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35/2005. (VIII. 26.) EüM decree
on clinical trials of investigational medicinal products for human use and good clinical practice
application
CLIV of 1997 on health. § (hereinafter: Eütv.)
(2) (o) and Regulation (EC) No 1907/2006 on medicinal products for human use.
évi XXV. Authorization received in Section 24 (2) (d) of the Act (hereinafter: Gytv.)
in accordance with Annex VI to promulgated by law, the Council of Europe emIbnegriy
lén✖y human rights and dignity in the application of biology and medicine
on the protection of the population of Oviedo (zhmtétnpy:
Supplement to the Convention on the Prohibition of the Cloning of Human Beings
In accordance with the provisions of its Protocol, I hereby order:
Jogtár demo?
§ 1 The requirements of this Decree with test preparations for human use
medical research (Eütv. 1u5t7m. §_, saotouvrácbeb = iankebtajno: gta
clinical trial). Does not qualify as a clinical trial a
a non-interventional trial in which:
(a) the medicinal product is not prescribed for the purpose of testing, and
(b) a medicinal product in the usual manner in clinical practice, in accordance with the terms of the marketing authorization
are ordered, and
(c) the involvement of the patient in a particular treatment strategy is not determined in advance by a study
plan, but the medicine is prescribed in accordance with current clinical practice and is prescribed
clearly separated from the decision to include the patient in the study, and
(d) in addition to normal clinical practice, the patient has additional diagnostic or
no monitoring procedure is used, and
(e) only epidemiological methods are used to analyze the data collected.
§ 2. (1) For the purposes of this Decree
(a) clinical trial: a medical trial performed on any human
research carried out at one or more test sites for the purpose of one or more test sites
preparation
(aa) the exploration of its clinical, pharmacological or pharmacodynamic effects; and
(b) the identification of the adverse drug reaction caused by it; or
(ac) study of absorption, distribution, metabolism and excretion,
to demonstrate the safety, efficacy, benefit / risk balance of the product
excluding non-interventional studies;
(b) multicenter clinical trial: according to the same study design, but
a clinical trial performed at more than one study site by more than one investigator,
where the test sites are located in the European Economic Area (hereinafter referred to as the EEA) and in the European Economic Area
Community or the
Under an international agreement concluded with the EEA in a State with the same status as an EEA Member State (a
hereinafter referred to as "EEA States") and in third countries;
(c) investigational medicinal product: active substance or placebo,
in a pharmaceutical form that is being tested in a clinical trial or as a reference (comparative)
used as a preparation, including preparations already on the market
but different from the agreed SPC or different
used in the presentation or packaging or from the indication in the approved summary of product characteristics
used in a different indication or with a medicinal product already authorized
used to collect additional data on
d) *
sponsor: any natural or legal person who you are
which initiates, conducts, and funds the clinical trial. It can be the investigator and the principal
the same person;
(e) investigator: a person qualified in medicine or dentistry whose task is to:
conducting a clinical trial at the study site;
(f) principal investigator: the responsible leader of the team at a particular investigation site if the
a clinical trial is conducted by a group of several investigators;
(g) investigator’s brochure: the investigator’s brochure or
a summary of the relevant clinical and non-clinical data on the product
for the study of the investigational medicinal product or products
benefit / risk associated with the clinical trial for the physician and the investigator
objective assessment. The prospectus must be updated by the sponsor at least annually;
h) study plan (protocol): study purpose, layout, methodology, statistical
deliberations and organization of a document containing the subjects
inclusion and exclusion criteria, monitoring and publication principles, including the study design
any successive versions and any amendments thereto;
(i) subject: a person in a clinical trial who is the subject of a clinical trial
who is participating in the study as a control;
j) *
informed consent: to participate in the study
requested person with legal capacity under the Eütv. A statement pursuant to Section 159 (1) (e),
or a minor with limited legal capacity and capacity to act with health care
In the case of a person who is partially restricted or incapacitated with regard to the exercise of related rights, the Eütv.
A statement pursuant to Section 159 (4) (d);
k) *
recruitment: the health of the person conducting the clinical trial
by the National Institute of Pharmacy and Food Health (hereinafter: OGYÉI)
authorized public call for the purpose of being a volunteer other than the patients he or she cares for
include individuals as subjects in a specific clinical trial;
(l) adverse event: a patient or subject treated with a study preparation
an adverse change in his state of health which is not necessarily causally related
with the treatment applied;
(m) adverse reaction: occurring at any dose of the test preparation
any adverse and undesirable reactions associated with the test preparation;
(n) serious adverse reaction or serious adverse event:
side effect or adverse event is severe if any dose of the study product is administered
subject’s death, life-threatening, hospitalization, ongoing hospitalization.
