.(None): to investigate.
p.(None): Section 20 * In the case of investigations and research referred to in Section 17 (1) (a) (aa), the National Chief Medical Officer, Section 17 (1) (a)
p.(None): (b) and (c) of the ETT TUKEB;
p.(None): during the investigation, continuously checks that the non-interventional investigation is conducted in accordance with professional rules,
p.(None): and in accordance with the terms of the permit and the protocol.
p.(None): Section 21 * (1) * If it is found during the inspection that the continuation of the non-interventional investigation does not comply with the permit,
p.(None): the conditions laid down in the study plan and the ministerial decree on human medical research, Section 17 (1)
p.(None): in the case of the examinations and research referred to in point (a) (aa), the national officer in charge, referred to in Article 17 (1) (a) (b)
p.(None): in the case of investigations and research, ETT TUKEB, in the case of investigations referred to in Article 16 (b) and (c), OGYÉI
p.(None): the investigation shall be immediately suspended or terminated.
p.(None): (2) * Following the suspension, the National Chief Medical Officer, ETT TUKEB, or OGYÉI shall, prior to the termination decision,
p.(None): request the views of the applicant, the investigator-in-charge and those involved in the non-interventional investigation by setting a time limit; and
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p.(None): f) Regional Ethics Committee: (159) of the Health Act, defined in a separate legislation
p.(None): Institutional Research Ethics Committee (RKEB);
p.(None): g) * IKEB: Institutional Ethics Committee, that is, an independent committee to be set up in every healthcare institution where
p.(None): and shall be responsible for verifying that the licensed and ethical
p.(None): ensure that the personal and material conditions are met and that the research plan
p.(None): standards, ethical requirements, with particular regard to the protection of those involved in research.
p.(None): Enable research
p.(None): Article 3 (1) * Research shall be carried out by the National Chief Medical Officer (hereinafter referred to as "licensor" for the purposes of this Chapter) in human medicine.
p.(None): as defined in the Ministerial Decree on Research - specialized authorities involved in administrative procedures
p.(None): according to the division of tasks according to the law defining the appointment of the person - the opinion of the ethics committee or
p.(None): is authorized and registered by the Regional Ethics Committee.
p.(None): (2) *
p.(None): 3. An application for a research permit shall be made by the researcher, the principal investigator or the principal (hereinafter referred to as 'the applicant' for the purposes of this Title).
p.(None): submit.
p.(None): (4) * A single permit shall be issued for research carried out in several centers.
p.(None): 3 / A. § * (1) An application for a research permit shall include:
p.(None): (a) the title of the research,
p.(None): b) the name, registered office, representative of the principal in Hungary and its address,
p.(None): (c) the name and address of the healthcare provider (s) participating in the research,
p.(None): (d) the name and function of the principal investigator and the research personnel,
p.(None): (e) the purpose of the research,
p.(None): (f) the date and expected duration of the research,
p.(None): (g) an indication of the intended research in one or more centers, the proposed research in the case of multi-center research;
p.(None): a list of locations.
p.(None): 2. The application shall be presented
p.(None): (a) the research plan,
p.(None): (b) the curriculum vitae of the principal investigator,
p.(None): (c) subject to the provisions of the Ministerial Decree on human medical research;
p.(None): a draft written briefing,
p.(None): (d) draft statements of consent of persons participating in the research,
p.(None): (e) an estimate of the additional costs incurred in the research,
p.(None): f. 164 (2) of the Liability Insurance contract issued by the insurer
p.(None): certificate
p.(None): (g) a draft specific data sheet, which must include all data, facts, events and information relevant to the research;
p.(None): can affect your outcome,
p.(None): (h) a statement of the remuneration of the principal investigator and the research contributor.
p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
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p.(None): endangering or endangering the life or health of subjects. The study director shall inform the applicant and the authorizing officer accordingly
p.(None): in order that the authorizing officer may, where necessary, act in accordance with paragraphs 1 to 3.
p.(None): European Database *
p.(None): 37 / A. § * The licensor
p.(None): (a) in the case of an application under Article 32 (2), the information specified in Sections 1, 3, 5 and 9 (a) (aa) to (b) of the Annex;
p.(None): data;
p.(None): b) at the same time as the provisions of Article 33 (3), the date and the reasons for the rejection decision;
p.(None): c) at the same time as the provisions of Article 34 para.
p.(None): d) at the same time as the provisions of Article 37 (3), the date and reasons for the decision granting the permit;
p.(None): e) in the case of Section 37 (4), the date and reasons for the decision of the applicant;
p.(None): f) in the case of Section 37 (5), the date and reasons of the investigator's decision
p.(None): transmits it to the European Database.
p.(None): 3 / A. TITLE *
p.(None): AUTHORIZATION OF RESEARCH ON THE USE OF IONIZING RADIATION *
p.(None): 37 / B. § * (1) The provisions of this Title shall apply to human medical research, clinical trials on
p.(None): and clinical devices intended for clinical use in human beings
p.(None): applicable if the research is carried out using ionizing radiation.
p.(None): (2) For the purposes of this Title, carers and facilitators are persons who knowingly and intentionally expose themselves to ionizing radiation,
p.(None): in the care and support of persons who have been or have been exposed to medical exposure
p.(None): in addition to their job responsibilities.
p.(None): (3) For other terms, the Directive on protection against ionizing radiation and the related authorization, reporting and control system
p.(None): 487/2015. (XII. 30.) of the Government of the Republic of Hungary shall be taken into consideration.
p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
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p.(None): (a) multi-center research: research based on the same research plan but carried out at more than one research site;
p.(None): (b) participant: a person who participates in the research as a subject, including a member of the control group;
p.(None): (c) "research supervisor" means a person who conducts research professionally;
p.(None): d) * Principal: any natural or legal person who initiates, directs or finances a research, provided that:
p.(None): the principal investigator and the principal may be the same person;
p.(None): (e) * Ethics Committee: the Scientific and Research Ethics Committee of the Scientific Council for Health (hereinafter referred to as "ETC TUKEB");
p.(None): Human Reproduction Committee of the Scientific Council for Health (hereinafter referred to as "ETT HRB");
p.(None): f) Regional Ethics Committee: (159) of the Health Act, defined in a separate legislation
p.(None): Institutional Research Ethics Committee (RKEB);
p.(None): g) * IKEB: Institutional Ethics Committee, that is, an independent committee to be set up in every healthcare institution where
p.(None): and shall be responsible for verifying that the licensed and ethical
p.(None): ensure that the personal and material conditions are met and that the research plan
p.(None): standards, ethical requirements, with particular regard to the protection of those involved in research.
p.(None): Enable research
p.(None): Article 3 (1) * Research shall be carried out by the National Chief Medical Officer (hereinafter referred to as "licensor" for the purposes of this Chapter) in human medicine.
p.(None): as defined in the Ministerial Decree on Research - specialized authorities involved in administrative procedures
p.(None): according to the division of tasks according to the law defining the appointment of the person - the opinion of the ethics committee or
p.(None): is authorized and registered by the Regional Ethics Committee.
p.(None): (2) *
p.(None): 3. An application for a research permit shall be made by the researcher, the principal investigator or the principal (hereinafter referred to as 'the applicant' for the purposes of this Title).
p.(None): submit.
p.(None): (4) * A single permit shall be issued for research carried out in several centers.
p.(None): 3 / A. § * (1) An application for a research permit shall include:
p.(None): (a) the title of the research,
p.(None): b) the name, registered office, representative of the principal in Hungary and its address,
p.(None): (c) the name and address of the healthcare provider (s) participating in the research,
p.(None): (d) the name and function of the principal investigator and the research personnel,
p.(None): (e) the purpose of the research,
p.(None): (f) the date and expected duration of the research,
p.(None): (g) an indication of the intended research in one or more centers, the proposed research in the case of multi-center research;
p.(None): a list of locations.
p.(None): 2. The application shall be presented
p.(None): (a) the research plan,
p.(None): (b) the curriculum vitae of the principal investigator,
p.(None): (c) subject to the provisions of the Ministerial Decree on human medical research;
...

p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
p.(None): c) a set of criteria for the recruitment, selection and exclusion of participants,
p.(None): (d) number of participants (total and per research site), gender, age, to be included in the research;
p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
p.(None): Section 5 *
p.(None): Section 6 In the case of research where licensing is not carried out by the ETT TUKEB or the ETT HRB,
p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
...

p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
p.(None): (f) the number, sex, age of participants planned to be included in the research, in the case of multi-center research, and per research site
p.(None): separately.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant,
p.(None): (b) the acting Ethics Committee or Regional Ethics Committee,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The applicant shall notify the decision to the competent IKEB, the head of the research establishment and, if the applicant is not the same,
p.(None): research leader - the research leader.
p.(None): remedy
p.(None): Section 10 *
p.(None): Modification of the authorization
p.(None): Article 11 (1) * After the exploration permit becomes final, the applicant may modify the exploration plan. Modification of the Research Plan -
p.(None): with the exception of paragraphs 2 to 5, the applicant shall notify the authorizing officer.
p.(None): 2. In the event of a major modification to the research plan pursuant to paragraph 3, the applicant shall request the amendment of the authorization.
p.(None): engedélyezőnél. The application shall state the reasons on which the changes are based and shall state the exact content of the amendments. If the change could affect the participants
p.(None): In the interest of safety, the draft modified version of the package leaflet and consent should be attached to the application.
p.(None): (3) A substantial modification of a research plan shall be deemed to be particularly if:
p.(None): a) the modification may affect the safety of the research participants,
p.(None): (b) the amendment may alter the interpretation of the scientific documents in support of the research,
p.(None): c) * the amendment concerns the prospectus for researchers,
p.(None): (d) the results of the research to date require a revision of the written prospectus,
p.(None): (e) * a new research site will be involved, or
p.(None): f) * the person in charge of the research changes.
p.(None): (3a) * If a substantial change in the research plan also affects those listed in Section 7, the Ethics Committee shall also apply to the modified protocol.
p.(None): issue a separate position statement from the authority.
p.(None): 4. If the authorizing agent permits the modification, the applicant shall continue the research in accordance with the modified research plan. The licensor is a
p.(None): may make the acceptance of the amendment subject to a condition relating to the research and the aspects referred to in Article 4. In this case, the applicant
p.(None): either continue the research under conditions specified by the licensor, or subject to conditions specified by the licensor
...

p.(None): clinical practice involving a partially restricted person with respect to a group of property matters
p.(None): in the case of investigation, 159 (4) and (5) and this decree are fully implemented.
p.(None): (3) *
p.(None): 4. Subject to authorized research, subjects and persons entitled to make a statement, the researchers,
p.(None): ethics committee or, if you participated in the authorization of the research, the regional research ethics committee, the research service provider
p.(None): and the IKEB may make a mark to the licensor if they consider that the research is required by the license or the research plan
p.(None): they carry on differently.
p.(None): Suspension and termination of research
p.(None): Section 13 * (1) If, during the inspection of the research, the licensor becomes aware of a circumstance that
p.(None): (a) the conditions for authorizing the research are no longer met,
p.(None): (b) the safety of the subjects participating in the research is jeopardized by the continuation of the research; or
p.(None): (c) there is doubt as to the scientific validity of the research,
p.(None): it may make the continuation of the research conditional on its decision and suspend the research by setting a deadline for the fulfillment of the condition.
p.(None): (2) If the applicant fails to comply with the decision within the time limit laid down in paragraph 1, if the research is suspended,
p.(None): and does not request an extension of the time limit, the authorizing officer shall terminate the search.
p.(None): 3. The authorizing officer's decision to suspend or terminate a research activity pursuant to paragraphs 1 and 2 and the reasons for it shall be imminent.
p.(None): notify the Ethics Committee acting as the authority or the Regional Ethics Committee referred to in Article 6 and, if terminated,
p.(None): unregistered.
p.(None): 4. If the applicant complies with the suspension decision, the authorizing officer shall decide whether to suspend the research.
p.(None): abolition. The decision to lift the suspension shall be obtained by the licensor through the competent ethics committee.
p.(None): and the expert opinion of the Regional Ethics Committee under § 6.
p.(None): Article 14 (1) * If the applicant wishes to suspend or terminate the research before its completion, stating the reasons therefor
p.(None): notifies the licensor, the Ethics Committee at the same time as the suspension or termination, and
p.(None): all relevant Hungarian research sites. On the basis of the applicant 's announcement that the research is suspended or terminated, the licensor shall:
p.(None): research with the status of suspended or terminated in the register.
p.(None): (2) The researcher shall immediately suspend the research and notify the principal investigator if he finds that the continuation of the research is
p.(None): the life or health of the participating subjects. The principal investigator shall inform the applicant and the authorizing officer accordingly,
p.(None): that, if necessary, the licensor shall proceed in accordance with Section 13 (1) - (2).
p.(None): Rules for the authorization of non-interventional investigations
p.(None): § 15 * In the case of an investigation not authorized under Article 16, the provisions of Articles 16 to 21 shall apply. § and human medicine
p.(None): shall be conducted in accordance with the provisions of the separate legislation on research.
p.(None): Section 16 * Non-interventional trial: a study not qualifying as a clinical trial under Titles 2 and 3, which
p.(None): (a) shall not be considered as medical research within the meaning of points (b) to (c) and the procedure for which it is carried out shall not
p.(None): normal health care,
p.(None): (b) Examination by a medical device bearing the CE marking, the purpose of which is to
p.(None): collection and processing of data generated by the application for its intended purpose,
p.(None): c) in the case of medicinal products, Gytv. Investigation according to § 1 point 8.
p.(None): Section 17 * (1) Conduct non-interventional investigations
p.(None): a) * in the case of investigations and research referred to in Article 16 (a)
p.(None): aa) * In the case of a study that does not involve embryo and / or germ / stem cell research, the ETT HRB Code of Ethics
p.(None): based on the opinion of the authority, the permission of the National Chief Medical Officer,
p.(None): (ab) in all other cases, the ETSC TUKEB professional ethics license
p.(None): possess it;
p.(None): (b) * in the case of an investigation as referred to in Article 16 (c)
p.(None): ba) * if the test is not the test referred to in point bb), the National Institute of Pharmacy and Food (the
p.(None): hereinafter referred to as "OGYÉI"),
p.(None): bb) * where compliance with an official decision to conduct a non-post-authorization safety study
p.(None): Gytv. Pharmacovigilance Risk Assessment Committee referred to in Article 1 (31) (a
p.(None): hereinafter referred to as "PRAC") and the ETT TUKEB ethical approval,
p.(None): be notified to OGYÉI before commencement;
p.(None): c) * in the case of investigations referred to in Section 16 (b), may be authorized by OGYÉI.
p.(None): (2) In the case of a study involving no intervention in minors, the ETT TUKEB shall, subject to the opinion of a pediatrician
p.(None): decision.
p.(None): (3) Unless the appeal is excluded by law, in the case of the licensing procedure of the ETC TUKEB, the proceedings of the second instance shall be continued by the ETC Bureau.
p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any document used in the conduct of the investigation.
p.(None): 17 / A. § * (1) The application for authorization shall be substantiated by the administrative service fee and shall be presented in the application.
...

p.(None): in the case of a pharmacovigilance investigation, the Gytv. Pharmacovigilance Risk Assessment Committee referred to in Section 1 point 31 (hereinafter PRAC)
p.(None): must be submitted to.
p.(None): 6. In the case of a non-post-authorization safety study, the study plan shall be subject to the procedure set out in European Directive 726/2004 / EC.
p.(None): pharmacovigilance activities required by Regulation (EC) No 45/2001 of the European Parliament and of the Council and Directive 2001/83 / EC of the European Parliament and of the Council
p.(None): shall comply with Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of this Regulation.
p.(None): 7. Where the sponsor submits the final results of the non-post-authorization safety study
p.(None): requesting a deferral, the information listed in paragraph 1 shall be accompanied by a statement of the reasons therefor.
p.(None): 8. For the purposes of this Regulation, the PRAC shall not be considered as a licensing authority.
p.(None): 17 / B. § * (1) In the case of non-interventional medical devices, the application shall be submitted in duplicate
p.(None): with the data content specified in the Annex to the Ministerial Decree on Human Medical Research.
p.(None): (2) In the case of non-interventional medical devices, studies on human medical
p.(None): 23/2002. (V. 9.) EüM Decree 20 / F-20 / S. Shall apply with the exceptions set forth in paragraphs 3 to 6.
p.(None): (3) The procedure laid down in this section shall be governed by Decree 23/2002. (V. 9.) EüM Decree 20 / G. And 20 / O. §
p.(None): shall not apply.
p.(None): 4. Within 30 days of completion of an investigation, the sponsor shall notify the authorizing officer of the end of the investigation and shall, at the same time,
p.(None): send a copy of the test documentation to the licensor. The licensor shall record the completion of the study in his records.
p.(None): 5. The test documentation shall include:
p.(None): (a) a summary of the studies: the title of the study, the particulars of the medical device used, the identity of the sponsor,
p.(None): evidence of the study, the baseline, procedure description, study start and end dates, results, conclusions,
p.(None): maker signature, date,
p.(None): (b) a description of the medical device tested, the materials used, the procedures used, any changes made during the test and the reasons for such changes,
p.(None): (c) a summary of the clinical investigation plan explaining any changes to the study,
p.(None): (d) the results of the study, an assessment of the end points specified in the protocol,
p.(None): (e) recording of adverse events,
p.(None): (f) a list of the standards taken into account in the examination,
p.(None): that the test documentation may serve as a basis for official controls.
p.(None): (6) The licensor shall submit a copy of the test documentation to the ETSC TUKEB for scientific, medical and ethical evaluation. The ETT
p.(None): TUKEB will notify the licensor of the result of the evaluation. The results of the assessment shall be recorded by the licensor in his records.
p.(None): Article 18 * (1) * In the case of investigations and research referred to in Article 16 (a), the sponsor shall submit the application for authorization to human
p.(None): in accordance with the provisions of the Ministerial Decree on Medical Research, in the case referred to in Article 17 (1) (a) (aa)
p.(None): to the National Chief Medical Officer, in the case of Section 17 (1) (a) (b), to the ETT TUKEB.
p.(None): (1a) * In the case of examinations and research referred to in Article 17 (1) (a) (aa),
p.(None): the National Chief Medical Officer shall assess whether the examination for which the application is being made is in fact a non-intervention investigation.
p.(None): (1b) * When considering an application under paragraph 1a, the National Chief Medical Officer shall request the opinion of the ETT HRB
p.(None): on the following issues:
p.(None): (a) whether the proposed study includes substantive, professional scientific questions and the methods used to answer them,
p.(None): (b) that the intended wording of the package leaflet and the statement of consent and the planned recruitment are in line with the
p.(None): of the Minister for Research.
p.(None): (2) * In the case of investigations and research referred to in Article 17 (1) (a) (b), the decision
p.(None): TUKEB appreciates that
p.(None): (a) whether the examination which is the subject of the application is in fact an intervention which does not interfere,
p.(None): (b) the planned research involves substantive, professional scientific questions and methods are appropriate to answer them,
p.(None): (c) that the intended wording of the package leaflet and the statement of consent, as well as the planned recruitment, are in line with human medical
p.(None): of the Minister for Research.
p.(None): (2a) * In the case of the tests referred to in Article 16 (b), the sponsor shall apply for authorization for human medical
p.(None): in accordance with the provisions of the Ministerial Decree on Research.
p.(None): (2b) * When assessing an application under paragraph 2a, OGYÉI shall assess whether:
p.(None): (a) whether the examination which is the subject of the application is in fact an intervention which does not interfere,
p.(None): (b) the conduct of the examination does not encourage the use of a medical device,
p.(None): (c) whether the device intended for testing is a legally placed medical device,
p.(None): (d) the medical purpose referred to in the study and the intended use described in the instructions for use are the same as in the research plan
...

