0A4F4F9BD490A749D5437F821CF06DF1
Executive Order No. 295 on Clinical Trials of Medicinal Products on Humans (2006)
https://www.retsinformation.dk/Forms/R0710.aspx?id=9891
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| 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
Political / criminal
Searching for indicator criminal:
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p.(None): The Danish Medicines Agency will be notified, registered.
p.(None): Order to change or stop clinical trials
p.(None): § 10. If the Danish Medicines Agency during the trial gets a basis for assuming that the trial is not carried out in
p.(None): in accordance with the application or permit, or if there are other circumstances which give rise to doubt
p.(None): regarding the safety and scientific aspects of the trial, the Danish Medicines Agency may require the trial
p.(None): changed or paused, or the board may prohibit the trial.
p.(None): PCS. 2. Before the Danish Medicines Agency makes a decision pursuant to subsection (1). 1, the Board requests a sponsor and / or investigator
p.(None): on an opinion which must be communicated to the Board within 7 days.
p.(None): PCS. 3. The Danish Medicines Agency may fail to obtain an opinion, cf. 2, if the Board considers that a postponement
p.(None): of the decision may pose a security risk to the subjects.
p.(None): PCS. 4. In the event of a decision to suspend or prohibit a trial, the Danish Medicines Agency shall immediately notify its decision
p.(None): as well as the rationale for the Scientific Ethics Committee concerned, the European Medicines Agency,
p.(None): Commission and other EU / EEA countries.
p.(None): penalty provisions
p.(None): § 11. Unless higher penalties are imposed under other legislation, penalties are imposed on those who
p.(None): 1) violates § 4 (1). 1 and 4, 5, 6, 7 or 8 of this Order, or
p.(None): 2) fails to comply with orders issued pursuant to section 10 (2). First
p.(None): PCS. 2. Companies may be imposed, etc. (legal persons) criminal liability in accordance with the rules of Chapter 5 of the Criminal Code.
p.(None): Effective Determination
p.(None): Section 12. The Order shall enter into force on 7 May 2004.
p.(None): Ministry of the Interior and Health, 26 April 2004
p.(None): Lars Løkke Rasmussen
p.(None): / Paul Schüder
p.(None): Official notes
p.(None): 1. The Order contains provisions implementing Council Directive 2001/20 / EEC of 4 April 2001, Official Journal L121, p. 34.
p.(None): rettinformation.dk always uses a temporary cookie (session cookie) on all pages. A session cookie expires when Accept cookies
p.(None): one has closed the browser. If you accept cookies, courtsinformation.dk saves this choice and whether you have one
p.(None): used simple search or field search of a cookie, which always expires after 12 months. Read more
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): Publication date: 06-05-2004
p.(None): Ministry of Health and Elderly
p.(None): Show more...
p.(None): Executive Order on Clinical Trials of Drugs on
p.(None): 1) Later amendments to the regulation
p.(None): people BEK no 903 of 18/08/2006
p.(None): Pursuant to section 24 (2). 9, 24a, para. 3 and 4, 24b, para. 5 and 24c, para. 1 of the Medicines Act, cf. Statutory Order No. 656 of
p.(None): Legislation the regulation concerns
p.(None): On 28 July 1995, as amended by Law No 382 of 28 May 2003,
p.(None): LBK No. 99 of 16/01/2018
p.(None): Field of application
p.(None): Changes in / cancels
p.(None): § 1. This Order covers all clinical trials of medicinal products for human beings for which authorization is sought.
p.(None): to be implemented in Denmark after 1 May 2004, cf. section 24 of the Medicines Act.
p.(None): Links to EU directives, cf. note 1
p.(None): PCS. 2. However, non-intervention trials are not covered by the Order. 32001L0020 html note
p.(None): Definitions Additional documents:
p.(None): Regulations implementing the EU
p.(None): Section 2. For the purposes of this Executive Order, the following terms shall be used in the meanings specified: Directive 32001L0020
p.(None): All circulars, guides, etc. to
p.(None): 1) Clinical Trials: Any trial of human beings intended to uncover or verify the clinical, pharmacological this Order.
p.(None): Decisions taken pursuant to this
p.(None): and / or other pharmacodynamic effects of one or more trial drugs and / or identifying adverse effects in a legal regulation
p.(None): Reports from the Ombudsman,
p.(None): or multiple trial drugs and / or to investigate the absorption, distribution, metabolism, and excretion of one or more of the applicants using this legal regulation
p.(None): test drugs to assess safety and / or efficacy.
p.(None): 2) Non-intervention trials: a study in which the drug or drugs are prescribed as usual in
p.(None): in accordance with the terms of the marketing authorization. The decision to prescribe that person
p.(None): drug is clearly separate from the decision to include the patient in the study. The treatment itself does not happen
p.(None): according to an experimental protocol, but follows common practice. No additional diagnostic or
p.(None): control procedures and epidemiological methods must be used to analyze the data collected.