prolongation of care, permanent or significant damage to health, disability
followed by or congenital anomaly, birth defect occurs;
(o) unexpected adverse reaction: an adverse reaction of a nature or severity
differs from the adverse reaction in the corresponding product information, such as the study preparation
the package leaflet prepared for the investigator or, in the case of a medicinal product, the summary of product characteristics;
(p) equivalence study: the study preparation is with another medicinal product
bioequivalence (based on pharmacokinetic results), pharmacodynamic or therapeutic equivalence
comparative study;
q) *
r) *
SUSAR (Suspected Unexpected Serious Adverse Reaction): assumed
unexpected serious side effect;
s) *
Phase I study: the tolerability of the test preparation,
safety, pharmacokinetics and pharmacodynamic effects are healthy
volunteers or special patient groups. A further goal of the Phase I study may be the therapeutic dose
range determination;
t) *
II. phase I study: the pharmacological effect of the test preparation
in an indication selected on the basis of the efficacy of the investigational medicinal product
confirmation of the dose-response relationship, the optimal therapeutic dose
safety and tolerability testing;
u) *
III. Phase I study: the efficacy of the study product,
safety and tolerability in a larger number of patients in a controlled, randomized, placebo-controlled
a test in a comparative test set-up;
v) *
ARC. Phase I study: the marketing authorization holder
a study using the test preparation in accordance with the SPC, which
aims to further investigate the benefit / risk balance, safety and tolerability.
(2) *
With regard to matters not covered by paragraph 1, this Regulation
in the Eütv., on medicinal products for human use and other, the pharmaceutical market
Act XCV of 2005 on the Amendment of Regulatory Acts. (hereinafter: GyT.), on man
medical research, clinical trials of human investigational medicinal products
and medical devices intended for human clinical use
in the legislation on the rules of the authorization procedure for clinical trials, human
legislation on the placing on the market of medicinal products for human use and for human use
contained in the legislation on the personal and material conditions of the manufacture of
definitions should be taken into account.
(3) In the case of investigational medicinal products, it is authorized to ensure the quality of medicinal products
the relevant provisions of the legislation on the conditions of qualification of a person shall also apply mutatis mutandis.
§ 3 (1) *
All clinical trials - bioavailability and bioequivalence
principles of good clinical practice (GCP)
in accordance with the Helsinki Declaration on Ethical Principles in Medical Research
be planned, carried out and reported. The current text of the GCP in the Hungarian language of OGYÉI
It publishes. OGYÉI will publish a notice about the publication and its place in the Health Bulletin.
(2) *
The design and conduct of clinical trials is professional
rules, in particular those published by the European Commission on clinical trials
In accordance with the current version of the detailed instructions, which are published by OGYÉI in Hungarian
publish in translation.
(3) *
The OGYÉI and the independent ethics committee according to the separate legislation, the
Clinical Pharmacology Ethics Committee of the Health Science Council (hereinafter: ETT KFEB)
issues methodological guidance on significant professional and ethical issues, in particular for each clinical trial
phases, the use of placebo in clinical trials.
On the publication of the guide and its place, the OGYÉI and the ETT KFEB as an appendix to the Hungarian Gazette
will publish a notice in the Official Journal of the European Union.
(4) *
This Regulation is intended for pediatric use
Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
Council Regulation on Advanced Therapy Medicinal Products and Directive 2001/83 / EC
and Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 amending Regulation (EC) No 726/2004
shall apply subject to Council Regulation.
Protection of test subjects
§ 4 The rights, safety and well-being of the subject shall be given priority over science and
against the interests of society, therefore the risk to the research subject should be kept to a minimum
restricted.
§ 5 (1) *
To perform a clinical trial, a study preparation in humans
may only be used with the permission of OGYÉI. Clinical examination is only authorized by OGYÉI
the conditions laid down in Decision
may be continued according to the requirements of an approved test plan.
(2) A person with legal capacity may be involved in a clinical trial if the Eütv. 159th
§ (1) - (3) and the requirements provided for in this Decree.
(3) A clinical trial shall not be a substitute for a subject appropriate to its condition
examinations and treatments.
(4) *
For the intended use of placebo, for official authorization
the research dossier submitted with the application must include the placebo to be used in the study
specific justification for the need for a control group. The use of placebo should not be reported to the subject
significant additional risk to it or cause irreversible damage to health
hazard. Placebo should only be used for the shortest time required by the test subject
should be monitored continuously during the study, immediately in the event of signs of significant deterioration
it must be provided with the best scientifically accepted therapy available.
(5) The clinical trial shall be designed and conducted in a manner that minimizes the subject
possible damage, pain, fear and anxiety. Age of the subject, health
All foreseeable risks associated with the condition should be considered in the clinical trial
planning and control.
(6) The health status of the subject prior to the commencement of the clinical trial during the clinical trial
must be carefully monitored and documented continuously and after the test.
(7) If persons of reproductive age are to be included in a clinical trial, the design of the clinical trial,
authorization, special attention shall be paid to the study subjects when informing the subjects
subject with respect to clinical
fertility, fertility, pregnancy or fertility at the time of the clinical trial.
pregnancy, embryonal / fetal health.
(8) *
In clinical trials, the right to information self - determination and the
CXII of 2011 on freedom of information. law, health and related
XLVII of 1997 on the processing and protection of personal data law as well as in separate legislation
The provisions on data processing set out in
(9) As a subject to a clinical trial, with the exception of healthy volunteers, the clinical trial
Patients cared for by a healthcare provider should be primarily involved.