p.(None): report to OGYÉI;
p.(None): c) *
p.(None): (1a) * A minor change to the protocol shall be notified by the applicant to the licensor.
p.(None): 2. A substantial modification of the protocol shall in particular be considered as:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation supporting the non-interventional study,
p.(None): c) the amendment concerns the prospectus for investigators,
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (3) * In the course of the procedure of the OGYÉI for the approval of the modification, the EWC TUKEB shall request the opinion of the competent authority in Section 18 (6) a) -c)
p.(None): above.
p.(None): 4. The following documents shall be sent in connection with the notification pursuant to paragraph 1 (b) (bb):
p.(None): (a) the PRAC approval document,
p.(None): (b) an amended protocol approved by the PRAC, indicating any parts modified,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any altered document used in the conduct of the investigation.
p.(None): (5) * In the case referred to in paragraph (1) (c), OGYÉI shall request the opinion of the ETT TUKEB in accordance with Article 18 (2c).
p.(None): to investigate.
p.(None): Section 20 * In the case of investigations and research referred to in Section 17 (1) (a) (aa), the National Chief Medical Officer, Section 17 (1) (a)
p.(None): (b) and (c) of the ETT TUKEB;
p.(None): during the investigation, continuously checks that the non-interventional investigation is conducted in accordance with professional rules,
p.(None): and in accordance with the terms of the permit and the protocol.
p.(None): Section 21 * (1) * If it is found during the inspection that the continuation of the non-interventional investigation does not comply with the permit,
p.(None): the conditions laid down in the study plan and the ministerial decree on human medical research, Section 17 (1)
p.(None): in the case of the examinations and research referred to in point (a) (aa), the national officer in charge, referred to in Article 17 (1) (a) (b)
p.(None): in the case of investigations and research, ETT TUKEB, in the case of investigations referred to in Article 16 (b) and (c), OGYÉI
p.(None): the investigation shall be immediately suspended or terminated.
p.(None): (2) * Following the suspension, the National Chief Medical Officer, ETT TUKEB, or OGYÉI shall, prior to the termination decision,
p.(None): request the views of the applicant, the investigator-in-charge and those involved in the non-interventional investigation by setting a time limit; and
p.(None): calls on the parties concerned to remedy the shortcomings and suggests ways of overcoming them. inasmuch
p.(None): no opinion is received within the time limit or the deficiency is not remedied within the time limit set in accordance with this paragraph,
p.(None): the Chief Medical Officer, ETT TUKEB, or OGYÉI terminates the non-intervention investigation by decision.
p.(None): (3) * If the applicant wishes to suspend or terminate the non-intervening investigation before its completion,
p.(None): shall notify the authorizing officer at the latest at the same time as the suspension or termination. The applicant does not intervene
p.(None): Based on its decision terminating the investigation, the licensor shall delete the non-interventional investigation from the record.
p.(None): TITLE 2
p.(None): AUTHORIZATION OF CLINICAL TRIAL INGREDIENTS
p.(None): Section 22 (1) The provisions of this title are contained in Gytv. Applicable in the case of a clinical trial according to § 1 point 7.
p.(None): 2. For the purposes of this Title:
p.(None): a) * sponsor: any natural or legal person who initiates, directs or finances a clinical trial
p.(None): that the investigator and the principal may be the same person;
p.(None): (b) subject: a subject who is using the IMP or who is in the clinical trial.
p.(None): participates as a control person;
p.(None): (c) Ethics Committee: the Clinical Pharmacology Ethics Committee of the Scientific Council on Health;
p.(None): (d) non-commercial clinical trial: a non-commercial clinical trial conducted by researchers independent of the pharmaceutical industry
p.(None): are conducted without the participation of the pharmaceutical industry, without being classified as a pharmaceutical industry if the marketing authorization holder
p.(None): provide the investigator with a marketing authorization as a medicinal product free of charge, but the
p.(None): does not otherwise participate in or otherwise support the investigation.
p.(None): Authorization of a clinical trial
p.(None): Article 23 (1) * The clinical trial shall be evaluated by the OGYÉI (hereinafter referred to as the licensor) for the evaluation of the submitted documents and the
p.(None): subject to the authority's opinion.
...