p.(None): 3) Appropriately designed application: An application containing the information that the Danish Medicines Agency must receive
p.(None): to subsequently be able to make a professional assessment of the trial as well as the benefits and risk of the participants.
p.(None): 4) Event: any adverse event in a patient or subject in a clinical trial after treatment with a
p.(None): drug, without necessarily linking this treatment to the adverse event.
p.(None): 5) Side effect: any harmful and undesirable reaction to a trial drug regardless of dose.
p.(None): 6) Unexpected side effect: a side effect whose nature or seriousness does not match the product information (e.g.
p.(None): investigator's brochure for an unapproved trial drug or, in the case of an approved product,
p.(None): the SPC).
p.(None): 7) Serious event or serious side effect: an event or side effect that, regardless of dose, results in death
p.(None): life-threatening, resulting in hospitalization or prolongation of current hospital stay, resulting in persistent or
p.(None): significant disability or incapacity or being a congenital anomaly or malformation.
p.(None): 8) Personal code number: the patient's trial number.
p.(None): The Danish Medicines Agency's processing of applications
p.(None): § 3. If an application for permission for a clinical trial is not properly designed, the Danish Medicines Agency shall sponsor
p.(None): notice of this.
p.(None): PCS. 2. The notification, cf. 1, shall be made as soon as possible upon receipt of the application and shall state the information
p.(None): that is missing, as well as a deadline for sending them.
p.(None): Trial protocol changes
p.(None): § 4. Before the sponsor makes changes to the trial protocol for an already permitted clinical trial, the sponsor must apply for
p.(None): The Danish Medicines Agency's permission for this, if the changes can affect:
p.(None): 1) the safety of subjects,
p.(None): 2) the interpretation of the scientific evidence on which the experiment is based;
p.(None): 3) the conduct or conduct of the experiment;
p.(None): 4) the quality or safety of any test drug used in the trial;
p.(None): or in the case of changes which are otherwise considered to be significant.
p.(None): PCS. 2. Upon receipt of an application for permission to change the trial protocol, the Danish Medicines Agency
p.(None): within 35 days sponsor notification of any reasoned objections to the proposed changes.
p.(None): PCS. 3. If the Danish Medicines Agency notifies the sponsor of a reasoned objection, the sponsor must adapt the planned
p.(None): amendment accordingly or withdraw its amendment application.
p.(None): PCS. 4. If the Danish Medicines Agency has no objection, the Board shall authorize the proposed changes and sponsor
p.(None): must then continue the clinical trial in accordance with the modified trial protocol.
p.(None): § 5. If the sponsor or investigator becomes aware of circumstances that could pose a risk to one
p.(None): sponsor or investigator must immediately take the necessary measures to protect
p.(None): subject.
p.(None): PCS. 2. The sponsor shall immediately notify the Danish Medicines Agency of these new circumstances and the measures taken,
p.(None): cf. First
p.(None): Investigators reporting incidents
p.(None): Section 6. Investigators must immediately report all serious incidents to the sponsor, with the exception of the serious
p.(None): events which in the trial protocol or investigator's brochure are designated as events that do not require immediate
p.(None): reporting. The report must be followed up by a detailed written report and in the immediate report as well as in the report.
p.(None): In the subsequent report, the investigator must identify the subjects with a personal code number.
p.(None): PCS. 2. Investigator shall also report to the sponsor events and / or abnormal analysis results which in
p.(None): The trial protocol is listed as being critical to the safety of the subjects. Reporting must be done in
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): in accordance with the terms of the marketing authorization. The decision to prescribe that person
p.(None): drug is clearly separate from the decision to include the patient in the study. The treatment itself does not happen
p.(None): according to an experimental protocol, but follows common practice. No additional diagnostic or
p.(None): control procedures and epidemiological methods must be used to analyze the data collected.
p.(None): 3) Appropriately designed application: An application containing the information that the Danish Medicines Agency must receive
p.(None): to subsequently be able to make a professional assessment of the trial as well as the benefits and risk of the participants.
p.(None): 4) Event: any adverse event in a patient or subject in a clinical trial after treatment with a
p.(None): drug, without necessarily linking this treatment to the adverse event.
p.(None): 5) Side effect: any harmful and undesirable reaction to a trial drug regardless of dose.
p.(None): 6) Unexpected side effect: a side effect whose nature or seriousness does not match the product information (e.g.
p.(None): investigator's brochure for an unapproved trial drug or, in the case of an approved product,
p.(None): the SPC).
p.(None): 7) Serious event or serious side effect: an event or side effect that, regardless of dose, results in death
p.(None): life-threatening, resulting in hospitalization or prolongation of current hospital stay, resulting in persistent or
p.(None): significant disability or incapacity or being a congenital anomaly or malformation.