(10) *
The healthcare provider conducting the clinical trial is the print media,
or by means of a call published on its website, as well as professional and patient organizations,
and may recruit competent subjects on the sponsor's website. The recruitment
the call must not be for advertising purposes or contain the trade name of the investigational medicinal product,
manufacturer and
the designation of the person authorized to place it on the market.
! (10a) *
In the case of a clinical trial pursuant to Section 7, the healthcare provider shall be
to comply with the requirements of paragraph 10
you can make the description of the planned clinical trials public on your own website as well as on the websites of professional and patient organizations.
(11) *
For the subject by participating in the clinical trial
loss of income and costs, in particular in connection with travel
Reimbursement may be made for costs incurred and justified. Other benefit to the subject
or fee - non-therapeutic pharmacokinetic or interaction, phase I, and
except for bioequivalence testing.
(12) Test preparations and any devices used for their administration to the sponsor
must be made available free of charge.
Informing the subject, consent to the clinical trial
§ 6. (1) The person with legal capacity to be involved in a clinical trial shall be the head of the clinical trial or
the examiner orally and in writing, in Hungarian, - or in the person's mother tongue, or by the person
in another language indicated as known - informs the Eütv.
159 (3) and (4).
(2) The person providing the information shall pay particular attention to examining whether the involvement is involved
the desired person is not incapacitated. The findings in this regard are provided by the information provider
person shall be recorded in the research and medical records.
3. The information and consent shall be recorded in a separate sheet. The consent form
and one original copy of each written information shall be retained in the research dossier,
and one original shall be handed over to the subject.
4. The written prospectus shall contain, in particular, the following, as appropriate:
(a) the identity of the clinical trial;
b) an indication of the research nature of the clinical trial, the purpose of the clinical trial, the expected duration,
the number of persons to be involved, the course of the clinical trial, the nature of the planned interventions,
frequency;
(c) other accepted treatment options available to the subject,
and information that the clinical trial is discontinuing treatment that has already begun
can mean and the treatment started
the consequences for the subject of its interruption;
(d) a detailed description of the possible and expected consequences, risks and inconveniences, and
an indication that adverse events that did not occur in advance may occur during the clinical trial
visible;
(e) a description of the reasonably foreseeable benefits or if the subject benefits from the clinical trial
not expected, disclosure of this fact;
f) *
harm to the subject related to the clinical trial
treatment to be provided in the event of the occurrence or violation of the right to privacy, compensation for damage, or
for the payment of damages and compensation [GyT. Section 21 (1)] and the manner of their use
information, as well as the name and contact details in Hungary of the person and organization to whom you are
to which the subject may turn in the event of damage;
(g) the reimbursement of costs to the subject, if any;
(h) a warning that the consent is voluntary and free from influence,
it may be withdrawn at any time, either orally or in writing, without giving reasons, without this being examined
subject would be at a disadvantage;
(i) rules on the handling of, and access to, subject data;
(j) when using a placebo, detailed information on the nature of the use of the placebo and whether the
the likelihood of the subject being placed in the placebo group;
(k) a brief pharmacological description of the test preparation;
(l) the nature of the test subject, if any, after completion of the study
receive additional health care;
m) *
n) *
and GyT. It is included in the liability insurance pursuant to Section 3 (5)
the name of the insurer.
(5) *
6. The subject's informed consent shall include at least the following:
(a) the identity of the clinical trial;
(b) the name of the healthcare provider where the clinical trial is to be conducted;
c) the name, position and position of the head of the clinical trial or the person providing the information
designation;
d) *
the identity of the subject (name, place and date of birth),
a minor with limited legal capacity and rights related to health care in his or her capacity to act
In the case of a partially restricted or incapacitated subject with regard to the exercise of Section 16
(hereinafter referred to as the person entitled to make a declaration) identifier
data;
e) *
a statement that the subject - limited
a minor with legal capacity and rights related to health care in his or her capacity for action
in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
person entitled to make a statement - for participation in a clinical trial
after giving the information provided for in paragraph 1, give its consent voluntarily, without influence
Aware that it may be revoked at any time, orally or in writing, without giving any reason;
(f) the date of signature of the statement of consent;
(g) the signature of the clinical trial director or information provider;
(h) the signature of the person giving his consent.
(7) *
The person providing the information and the subject - and to a limited extent
a minor with legal capacity and rights related to health care in his or her capacity for action
partially restricted or
in the case of an incapacitated subject, the person entitled to make the statement
He shall also sign the written information referred to in paragraph 4.
8. In the case of an oral statement of consent, the two witnesses shall certify that the subject is in accordance with paragraph 4.
received and informed of the statement of consent referred to in paragraph 6
he verbally agreed.
(9) *
6 / A. § *
(1) If a human genetic study is performed during a clinical trial
the subject shall be informed separately. For information out
it should also cover the right of the subject to be sampled separately
refuse, in which case the genetic data relating to him will remain anonymous
cannot be used in any way. Refusal of sampling does not constitute participation of the subject
obstacle in the remainder of the clinical trial. Information on and consent to sampling
should be included in a separate document.