p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
p.(None): to the licensor - at least the justification of the study, the number of subjects to be involved, the planned time of the study and the recruitment methods
p.(None): a simplified study plan shall be submitted.
p.(None): Article 26 (1) The decision of the authorizing officer shall include, in accordance with the nature of the investigation in question:
p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant or the sponsor,
p.(None): (b) the competent administrative authorities,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): (3) * The licensor shall send the decision of the professional-ethical authority together with the decision to the principal.
p.(None): 26 / A. § * Phase I clinical trials may only be performed at a clinical pharmacology site approved by OGYÉI. The certification
p.(None): the procedure shall be carried out at the request of the service provider's manager. The certification process shall be repeated every three years.
p.(None): 26 / B. § * The sponsor shall notify the decision of OGYÉI regarding the authorization of the clinical trial health care provider
p.(None): send the decision of the OGYÉI and the study plan in Hungarian before commencing the investigation and
p.(None): refer to the relevant IKEB. If the healthcare provider is not a healthcare institution, the IKEB of that institution is competent,
p.(None): which is the headquarters of the investigating provider in the emergency medical care area of the healthcare institution.
p.(None): Modification of the authorization
p.(None): Article 27 (1) * After the study permit becomes final, the applicant may modify the study plan. In the test plan
p.(None): with the exception of paragraphs 2 to 6, shall be notified by the applicant to the authorization holder.
p.(None): (2) * In the case of a substantial modification of the protocol, the applicant shall apply to the licensor for a modification of the authorization. THE
p.(None): the application must state the reasons on which it is based and the exact content of the changes.
p.(None): (3) A substantial modification of the protocol (hereinafter referred to as a "substantial modification") is considered to be in particular if:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation in support of the study;
p.(None): (c) the amendment concerns the prospectus for investigators; or
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (4) *
p.(None): 5. If the variation is approved by the licensor, the sponsor shall proceed with the clinical investigation in accordance with the modified protocol. The
p.(None): the licensor may make the acceptance of the modification subject to a professional condition related to the investigation or the aspects referred to in Section 23 (3).
p.(None): In this case, the investigator shall continue the investigation in accordance with the conditions specified by the sponsor or the licensor, or if so
p.(None): does not intend to comply with the conditions specified by the licensor, it shall continue the study in accordance with the original protocol and
p.(None): notifies the licensor. If the application is rejected, the sponsor shall continue the investigation in accordance with the original protocol. More modifications
p.(None): in the case of a change, the authorizing officer shall provide separately for the amendments contained in the application.
p.(None): 6. In matters not covered by paragraphs 2 to 5, Articles 23 to 26 shall apply to the application for amendment. Of the Act
p.(None): apply mutatis mutandis.
p.(None): 27 / A. § * When new, relevant information about a clinical trial becomes known that affects the written information,
p.(None): an amendment to the permit shall be requested. Subject to the amended written information, the subject shall be re - informed and
p.(None): consent to the continuation of the clinical trial.
p.(None): Inspection of the test
p.(None): Section 28 (1) The licensor may carry out controls before, during and after clinical trials.
p.(None): follow-up to applications for import authorizations. The authorizing officer shall keep records of the checks.
p.(None): 2. During the authorized clinical trial, the licensor shall verify:
p.(None): (a) compliance with the provisions concerning the manufacture, labeling and dispatch of the investigational medicinal product to a health establishment,
p.(None): in particular, certificates of compliance with good manufacturing practice for medicinal products,
p.(None): (b) appropriate documentation of the data in the clinical trial,
p.(None): (c) adherence to GCP principles; and
p.(None): (d) the continuation of the clinical trial as provided for in the authorization and the protocol.
p.(None): 3. After verification, the authorizing officer shall draw up an inspection report and make it available to the sponsor. Upon request, the
p.(None): the authorizing officer shall make the report available to the Ethics Committee, to the States party to the EEA Agreement and to the EMEA.
p.(None): 4. If the inspection reveals that the conduct of the clinical trial does not comply with the authorization or this Title,
p.(None): or the clinical trial poses a serious risk to the life or health of the subjects,
p.(None): it shall immediately send the minutes to the sponsor and to the Ethics Committee and proceed as provided in Article 29 (1) - (2).
p.(None): 5. If the deficiencies found during the inspection are of minor importance, the safety of the subjects shall not be endangered.
p.(None): calls on those concerned to remedy these shortcomings and suggests ways of overcoming them;
p.(None): notify the sponsor and the study director.
p.(None): Suspension and termination of the clinical trial
p.(None): Article 29 (1) If it is found during the inspection that
p.(None): (a) the continuation of the study does not comply with the authorization, the protocol, or this Title, and the clinical investigation of the IMP
p.(None): the conditions laid down in separate legislation,
p.(None): (b) the study endangers the life, health or safety of the subjects; or
p.(None): (c) the scientific validity of the study is in doubt,
p.(None): the licensor shall immediately suspend the study and send the report to the sponsor and to the Ethics Committee.
p.(None): 2. Except in the case of imminent danger to the subjects, following the suspension, before the termination decision is taken:
p.(None): the licensor shall seek the opinion of the sponsor, the investigators and those involved in the investigation within a seven-day time limit, and shall
p.(None): stakeholders to address the deficiencies and propose ways to address them. If
p.(None): the sponsor, the investigators or those involved in the investigation do not express their opinion or the deficiency within the time limit by the licensor
p.(None): within a specified time period, the licensor shall terminate the investigation by a decision and send its decision to the sponsor
p.(None): and the authority.
p.(None): 3. The decision of the licensor to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor
p.(None): Notify the Ethics Committee, the competent authorities of the EEA States involved in the investigation and the EMEA, and
p.(None): will delete the investigation from its records.
p.(None): 4. If the sponsor wishes to suspend the clinical trial, he shall, at the latest by means of the data sheet available on the website of the EMEA:
p.(None): at the same time as the suspension, notify the licensor and all relevant Hungarian testing sites. The licensor is based on this
p.(None): the suspension shall be notified to the Ethics Committee.
p.(None): 5. The sponsor shall notify the authorizing officer of the termination of the study by means of a datasheet downloadable from the EMEA website. Enabling the test
p.(None): notice of termination shall be sent to the Ethics Committee.
p.(None): (6) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
p.(None): endangering or endangering the life or health of the subjects. The study director shall notify the sponsor and the licensor accordingly,
p.(None): where necessary, the authorizing officer shall act in accordance with paragraphs 1 to 2.
p.(None): TITLE 3
p.(None): AUTHORIZATION OF CLINICAL TRIALS IN MEDICAL DEVICES *
p.(None): Article 30 (1) * Except as provided in paragraphs (2) - (3), the provisions of this Title shall be applied to human
p.(None): shall apply to clinical trials conducted with medical devices intended for clinical investigation.
p.(None): (2) * The provisions of this Title shall not apply to the tests referred to in Article 16 (b).
p.(None): 3. This Title shall not apply to IVDs covered by specific legislation on in vitro diagnostic medical devices.
p.(None): investigations.
p.(None): Section 31 (1) For the purposes of this Title:
p.(None): (a) * sponsor: any natural or legal person who, under his own name, is preparing a clinical trial device for a clinical trial,
p.(None): particularly
p.(None): (aa) assemble, package, process, refurbish, label, and label the device intended for clinical investigation, unless already
p.(None): assembles or adapts devices placed on the market to a specific patient in the course of medical treatment for their intended purpose
p.(None): according to individual needs,
p.(None): (ab) designs, manufactures, packages, labels, on its own responsibility, a device intended for clinical investigation, whether or not such operations are performed by itself;
p.(None): or is commissioned by or on behalf of another;
p.(None): (b) * Authorized representative: the natural or legal person responsible for the preparation of the device intended for clinical investigation by the sponsor.
p.(None): a legal entity which, subject to the agreement of the sponsor with the sponsor during the authorization and conduct of the clinical trial,
p.(None): act on behalf of;
p.(None): (c) subject: a person participating in the clinical trial who is using the clinical trial device or who is in the clinical trial.
p.(None): participates as a control person;
p.(None): d) *
p.(None): (2) * For the purposes of this title, the provisions of the Ministerial Decree on Medical Devices
p.(None): and the Ministerial Decree on the Clinical Trial of Medical Devices
p.(None): to take into account.
p.(None): Authorization of a clinical trial
p.(None): Article 32 (1) * The investigation shall be authorized and registered by OGYÉI (hereinafter referred to as "licensor").
p.(None): (2) * OGYÉI examines whether a substance intended to be used in a clinical trial is an integral part of a device which, when used alone, is licensed under Gytv.
p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
p.(None): (g) the registration number of the test.
p.(None): 2. The authorizing officer shall send his decision:
p.(None): (a) the applicant,
p.(None): (b) the competent authority acting,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The decision of the authorizing officer shall be a condition for the opening of the investigation.
p.(None): 4. Where the licensor has notified the applicant of an Annex III, as notified by the applicant, Class IIa and IIa or IIb implantable, durable
p.(None): does not make a decision regarding the clinical investigation of invasive devices for use within the time limit specified in the Health Care Act,
p.(None): on expiry of that period, the manufacturer may commence an investigation. The applicant shall notify the authorizing officer of the investigation so initiated
p.(None): the licensor shall register the investigation in accordance with Article 32 (1).
p.(None): Modification of the authorization
p.(None): Section 35 (1) * After the study permit becomes final, the applicant may modify the study plan. The study design and the study
p.(None): with the exception of paragraphs 2 to 6, the applicant shall without delay notify the authorizing authority of any change in the particulars contained in the authorization.
p.(None): 2. In the case of a modification of the protocol pursuant to paragraph 3, the applicant shall apply to the licensor for a modification of the authorization. THE
p.(None): the application must state the reasons on which it is based and the exact content of the changes. Where the modification may affect the safety of participants,
p.(None): the application shall be accompanied by the draft modified version of the package leaflet and the letter of agreement.
p.(None): A substantial change in the protocol shall be deemed to occur if:
p.(None): (a) the modification relates to the purpose, circumstances or mode of action of the device,
p.(None): (b) the amendment may alter the interpretation of the scientific documentation in support of the study;
p.(None): (c) the amendment concerns the prospectus for investigators; or
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (4) * If a substantial change in the study plan also affects those listed in Article 33 (4),
p.(None): the authority issues a position.
p.(None): 5. If the authorizing officer authorizes the variation, the applicant shall continue the investigation with the modified protocol. The licensor is a
p.(None): may make the acceptance of the amendment subject to the professional condition relating to the investigation and the aspects referred to in Article 32 (3). In this case
p.(None): carry out the investigation in accordance with the conditions laid down by the applicant or the licensor, or where specified by the licensor
p.(None): If it does not intend to comply with these conditions, it shall continue the investigation in accordance with the original protocol and notify the licensor thereof. THE
p.(None): the applicant shall continue the examination in accordance with the original protocol if the application is rejected. In the case of multiple modifications, the licensor shall:
p.(None): provided separately in the application.
p.(None): 6. In matters not covered by paragraphs 2 to 5, Articles 32 to 34 shall apply to the request for amendment. Of the Act
p.(None): apply mutatis mutandis.
p.(None): Inspection of the test
p.(None): Article 36 (1) The licensor may carry out inspections before, during and after the commencement of investigations.
p.(None): license. The authorizing officer shall keep records of the checks.
p.(None): 2. The licensing inspector may be the person who has the creditor's credentials relating to him. The
p.(None): prior to commencement of the inspection, the inspector shall present the credential issued by the licensor.
p.(None): 3. During an authorized examination, the licensor may verify:
p.(None): (a) the intended use of the test device,
p.(None): (b) the documentation of the data as required during the investigation,
p.(None): (c) compliance with the safety requirements for the device; and
p.(None): (d) the continuation of the study as required by the permit and the protocol.
p.(None): 4. The authorizing officer shall keep a record of the checks carried out in accordance with paragraph 3, with a copy to the applicant. The
p.(None): in the case of an application for authorization, the Protocol shall be made available to the specialized authority and the authorities of the States party to the EEA Agreement
p.(None): provide.
p.(None): 5. Subject to authorized investigations, subjects and persons entitled to make statements, investigators,
p.(None): the head of the investigating service provider may apply a signal to the licensor if they consider that the investigator in the license or
p.(None): Contrary to the protocol.
p.(None): 6. If the deficiencies found during the inspection are of minor importance, the authorizing officer shall call upon the applicant to remedy the deficiencies.
p.(None): eliminate them.
p.(None): Suspension and termination of the clinical trial
p.(None): Section 37 (1) * If it is found that
p.(None): (a) the continuation of the study does not comply with the authorization, the research plan or this Title and the medical devices;
p.(None): the conditions laid down in specific legislation on clinical trials,
p.(None): (b) the life, health or safety of the subjects or staff is endangered by the investigation,
p.(None): (c) the examination is contrary to public policy or public health; or
p.(None): d) the applicant has not complied with the notice under Section 36 (6),
p.(None): the authorizing officer shall immediately suspend the examination and send the inspection report to the applicant and to the competent authority.
p.(None): 2. Following suspension, before the termination decision, except in case of imminent danger to the participants in the research:
p.(None): - the authorizing officer shall request the opinion of the applicant, the investigators and the investigators by setting a time-limit of seven days,
p.(None): and calls on those concerned to close the gap. If the applicant, the investigators, or in the investigation
p.(None): the contributors fail to deliver their opinion within the time limit or to rectify the deficiency within the time limit set by the licensor
p.(None): the authorizing officer shall terminate the investigation by decision and shall communicate its decision to the applicant and to the Authority.
p.(None): 3. The decision of the authorizing officer to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor shall be forthwith made.
p.(None): it shall notify the special authority, the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation and the European Commission. The
p.(None): the licensor shall indicate in the register the fact of suspension or termination.
p.(None): 4. If the applicant wishes to suspend or terminate the investigation before its completion, the reasons shall be stated at the latest in the list of the reasons.
p.(None): at the same time suspend or terminate the notification to the licensor, the administration and all relevant Hungarian testing sites.
p.(None): Upon the applicant's decision to terminate the investigation, the licensor shall delete the investigation from the register. The licensor is the termination
p.(None): It shall immediately inform the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation of its decision and the reasons therefor.
p.(None): (5) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
p.(None): endangering or endangering the life or health of subjects. The study director shall inform the applicant and the authorizing officer accordingly
p.(None): in order that the authorizing officer may, where necessary, act in accordance with paragraphs 1 to 3.
p.(None): European Database *
p.(None): 37 / A. § * The licensor
p.(None): (a) in the case of an application under Article 32 (2), the information specified in Sections 1, 3, 5 and 9 (a) (aa) to (b) of the Annex;
p.(None): data;
p.(None): b) at the same time as the provisions of Article 33 (3), the date and the reasons for the rejection decision;
p.(None): c) at the same time as the provisions of Article 34 para.
p.(None): d) at the same time as the provisions of Article 37 (3), the date and reasons for the decision granting the permit;
p.(None): e) in the case of Section 37 (4), the date and reasons for the decision of the applicant;
p.(None): f) in the case of Section 37 (5), the date and reasons of the investigator's decision
p.(None): transmits it to the European Database.
p.(None): 3 / A. TITLE *
p.(None): AUTHORIZATION OF RESEARCH ON THE USE OF IONIZING RADIATION *
p.(None): 37 / B. § * (1) The provisions of this Title shall apply to human medical research, clinical trials on
p.(None): and clinical devices intended for clinical use in human beings
p.(None): applicable if the research is carried out using ionizing radiation.
p.(None): (2) For the purposes of this Title, carers and facilitators are persons who knowingly and intentionally expose themselves to ionizing radiation,
p.(None): in the care and support of persons who have been or have been exposed to medical exposure
p.(None): in addition to their job responsibilities.
p.(None): (3) For other terms, the Directive on protection against ionizing radiation and the related authorization, reporting and control system
p.(None): 487/2015. (XII. 30.) of the Government of the Republic of Hungary shall be taken into consideration.
p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
p.(None): (c) information of particular importance to the radiation protection of participants and assistants and supporters:
p.(None): (ca) their sex,
p.(None): (cb) their age,
p.(None): (cc) the fact that they are pregnant or have a child,
p.(None): (cd) measures taken to optimize their exposure,
p.(None): (ce) the fact that they have participated in previous radiation exposure research programs,
p.(None): (d) information concerning the researchers and the institution carrying out the research:
p.(None): (da) if research is carried out by a holder of a license for the use of nuclear energy, the use of radioactive material or ionizing radiation;
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p.(None): Control of research
p.(None): Article 12 (1) * During the research period the licensor shall check that the research is carried out in accordance with the rules of
p.(None): plan. The Licensor shall involve the Ethics Committee in any matter related to the scope of their responsibilities.
p.(None): or IKEB to conduct the audit. The Ethics Committee and the IKEB shall be subject to the laws and regulations governing the licensing procedure
p.(None): contributes to the audit.
p.(None): (2) * During the research, the Ethics Committee acting as the authority and the IKEB shall observe that:
p.(None): (a) the research is carried out as required by the permit and the research plan,
p.(None): (b) the information and consent of the participant is in accordance with the terms of the ministerial decision on human medical research;
p.(None): the requirements of the Regulation,
p.(None): (c) the manner in which the subjects in the trial were selected complies with the authorization,
p.(None): (d) the processing of the personal data of the participants is lawful,
p.(None): (e) the rights of minors who are incapacitated or incapacitated for health and who have legal capacity to act,
p.(None): clinical practice involving a partially restricted person with respect to a group of property matters
p.(None): in the case of investigation, 159 (4) and (5) and this decree are fully implemented.
p.(None): (3) *
p.(None): 4. Subject to authorized research, subjects and persons entitled to make a statement, the researchers,
p.(None): ethics committee or, if you participated in the authorization of the research, the regional research ethics committee, the research service provider
p.(None): and the IKEB may make a mark to the licensor if they consider that the research is required by the license or the research plan
p.(None): they carry on differently.
p.(None): Suspension and termination of research
p.(None): Section 13 * (1) If, during the inspection of the research, the licensor becomes aware of a circumstance that
p.(None): (a) the conditions for authorizing the research are no longer met,
p.(None): (b) the safety of the subjects participating in the research is jeopardized by the continuation of the research; or
p.(None): (c) there is doubt as to the scientific validity of the research,
p.(None): it may make the continuation of the research conditional on its decision and suspend the research by setting a deadline for the fulfillment of the condition.
p.(None): (2) If the applicant fails to comply with the decision within the time limit laid down in paragraph 1, if the research is suspended,
p.(None): and does not request an extension of the time limit, the authorizing officer shall terminate the search.
p.(None): 3. The authorizing officer's decision to suspend or terminate a research activity pursuant to paragraphs 1 and 2 and the reasons for it shall be imminent.
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p.(None): a copy of the permit for the operation of equipment that generates but does not contain radioactive material and
p.(None): regulations and description of the workplace radiation protection,
p.(None): d (b) evidence of professional qualifications for radiation protection designers, approvers and contractors in the field of research and radiation protection
p.(None): copy of the document,
p.(None): (e) the expected exposure of participants, workers, carers and assistants and the general public during the research;
p.(None): risk analysis describing the estimation of radiation exposure.
p.(None): TITLE 4
p.(None): ON PUBLIC HEALTH AND MEDICAL SERVICE AND PHARMACEUTICAL
p.(None): ON THE DESIGNATION OF A PUBLIC ADMINISTRATION (XII. 28.) KORM. REGULATION AND IT
p.(None): 295/2004 ON THE HEALTH AUTHORIZATION AND ADMINISTRATION OFFICE (X. 28.) KORM.
p.(None): AMENDMENT OF THE REGULATION
p.(None): 38-39. § *
p.(None): Article 40 (1) This Decree on medicinal products for pediatric use, as well as Decree 1768/92, 2001/2001
p.(None): Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Directive 2001/83 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.(None): and on advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004,
p.(None): It shall apply subject to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.
p.(None): 2. This Regulation is intended to ensure compliance with the following acts of the Union:
p.(None): (a) Council Directive 90/385 / EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
p.(None): directive,
p.(None): (b) Directive 93/42 / EEC of the European Parliament and of the Council of 14 June 1993 concerning medical devices,
p.(None): (c) Council Directive 90/385 / EEC on the approximation of the laws of the Member States relating to active implantable medical devices,
p.(None): Council Directive 93/42 / EEC concerning medical devices and Directive 98/8 / EC concerning the placing of biocidal products on the market
p.(None): Directive 2007/47 / EC of the European Parliament and of the Council of 5 September 2007 amending
p.(None): (d) * Directive 2001/83 / EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
p.(None): amending Directive 2010/84 / EU of the European Parliament and of the Council of 15 December 2010 on pharmacovigilance,
p.(None): (e) * Basic safety requirements for protection against the dangers arising from exposure to ionizing radiation
p.(None): establishing and repealing Directives 89/618 / Euratom, 90/641 / Euratom, 96/29 / Euratom, 97/43 / Euratom and 2003/122 / Euratom
p.(None): repealing Council Directive 2013/59 / EURATOM of 5 December 2013
p.(None): (3) * This Regulation is Commission Decision 2010/227 / EU of 19 April 2010 on the European Database of Medical Devices (EUDAMED).
p.(None): establish the measures necessary for its implementation.
p.(None): Article 41 (1) Except as provided in subsection (2), this Decree shall enter into force on the day following its promulgation,
p.(None): in the case of applications which have been submitted previously but not decided, the provisions of this Regulation shall apply.
p.(None): (2) Section 40 (2) shall enter into force on 21 March 2010.
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p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
p.(None): (f) the number, sex, age of participants planned to be included in the research, in the case of multi-center research, and per research site
p.(None): separately.
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p.(None): (c) the study is not a clinical trial,
p.(None): d) *
p.(None): (5) * In the case of the investigation referred to in Section 17 (1) (b) (ba), at the request of OGYÉI, the ETT TUKEB shall investigate
p.(None): (6) (a) to (c).
p.(None): (6) In the case of the investigation referred to in Article 17 (1) (b) (bb), the EWC shall assess whether:
p.(None): (a) that the intended wording of the package leaflet, consent and recruitment is consistent with the human medical
p.(None): Ministerial Decree on Research,
p.(None): (b) that the investigation does not endanger the life or physical integrity of the person being examined,
p.(None): c) the investigation does not violate the rights of the person under investigation,
p.(None): (d) whether the study is scientifically substantiated.
p.(None): Article 19 (1) * After the non-interventional study permit has become final, the sponsor may modify the study plan. THE
p.(None): in the case of a substantial modification of the protocol, the sponsor, stating the reasons and the exact content of the modification,
p.(None): a) * in the case of investigations and research referred to in Section 16 a), apply to the licensor for a modification of the permit;
p.(None): b) a
p.(None): ba) * In the case of an investigation as referred to in Article 16 (b) and Article 17 (1) (b) (ba), you must apply for an amendment of the authorization
p.(None): at OGYÉI,
p.(None): bb) * In the case of the investigation referred to in Section 17 (1) (b) (bb), the PRAC must approve the change and the ETT TUKEB ethical approval
p.(None): you should ask. If approved by the PRAC and approved by ETT TUKEB, it must be submitted at the latest by the time the change is implemented.
p.(None): report to OGYÉI;
p.(None): c) *
p.(None): (1a) * A minor change to the protocol shall be notified by the applicant to the licensor.
p.(None): 2. A substantial modification of the protocol shall in particular be considered as:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation supporting the non-interventional study,
p.(None): c) the amendment concerns the prospectus for investigators,
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (3) * In the course of the procedure of the OGYÉI for the approval of the modification, the EWC TUKEB shall request the opinion of the competent authority in Section 18 (6) a) -c)
p.(None): above.
p.(None): 4. The following documents shall be sent in connection with the notification pursuant to paragraph 1 (b) (bb):
p.(None): (a) the PRAC approval document,
p.(None): (b) an amended protocol approved by the PRAC, indicating any parts modified,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any altered document used in the conduct of the investigation.
p.(None): (5) * In the case referred to in paragraph (1) (c), OGYÉI shall request the opinion of the ETT TUKEB in accordance with Article 18 (2c).
p.(None): to investigate.
p.(None): Section 20 * In the case of investigations and research referred to in Section 17 (1) (a) (aa), the National Chief Medical Officer, Section 17 (1) (a)
p.(None): (b) and (c) of the ETT TUKEB;
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p.(None): (c) the technical feasibility of the proposed study and the suitability of the test methods were included in the objectives of the protocol.
p.(None): answer,
p.(None): (d) the adequacy of the test plan to professional requirements,
p.(None): (e) the expected risks and the expected therapeutic benefit,
p.(None): (f) the suitability of the investigational medicinal product for human use in terms of drug quality;
p.(None): (g) the adequacy of third party liability insurance.
p.(None): (4) * The proposed text of the recruitment notice and the method of recruitment shall be provided by the official approval of the clinical trial and
p.(None): request for ethical review. The published recruitment notice shall include a reference to the existence of an official authorization. The recruitment
p.(None): in the event of a deviation from its authorized method and text, an amendment to the authorization shall be initiated.
p.(None): Section 24 (1) *
p.(None): (2) The Ethics Committee shall formulate the position of the Authority in the composition specified in separate legislation on the following matters:
p.(None): (a) providing opinions on bioequivalence studies,
p.(None): b) IV. review of phase I clinical trials,
p.(None): (c) technical issues related to substantial modification of the protocol;
p.(None): (d) in the case of extraordinary reasons justifying the extraordinary procedure indicated by the licensor, as decided by the chairman of the Ethics Committee;
p.(None): procedures.
p.(None): (3) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial planned to involve a partially restricted person, the Ethics Committee shall be competent
p.(None): In developing its position, it examines whether the Whether Article 159 (4) and (5) are fully implemented,
p.(None): that its capacity to act in the exercise of rights relating to health care is partially or totally restricted
p.(None): minors, and Section 2: 9 of Act V of 2013 on the Civil Code. Of the Act, the question in question is that of incapacitated minors
p.(None): and in the clinical trial in minors with specialist examination of the disease and the patient population concerned,
p.(None): and a specialist in pediatrics and, if necessary, a teacher or psychiatrist.
p.(None): (4) * Ethics Committee declares in professional statement on professional and ethical adequacy of clinical trial
p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
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p.(None): follow-up to applications for import authorizations. The authorizing officer shall keep records of the checks.
p.(None): 2. During the authorized clinical trial, the licensor shall verify:
p.(None): (a) compliance with the provisions concerning the manufacture, labeling and dispatch of the investigational medicinal product to a health establishment,
p.(None): in particular, certificates of compliance with good manufacturing practice for medicinal products,
p.(None): (b) appropriate documentation of the data in the clinical trial,
p.(None): (c) adherence to GCP principles; and
p.(None): (d) the continuation of the clinical trial as provided for in the authorization and the protocol.
p.(None): 3. After verification, the authorizing officer shall draw up an inspection report and make it available to the sponsor. Upon request, the
p.(None): the authorizing officer shall make the report available to the Ethics Committee, to the States party to the EEA Agreement and to the EMEA.
p.(None): 4. If the inspection reveals that the conduct of the clinical trial does not comply with the authorization or this Title,
p.(None): or the clinical trial poses a serious risk to the life or health of the subjects,
p.(None): it shall immediately send the minutes to the sponsor and to the Ethics Committee and proceed as provided in Article 29 (1) - (2).
p.(None): 5. If the deficiencies found during the inspection are of minor importance, the safety of the subjects shall not be endangered.
p.(None): calls on those concerned to remedy these shortcomings and suggests ways of overcoming them;
p.(None): notify the sponsor and the study director.
p.(None): Suspension and termination of the clinical trial
p.(None): Article 29 (1) If it is found during the inspection that
p.(None): (a) the continuation of the study does not comply with the authorization, the protocol, or this Title, and the clinical investigation of the IMP
p.(None): the conditions laid down in separate legislation,
p.(None): (b) the study endangers the life, health or safety of the subjects; or
p.(None): (c) the scientific validity of the study is in doubt,
p.(None): the licensor shall immediately suspend the study and send the report to the sponsor and to the Ethics Committee.
p.(None): 2. Except in the case of imminent danger to the subjects, following the suspension, before the termination decision is taken:
p.(None): the licensor shall seek the opinion of the sponsor, the investigators and those involved in the investigation within a seven-day time limit, and shall
p.(None): stakeholders to address the deficiencies and propose ways to address them. If
p.(None): the sponsor, the investigators or those involved in the investigation do not express their opinion or the deficiency within the time limit by the licensor
p.(None): within a specified time period, the licensor shall terminate the investigation by a decision and send its decision to the sponsor
p.(None): and the authority.
p.(None): 3. The decision of the licensor to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor
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p.(None): (2) * OGYÉI examines whether a substance intended to be used in a clinical trial is an integral part of a device which, when used alone, is licensed under Gytv.
p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
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p.(None): apply mutatis mutandis.
p.(None): Inspection of the test
p.(None): Article 36 (1) The licensor may carry out inspections before, during and after the commencement of investigations.
p.(None): license. The authorizing officer shall keep records of the checks.
p.(None): 2. The licensing inspector may be the person who has the creditor's credentials relating to him. The
p.(None): prior to commencement of the inspection, the inspector shall present the credential issued by the licensor.
p.(None): 3. During an authorized examination, the licensor may verify:
p.(None): (a) the intended use of the test device,
p.(None): (b) the documentation of the data as required during the investigation,
p.(None): (c) compliance with the safety requirements for the device; and
p.(None): (d) the continuation of the study as required by the permit and the protocol.
p.(None): 4. The authorizing officer shall keep a record of the checks carried out in accordance with paragraph 3, with a copy to the applicant. The
p.(None): in the case of an application for authorization, the Protocol shall be made available to the specialized authority and the authorities of the States party to the EEA Agreement
p.(None): provide.
p.(None): 5. Subject to authorized investigations, subjects and persons entitled to make statements, investigators,
p.(None): the head of the investigating service provider may apply a signal to the licensor if they consider that the investigator in the license or
p.(None): Contrary to the protocol.
p.(None): 6. If the deficiencies found during the inspection are of minor importance, the authorizing officer shall call upon the applicant to remedy the deficiencies.
p.(None): eliminate them.
p.(None): Suspension and termination of the clinical trial
p.(None): Section 37 (1) * If it is found that
p.(None): (a) the continuation of the study does not comply with the authorization, the research plan or this Title and the medical devices;
p.(None): the conditions laid down in specific legislation on clinical trials,
p.(None): (b) the life, health or safety of the subjects or staff is endangered by the investigation,
p.(None): (c) the examination is contrary to public policy or public health; or
p.(None): d) the applicant has not complied with the notice under Section 36 (6),
p.(None): the authorizing officer shall immediately suspend the examination and send the inspection report to the applicant and to the competent authority.
p.(None): 2. Following suspension, before the termination decision, except in case of imminent danger to the participants in the research:
p.(None): - the authorizing officer shall request the opinion of the applicant, the investigators and the investigators by setting a time-limit of seven days,
p.(None): and calls on those concerned to close the gap. If the applicant, the investigators, or in the investigation
p.(None): the contributors fail to deliver their opinion within the time limit or to rectify the deficiency within the time limit set by the licensor
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p.(None): all relevant Hungarian research sites. On the basis of the applicant 's announcement that the research is suspended or terminated, the licensor shall:
p.(None): research with the status of suspended or terminated in the register.
p.(None): (2) The researcher shall immediately suspend the research and notify the principal investigator if he finds that the continuation of the research is
p.(None): the life or health of the participating subjects. The principal investigator shall inform the applicant and the authorizing officer accordingly,
p.(None): that, if necessary, the licensor shall proceed in accordance with Section 13 (1) - (2).
p.(None): Rules for the authorization of non-interventional investigations
p.(None): § 15 * In the case of an investigation not authorized under Article 16, the provisions of Articles 16 to 21 shall apply. § and human medicine
p.(None): shall be conducted in accordance with the provisions of the separate legislation on research.
p.(None): Section 16 * Non-interventional trial: a study not qualifying as a clinical trial under Titles 2 and 3, which
p.(None): (a) shall not be considered as medical research within the meaning of points (b) to (c) and the procedure for which it is carried out shall not
p.(None): normal health care,
p.(None): (b) Examination by a medical device bearing the CE marking, the purpose of which is to
p.(None): collection and processing of data generated by the application for its intended purpose,
p.(None): c) in the case of medicinal products, Gytv. Investigation according to § 1 point 8.
p.(None): Section 17 * (1) Conduct non-interventional investigations
p.(None): a) * in the case of investigations and research referred to in Article 16 (a)
p.(None): aa) * In the case of a study that does not involve embryo and / or germ / stem cell research, the ETT HRB Code of Ethics
p.(None): based on the opinion of the authority, the permission of the National Chief Medical Officer,
p.(None): (ab) in all other cases, the ETSC TUKEB professional ethics license
p.(None): possess it;
p.(None): (b) * in the case of an investigation as referred to in Article 16 (c)
p.(None): ba) * if the test is not the test referred to in point bb), the National Institute of Pharmacy and Food (the
p.(None): hereinafter referred to as "OGYÉI"),
p.(None): bb) * where compliance with an official decision to conduct a non-post-authorization safety study
p.(None): Gytv. Pharmacovigilance Risk Assessment Committee referred to in Article 1 (31) (a
p.(None): hereinafter referred to as "PRAC") and the ETT TUKEB ethical approval,
p.(None): be notified to OGYÉI before commencement;
p.(None): c) * in the case of investigations referred to in Section 16 (b), may be authorized by OGYÉI.
p.(None): (2) In the case of a study involving no intervention in minors, the ETT TUKEB shall, subject to the opinion of a pediatrician
p.(None): decision.
p.(None): (3) Unless the appeal is excluded by law, in the case of the licensing procedure of the ETC TUKEB, the proceedings of the second instance shall be continued by the ETC Bureau.
p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
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p.(None): b) the name, registered office, representative of the principal in Hungary and its address,
p.(None): (c) the name and address of the healthcare provider (s) participating in the research,
p.(None): (d) the name and function of the principal investigator and the research personnel,
p.(None): (e) the purpose of the research,
p.(None): (f) the date and expected duration of the research,
p.(None): (g) an indication of the intended research in one or more centers, the proposed research in the case of multi-center research;
p.(None): a list of locations.
p.(None): 2. The application shall be presented
p.(None): (a) the research plan,
p.(None): (b) the curriculum vitae of the principal investigator,
p.(None): (c) subject to the provisions of the Ministerial Decree on human medical research;
p.(None): a draft written briefing,
p.(None): (d) draft statements of consent of persons participating in the research,
p.(None): (e) an estimate of the additional costs incurred in the research,
p.(None): f. 164 (2) of the Liability Insurance contract issued by the insurer
p.(None): certificate
p.(None): (g) a draft specific data sheet, which must include all data, facts, events and information relevant to the research;
p.(None): can affect your outcome,
p.(None): (h) a statement of the remuneration of the principal investigator and the research contributor.
p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
p.(None): c) a set of criteria for the recruitment, selection and exclusion of participants,
p.(None): (d) number of participants (total and per research site), gender, age, to be included in the research;
p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
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p.(None): d) * Principal: any natural or legal person who initiates, directs or finances a research, provided that:
p.(None): the principal investigator and the principal may be the same person;
p.(None): (e) * Ethics Committee: the Scientific and Research Ethics Committee of the Scientific Council for Health (hereinafter referred to as "ETC TUKEB");
p.(None): Human Reproduction Committee of the Scientific Council for Health (hereinafter referred to as "ETT HRB");
p.(None): f) Regional Ethics Committee: (159) of the Health Act, defined in a separate legislation
p.(None): Institutional Research Ethics Committee (RKEB);
p.(None): g) * IKEB: Institutional Ethics Committee, that is, an independent committee to be set up in every healthcare institution where
p.(None): and shall be responsible for verifying that the licensed and ethical
p.(None): ensure that the personal and material conditions are met and that the research plan
p.(None): standards, ethical requirements, with particular regard to the protection of those involved in research.
p.(None): Enable research
p.(None): Article 3 (1) * Research shall be carried out by the National Chief Medical Officer (hereinafter referred to as "licensor" for the purposes of this Chapter) in human medicine.
p.(None): as defined in the Ministerial Decree on Research - specialized authorities involved in administrative procedures
p.(None): according to the division of tasks according to the law defining the appointment of the person - the opinion of the ethics committee or
p.(None): is authorized and registered by the Regional Ethics Committee.
p.(None): (2) *
p.(None): 3. An application for a research permit shall be made by the researcher, the principal investigator or the principal (hereinafter referred to as 'the applicant' for the purposes of this Title).
p.(None): submit.
p.(None): (4) * A single permit shall be issued for research carried out in several centers.
p.(None): 3 / A. § * (1) An application for a research permit shall include:
p.(None): (a) the title of the research,
p.(None): b) the name, registered office, representative of the principal in Hungary and its address,
p.(None): (c) the name and address of the healthcare provider (s) participating in the research,
p.(None): (d) the name and function of the principal investigator and the research personnel,
p.(None): (e) the purpose of the research,
p.(None): (f) the date and expected duration of the research,
p.(None): (g) an indication of the intended research in one or more centers, the proposed research in the case of multi-center research;
p.(None): a list of locations.
p.(None): 2. The application shall be presented
p.(None): (a) the research plan,
p.(None): (b) the curriculum vitae of the principal investigator,
p.(None): (c) subject to the provisions of the Ministerial Decree on human medical research;
p.(None): a draft written briefing,
p.(None): (d) draft statements of consent of persons participating in the research,
p.(None): (e) an estimate of the additional costs incurred in the research,
p.(None): f. 164 (2) of the Liability Insurance contract issued by the insurer
p.(None): certificate
...

p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
p.(None): (f) the number, sex, age of participants planned to be included in the research, in the case of multi-center research, and per research site
p.(None): separately.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant,
p.(None): (b) the acting Ethics Committee or Regional Ethics Committee,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The applicant shall notify the decision to the competent IKEB, the head of the research establishment and, if the applicant is not the same,
p.(None): research leader - the research leader.
p.(None): remedy
p.(None): Section 10 *
p.(None): Modification of the authorization
p.(None): Article 11 (1) * After the exploration permit becomes final, the applicant may modify the exploration plan. Modification of the Research Plan -
p.(None): with the exception of paragraphs 2 to 5, the applicant shall notify the authorizing officer.
...

p.(None): Suspension and termination of research
p.(None): Section 13 * (1) If, during the inspection of the research, the licensor becomes aware of a circumstance that
p.(None): (a) the conditions for authorizing the research are no longer met,
p.(None): (b) the safety of the subjects participating in the research is jeopardized by the continuation of the research; or
p.(None): (c) there is doubt as to the scientific validity of the research,
p.(None): it may make the continuation of the research conditional on its decision and suspend the research by setting a deadline for the fulfillment of the condition.
p.(None): (2) If the applicant fails to comply with the decision within the time limit laid down in paragraph 1, if the research is suspended,
p.(None): and does not request an extension of the time limit, the authorizing officer shall terminate the search.
p.(None): 3. The authorizing officer's decision to suspend or terminate a research activity pursuant to paragraphs 1 and 2 and the reasons for it shall be imminent.
p.(None): notify the Ethics Committee acting as the authority or the Regional Ethics Committee referred to in Article 6 and, if terminated,
p.(None): unregistered.
p.(None): 4. If the applicant complies with the suspension decision, the authorizing officer shall decide whether to suspend the research.
p.(None): abolition. The decision to lift the suspension shall be obtained by the licensor through the competent ethics committee.
p.(None): and the expert opinion of the Regional Ethics Committee under § 6.
p.(None): Article 14 (1) * If the applicant wishes to suspend or terminate the research before its completion, stating the reasons therefor
p.(None): notifies the licensor, the Ethics Committee at the same time as the suspension or termination, and
p.(None): all relevant Hungarian research sites. On the basis of the applicant 's announcement that the research is suspended or terminated, the licensor shall:
p.(None): research with the status of suspended or terminated in the register.
p.(None): (2) The researcher shall immediately suspend the research and notify the principal investigator if he finds that the continuation of the research is
p.(None): the life or health of the participating subjects. The principal investigator shall inform the applicant and the authorizing officer accordingly,
p.(None): that, if necessary, the licensor shall proceed in accordance with Section 13 (1) - (2).
p.(None): Rules for the authorization of non-interventional investigations
p.(None): § 15 * In the case of an investigation not authorized under Article 16, the provisions of Articles 16 to 21 shall apply. § and human medicine
p.(None): shall be conducted in accordance with the provisions of the separate legislation on research.
p.(None): Section 16 * Non-interventional trial: a study not qualifying as a clinical trial under Titles 2 and 3, which
p.(None): (a) shall not be considered as medical research within the meaning of points (b) to (c) and the procedure for which it is carried out shall not
p.(None): normal health care,
p.(None): (b) Examination by a medical device bearing the CE marking, the purpose of which is to
p.(None): collection and processing of data generated by the application for its intended purpose,
p.(None): c) in the case of medicinal products, Gytv. Investigation according to § 1 point 8.
p.(None): Section 17 * (1) Conduct non-interventional investigations
p.(None): a) * in the case of investigations and research referred to in Article 16 (a)
p.(None): aa) * In the case of a study that does not involve embryo and / or germ / stem cell research, the ETT HRB Code of Ethics
p.(None): based on the opinion of the authority, the permission of the National Chief Medical Officer,
p.(None): (ab) in all other cases, the ETSC TUKEB professional ethics license
p.(None): possess it;
p.(None): (b) * in the case of an investigation as referred to in Article 16 (c)
p.(None): ba) * if the test is not the test referred to in point bb), the National Institute of Pharmacy and Food (the
p.(None): hereinafter referred to as "OGYÉI"),
p.(None): bb) * where compliance with an official decision to conduct a non-post-authorization safety study
p.(None): Gytv. Pharmacovigilance Risk Assessment Committee referred to in Article 1 (31) (a
p.(None): hereinafter referred to as "PRAC") and the ETT TUKEB ethical approval,
p.(None): be notified to OGYÉI before commencement;
p.(None): c) * in the case of investigations referred to in Section 16 (b), may be authorized by OGYÉI.
p.(None): (2) In the case of a study involving no intervention in minors, the ETT TUKEB shall, subject to the opinion of a pediatrician
p.(None): decision.
p.(None): (3) Unless the appeal is excluded by law, in the case of the licensing procedure of the ETC TUKEB, the proceedings of the second instance shall be continued by the ETC Bureau.
p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any document used in the conduct of the investigation.
p.(None): 17 / A. § * (1) The application for authorization shall be substantiated by the administrative service fee and shall be presented in the application.
p.(None): (a) the protocol,
p.(None): (b) the curriculum vitae of the coordinating investigator;
p.(None): (c) draft information for subjects (except for retrospective studies),
p.(None): (d) the draft statement of consent of subjects (except for retrospective studies),
p.(None): (e) in the case of recruitment, a draft recruitment plan,
p.(None): (f) in the case of a non-interventional study with a healthcare provider, a statement by the applicant that:
p.(None): has made a notification under the Ministerial Decree on medical research.
p.(None): 2. The request shall include a statement of intent from the investigator or coordinating investigator to the effect that the investigator shall:
p.(None): shall, if approved, implement the study plan known to it in accordance with its terms and the terms of the permit decision.
p.(None): 3. The test plan referred to in paragraph 1 (a) shall be included
p.(None): (a) the purpose, layout, methodology, organization and publication principles of the study;
...