(2) Prior to sampling for the purpose of human genetic testing, the subject is subject to genetic counseling
shall be informed within the framework of:
(a) the purpose, quantitative and qualitative details of the sampling,
(b) the benefits and risks of performing or not performing the study,
(c) any possible outcome for the data subject and his or her close relatives
consequences,
(d) the methods and duration of storage of the genetic sample and data, the genetic data stored in different forms
samples and the possibilities for identifying data,
(e) unless otherwise stated by the subject, the genetic sample is in an archived collection
the possible transfer of stored genetic samples,
(f) that he or she is entitled to have access to the genetic data generated by the human genetic test; and
(g) whether it may decide to place the sample it provides in a biobank;
placement method so that a sample is possible
(ga) storage of personal data,
gb) in encrypted form,
gc) pseudonymised, ie in a form in which the
the replacement code has been made available to the subject exclusively,
(gd) anonymised, ie in a form where all the data relating to the subject are available
personally identifiable information has been rendered inoperable.
(3) The test subject shall also be informed that the sample placed in the biobank may decide to continue
participation in research. In this case, the subject must declare that:
according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
that is, it contributes to its use for diagnostic and research purposes.
6 / B. § *
(1) If a human genetic study is performed during a clinical trial
shall be sampled, a separate statement of consent shall be drawn up.
2. The subject's informed consent shall include at least the following:
a) the identification data of the clinical trial,
(b) the name of the healthcare provider where the clinical trial is to be conducted,
c) the name, position and position of the head of the clinical trial or the person providing the information
Name,
d) *
the identity of the subject (name, place and date of birth),
a minor with limited legal capacity and rights related to health care in his or her capacity to act
partially restricted or
in the case of an incapacitated subject, the Eütv. The person entitled to make a declaration pursuant to § 16 (a
hereinafter referred to as "the person entitled to make the declaration"),
e) *
a statement that the subject - limited
a minor with legal capacity and rights related to health care in his or her capacity for action
in the case of a subject who is partially restricted or incapacitated with regard to the exercise of
person entitled to make a declaration - in a genetic test for pharmacological purposes
consent to participate in accordance with Article 6 / A. § or waiver thereof
voluntarily, without influence, knowing that at any time, orally or in writing, without giving reasons,
revocable,
(f) consent to the taking of a sample of the quantity and quality indicated in the prospectus and to the subject
to use your data,
(g) a statement as to how the samples will be handled, stating that it may decide on the sample to be provided
biobank and the method of disposal, so it is possible to place the sample in 6 / A. §
Storage and disposal in accordance with paragraph 2 (g),
(h) the subject's statement on further sampling of the sample placed in the biobank
participation; in this case, the subject must declare that:
according to the primary purpose of sampling, for diagnostic purposes only, or for any purpose other than
ie it contributes to its use for diagnostic and research purposes,
(i) the manner in which the result is to be communicated, even if the subject does not have access to it,
j) consent to or exclusion from any future request,
k) the date of signature of the statement of consent,
l) the signature of the head of the clinical trial or the person providing the information,
(m) the signature of the person giving his consent.
Clinical trials in minors
§ 7 Clinical examination of minors according to Eütv. Section 159 (4) and Section 4
Even in the case of the correct application of the provisions of § 6, it can only be performed if all of the following conditions are met:
(a) the research in question is essential for clinical trials on persons with legal capacity
or to validate data obtained through other research methods;
(b) the research is directly related to the clinical condition in which the minor suffers or is of a nature
which can only be performed on minors;
(c) the consent of the person entitled to make the statement to the opinion; and
contains the probable will of a minor capable of assessing the situation, and this statement at any time
can be revoked without the minor suffering any disadvantage;
(d) an investigator with experience in relation to minors shall, depending on his or her intellectual level,
properly informed of the study, adverse and beneficial effects in a way that is comprehensible to him;
(e) the investigator or study director shall take into account the views of a minor who is able to form an opinion and assess the situation;
expressly discourages participation in the clinical trial or the exclusion of any person from the trial at any time.
step;
f) persuasion by any material means, except for the compensation pursuant to Section 5 (11), or
no financial incentive is applied, no other benefit or fee may be granted to the minor subject;
(g) the authorization of medicinal products for human or veterinary use; and
laying down Community procedures for the supervision of
Establishing a European Medicines Agency
European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council
hereinafter referred to as the EMEA);
(h) a clinical examination for pain, anxiety, fear and any other condition associated with illness and
designed and maintained to minimize the foreseeable risk associated with its state of development;
(i) the study is performed in such a way that both the risk threshold and the degree of pain are
defined and continuously monitored;
j) in the possession of the opinion of the pediatric specialist of the EGTC KFEB, professionally and ethically
test plan.
Involvement of incapacitated adults in a clinical trial
§ 8 A person who has previously had legal capacity may not be involved in any clinical trial
expressly excluded his participation in such studies. It cannot be included in a specific clinical trial
who has previously refused to give his consent to the
testing.
§ 9 *
Rights related to health care in its capacity to act
partially or completely limited in its capacity to act, and
Act V of 2013 on the Civil Code 2: 9. In the case of adults who are incapable of acting in accordance with
for research carried out in urgent need, the Eütv. Except in the case pursuant to Section 160 of the Eütv. § 159
Paragraph 4 and paragraphs 4 to 6. and § 8 only in that case
a clinical trial may be performed if all of the following conditions are met:
(a) the statement of consent of the person entitled to make the statement shall be the presumed will of the subject
and may be revoked at any time without prejudice to the subject;
(b) the subject has been adequately informed of the study in a manner that is comprehensible to the subject, favorable and
adverse effects;
(c) the investigator and the study director take full account of the opinion
and a subject capable of assessing the situation explicitly precludes access to the clinical trial
participation or wish to withdraw from the investigation at any time;
d) inducement or financial means of any kind, except for the compensation pursuant to Section 5 (11)
no incentive is applied, no other benefit or charge shall be granted to the subject;
(e) the research in question is essential for clinical trials on persons with legal capacity
or other research methods and is directly related to a
a clinical condition that is life-threatening or significantly detrimental to mental health and in which the person concerned suffers;
(f) the clinical examination for pain, anxiety, fear and any other illness and disease.
designed and maintained to minimize the foreseeable risk associated with the current condition of the subject;
(g) the study is performed in such a way that both the risk threshold and the degree of pain are
defined and continuously monitored;
(h) the EGTC KFEB is an expert opinion appropriate to the disease in question and the group of patients concerned
professionally and ethically supports the study plan in its possession;
(i) there are reasonable grounds for believing that the use of the investigational medicinal product outweighs the adverse effects
effects on the patient or no risk at all.
§ 10 The persons listed in § 9 shall not be included in a clinical trial as healthy volunteers
can be involved.
§ 11 If the subject during the clinical trial is due to either a court decision or a change in his or her condition
becomes effective, the clinical trial shall be informed as soon as possible and the
With the proper application of the provisions of §, your consent must be obtained to continue it.
Otherwise, the clinical trial may not be continued in the person concerned.
Preconditions for applying for an official permit
§ 12. (1) *
If the principal is some or all, related to the investigation
entrusts another natural or legal person with the performance of his duties, in which case the principal shall also be liable
the provisions on clinical trials contained in this Regulation and in specific legislation
compliance. If the principal is not established in a State party to the EEA Agreement, the legal
must be established in a State party to the EEA Agreement.
(2) - (5) *
(6) For the clinical trial of the investigational medicinal product between the healthcare provider and the sponsor
contract may be concluded before the authorization procedure, but
conditional official authorization of the clinical trial.
(7) *
Official authorization of a clinical trial
§ 13. (1) *
(2) The use of an investigational medicinal product in humans may be authorized if the clinical trial
the personal and material conditions of the test site (s) comply with the requirements of Article 2 of this Regulation
the conditions set out in Annex I.
(3) - (4) *
§ 14. * (1) *
(2) With regard to clinical trials, IKEB is responsible for the rights and safety of subjects
protection. IKEB may not issue professional-ethical opinions on clinical trials.
(3) *
§ 15. *
Procedure of the EGTC KFEB
§ 16 (1) *
prevail.
For the composition of the EGTC KFEB, the Eütv. Section 159 (6)
2. The sponsor may request an opinion from the EGTC KFEB in relation to clinical trials on any professional-ethical
to which the EGTC KFEB will reply within sixty days.
Section 17 (1) - (7) *
(8) The EGTC KFEB shall keep the inspection master file and, by archiving, the investigators
documents relating to the professional qualifications and inspection procedures of the inspection
for three years after its completion.
§ 18 *
18 / A. § *
Clinical trial control
§ 19. (1) *
The inspector of OGYÉI is a pharmacist or a medical university
a diploma or equivalent recognized by the university and not more than five years old, awarded by a university
may be a person with a certificate of successful completion of an organized GCP course. OGYÉI is
keep a register of inspectors. Before starting the inspection, the inspector is inspected by OGYÉI
presents the certificate of inspection issued.
(2) - (4) *
(5) *
During an approved clinical trial, subjects and
persons entitled to make a statement, investigators, the EGTC KFEB, the head of the service provider conducting the investigation, and
IKEB may file a complaint with OGYÉI if, in their opinion, the clinical trial is
different from those specified in the authorization or the test plan. The approved clinical trial
IKEB may also communicate its comments to the study director and the service provider's manager, as well as
may send it to the EGTC KFEB, which shall, if justified, initiate an inspection at OGYÉI.
(6) - (7) *
(8) *
The inspector referred to in paragraph 1 shall declare in writing that:
what are the interests, business and other relationships with the parties under control. This
this statement shall be taken into account when appointing the inspector for an ad hoc inspection.
(9) *
At the request of OGYÉI, the client is obliged to carry out the inspection within 1 working day
a quantity of the appropriate batch of the preparation suitable for quality control
made.