p.(None): maker signature, date,
p.(None): (b) a description of the medical device tested, the materials used, the procedures used, any changes made during the test and the reasons for such changes,
p.(None): (c) a summary of the clinical investigation plan explaining any changes to the study,
p.(None): (d) the results of the study, an assessment of the end points specified in the protocol,
p.(None): (e) recording of adverse events,
p.(None): (f) a list of the standards taken into account in the examination,
p.(None): that the test documentation may serve as a basis for official controls.
p.(None): (6) The licensor shall submit a copy of the test documentation to the ETSC TUKEB for scientific, medical and ethical evaluation. The ETT
p.(None): TUKEB will notify the licensor of the result of the evaluation. The results of the assessment shall be recorded by the licensor in his records.
p.(None): Article 18 * (1) * In the case of investigations and research referred to in Article 16 (a), the sponsor shall submit the application for authorization to human
p.(None): in accordance with the provisions of the Ministerial Decree on Medical Research, in the case referred to in Article 17 (1) (a) (aa)
p.(None): to the National Chief Medical Officer, in the case of Section 17 (1) (a) (b), to the ETT TUKEB.
p.(None): (1a) * In the case of examinations and research referred to in Article 17 (1) (a) (aa),
p.(None): the National Chief Medical Officer shall assess whether the examination for which the application is being made is in fact a non-intervention investigation.
p.(None): (1b) * When considering an application under paragraph 1a, the National Chief Medical Officer shall request the opinion of the ETT HRB
p.(None): on the following issues:
p.(None): (a) whether the proposed study includes substantive, professional scientific questions and the methods used to answer them,
p.(None): (b) that the intended wording of the package leaflet and the statement of consent and the planned recruitment are in line with the
p.(None): of the Minister for Research.
p.(None): (2) * In the case of investigations and research referred to in Article 17 (1) (a) (b), the decision
p.(None): TUKEB appreciates that
p.(None): (a) whether the examination which is the subject of the application is in fact an intervention which does not interfere,
p.(None): (b) the planned research involves substantive, professional scientific questions and methods are appropriate to answer them,
p.(None): (c) that the intended wording of the package leaflet and the statement of consent, as well as the planned recruitment, are in line with human medical
p.(None): of the Minister for Research.
p.(None): (2a) * In the case of the tests referred to in Article 16 (b), the sponsor shall apply for authorization for human medical
p.(None): in accordance with the provisions of the Ministerial Decree on Research.
p.(None): (2b) * When assessing an application under paragraph 2a, OGYÉI shall assess whether:
p.(None): (a) whether the examination which is the subject of the application is in fact an intervention which does not interfere,
p.(None): (b) the conduct of the examination does not encourage the use of a medical device,
p.(None): (c) whether the device intended for testing is a legally placed medical device,
p.(None): (d) the medical purpose referred to in the study and the intended use described in the instructions for use are the same as in the research plan
p.(None): defined,
p.(None): (e) that the applicant has taken all reasonable steps to avoid the occurrence of an incident or accident.
p.(None): (2c) * When considering an application under paragraph 2a, OGYÉI shall request the opinion of the ETUC TUKEB on the following issues:
p.(None): (a) whether the proposed study includes substantive, professional scientific questions and methods capable of answering them,
p.(None): (b) that the intended wording of the package leaflet and the statement of consent and the planned recruitment are in line with the
p.(None): of the Minister for Research.
p.(None): (3) * In the case of the investigation referred to in Article 16 (c), the sponsor
p.(None): a) * in the case of § 17 (1) (b) (ba), the authorization of the Minister for Human Medical Research
p.(None): of the OGYÉI,
p.(None): b) in the case of Section 17 (1) (b) (bb), the ethics license from the ETSC TUKEB
p.(None): you ask.
p.(None): (4) * In the case of the investigation referred to in Article 17 (1) (b) (ba), OGYÉI shall assess during the licensing procedure whether:
p.(None): (a) the conduct of the study does not encourage the use of medicinal products,
p.(None): (b) whether the design of the trial meets the objectives of the trial,
p.(None): (c) the study is not a clinical trial,
p.(None): d) *
p.(None): (5) * In the case of the investigation referred to in Section 17 (1) (b) (ba), at the request of OGYÉI, the ETT TUKEB shall investigate
p.(None): (6) (a) to (c).
p.(None): (6) In the case of the investigation referred to in Article 17 (1) (b) (bb), the EWC shall assess whether:
p.(None): (a) that the intended wording of the package leaflet, consent and recruitment is consistent with the human medical
p.(None): Ministerial Decree on Research,
p.(None): (b) that the investigation does not endanger the life or physical integrity of the person being examined,
p.(None): c) the investigation does not violate the rights of the person under investigation,
p.(None): (d) whether the study is scientifically substantiated.
p.(None): Article 19 (1) * After the non-interventional study permit has become final, the sponsor may modify the study plan. THE
p.(None): in the case of a substantial modification of the protocol, the sponsor, stating the reasons and the exact content of the modification,
p.(None): a) * in the case of investigations and research referred to in Section 16 a), apply to the licensor for a modification of the permit;
p.(None): b) a
p.(None): ba) * In the case of an investigation as referred to in Article 16 (b) and Article 17 (1) (b) (ba), you must apply for an amendment of the authorization
p.(None): at OGYÉI,
p.(None): bb) * In the case of the investigation referred to in Section 17 (1) (b) (bb), the PRAC must approve the change and the ETT TUKEB ethical approval
p.(None): you should ask. If approved by the PRAC and approved by ETT TUKEB, it must be submitted at the latest by the time the change is implemented.
p.(None): report to OGYÉI;
p.(None): c) *
p.(None): (1a) * A minor change to the protocol shall be notified by the applicant to the licensor.
p.(None): 2. A substantial modification of the protocol shall in particular be considered as:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation supporting the non-interventional study,
p.(None): c) the amendment concerns the prospectus for investigators,
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (3) * In the course of the procedure of the OGYÉI for the approval of the modification, the EWC TUKEB shall request the opinion of the competent authority in Section 18 (6) a) -c)
p.(None): above.
p.(None): 4. The following documents shall be sent in connection with the notification pursuant to paragraph 1 (b) (bb):
p.(None): (a) the PRAC approval document,
p.(None): (b) an amended protocol approved by the PRAC, indicating any parts modified,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any altered document used in the conduct of the investigation.
p.(None): (5) * In the case referred to in paragraph (1) (c), OGYÉI shall request the opinion of the ETT TUKEB in accordance with Article 18 (2c).
p.(None): to investigate.
p.(None): Section 20 * In the case of investigations and research referred to in Section 17 (1) (a) (aa), the National Chief Medical Officer, Section 17 (1) (a)
p.(None): (b) and (c) of the ETT TUKEB;
p.(None): during the investigation, continuously checks that the non-interventional investigation is conducted in accordance with professional rules,
p.(None): and in accordance with the terms of the permit and the protocol.
p.(None): Section 21 * (1) * If it is found during the inspection that the continuation of the non-interventional investigation does not comply with the permit,
p.(None): the conditions laid down in the study plan and the ministerial decree on human medical research, Section 17 (1)
p.(None): in the case of the examinations and research referred to in point (a) (aa), the national officer in charge, referred to in Article 17 (1) (a) (b)
p.(None): in the case of investigations and research, ETT TUKEB, in the case of investigations referred to in Article 16 (b) and (c), OGYÉI
p.(None): the investigation shall be immediately suspended or terminated.
p.(None): (2) * Following the suspension, the National Chief Medical Officer, ETT TUKEB, or OGYÉI shall, prior to the termination decision,
p.(None): request the views of the applicant, the investigator-in-charge and those involved in the non-interventional investigation by setting a time limit; and
p.(None): calls on the parties concerned to remedy the shortcomings and suggests ways of overcoming them. inasmuch
p.(None): no opinion is received within the time limit or the deficiency is not remedied within the time limit set in accordance with this paragraph,
p.(None): the Chief Medical Officer, ETT TUKEB, or OGYÉI terminates the non-intervention investigation by decision.
p.(None): (3) * If the applicant wishes to suspend or terminate the non-intervening investigation before its completion,
p.(None): shall notify the authorizing officer at the latest at the same time as the suspension or termination. The applicant does not intervene
p.(None): Based on its decision terminating the investigation, the licensor shall delete the non-interventional investigation from the record.
p.(None): TITLE 2
p.(None): AUTHORIZATION OF CLINICAL TRIAL INGREDIENTS
p.(None): Section 22 (1) The provisions of this title are contained in Gytv. Applicable in the case of a clinical trial according to § 1 point 7.
p.(None): 2. For the purposes of this Title:
p.(None): a) * sponsor: any natural or legal person who initiates, directs or finances a clinical trial
p.(None): that the investigator and the principal may be the same person;
p.(None): (b) subject: a subject who is using the IMP or who is in the clinical trial.
p.(None): participates as a control person;
p.(None): (c) Ethics Committee: the Clinical Pharmacology Ethics Committee of the Scientific Council on Health;
p.(None): (d) non-commercial clinical trial: a non-commercial clinical trial conducted by researchers independent of the pharmaceutical industry
p.(None): are conducted without the participation of the pharmaceutical industry, without being classified as a pharmaceutical industry if the marketing authorization holder
p.(None): provide the investigator with a marketing authorization as a medicinal product free of charge, but the
p.(None): does not otherwise participate in or otherwise support the investigation.
p.(None): Authorization of a clinical trial
p.(None): Article 23 (1) * The clinical trial shall be evaluated by the OGYÉI (hereinafter referred to as the licensor) for the evaluation of the submitted documents and the
p.(None): subject to the authority's opinion.
p.(None): (1a) * The conditions laid down in the decision authorizing the clinical trial and the specifications of the approved protocol and
p.(None): the requirements for the commencement and control of a clinical trial shall constitute a code of conduct.
p.(None): 2. The application for authorization may be downloaded from the sponsor in duplicate on the European Medicines Agency (EMEA) website.
p.(None): sheet, accompanied by the documents specified therein.
p.(None): 3. During the licensing procedure, the licensor shall examine it in accordance with the nature of the study in question
p.(None): (a) the completion and adequacy of the pre-clinical tests,
p.(None): (b) clinical trials carried out with the investigational product up to the time of application;
p.(None): (c) the technical feasibility of the proposed study and the suitability of the test methods were included in the objectives of the protocol.
p.(None): answer,
p.(None): (d) the adequacy of the test plan to professional requirements,
p.(None): (e) the expected risks and the expected therapeutic benefit,
p.(None): (f) the suitability of the investigational medicinal product for human use in terms of drug quality;
p.(None): (g) the adequacy of third party liability insurance.
p.(None): (4) * The proposed text of the recruitment notice and the method of recruitment shall be provided by the official approval of the clinical trial and
p.(None): request for ethical review. The published recruitment notice shall include a reference to the existence of an official authorization. The recruitment
p.(None): in the event of a deviation from its authorized method and text, an amendment to the authorization shall be initiated.
p.(None): Section 24 (1) *
...

p.(None): procedures.
p.(None): (3) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial planned to involve a partially restricted person, the Ethics Committee shall be competent
p.(None): In developing its position, it examines whether the Whether Article 159 (4) and (5) are fully implemented,
p.(None): that its capacity to act in the exercise of rights relating to health care is partially or totally restricted
p.(None): minors, and Section 2: 9 of Act V of 2013 on the Civil Code. Of the Act, the question in question is that of incapacitated minors
p.(None): and in the clinical trial in minors with specialist examination of the disease and the patient population concerned,
p.(None): and a specialist in pediatrics and, if necessary, a teacher or psychiatrist.
p.(None): (4) * Ethics Committee declares in professional statement on professional and ethical adequacy of clinical trial
p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
p.(None): to the licensor - at least the justification of the study, the number of subjects to be involved, the planned time of the study and the recruitment methods
p.(None): a simplified study plan shall be submitted.
p.(None): Article 26 (1) The decision of the authorizing officer shall include, in accordance with the nature of the investigation in question:
p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant or the sponsor,
p.(None): (b) the competent administrative authorities,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): (3) * The licensor shall send the decision of the professional-ethical authority together with the decision to the principal.
p.(None): 26 / A. § * Phase I clinical trials may only be performed at a clinical pharmacology site approved by OGYÉI. The certification
...

p.(None): 4. If the inspection reveals that the conduct of the clinical trial does not comply with the authorization or this Title,
p.(None): or the clinical trial poses a serious risk to the life or health of the subjects,
p.(None): it shall immediately send the minutes to the sponsor and to the Ethics Committee and proceed as provided in Article 29 (1) - (2).
p.(None): 5. If the deficiencies found during the inspection are of minor importance, the safety of the subjects shall not be endangered.
p.(None): calls on those concerned to remedy these shortcomings and suggests ways of overcoming them;
p.(None): notify the sponsor and the study director.
p.(None): Suspension and termination of the clinical trial
p.(None): Article 29 (1) If it is found during the inspection that
p.(None): (a) the continuation of the study does not comply with the authorization, the protocol, or this Title, and the clinical investigation of the IMP
p.(None): the conditions laid down in separate legislation,
p.(None): (b) the study endangers the life, health or safety of the subjects; or
p.(None): (c) the scientific validity of the study is in doubt,
p.(None): the licensor shall immediately suspend the study and send the report to the sponsor and to the Ethics Committee.
p.(None): 2. Except in the case of imminent danger to the subjects, following the suspension, before the termination decision is taken:
p.(None): the licensor shall seek the opinion of the sponsor, the investigators and those involved in the investigation within a seven-day time limit, and shall
p.(None): stakeholders to address the deficiencies and propose ways to address them. If
p.(None): the sponsor, the investigators or those involved in the investigation do not express their opinion or the deficiency within the time limit by the licensor
p.(None): within a specified time period, the licensor shall terminate the investigation by a decision and send its decision to the sponsor
p.(None): and the authority.
p.(None): 3. The decision of the licensor to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor
p.(None): Notify the Ethics Committee, the competent authorities of the EEA States involved in the investigation and the EMEA, and
p.(None): will delete the investigation from its records.
p.(None): 4. If the sponsor wishes to suspend the clinical trial, he shall, at the latest by means of the data sheet available on the website of the EMEA:
p.(None): at the same time as the suspension, notify the licensor and all relevant Hungarian testing sites. The licensor is based on this
p.(None): the suspension shall be notified to the Ethics Committee.
p.(None): 5. The sponsor shall notify the authorizing officer of the termination of the study by means of a datasheet downloadable from the EMEA website. Enabling the test
p.(None): notice of termination shall be sent to the Ethics Committee.
p.(None): (6) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
p.(None): endangering or endangering the life or health of the subjects. The study director shall notify the sponsor and the licensor accordingly,
p.(None): where necessary, the authorizing officer shall act in accordance with paragraphs 1 to 2.
p.(None): TITLE 3
...

p.(None): participates as a control person;
p.(None): d) *
p.(None): (2) * For the purposes of this title, the provisions of the Ministerial Decree on Medical Devices
p.(None): and the Ministerial Decree on the Clinical Trial of Medical Devices
p.(None): to take into account.
p.(None): Authorization of a clinical trial
p.(None): Article 32 (1) * The investigation shall be authorized and registered by OGYÉI (hereinafter referred to as "licensor").
p.(None): (2) * OGYÉI examines whether a substance intended to be used in a clinical trial is an integral part of a device which, when used alone, is licensed under Gytv.
p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
p.(None): (g) the registration number of the test.
p.(None): 2. The authorizing officer shall send his decision:
p.(None): (a) the applicant,
p.(None): (b) the competent authority acting,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The decision of the authorizing officer shall be a condition for the opening of the investigation.
...

p.(None): provide.
p.(None): 5. Subject to authorized investigations, subjects and persons entitled to make statements, investigators,
p.(None): the head of the investigating service provider may apply a signal to the licensor if they consider that the investigator in the license or
p.(None): Contrary to the protocol.
p.(None): 6. If the deficiencies found during the inspection are of minor importance, the authorizing officer shall call upon the applicant to remedy the deficiencies.
p.(None): eliminate them.
p.(None): Suspension and termination of the clinical trial
p.(None): Section 37 (1) * If it is found that
p.(None): (a) the continuation of the study does not comply with the authorization, the research plan or this Title and the medical devices;
p.(None): the conditions laid down in specific legislation on clinical trials,
p.(None): (b) the life, health or safety of the subjects or staff is endangered by the investigation,
p.(None): (c) the examination is contrary to public policy or public health; or
p.(None): d) the applicant has not complied with the notice under Section 36 (6),
p.(None): the authorizing officer shall immediately suspend the examination and send the inspection report to the applicant and to the competent authority.
p.(None): 2. Following suspension, before the termination decision, except in case of imminent danger to the participants in the research:
p.(None): - the authorizing officer shall request the opinion of the applicant, the investigators and the investigators by setting a time-limit of seven days,
p.(None): and calls on those concerned to close the gap. If the applicant, the investigators, or in the investigation
p.(None): the contributors fail to deliver their opinion within the time limit or to rectify the deficiency within the time limit set by the licensor
p.(None): the authorizing officer shall terminate the investigation by decision and shall communicate its decision to the applicant and to the Authority.
p.(None): 3. The decision of the authorizing officer to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor shall be forthwith made.
p.(None): it shall notify the special authority, the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation and the European Commission. The
p.(None): the licensor shall indicate in the register the fact of suspension or termination.
p.(None): 4. If the applicant wishes to suspend or terminate the investigation before its completion, the reasons shall be stated at the latest in the list of the reasons.
p.(None): at the same time suspend or terminate the notification to the licensor, the administration and all relevant Hungarian testing sites.
p.(None): Upon the applicant's decision to terminate the investigation, the licensor shall delete the investigation from the register. The licensor is the termination
p.(None): It shall immediately inform the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation of its decision and the reasons therefor.
p.(None): (5) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
...

p.(None): (e) where a device, drug substance or human blood derivative is an integral part of the device,
p.(None): details of any tests carried out to assess its safety, quality and usefulness, taking into account the intended purpose of the device;
p.(None): (f) where the device is manufactured utilizing tissue of animal origin in order to reduce the risk of infection
p.(None): the risk management measures taken;
p.(None): (g) results of design calculations made, examinations carried out and technical tests carried out.
p.(None): The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are
p.(None): the documentation referred to in this point. The manufacturer must authorize the assessment of the effectiveness of these measures and, where appropriate,
p.(None): control.
p.(None): 10. Method, surface, time of contact of the parts that are in direct contact with the test subject or the operator, the material (s) used
p.(None): confirmation of biocompatibility, safety data sheet
p.(None): 11. Requirements for sterility and sterilization process and how to ensure it
p.(None): 12. Draft label
p.(None): 13. Draft instruction manual
p.(None): 14. Declaration that the device (s) intended for the clinical trial, in addition to the aspects being investigated,
p.(None): the essential requirements contained in Annex 1 to the Separate Medical Device Act and the manufacturer has done everything in its power
p.(None): protecting the health and safety of participants in a trial
p.(None): Clinical trial data and documentation
p.(None): 15. * In the case of a multicentre investigation, the opinion of the Ethics Committee of the State Party to the EEA Agreement, if any
p.(None): 16. Clinical trial design, including:
p.(None): (a) the purpose of the study (in terms of efficacy),
p.(None): (b) a precise, objective determination of the achievement of the test objective;
p.(None): (c) a description of the test method used (eg double-blind, randomized, etc.),
p.(None): (d) a description of the test procedure,
p.(None): (e) factors affecting the outcome of the test (eg other disease),
p.(None): f) a sample data sheet, algorithm, written instruction needed to evaluate the study,
p.(None): (g) a follow-up plan,
p.(None): (h) the scientific, medical and technical justification for the study,
p.(None): (i) the criteria for the selection of subjects to be investigated,
p.(None): (j) identification and justification of the number of subjects to be included in the study,
p.(None): (k) the identification of the items under examination,
p.(None): (l) identification of any other device which is not covered by the CE marking and is not involved in the test,
p.(None): (m) the identification of the other devices which are not covered by the CE marking and which are not subject to the test;
p.(None): showing how the safety of the test can be guaranteed,
p.(None): (n) risk analysis and risk assessment, a detailed assessment of the likely risks and adverse reactions, or their elimination; or
p.(None): how to reduce them,
p.(None): (o) an analysis and justification of the acceptability of the intended performance and the proportion of the risks and adverse reactions likely to occur,
p.(None): (p) a copy of the evidence of formal qualifications of the investigating staff,
p.(None): (q) patient information and consent,
p.(None): (r) procedure to be followed in the event of an unexpected event, list of notifiers, time limit for notification;
p.(None): (s) the criteria for stopping the clinical trial,
p.(None): t) * commencement of research activity by the clinical trial health care provider to cover compensation and damages
p.(None): prior confirmation of the research liability insurance corresponding to the risks,
p.(None): (u) material and personal conditions of the research,
p.(None): (v) * Planned text of recruitment notice and description of recruitment method.
p.(None): 17. III. the quality assurance certificate in the case of a clinical trial of a device of risk class and an active implant
p.(None): 18. *
p.(None): 19. In the case of a multicentre study, if any, a study already published by the Ethics Committee of the EEA Contracting State
p.(None): opinion
p.(None): Annex 2 to Regulation 235/2009 (X. 20.) Government Decree *
p.(None):  Back to top
p.(None): Information Sites Follow us
p.(None): About Wolters Kluwer
p.(None): FAQ Wolters Kluwer  
p.(None): History
p.(None): Privacy Notice Legal Notice
p.(None): Our core values
p.(None): Media Offer Trainings
p.(None): Sales Representatives
p.(None): Tax Online
p.(None): Customer service
p.(None): lawyers World
p.(None): Because it is important that you make the right decision!
p.(None): Contact Us Cookies Imprint
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General/Other / Incapacitated

Searching for indicator incapacitated:

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p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
p.(None): a) identification of the research, title, number of the research,
p.(None): b) the name, registered office, name and address of the Hungarian representative providing the research funding,
p.(None): c) the name (s), seat (s), type of institution (s) participating in the research,
p.(None): (d) the name of the principal investigator,
p.(None): (e) the expected duration of the research,
p.(None): (f) the number, sex, age of participants planned to be included in the research, in the case of multi-center research, and per research site
p.(None): separately.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant,
p.(None): (b) the acting Ethics Committee or Regional Ethics Committee,
p.(None): c) * to the National Health Insurance Fund Manager.
...

p.(None): in the event of rejection, proceed with the investigation in accordance with the original research plan. In the case of multiple modifications, the licensor shall include in the application
p.(None): for specific changes.
p.(None): (5) In addition, the provisions concerning authorization shall apply mutatis mutandis to the application for amendment.
p.(None): Control of research
p.(None): Article 12 (1) * During the research period the licensor shall check that the research is carried out in accordance with the rules of
p.(None): plan. The Licensor shall involve the Ethics Committee in any matter related to the scope of their responsibilities.
p.(None): or IKEB to conduct the audit. The Ethics Committee and the IKEB shall be subject to the laws and regulations governing the licensing procedure
p.(None): contributes to the audit.
p.(None): (2) * During the research, the Ethics Committee acting as the authority and the IKEB shall observe that:
p.(None): (a) the research is carried out as required by the permit and the research plan,
p.(None): (b) the information and consent of the participant is in accordance with the terms of the ministerial decision on human medical research;
p.(None): the requirements of the Regulation,
p.(None): (c) the manner in which the subjects in the trial were selected complies with the authorization,
p.(None): (d) the processing of the personal data of the participants is lawful,
p.(None): (e) the rights of minors who are incapacitated or incapacitated for health and who have legal capacity to act,
p.(None): clinical practice involving a partially restricted person with respect to a group of property matters
p.(None): in the case of investigation, 159 (4) and (5) and this decree are fully implemented.
p.(None): (3) *
p.(None): 4. Subject to authorized research, subjects and persons entitled to make a statement, the researchers,
p.(None): ethics committee or, if you participated in the authorization of the research, the regional research ethics committee, the research service provider
p.(None): and the IKEB may make a mark to the licensor if they consider that the research is required by the license or the research plan
p.(None): they carry on differently.
p.(None): Suspension and termination of research
p.(None): Section 13 * (1) If, during the inspection of the research, the licensor becomes aware of a circumstance that
p.(None): (a) the conditions for authorizing the research are no longer met,
p.(None): (b) the safety of the subjects participating in the research is jeopardized by the continuation of the research; or
p.(None): (c) there is doubt as to the scientific validity of the research,
p.(None): it may make the continuation of the research conditional on its decision and suspend the research by setting a deadline for the fulfillment of the condition.
p.(None): (2) If the applicant fails to comply with the decision within the time limit laid down in paragraph 1, if the research is suspended,
p.(None): and does not request an extension of the time limit, the authorizing officer shall terminate the search.
...

p.(None): (c) the technical feasibility of the proposed study and the suitability of the test methods were included in the objectives of the protocol.
p.(None): answer,
p.(None): (d) the adequacy of the test plan to professional requirements,
p.(None): (e) the expected risks and the expected therapeutic benefit,
p.(None): (f) the suitability of the investigational medicinal product for human use in terms of drug quality;
p.(None): (g) the adequacy of third party liability insurance.
p.(None): (4) * The proposed text of the recruitment notice and the method of recruitment shall be provided by the official approval of the clinical trial and
p.(None): request for ethical review. The published recruitment notice shall include a reference to the existence of an official authorization. The recruitment
p.(None): in the event of a deviation from its authorized method and text, an amendment to the authorization shall be initiated.
p.(None): Section 24 (1) *
p.(None): (2) The Ethics Committee shall formulate the position of the Authority in the composition specified in separate legislation on the following matters:
p.(None): (a) providing opinions on bioequivalence studies,
p.(None): b) IV. review of phase I clinical trials,
p.(None): (c) technical issues related to substantial modification of the protocol;
p.(None): (d) in the case of extraordinary reasons justifying the extraordinary procedure indicated by the licensor, as decided by the chairman of the Ethics Committee;
p.(None): procedures.
p.(None): (3) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial planned to involve a partially restricted person, the Ethics Committee shall be competent
p.(None): In developing its position, it examines whether the Whether Article 159 (4) and (5) are fully implemented,
p.(None): that its capacity to act in the exercise of rights relating to health care is partially or totally restricted
p.(None): minors, and Section 2: 9 of Act V of 2013 on the Civil Code. Of the Act, the question in question is that of incapacitated minors
p.(None): and in the clinical trial in minors with specialist examination of the disease and the patient population concerned,
p.(None): and a specialist in pediatrics and, if necessary, a teacher or psychiatrist.
p.(None): (4) * Ethics Committee declares in professional statement on professional and ethical adequacy of clinical trial
p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
...

p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
...

General/Other / Public Emergency

Searching for indicator emergency:

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p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant or the sponsor,
p.(None): (b) the competent administrative authorities,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): (3) * The licensor shall send the decision of the professional-ethical authority together with the decision to the principal.
p.(None): 26 / A. § * Phase I clinical trials may only be performed at a clinical pharmacology site approved by OGYÉI. The certification
p.(None): the procedure shall be carried out at the request of the service provider's manager. The certification process shall be repeated every three years.
p.(None): 26 / B. § * The sponsor shall notify the decision of OGYÉI regarding the authorization of the clinical trial health care provider
p.(None): send the decision of the OGYÉI and the study plan in Hungarian before commencing the investigation and
p.(None): refer to the relevant IKEB. If the healthcare provider is not a healthcare institution, the IKEB of that institution is competent,
p.(None): which is the headquarters of the investigating provider in the emergency medical care area of the healthcare institution.
p.(None): Modification of the authorization
p.(None): Article 27 (1) * After the study permit becomes final, the applicant may modify the study plan. In the test plan
p.(None): with the exception of paragraphs 2 to 6, shall be notified by the applicant to the authorization holder.
p.(None): (2) * In the case of a substantial modification of the protocol, the applicant shall apply to the licensor for a modification of the authorization. THE
p.(None): the application must state the reasons on which it is based and the exact content of the changes.
p.(None): (3) A substantial modification of the protocol (hereinafter referred to as a "substantial modification") is considered to be in particular if:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation in support of the study;
p.(None): (c) the amendment concerns the prospectus for investigators; or
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (4) *
p.(None): 5. If the variation is approved by the licensor, the sponsor shall proceed with the clinical investigation in accordance with the modified protocol. The
p.(None): the licensor may make the acceptance of the modification subject to a professional condition related to the investigation or the aspects referred to in Section 23 (3).
p.(None): In this case, the investigator shall continue the investigation in accordance with the conditions specified by the sponsor or the licensor, or if so
p.(None): does not intend to comply with the conditions specified by the licensor, it shall continue the study in accordance with the original protocol and
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): can affect your outcome,
p.(None): (h) a statement of the remuneration of the principal investigator and the research contributor.
p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
p.(None): c) a set of criteria for the recruitment, selection and exclusion of participants,
p.(None): (d) number of participants (total and per research site), gender, age, to be included in the research;
p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
p.(None): Section 5 *
p.(None): Section 6 In the case of research where licensing is not carried out by the ETT TUKEB or the ETT HRB,
p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
...

p.(None): research leader - the research leader.
p.(None): remedy
p.(None): Section 10 *
p.(None): Modification of the authorization
p.(None): Article 11 (1) * After the exploration permit becomes final, the applicant may modify the exploration plan. Modification of the Research Plan -
p.(None): with the exception of paragraphs 2 to 5, the applicant shall notify the authorizing officer.
p.(None): 2. In the event of a major modification to the research plan pursuant to paragraph 3, the applicant shall request the amendment of the authorization.
p.(None): engedélyezőnél. The application shall state the reasons on which the changes are based and shall state the exact content of the amendments. If the change could affect the participants
p.(None): In the interest of safety, the draft modified version of the package leaflet and consent should be attached to the application.
p.(None): (3) A substantial modification of a research plan shall be deemed to be particularly if:
p.(None): a) the modification may affect the safety of the research participants,
p.(None): (b) the amendment may alter the interpretation of the scientific documents in support of the research,
p.(None): c) * the amendment concerns the prospectus for researchers,
p.(None): (d) the results of the research to date require a revision of the written prospectus,
p.(None): (e) * a new research site will be involved, or
p.(None): f) * the person in charge of the research changes.
p.(None): (3a) * If a substantial change in the research plan also affects those listed in Section 7, the Ethics Committee shall also apply to the modified protocol.
p.(None): issue a separate position statement from the authority.
p.(None): 4. If the authorizing agent permits the modification, the applicant shall continue the research in accordance with the modified research plan. The licensor is a
p.(None): may make the acceptance of the amendment subject to a condition relating to the research and the aspects referred to in Article 4. In this case, the applicant
p.(None): either continue the research under conditions specified by the licensor, or subject to conditions specified by the licensor
p.(None): if it does not intend to do so, it shall continue the research in accordance with the original research plan and notify the licensor accordingly. The applicant is the application
p.(None): in the event of rejection, proceed with the investigation in accordance with the original research plan. In the case of multiple modifications, the licensor shall include in the application
p.(None): for specific changes.
p.(None): (5) In addition, the provisions concerning authorization shall apply mutatis mutandis to the application for amendment.
p.(None): Control of research
p.(None): Article 12 (1) * During the research period the licensor shall check that the research is carried out in accordance with the rules of
p.(None): plan. The Licensor shall involve the Ethics Committee in any matter related to the scope of their responsibilities.
p.(None): or IKEB to conduct the audit. The Ethics Committee and the IKEB shall be subject to the laws and regulations governing the licensing procedure
p.(None): contributes to the audit.
p.(None): (2) * During the research, the Ethics Committee acting as the authority and the IKEB shall observe that:
p.(None): (a) the research is carried out as required by the permit and the research plan,
p.(None): (b) the information and consent of the participant is in accordance with the terms of the ministerial decision on human medical research;
p.(None): the requirements of the Regulation,
p.(None): (c) the manner in which the subjects in the trial were selected complies with the authorization,
p.(None): (d) the processing of the personal data of the participants is lawful,
p.(None): (e) the rights of minors who are incapacitated or incapacitated for health and who have legal capacity to act,
p.(None): clinical practice involving a partially restricted person with respect to a group of property matters
p.(None): in the case of investigation, 159 (4) and (5) and this decree are fully implemented.
p.(None): (3) *
p.(None): 4. Subject to authorized research, subjects and persons entitled to make a statement, the researchers,
p.(None): ethics committee or, if you participated in the authorization of the research, the regional research ethics committee, the research service provider
p.(None): and the IKEB may make a mark to the licensor if they consider that the research is required by the license or the research plan
p.(None): they carry on differently.
p.(None): Suspension and termination of research
p.(None): Section 13 * (1) If, during the inspection of the research, the licensor becomes aware of a circumstance that
p.(None): (a) the conditions for authorizing the research are no longer met,
p.(None): (b) the safety of the subjects participating in the research is jeopardized by the continuation of the research; or
p.(None): (c) there is doubt as to the scientific validity of the research,
p.(None): it may make the continuation of the research conditional on its decision and suspend the research by setting a deadline for the fulfillment of the condition.
p.(None): (2) If the applicant fails to comply with the decision within the time limit laid down in paragraph 1, if the research is suspended,
p.(None): and does not request an extension of the time limit, the authorizing officer shall terminate the search.
p.(None): 3. The authorizing officer's decision to suspend or terminate a research activity pursuant to paragraphs 1 and 2 and the reasons for it shall be imminent.
p.(None): notify the Ethics Committee acting as the authority or the Regional Ethics Committee referred to in Article 6 and, if terminated,
p.(None): unregistered.
p.(None): 4. If the applicant complies with the suspension decision, the authorizing officer shall decide whether to suspend the research.
p.(None): abolition. The decision to lift the suspension shall be obtained by the licensor through the competent ethics committee.
p.(None): and the expert opinion of the Regional Ethics Committee under § 6.
p.(None): Article 14 (1) * If the applicant wishes to suspend or terminate the research before its completion, stating the reasons therefor
p.(None): notifies the licensor, the Ethics Committee at the same time as the suspension or termination, and
p.(None): all relevant Hungarian research sites. On the basis of the applicant 's announcement that the research is suspended or terminated, the licensor shall:
p.(None): research with the status of suspended or terminated in the register.
p.(None): (2) The researcher shall immediately suspend the research and notify the principal investigator if he finds that the continuation of the research is
p.(None): the life or health of the participating subjects. The principal investigator shall inform the applicant and the authorizing officer accordingly,
p.(None): that, if necessary, the licensor shall proceed in accordance with Section 13 (1) - (2).
p.(None): Rules for the authorization of non-interventional investigations
p.(None): § 15 * In the case of an investigation not authorized under Article 16, the provisions of Articles 16 to 21 shall apply. § and human medicine
p.(None): shall be conducted in accordance with the provisions of the separate legislation on research.
p.(None): Section 16 * Non-interventional trial: a study not qualifying as a clinical trial under Titles 2 and 3, which
p.(None): (a) shall not be considered as medical research within the meaning of points (b) to (c) and the procedure for which it is carried out shall not
p.(None): normal health care,
p.(None): (b) Examination by a medical device bearing the CE marking, the purpose of which is to
p.(None): collection and processing of data generated by the application for its intended purpose,
p.(None): c) in the case of medicinal products, Gytv. Investigation according to § 1 point 8.
p.(None): Section 17 * (1) Conduct non-interventional investigations
p.(None): a) * in the case of investigations and research referred to in Article 16 (a)
p.(None): aa) * In the case of a study that does not involve embryo and / or germ / stem cell research, the ETT HRB Code of Ethics
p.(None): based on the opinion of the authority, the permission of the National Chief Medical Officer,
p.(None): (ab) in all other cases, the ETSC TUKEB professional ethics license
p.(None): possess it;
p.(None): (b) * in the case of an investigation as referred to in Article 16 (c)
p.(None): ba) * if the test is not the test referred to in point bb), the National Institute of Pharmacy and Food (the
p.(None): hereinafter referred to as "OGYÉI"),
p.(None): bb) * where compliance with an official decision to conduct a non-post-authorization safety study
p.(None): Gytv. Pharmacovigilance Risk Assessment Committee referred to in Article 1 (31) (a
p.(None): hereinafter referred to as "PRAC") and the ETT TUKEB ethical approval,
p.(None): be notified to OGYÉI before commencement;
p.(None): c) * in the case of investigations referred to in Section 16 (b), may be authorized by OGYÉI.
p.(None): (2) In the case of a study involving no intervention in minors, the ETT TUKEB shall, subject to the opinion of a pediatrician
p.(None): decision.
p.(None): (3) Unless the appeal is excluded by law, in the case of the licensing procedure of the ETC TUKEB, the proceedings of the second instance shall be continued by the ETC Bureau.
p.(None): juice.
p.(None): 4. The notification pursuant to paragraph 1 (b) (bb) shall be accompanied by the following documents:
p.(None): (a) a letter of agreement issued by the PRAC,
p.(None): (b) a test plan approved by the PRAC,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any document used in the conduct of the investigation.
...

p.(None): (d) the method of statistical processing of data obtained during the study,
p.(None): (e) the planned time and place for the examination,
p.(None): (f) the source of the research funding,
p.(None): g) the name and seat of the applicant.
p.(None): 4. Where the non-interventional investigation is carried out by a healthcare provider, the examination site referred to in paragraph 3 (e) shall be the following:
p.(None): the name and address of the healthcare provider shall be included in the test plan referred to in paragraph 1 (a).
p.(None): (5) In the case of Article 17 (1) (b) p o n t b b), the draft study plan shall not entail any intervention after authorization.
p.(None): in the case of a pharmacovigilance investigation, the Gytv. Pharmacovigilance Risk Assessment Committee referred to in Section 1 point 31 (hereinafter PRAC)
p.(None): must be submitted to.
p.(None): 6. In the case of a non-post-authorization safety study, the study plan shall be subject to the procedure set out in European Directive 726/2004 / EC.
p.(None): pharmacovigilance activities required by Regulation (EC) No 45/2001 of the European Parliament and of the Council and Directive 2001/83 / EC of the European Parliament and of the Council
p.(None): shall comply with Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of this Regulation.
p.(None): 7. Where the sponsor submits the final results of the non-post-authorization safety study
p.(None): requesting a deferral, the information listed in paragraph 1 shall be accompanied by a statement of the reasons therefor.
p.(None): 8. For the purposes of this Regulation, the PRAC shall not be considered as a licensing authority.
p.(None): 17 / B. § * (1) In the case of non-interventional medical devices, the application shall be submitted in duplicate
p.(None): with the data content specified in the Annex to the Ministerial Decree on Human Medical Research.
p.(None): (2) In the case of non-interventional medical devices, studies on human medical
p.(None): 23/2002. (V. 9.) EüM Decree 20 / F-20 / S. Shall apply with the exceptions set forth in paragraphs 3 to 6.
p.(None): (3) The procedure laid down in this section shall be governed by Decree 23/2002. (V. 9.) EüM Decree 20 / G. And 20 / O. §
p.(None): shall not apply.
p.(None): 4. Within 30 days of completion of an investigation, the sponsor shall notify the authorizing officer of the end of the investigation and shall, at the same time,
p.(None): send a copy of the test documentation to the licensor. The licensor shall record the completion of the study in his records.
p.(None): 5. The test documentation shall include:
p.(None): (a) a summary of the studies: the title of the study, the particulars of the medical device used, the identity of the sponsor,
p.(None): evidence of the study, the baseline, procedure description, study start and end dates, results, conclusions,
p.(None): maker signature, date,
p.(None): (b) a description of the medical device tested, the materials used, the procedures used, any changes made during the test and the reasons for such changes,
p.(None): (c) a summary of the clinical investigation plan explaining any changes to the study,
p.(None): (d) the results of the study, an assessment of the end points specified in the protocol,
p.(None): (e) recording of adverse events,
p.(None): (f) a list of the standards taken into account in the examination,
p.(None): that the test documentation may serve as a basis for official controls.
...