§ 20 *
Reporting of adverse events
§ 21. (1) *
The investigator is all severe at the test site
immediately notify the sponsor and IKEB of any adverse event, except for those
according to the study plan or the prospectus prepared for the investigators
reporting. The investigator shall provide a detailed written report of the incident upon immediate notification
also sends to the client and IKEB. In the notification and the written report, the subject is exclusively unique
identifiable by its code.
(2) In the study plan, it was identified as being of high importance for the safety assessment of the study
adverse events or laboratory abnormalities as specified by the investigator in the study plan,
report to the principal within the time specified therein.
(3) In the event of a reported death of a subject, the investigator shall request any additional information
provides for the principal and IKEB.
(4) The sponsor shall keep detailed records of all adverse events reported by the investigator. This
available to the States party to the EEA Agreement upon request
in which the clinical trial is conducted.
Reporting of serious side effects
§ 22 *
(1) *
The principal is required to take care of any death or life
endangering SUSAR and all relevant information
but no later than seven days after becoming aware of it, the EMEA EudraVigilance
database. The sponsor will take care of all fatalities occurring at all test sites in Hungary
life-threatening SUSAR and all relevant information is prompt - but no later than
within seven days of becoming aware of its electronic report to OGYÉI,
to the competent authority of the EEA EGCC and of the State concerned which is a party to the EEA Agreement. To the principal
within a further eight days, any significant data obtained during the follow-up of the adverse reaction in question
must report.
(2) *
The principal must take care of all other SUSARs promptly - but
within fifteen days of becoming aware of the report to the EMEA EudraVigilance
database. The Client shall provide all other SUSARs occurring at the Hungarian test site
immediately, but no later than fifteen days after becoming aware of it, send it electronically to OGYÉI,
the competent authority of the EEA EGCC and the States party to the EEA Agreement.
(3) *
The sponsor is responsible for each specific test preparation
periodically, in the form of a summary list of SUSAR occurring in the clinical trial
participating all investigators.
(4) *
The sponsor of the clinical trial for the entire duration of the trial
all serious suspected adverse reactions to the product,
and an electronic report on the safety of the subjects once a year
shall be sent to OGYÉI, the EGTC KFEB and the competent authority of the State concerned which is a party to the EEA Agreement.
(5) *
OGYÉI keeps records of each test preparation
SUSAR. In the case of non-commercial tests, OGYÉI is all of that test
SUSAR which has come to its notice in connection with the preparation without delay, but no later than
The EMEA shall report to the EudraVigilance database within the deadline set out in paragraph 2.
(6) *
In addition to the provisions of Section 21 and this Section, the investigation
endangering the safety of subjects by continuing the study or the study preparation
after the occurrence of new information or event related to the development of the
investigator should take appropriate urgent safety measures in order to conduct the test
the girls
protect against all imminent dangers. The principal is informed of such events and the action taken
immediately, but no later than within 24 hours, inform OGYÉI and ETT KFEB in writing.
Report on the completion of the investigation
§ 23 *
Within ninety days of the completion of the investigation, the sponsor shall:
It will notify OGYÉI of the completion of the study in a form that can be downloaded from the EMEA website. OGYÉI a
inform the EGTC KFEB within eight days of the notification.
Retention of test documentation
§ 24. (1) The inspection master file shall contain the basic documents
which allow both the conduct of the clinical trial and the quality of the data
be evaluable. The documents must indicate whether the investigators and the sponsor have complied
the principles of GCP. The test master file shall be based on an inspection carried out by an independent auditor or a
for official control.
(2) The sponsor and the investigator shall post-investigate the clinical trial
for at least five years after the completion of the investigation
keep it and archive it in a way that makes it easy to find. The principal must be out
designate those who are responsible for archiving at the client and have access to the archives solely for that purpose
should be limited to those entitled to
(3) Any ownership of the processed data and test documentation
change must be documented. Written to the new owner
a statement on data management and archiving
compliance with the provisions of
(4) The media used for archiving must be such that the documents are complete and legible.
remain.
Miscellaneous and transitional provisions
§ 25. (1) This Decree - with the exception of paragraph (2) - shall enter into force on 15 September 2005 by:
shall apply to proceedings instituted after its entry into force.
(2) The provision contained in subsection (9), section 6 (4) (n) and a
Section 17 (2) (m) shall enter into force on 1 November 2005, with the derogation provided for in Section (4)
into force.
(3) *
(4) *
(5) - (6) *
(7) *
The principal shall be responsible for the procedures provided for in this Regulation
is obliged to pay an administrative service fee of the amount specified by law. The
administrative service fee does not include VAT. Non - commercial investigation
There is no administrative service fee for authorization procedures.