p.(None): (d) whether the study is scientifically substantiated.
p.(None): Article 19 (1) * After the non-interventional study permit has become final, the sponsor may modify the study plan. THE
p.(None): in the case of a substantial modification of the protocol, the sponsor, stating the reasons and the exact content of the modification,
p.(None): a) * in the case of investigations and research referred to in Section 16 a), apply to the licensor for a modification of the permit;
p.(None): b) a
p.(None): ba) * In the case of an investigation as referred to in Article 16 (b) and Article 17 (1) (b) (ba), you must apply for an amendment of the authorization
p.(None): at OGYÉI,
p.(None): bb) * In the case of the investigation referred to in Section 17 (1) (b) (bb), the PRAC must approve the change and the ETT TUKEB ethical approval
p.(None): you should ask. If approved by the PRAC and approved by ETT TUKEB, it must be submitted at the latest by the time the change is implemented.
p.(None): report to OGYÉI;
p.(None): c) *
p.(None): (1a) * A minor change to the protocol shall be notified by the applicant to the licensor.
p.(None): 2. A substantial modification of the protocol shall in particular be considered as:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation supporting the non-interventional study,
p.(None): c) the amendment concerns the prospectus for investigators,
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (3) * In the course of the procedure of the OGYÉI for the approval of the modification, the EWC TUKEB shall request the opinion of the competent authority in Section 18 (6) a) -c)
p.(None): above.
p.(None): 4. The following documents shall be sent in connection with the notification pursuant to paragraph 1 (b) (bb):
p.(None): (a) the PRAC approval document,
p.(None): (b) an amended protocol approved by the PRAC, indicating any parts modified,
p.(None): (c) a copy of the ethical license of the EGTC,
p.(None): (d) the original and the Hungarian language version of any altered document used in the conduct of the investigation.
p.(None): (5) * In the case referred to in paragraph (1) (c), OGYÉI shall request the opinion of the ETT TUKEB in accordance with Article 18 (2c).
p.(None): to investigate.
p.(None): Section 20 * In the case of investigations and research referred to in Section 17 (1) (a) (aa), the National Chief Medical Officer, Section 17 (1) (a)
p.(None): (b) and (c) of the ETT TUKEB;
p.(None): during the investigation, continuously checks that the non-interventional investigation is conducted in accordance with professional rules,
p.(None): and in accordance with the terms of the permit and the protocol.
p.(None): Section 21 * (1) * If it is found during the inspection that the continuation of the non-interventional investigation does not comply with the permit,
p.(None): the conditions laid down in the study plan and the ministerial decree on human medical research, Section 17 (1)
p.(None): in the case of the examinations and research referred to in point (a) (aa), the national officer in charge, referred to in Article 17 (1) (a) (b)
p.(None): in the case of investigations and research, ETT TUKEB, in the case of investigations referred to in Article 16 (b) and (c), OGYÉI
...

p.(None): Based on its decision terminating the investigation, the licensor shall delete the non-interventional investigation from the record.
p.(None): TITLE 2
p.(None): AUTHORIZATION OF CLINICAL TRIAL INGREDIENTS
p.(None): Section 22 (1) The provisions of this title are contained in Gytv. Applicable in the case of a clinical trial according to § 1 point 7.
p.(None): 2. For the purposes of this Title:
p.(None): a) * sponsor: any natural or legal person who initiates, directs or finances a clinical trial
p.(None): that the investigator and the principal may be the same person;
p.(None): (b) subject: a subject who is using the IMP or who is in the clinical trial.
p.(None): participates as a control person;
p.(None): (c) Ethics Committee: the Clinical Pharmacology Ethics Committee of the Scientific Council on Health;
p.(None): (d) non-commercial clinical trial: a non-commercial clinical trial conducted by researchers independent of the pharmaceutical industry
p.(None): are conducted without the participation of the pharmaceutical industry, without being classified as a pharmaceutical industry if the marketing authorization holder
p.(None): provide the investigator with a marketing authorization as a medicinal product free of charge, but the
p.(None): does not otherwise participate in or otherwise support the investigation.
p.(None): Authorization of a clinical trial
p.(None): Article 23 (1) * The clinical trial shall be evaluated by the OGYÉI (hereinafter referred to as the licensor) for the evaluation of the submitted documents and the
p.(None): subject to the authority's opinion.
p.(None): (1a) * The conditions laid down in the decision authorizing the clinical trial and the specifications of the approved protocol and
p.(None): the requirements for the commencement and control of a clinical trial shall constitute a code of conduct.
p.(None): 2. The application for authorization may be downloaded from the sponsor in duplicate on the European Medicines Agency (EMEA) website.
p.(None): sheet, accompanied by the documents specified therein.
p.(None): 3. During the licensing procedure, the licensor shall examine it in accordance with the nature of the study in question
p.(None): (a) the completion and adequacy of the pre-clinical tests,
p.(None): (b) clinical trials carried out with the investigational product up to the time of application;
p.(None): (c) the technical feasibility of the proposed study and the suitability of the test methods were included in the objectives of the protocol.
p.(None): answer,
p.(None): (d) the adequacy of the test plan to professional requirements,
p.(None): (e) the expected risks and the expected therapeutic benefit,
p.(None): (f) the suitability of the investigational medicinal product for human use in terms of drug quality;
p.(None): (g) the adequacy of third party liability insurance.
p.(None): (4) * The proposed text of the recruitment notice and the method of recruitment shall be provided by the official approval of the clinical trial and
p.(None): request for ethical review. The published recruitment notice shall include a reference to the existence of an official authorization. The recruitment
p.(None): in the event of a deviation from its authorized method and text, an amendment to the authorization shall be initiated.
p.(None): Section 24 (1) *
p.(None): (2) The Ethics Committee shall formulate the position of the Authority in the composition specified in separate legislation on the following matters:
p.(None): (a) providing opinions on bioequivalence studies,
p.(None): b) IV. review of phase I clinical trials,
p.(None): (c) technical issues related to substantial modification of the protocol;
p.(None): (d) in the case of extraordinary reasons justifying the extraordinary procedure indicated by the licensor, as decided by the chairman of the Ethics Committee;
p.(None): procedures.
p.(None): (3) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial planned to involve a partially restricted person, the Ethics Committee shall be competent
p.(None): In developing its position, it examines whether the Whether Article 159 (4) and (5) are fully implemented,
p.(None): that its capacity to act in the exercise of rights relating to health care is partially or totally restricted
p.(None): minors, and Section 2: 9 of Act V of 2013 on the Civil Code. Of the Act, the question in question is that of incapacitated minors
p.(None): and in the clinical trial in minors with specialist examination of the disease and the patient population concerned,
p.(None): and a specialist in pediatrics and, if necessary, a teacher or psychiatrist.
p.(None): (4) * Ethics Committee declares in professional statement on professional and ethical adequacy of clinical trial
p.(None): additional conditions are required.
p.(None): (5) The Ethics Committee shall take into account the opinion of the European Committee when formulating its position in the case of a multicentre clinical trial.
p.(None): The examination by the Ethics Committee of a State party to the Agreement on the European Economic Area (hereinafter referred to as "the EEA Agreement")
p.(None): provided that the principal provides the full text thereof, if necessary in Hungarian translation.
p.(None): (6) *
p.(None): (7) The Licensor shall document the ethics committee's procedures in accordance with the principles of Good Clinical Practice (GCP).
p.(None): at least once a year for quality assurance.
p.(None): Section 25 (1) * The licensor shall decide on the immunology on the basis of the evaluation of the submitted documents and the opinion of the specialized authority
p.(None): for the authorization of a clinical trial with an investigational medicinal product.
p.(None): (2) *
p.(None): 3. With regard to non-commercial investigations, the provisions of this Title shall apply with the exception that for these investigations
p.(None): to the licensor - at least the justification of the study, the number of subjects to be involved, the planned time of the study and the recruitment methods
p.(None): a simplified study plan shall be submitted.
p.(None): Article 26 (1) The decision of the authorizing officer shall include, in accordance with the nature of the investigation in question:
p.(None): (a) identification of the clinical trial, trial title, number, phase;
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the name, address and, if any, the name and address of the principal of the principal in Hungary,
p.(None): (d) the name and address of the healthcare providers to be examined,
p.(None): (e) the name of the clinical trial leader,
p.(None): (f) the expected duration of the clinical trial.
p.(None): 2. The decision of the authorizing officer shall be sent:
p.(None): (a) the applicant or the sponsor,
p.(None): (b) the competent administrative authorities,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): (3) * The licensor shall send the decision of the professional-ethical authority together with the decision to the principal.
p.(None): 26 / A. § * Phase I clinical trials may only be performed at a clinical pharmacology site approved by OGYÉI. The certification
p.(None): the procedure shall be carried out at the request of the service provider's manager. The certification process shall be repeated every three years.
p.(None): 26 / B. § * The sponsor shall notify the decision of OGYÉI regarding the authorization of the clinical trial health care provider
p.(None): send the decision of the OGYÉI and the study plan in Hungarian before commencing the investigation and
p.(None): refer to the relevant IKEB. If the healthcare provider is not a healthcare institution, the IKEB of that institution is competent,
p.(None): which is the headquarters of the investigating provider in the emergency medical care area of the healthcare institution.
p.(None): Modification of the authorization
p.(None): Article 27 (1) * After the study permit becomes final, the applicant may modify the study plan. In the test plan
p.(None): with the exception of paragraphs 2 to 6, shall be notified by the applicant to the authorization holder.
p.(None): (2) * In the case of a substantial modification of the protocol, the applicant shall apply to the licensor for a modification of the authorization. THE
p.(None): the application must state the reasons on which it is based and the exact content of the changes.
p.(None): (3) A substantial modification of the protocol (hereinafter referred to as a "substantial modification") is considered to be in particular if:
p.(None): (a) the modification may affect the safety of the subjects;
p.(None): (b) the amendment may alter the interpretation of the scientific documentation in support of the study;
p.(None): (c) the amendment concerns the prospectus for investigators; or
...

p.(None): 5. If the deficiencies found during the inspection are of minor importance, the safety of the subjects shall not be endangered.
p.(None): calls on those concerned to remedy these shortcomings and suggests ways of overcoming them;
p.(None): notify the sponsor and the study director.
p.(None): Suspension and termination of the clinical trial
p.(None): Article 29 (1) If it is found during the inspection that
p.(None): (a) the continuation of the study does not comply with the authorization, the protocol, or this Title, and the clinical investigation of the IMP
p.(None): the conditions laid down in separate legislation,
p.(None): (b) the study endangers the life, health or safety of the subjects; or
p.(None): (c) the scientific validity of the study is in doubt,
p.(None): the licensor shall immediately suspend the study and send the report to the sponsor and to the Ethics Committee.
p.(None): 2. Except in the case of imminent danger to the subjects, following the suspension, before the termination decision is taken:
p.(None): the licensor shall seek the opinion of the sponsor, the investigators and those involved in the investigation within a seven-day time limit, and shall
p.(None): stakeholders to address the deficiencies and propose ways to address them. If
p.(None): the sponsor, the investigators or those involved in the investigation do not express their opinion or the deficiency within the time limit by the licensor
p.(None): within a specified time period, the licensor shall terminate the investigation by a decision and send its decision to the sponsor
p.(None): and the authority.
p.(None): 3. The decision of the licensor to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor
p.(None): Notify the Ethics Committee, the competent authorities of the EEA States involved in the investigation and the EMEA, and
p.(None): will delete the investigation from its records.
p.(None): 4. If the sponsor wishes to suspend the clinical trial, he shall, at the latest by means of the data sheet available on the website of the EMEA:
p.(None): at the same time as the suspension, notify the licensor and all relevant Hungarian testing sites. The licensor is based on this
p.(None): the suspension shall be notified to the Ethics Committee.
p.(None): 5. The sponsor shall notify the authorizing officer of the termination of the study by means of a datasheet downloadable from the EMEA website. Enabling the test
p.(None): notice of termination shall be sent to the Ethics Committee.
p.(None): (6) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
p.(None): endangering or endangering the life or health of the subjects. The study director shall notify the sponsor and the licensor accordingly,
p.(None): where necessary, the authorizing officer shall act in accordance with paragraphs 1 to 2.
p.(None): TITLE 3
p.(None): AUTHORIZATION OF CLINICAL TRIALS IN MEDICAL DEVICES *
p.(None): Article 30 (1) * Except as provided in paragraphs (2) - (3), the provisions of this Title shall be applied to human
p.(None): shall apply to clinical trials conducted with medical devices intended for clinical investigation.
...