(8) *
(9) *
(10) *
(11) This Regulation complies with the following Union acts:
(a) Directive 2001/20 / EC of the European Parliament and of the Council of 4 April 2001 on human consumption
good clinical practice to be used in clinical trials with
approximation of the laws, regulations and administrative provisions of the Member States
(b) European Commission Directive 2005/28 / EC of 8 April 2005 on the principles and principles of good clinical practice
laying down detailed guidelines for the use of investigational medicinal products for human use,
and the authorization to manufacture or import such products;
c) *
(12) *
This Regulation is intended for pediatric use
Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC
and Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 amending Regulation (EC) No 726/2004
lays down the provisions necessary for the implementation of this Council Regulation.
(13) *
This Regulation shall apply to advanced therapy medicinal products and to
Of 13 November 2007 amending Directive 2001/83 / EC and Regulation (EC) No 726/2004
Provisions necessary for the implementation of Regulation (EC) No 1394/2007 of the European Parliament and of the Council
states.
Annex 1 to Decree 35/2005 (VIII. 26.) EüM *
Annex 2 to Decree 35/2005 (VIII. 26.) EüM
Personal and material conditions for conducting clinical trials
In terms of their scope, the following types of test sites can be distinguished:
I. Clinical pharmacology site for phase I study
II. Clinical trial site II. phase test
III. Other clinical trial site
I. Clinical pharmacology site for phase I study
A) Material conditions:
The clinical pharmacology research site is a university clinic or a hospital department at the institution
a unit with an intensive care unit background, separate from active patient care, for which
laboratory equipment and facilities for the Phase I study are available.
A clinical pharmacology test site shall be provided locally in a separate piece of legislation, a
the minimum conditions for on-call time for machinery and other equipment
equipment, with the exception of the maternity unit package and the car.
The number of beds for a clinical trial shall be specified in the decision to classify the trial site.
B) Personal conditions:
1. The head of the clinical pharmacology site must have:
a) a specialist in a clinical profession,
(b) a clinical pharmacological examination.
2. The examiner must have
a) a specialist in a clinical profession,
(b) by a clinical pharmacological examination or not more than five years before the start of the clinical trial.
with proof of successful completion of an older university-organized GCP course.
3. *
The study director must have clinical pharmacology
specialist examination.
II. Clinical trial site II. phase test
THE)  *
Material conditions:
Inpatient department or outpatient clinic in a university clinic or hospital,
or other specialist practice that has appropriate diagnostic units and that complies
the minimum personal and material conditions of the health care provider specified in a separate legal regulation, and a
it also has the means and equipment necessary to perform the planned test.
B) Personal conditions:
The study director should have the intended use of the study preparation
with a specialist examination in an appropriate clinical field and a clinical pharmacology examination, or for five years
with no older certificate of completion of a GCP course organized by a university. If
there are minors to be included in the study, and a pediatrician to be included in the study
must also be.
III. *
Clinical trial site for other clinical trials
1. Other clinical investigations may be performed in accordance with Annex II. Material as defined in point A)
conditions, and in a general practitioner’s or home pediatrician’s office. *
2. The study director must have a certificate not older than five years
that he has completed a GCP course organized by a university. *
Annex 3 to Decree 35/2005 (VIII. 26.) EüM *
Modified: 16/2014. (III. 12.) of the EMMI Decree § 12 a). Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
Modified: 3/2014. (I. 16.) EMMI Decree § 17 a), 23/2015. (IV. 28.) of the EMMI Decree § 72 a).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a).
Repealed: 21 X 2009.
Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Filed: 32/2009. (X. 20.) EüM Decree § 1 (1). Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Found: 32/2009 (X. 20.) EüM Decree § 1 (2). Modified: 16/2014. (III. 12.) EMMI Decree § 11 b).
Modified: 3/2014. (I. 16.) EMMI Decree § 17 b), 23/2015. (IV. 28.) EMMI Decree § 72 b).
Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), 23/2015. (IV. 28.) EMMI Decree § 72 c).
Filed: 32/2009. (X. 20.) EüM decree § 2. Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), d), 23/2015. (ARC.
28.) Article 72 c), d) of the EMMI Decree.
Found: 53/2008. (XII. 31.) EüM Decree § 2 (1). Renumbered 32/2009. (X. 20.) EüM decree § 2.
For non-executable amendments, see 32/2009. (X. 20.) EüM Decree § 12 (4) b).
Found: 8/2018. (II. 13.) EMMI Decree § 27 (1). Valid: 2018. II. 14
from.
Found: 32/2009 (X. 20.) EüM Decree § 3 (1). Effective from 21 December 2009. It was submitted before, but away
in the case of pending examination requests, the provisions of this Regulation shall apply.
Modified: 16/2014. (III. 12.) EMMI Decree § 11 c).
Found: 8/2018. (II. 13.) EMMI Decree § 27 (2). Valid: 2018. II. From 14 p.m.
Filed: 18/2018. (VII. 4.) EMMI Decree § 4. Valid: 2018. VII. from 5.
The text of the second sentence was established: 32/2009. (X. 20.) EüM decree 3.
§ (3). Effective: X. 21, 2009. In the case of examination requests submitted before that but not adjudicated, the e
Regulation shall apply.
Modified: 16/2014. (III. 12.) EMMI Decree § 11 d).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 e).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a). Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
Repealed by: 8/2018. (II. 13.) EMMI Decree § 28 a). Repealed: 2018. II. 14 onwards.
Filed: 32/2009. (X. 20.) EüM decree § 4. Effective: X. 21, 2009. It was submitted before, but not judged
in the case of requests for inspections, the provisions of this Regulation shall apply.
Filed: 32/2009. (X. 20.) EüM decree § 4. Effective: X. 21, 2009. It was submitted before, but not judged
in the case of requests for inspections, the provisions of this Regulation shall apply.
Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a).
Modified: 16/2014. (III. 12.) of the EMMI Decree § 11 a). Modified: 16/2014. (III. 12.) EMMI Decree § 11 f).
Modified: 16/2014. (III. 12.) EMMI Decree § 12 b).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed by: 8/2018. (II. 13.) EMMI Decree § 28 b). Repealed: 2018. II. 14 onwards.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Found: 32/2009 (X. 20.) EüM decree § 5. Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Repealed by: 8/2018. (II. 13.) EMMI Decree § 28 c). Repealed: 2018. II. 14 onwards.
Repealed by: 8/2018. (II. 13.) EMMI Decree § 28 c). Repealed: 2018. II. 14 onwards.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed the previous second sentence: 32/2009. (X. 20.) EüM Decree § 12 (4) a). Invalid: X. 2009
21 onwards.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed with previous subtitle: 32/2009. (X. 20.) EüM Decree § 12 (4) a). Invalid: X. 2009
21 onwards.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), e), 23/2015. (IV. 28.) EMMI Decree § 72 c), e).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Modified: 3/2014. (I. 16.) EMMI Decree § 17 f), 23/2015. (IV. 28.) EMMI Decree § 72 f), g).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Completed: 31/2006. (VIII. 23.) EüM decree § 3. Effective: VIII. From 28. Filed: 32/2009. (X. 20.) EüM
§ 6 of the Decree. Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), 23/2015. (IV. 28.) EMMI Decree § 72 c).
Repealed with previous subtitle: 32/2009. (X. 20.) EüM Decree § 12 (4) a). Invalid: X. 2009
21 onwards.
Amended by: 32/2009 (X. 20.) EüM Decree § 12 (3).
Found: 32/2009 (X. 20.) EüM decree § 7. Effective: X. 21, 2009. It was submitted before, but not
In the case of pending applications for examination, the provisions of this Regulation shall apply.
Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), 23/2015. (IV. 28.) EMMI Decree § 72 c).
Modified: 3/2014. (I. 16.) EMMI Decree § 17 c), 23/2015. (IV. 28.) EMMI Decree § 72 c).
Found: 3/2014. (I. 16.) EMMI Decree § 16 (1). Effective from 26 January 2014.
Modified: 3/2014. (I. 16.) EMMI Decree § 17 g), 23/2015. (IV. 28.) EMMI Decree § 72 h).
Found: 3/2014. (I. 16.) EMMI Decree § 16 (2). Amended by 23/2015. (IV. 28.) EMMI Decree § 72 c), d).
Modified: 3/2014. (I. 16.) EMMI Decree § 17 h), 23/2015. (IV. 28.) EMMI
Section 72 (i) of the Decree.
Found: 32/2009 (X. 20.) EüM decree § 8. Modified: 3/2014. (I. 16.) EMMI Decree § 17 d), g), 23/2015.
(IV. 28.) EMMI Decree § 72 d), h). Repealed by: 118/2008. (V. 8.) Government Decree 5. § 104.
Repealed: from 16 May 2008.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed by: 118/2008. (V. 8.) Government Decree § 5 104. Invalid: from 16 V. 2008.
Inserted last sentence: 32/2009. (X. 20.) EüM decree § 9. Effective: X. 21, 2009. Before this
In the case of requests for examination submitted but not pending, the provisions of this Regulation shall apply.
Repealed: Section 25 (10) of the same decree. Repealed: 2005. XI. From 1.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Repealed by: 118/2008. (V. 8.) Government Decree § 5 104. Invalid: from 16 V. 2008.
Repealed by:. (XII. 31.) EüM Decree pursuant to Section 6 (3). Repealed: 2008. XII. 31 onwards.
Filed: 53/2008. (XII. 31.) EüM Decree § 2 (2). Valid: 2008. XII. 31 onwards.
Filed: 53/2008. (XII. 31.) EüM Decree § 2 (2). Valid: 2008. XII. 31 onwards.
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.
Filed: 32/2009. (X. 20.) EüM Decree § 10 (1). Effective: X. 21, 2009.
See 32/2009. (X. 20.) EüM Decree § 12 (2). Amended by: 32/2009 (X. 20.) EüM Decree § 12 (4) b).
Found: 32/2009 (X. 20.) EüM Decree § 10 (2). Effective from 21 December 2009.
See 32/2009. (X. 20.) EüM decree § 12 (1).
See 32/2009. (X. 20.) EüM Decree § 12 (2).
Repealed by: 32/2009 (X. 20.) EüM Decree § 12 (4) a). Repealed: 21 X 2009.