p.(None): d) *
p.(None): (2) * For the purposes of this title, the provisions of the Ministerial Decree on Medical Devices
p.(None): and the Ministerial Decree on the Clinical Trial of Medical Devices
p.(None): to take into account.
p.(None): Authorization of a clinical trial
p.(None): Article 32 (1) * The investigation shall be authorized and registered by OGYÉI (hereinafter referred to as "licensor").
p.(None): (2) * OGYÉI examines whether a substance intended to be used in a clinical trial is an integral part of a device which, when used alone, is licensed under Gytv.
p.(None): is considered to be a medicinal product and has an additive effect on the human body in relation to its effects.
p.(None): 3. The authorizing officer shall submit the application and the complete dossier submitted to a formal examination in accordance with the following criteria:
p.(None): evaluate:
p.(None): (a) whether the device intended for clinical investigation is a medical device,
p.(None): (b) the clinical trial device and its associated documentation, other than its performance and expected side effects, are adequate
p.(None): essential requirements under separate legislation,
p.(None): (c) demonstration of the applicant's declared performance and assessment of expected adverse reactions in accordance with the protocol of the study;
p.(None): applied in accordance with current scientific knowledge, in an objective and reproducible manner,
p.(None): (d) the applicant has taken all reasonable steps to avoid incidents and accidents.
p.(None): Article 33 (1) The licensor shall decide on the authorization of the clinical trial on the basis of the submitted documentation and the opinion of the competent authority.
p.(None): (2) *
p.(None): 3. The authorizing officer shall notify the competent authorities of the Contracting Parties to the EEA Agreement and the European Commission of the refusal of an investigation.
p.(None): (4) *
p.(None): (5) * Rights of a minor who is incapacitated, incapacitated or incapacitated for health care
p.(None): In the case of a clinical trial which is planned to involve a partially restricted person in the exercise of his / her functions, the authority shall be specialized
p.(None): In developing its position, it examines whether the Eütv. Of Article 159 (4) to (5) are fulfilled in full by:
p.(None): they are partially or completely restricted in their legal capacity to exercise health care rights,
p.(None): and Act V: 2: 9 of the Civil Code 2013. Of the Act on Disabled Persons of the age of
p.(None): and, in the case of a clinical trial in minors with an appropriate examination in the relevant patient group,
p.(None): use a specialist pediatric examiner and, if necessary, a teacher or psychiatrist.
p.(None): (6) In the case of a multicentre clinical trial, the Authority will take into account the EEA opinion when formulating its position.
p.(None): the opinion of the Ethics Committee of a State Party to the Agreement on the investigation, if available to the applicant
p.(None): provide.
p.(None): (7) The special investigation dossier and the archiving, the professional qualifications of the investigators and the verification procedures shall be carried out by the specialized authority.
p.(None): documents shall be retained for three years after the completion of the investigation.
p.(None): (8) *
p.(None): Article 34 (1) The decision of the authorizing officer shall contain:
p.(None): a) clinical trial identification data, trial title, trial number,
p.(None): (b) intended number, sex, age range of subjects,
p.(None): (c) the applicant's name, registered office and the name and address of his representative in Hungary,
p.(None): (d) the name, the seat and the type of clinical trial site of the healthcare providers to be examined,
p.(None): (e) the name and function of the head of the clinical trial,
p.(None): (f) the expected duration of the clinical trial,
p.(None): (g) the registration number of the test.
p.(None): 2. The authorizing officer shall send his decision:
p.(None): (a) the applicant,
p.(None): (b) the competent authority acting,
p.(None): c) * to the National Health Insurance Fund Manager.
p.(None): 3. The decision of the authorizing officer shall be a condition for the opening of the investigation.
p.(None): 4. Where the licensor has notified the applicant of an Annex III, as notified by the applicant, Class IIa and IIa or IIb implantable, durable
p.(None): does not make a decision regarding the clinical investigation of invasive devices for use within the time limit specified in the Health Care Act,
p.(None): on expiry of that period, the manufacturer may commence an investigation. The applicant shall notify the authorizing officer of the investigation so initiated
p.(None): the licensor shall register the investigation in accordance with Article 32 (1).
p.(None): Modification of the authorization
p.(None): Section 35 (1) * After the study permit becomes final, the applicant may modify the study plan. The study design and the study
p.(None): with the exception of paragraphs 2 to 6, the applicant shall without delay notify the authorizing authority of any change in the particulars contained in the authorization.
p.(None): 2. In the case of a modification of the protocol pursuant to paragraph 3, the applicant shall apply to the licensor for a modification of the authorization. THE
p.(None): the application must state the reasons on which it is based and the exact content of the changes. Where the modification may affect the safety of participants,
p.(None): the application shall be accompanied by the draft modified version of the package leaflet and the letter of agreement.
p.(None): A substantial change in the protocol shall be deemed to occur if:
p.(None): (a) the modification relates to the purpose, circumstances or mode of action of the device,
p.(None): (b) the amendment may alter the interpretation of the scientific documentation in support of the study;
p.(None): (c) the amendment concerns the prospectus for investigators; or
p.(None): (d) the results of the examination so far necessitate an amendment to the written prospectus.
p.(None): (4) * If a substantial change in the study plan also affects those listed in Article 33 (4),
p.(None): the authority issues a position.
p.(None): 5. If the authorizing officer authorizes the variation, the applicant shall continue the investigation with the modified protocol. The licensor is a
p.(None): may make the acceptance of the amendment subject to the professional condition relating to the investigation and the aspects referred to in Article 32 (3). In this case
p.(None): carry out the investigation in accordance with the conditions laid down by the applicant or the licensor, or where specified by the licensor
p.(None): If it does not intend to comply with these conditions, it shall continue the investigation in accordance with the original protocol and notify the licensor thereof. THE
p.(None): the applicant shall continue the examination in accordance with the original protocol if the application is rejected. In the case of multiple modifications, the licensor shall:
p.(None): provided separately in the application.
p.(None): 6. In matters not covered by paragraphs 2 to 5, Articles 32 to 34 shall apply to the request for amendment. Of the Act
p.(None): apply mutatis mutandis.
p.(None): Inspection of the test
p.(None): Article 36 (1) The licensor may carry out inspections before, during and after the commencement of investigations.
p.(None): license. The authorizing officer shall keep records of the checks.
p.(None): 2. The licensing inspector may be the person who has the creditor's credentials relating to him. The
p.(None): prior to commencement of the inspection, the inspector shall present the credential issued by the licensor.
p.(None): 3. During an authorized examination, the licensor may verify:
p.(None): (a) the intended use of the test device,
p.(None): (b) the documentation of the data as required during the investigation,
p.(None): (c) compliance with the safety requirements for the device; and
p.(None): (d) the continuation of the study as required by the permit and the protocol.
p.(None): 4. The authorizing officer shall keep a record of the checks carried out in accordance with paragraph 3, with a copy to the applicant. The
p.(None): in the case of an application for authorization, the Protocol shall be made available to the specialized authority and the authorities of the States party to the EEA Agreement
p.(None): provide.
p.(None): 5. Subject to authorized investigations, subjects and persons entitled to make statements, investigators,
p.(None): the head of the investigating service provider may apply a signal to the licensor if they consider that the investigator in the license or
p.(None): Contrary to the protocol.
p.(None): 6. If the deficiencies found during the inspection are of minor importance, the authorizing officer shall call upon the applicant to remedy the deficiencies.
p.(None): eliminate them.
p.(None): Suspension and termination of the clinical trial
p.(None): Section 37 (1) * If it is found that
p.(None): (a) the continuation of the study does not comply with the authorization, the research plan or this Title and the medical devices;
p.(None): the conditions laid down in specific legislation on clinical trials,
p.(None): (b) the life, health or safety of the subjects or staff is endangered by the investigation,
p.(None): (c) the examination is contrary to public policy or public health; or
p.(None): d) the applicant has not complied with the notice under Section 36 (6),
p.(None): the authorizing officer shall immediately suspend the examination and send the inspection report to the applicant and to the competent authority.
p.(None): 2. Following suspension, before the termination decision, except in case of imminent danger to the participants in the research:
p.(None): - the authorizing officer shall request the opinion of the applicant, the investigators and the investigators by setting a time-limit of seven days,
p.(None): and calls on those concerned to close the gap. If the applicant, the investigators, or in the investigation
p.(None): the contributors fail to deliver their opinion within the time limit or to rectify the deficiency within the time limit set by the licensor
p.(None): the authorizing officer shall terminate the investigation by decision and shall communicate its decision to the applicant and to the Authority.
p.(None): 3. The decision of the authorizing officer to suspend or terminate the investigation pursuant to paragraphs 1 to 2 and the reasons therefor shall be forthwith made.
p.(None): it shall notify the special authority, the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation and the European Commission. The
p.(None): the licensor shall indicate in the register the fact of suspension or termination.
p.(None): 4. If the applicant wishes to suspend or terminate the investigation before its completion, the reasons shall be stated at the latest in the list of the reasons.
p.(None): at the same time suspend or terminate the notification to the licensor, the administration and all relevant Hungarian testing sites.
p.(None): Upon the applicant's decision to terminate the investigation, the licensor shall delete the investigation from the register. The licensor is the termination
p.(None): It shall immediately inform the competent authorities of the States Parties to the EEA Agreement which are the object of the investigation of its decision and the reasons therefor.
p.(None): (5) The investigator shall immediately suspend the investigation and notify the study director if he / she finds that resuming the investigation
p.(None): endangering or endangering the life or health of subjects. The study director shall inform the applicant and the authorizing officer accordingly
p.(None): in order that the authorizing officer may, where necessary, act in accordance with paragraphs 1 to 3.
p.(None): European Database *
p.(None): 37 / A. § * The licensor
p.(None): (a) in the case of an application under Article 32 (2), the information specified in Sections 1, 3, 5 and 9 (a) (aa) to (b) of the Annex;
p.(None): data;
p.(None): b) at the same time as the provisions of Article 33 (3), the date and the reasons for the rejection decision;
p.(None): c) at the same time as the provisions of Article 34 para.
p.(None): d) at the same time as the provisions of Article 37 (3), the date and reasons for the decision granting the permit;
p.(None): e) in the case of Section 37 (4), the date and reasons for the decision of the applicant;
p.(None): f) in the case of Section 37 (5), the date and reasons of the investigator's decision
p.(None): transmits it to the European Database.
p.(None): 3 / A. TITLE *
p.(None): AUTHORIZATION OF RESEARCH ON THE USE OF IONIZING RADIATION *
p.(None): 37 / B. § * (1) The provisions of this Title shall apply to human medical research, clinical trials on
p.(None): and clinical devices intended for clinical use in human beings
p.(None): applicable if the research is carried out using ionizing radiation.
p.(None): (2) For the purposes of this Title, carers and facilitators are persons who knowingly and intentionally expose themselves to ionizing radiation,
p.(None): in the care and support of persons who have been or have been exposed to medical exposure
p.(None): in addition to their job responsibilities.
p.(None): (3) For other terms, the Directive on protection against ionizing radiation and the related authorization, reporting and control system
p.(None): 487/2015. (XII. 30.) of the Government of the Republic of Hungary shall be taken into consideration.
p.(None):  37 / C. § * (1) * A 37 / B. (1) of the Act, except for human research,
p.(None): the licensor shall also obtain the position of the national officer in charge.
p.(None):  (2) * When drawing up the position of the authority, the National Chief Medical Officer shall, in accordance with the nature of the research in question,
p.(None): the radiological adequacy of documentation in addition to the criteria set out in Section 7 a), d), f), l) and n) according to the following aspects
p.(None): examine:
p.(None): (a) the justification of the radiation exposure of participants and carers and assistants,
p.(None): (b) the adequacy of optimization measures,
p.(None): (c) the individual dose level and the adequacy of the dose constraint for caregivers and assistants.
p.(None): (3) All the provisions of Section 37 / B. (1) of the Law on Radiocommunication
p.(None): documentation must be provided with the following content:
p.(None): (a) patients who voluntarily undertake to participate in the research and for whom such participation is expected to be diagnostic or
p.(None): there will be a therapeutic benefit in determining the individual dose level,
p.(None): (b) determination of dose constraint for participants for whom no direct health benefit is expected from exposure
p.(None): effect,
p.(None): (c) information of particular importance to the radiation protection of participants and assistants and supporters:
p.(None): (ca) their sex,
p.(None): (cb) their age,
p.(None): (cc) the fact that they are pregnant or have a child,
p.(None): (cd) measures taken to optimize their exposure,
p.(None): (ce) the fact that they have participated in previous radiation exposure research programs,
p.(None): (d) information concerning the researchers and the institution carrying out the research:
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

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p.(None): a draft written briefing,
p.(None): (d) draft statements of consent of persons participating in the research,
p.(None): (e) an estimate of the additional costs incurred in the research,
p.(None): f. 164 (2) of the Liability Insurance contract issued by the insurer
p.(None): certificate
p.(None): (g) a draft specific data sheet, which must include all data, facts, events and information relevant to the research;
p.(None): can affect your outcome,
p.(None): (h) a statement of the remuneration of the principal investigator and the research contributor.
p.(None): (3) Included in the research plan
p.(None): a) a detailed description of the purpose, justification and expected result of the research,
p.(None): b) the identification of literary references supporting the scientific validity and justification of the research,
p.(None): c) a set of criteria for the recruitment, selection and exclusion of participants,
p.(None): (d) number of participants (total and per research site), gender, age, to be included in the research;
p.(None): e) a description of the research method and the interventions applied,
p.(None): f) description of adverse events and serious adverse events, and the procedure to be followed in the event of their occurrence,
p.(None): (g) arrangements for the processing of participants' personal and medical data;
p.(None): (h) the method of statistical processing of data resulting from the research,
p.(None): (i) a statement by the principal investigator that the design of the research plan is in accordance with current legislation and by the World Medical Association;
p.(None): of the Helsinki Declaration.
p.(None): 4. The data referred to in points (a) to (h) of paragraph 3 shall be considered as data of public interest. Authorization and acceptability of the research design
p.(None): The scientific working hypothesis for the research plan, and in particular pharmaceutical research, shall not constitute data of public interest
p.(None): results of preclinical studies. This information is only available to the authority or ethics committee.
p.(None): § 4 The authorizing officer shall evaluate the application and the documentation submitted. It does so in accordance with the nature of the research in question
p.(None): a) the suitability of the researcher's personal and material conditions,
p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
p.(None): Section 5 *
p.(None): Section 6 In the case of research where licensing is not carried out by the ETT TUKEB or the ETT HRB,
p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
...

General/Other / participants in a control group

Searching for indicator control group:

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p.(None): Section 1 (1) The provisions of this Decree
p.(None): should be applied to all CLIV 1997 Health Regulations. (hereinafter referred to as: “Eutv.”)
p.(None): your website
p.(None): Page Usage Analysis of Wolters Kluwer Hungary Kft.
p.(None): human medicine
p.(None): activities use research (hereinafter:
p.(None): order research)
p.(None): to personalize it.
p.(None): with offers
p.(None): search for it at the contact details you provided (if you have one
p.(None): 2. The provisions of Title 1 shall apply
p.(None): contact information eg. registration for the authorization of all non-paragraph 3 medical research.
p.(None): in)
p.(None): (3) * The Az
p.(None): for human use
p.(None): pages are complete, all bypassed
p.(None): convenience drugs and other things called "Comfort
p.(None): XCV of 2005 amending the laws governing the pharmaceutical market for the provision of such a function.
p.(None): cookie "setting. You can change your cookie settings at any time
p.(None): 1 of the Act on Companies Act (hereinafter: Gytv.)
p.(None): browser (Firefox, § 7)
p.(None): Chrome by Explorer,
p.(None): Safari, Internet clinical trial
p.(None): Microsoft licensing
p.(None): Edge). Title 2, Clinical Devices
p.(None): for testingAWolters
p.(None): Address 3Kluwer Hungary Ltd.'s data management information can be found here.
p.(None): shall be governed by its provisions.
p.(None): TITLE 1
p.(None): AUTHORIZING HUMAN RESEARCH
p.(None): § 2. For the purposes of this title
p.(None): (a) multi-center research: research based on the same research plan but carried out at more than one research site;
p.(None): (b) participant: a person who participates in the research as a subject, including a member of the control group;
p.(None): (c) "research supervisor" means a person who conducts research professionally;
p.(None): d) * Principal: any natural or legal person who initiates, directs or finances a research, provided that:
p.(None): the principal investigator and the principal may be the same person;
p.(None): (e) * Ethics Committee: the Scientific and Research Ethics Committee of the Scientific Council for Health (hereinafter referred to as "ETC TUKEB");
p.(None): Human Reproduction Committee of the Scientific Council for Health (hereinafter referred to as "ETT HRB");
p.(None): f) Regional Ethics Committee: (159) of the Health Act, defined in a separate legislation
p.(None): Institutional Research Ethics Committee (RKEB);
p.(None): g) * IKEB: Institutional Ethics Committee, that is, an independent committee to be set up in every healthcare institution where
p.(None): and shall be responsible for verifying that the licensed and ethical
p.(None): ensure that the personal and material conditions are met and that the research plan
p.(None): standards, ethical requirements, with particular regard to the protection of those involved in research.
p.(None): Enable research
p.(None): Article 3 (1) * Research shall be carried out by the National Chief Medical Officer (hereinafter referred to as "licensor" for the purposes of this Chapter) in human medicine.
p.(None): as defined in the Ministerial Decree on Research - specialized authorities involved in administrative procedures
...

Searching for indicator placebo:

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p.(None): (b) the adequacy of liability insurance under separate legislation,
p.(None): (c) the adequacy of the processing of the personal data of the research participants and the persons entitled to access them;
p.(None): requirements,
p.(None): d) whether the proposed research meets the conditions set out in the PPA.
p.(None): Section 5 *
p.(None): Section 6 In the case of research where licensing is not carried out by the ETT TUKEB or the ETT HRB,
p.(None): the competent regional ethics committee shall take its decision into account. The area of competence of regional ethics committees is human
p.(None): is covered by a separate legal act on medical research.
p.(None): Section 7 The Ethics Committee shall, in its position paper, state the nature of the research specified in the application for a research permit.
p.(None): appropriately
p.(None): a) the validity and scientific validity of the research,
p.(None): b) ethical adequacy or non-compliance of the research,
p.(None): (c) whether each participant is entitled to receive health care justified by his or her state of health, in accordance with the research plan;
p.(None): (d) the adequacy of a prior assessment of the expected benefits and risks, the risks to the participants and the expected research
p.(None): proportionality of its result,
p.(None): e) * professional competence and ethical suitability of the research leader,
p.(None): f) the adequacy and completeness of the written information,
p.(None): (g) the adequacy of the statement of consent,
p.(None): h) the justification for using a placebo group,
p.(None): (i) the appropriateness of the reimbursement to research participants,
p.(None): (j) the modalities and conditions for the recruitment and selection of the participants in the research, the justification for the recruitment,
p.(None): its intended text and its adequacy,
p.(None): (k) the adequacy of the statistical processing method used to carry out the research,
p.(None): l) * if the research is pregnant, restricted in his / her freedom (Section 161 Eutv), a minor with limited legal capacity, and
p.(None): is also exercised with regard to the exercise of rights relating to health care by a person of a partially restricted legal age or incapacitated,
p.(None): the justification for their involvement and the adequacy of protection of their interests,
p.(None): (m) the adequacy of the remuneration of the principal investigator and the research contributor,
p.(None): (n) whether the expected risk outweighs the expected therapeutic benefit.
p.(None): § 8 In the process of authorizing research under § 6, the opinion of the Regional Ethics Committee shall be with due regard to the considerations contained in § 7.
p.(None): develops.
p.(None): Section 9 (1) The decision of the licensor shall include, in accordance with the nature of the research:
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
age	Age
authority	Relationship to Authority
blind	visual impairment
child	Child
control group	participants in a control group
disabled	Mentally Disabled
drug	Drug Usage
embryo	embryo
emergency	Public Emergency
gender	gender
helsinki	declaration of helsinki
incapacitated	Incapacitated
job	Occupation
language	Linguistic Proficiency
minor	Youth/Minors
officer	Police Officer
opinion	philosophical differences/differences of opinion
party	political affiliation
placebo	participants in a control group
pregnant	Pregnant
property	Property Ownership
restricted	Incarcerated
single	Marital Status
substance	Drug Usage
union	Trade Union Membership
usage	Drug Usage

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
control group	['placebo']
drug	['substance', 'usage']
placebo	['controlXgroup']
substance	['drug', 'usage']
usage	['drug', 'substance']

Trigger Words

capacity

consent

developing

ethics

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	6
Health	Drug Usage	drug	2
Health	Drug Usage	substance	2
Health	Drug Usage	usage	2
Health	Mentally Disabled	disabled	1
Health	Pregnant	pregnant	2
Health	visual impairment	blind	1
Social	Access to Social Goods	access	1
Social	Age	age	8
Social	Child	child	1
Social	Incarcerated	restricted	7
Social	Linguistic Proficiency	language	2
Social	Marital Status	single	1
Social	Occupation	job	1
Social	Police Officer	officer	44
Social	Property Ownership	property	1
Social	Trade Union Membership	union	1
Social	Youth/Minors	minor	6
Social	embryo	embryo	1
Social	gender	gender	1
Social	philosophical differences/differences of opinion	opinion	22
General/Other	Incapacitated	incapacitated	10
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	24
General/Other	declaration of helsinki	helsinki	1
General/Other	participants in a control group	control group	1
General/Other	participants in a control group	placebo	1

Decree No. 235/2009 (X.20.) from the Hungarian Government on the Regulations of Giving Permission for Human Medical Experiments, for Clinical Studies of Experimental Medicinal Products, and for the Clinical Studies of the Medical Devices

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / political affiliation

Health / Drug Usage

Health / Mentally Disabled

Health / Pregnant

Health / visual impairment

Social / Access to Social Goods

Social / Age

Social / Child

Social / Incarcerated

Social / Linguistic Proficiency

Social / Marital Status

Social / Occupation

Social / Police Officer

Social / Property Ownership

Social / Trade Union Membership

Social / Youth/Minors

Social / embryo

Social / gender

Social / philosophical differences/differences of opinion

General/Other / Incapacitated

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / declaration of helsinki

General/Other / participants in a control group

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input