p.(None): 8) Personal code number: the patient's trial number.
p.(None): The Danish Medicines Agency's processing of applications
p.(None): § 3. If an application for permission for a clinical trial is not properly designed, the Danish Medicines Agency shall sponsor
p.(None): notice of this.
p.(None): PCS. 2. The notification, cf. 1, shall be made as soon as possible upon receipt of the application and shall state the information
p.(None): that is missing, as well as a deadline for sending them.
p.(None): Trial protocol changes
p.(None): § 4. Before the sponsor makes changes to the trial protocol for an already permitted clinical trial, the sponsor must apply for
p.(None): The Danish Medicines Agency's permission for this, if the changes can affect:
p.(None): 1) the safety of subjects,
p.(None): 2) the interpretation of the scientific evidence on which the experiment is based;
p.(None): 3) the conduct or conduct of the experiment;
p.(None): 4) the quality or safety of any test drug used in the trial;
p.(None): or in the case of changes which are otherwise considered to be significant.
p.(None): PCS. 2. Upon receipt of an application for permission to change the trial protocol, the Danish Medicines Agency
p.(None): within 35 days sponsor notification of any reasoned objections to the proposed changes.
p.(None): PCS. 3. If the Danish Medicines Agency notifies the sponsor of a reasoned objection, the sponsor must adapt the planned
p.(None): amendment accordingly or withdraw its amendment application.
p.(None): PCS. 4. If the Danish Medicines Agency has no objection, the Board shall authorize the proposed changes and sponsor
p.(None): must then continue the clinical trial in accordance with the modified trial protocol.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): Sponsor's reporting of serious side effects
p.(None): Section 8. The sponsor must ensure that all information about unexpected and serious suspected adverse reactions that are fatal or
p.(None): life-threatening, registered and reported to the Danish Medicines Agency.
p.(None): PCS. 2. Reporting, cf. 1, must be done as soon as possible and no later than 7 days after the sponsor has become aware of such
p.(None): side effect.
p.(None): PCS. 3. Not later than 8 days after the report, the sponsor must notify the Danish Medicines Agency of all relevant information
p.(None): sponsors and investigators' follow-up to the report.
p.(None): PCS. 4. All unexpected and serious suspected adverse reactions other than those referred to in para. 1 shall be reported to
p.(None): The Danish Medicines Agency no later than 15 days after the sponsor became aware of these.
p.(None): PCS. 5. The sponsor must notify all relevant investigators of the adverse reactions mentioned above.
p.(None): § 9. The Danish Medicines Agency shall ensure that all unexpected and serious suspected adverse reactions that are reported
p.(None): The Danish Medicines Agency will be notified, registered.
p.(None): Order to change or stop clinical trials
p.(None): § 10. If the Danish Medicines Agency during the trial gets a basis for assuming that the trial is not carried out in
p.(None): in accordance with the application or permit, or if there are other circumstances which give rise to doubt
p.(None): regarding the safety and scientific aspects of the trial, the Danish Medicines Agency may require the trial
p.(None): changed or paused, or the board may prohibit the trial.
p.(None): PCS. 2. Before the Danish Medicines Agency makes a decision pursuant to subsection (1). 1, the Board requests a sponsor and / or investigator
p.(None): on an opinion which must be communicated to the Board within 7 days.
p.(None): PCS. 3. The Danish Medicines Agency may fail to obtain an opinion, cf. 2, if the Board considers that a postponement
p.(None): of the decision may pose a security risk to the subjects.
p.(None): PCS. 4. In the event of a decision to suspend or prohibit a trial, the Danish Medicines Agency shall immediately notify its decision
p.(None): as well as the rationale for the Scientific Ethics Committee concerned, the European Medicines Agency,
p.(None): Commission and other EU / EEA countries.
p.(None): penalty provisions
p.(None): § 11. Unless higher penalties are imposed under other legislation, penalties are imposed on those who
p.(None): 1) violates § 4 (1). 1 and 4, 5, 6, 7 or 8 of this Order, or
p.(None): 2) fails to comply with orders issued pursuant to section 10 (2). First
p.(None): PCS. 2. Companies may be imposed, etc. (legal persons) criminal liability in accordance with the rules of Chapter 5 of the Criminal Code.
p.(None): Effective Determination
p.(None): Section 12. The Order shall enter into force on 7 May 2004.
p.(None): Ministry of the Interior and Health, 26 April 2004
p.(None): Lars Løkke Rasmussen
p.(None): / Paul Schüder
p.(None): Official notes
p.(None): 1. The Order contains provisions implementing Council Directive 2001/20 / EEC of 4 April 2001, Official Journal L121, p. 34.
p.(None): rettinformation.dk always uses a temporary cookie (session cookie) on all pages. A session cookie expires when Accept cookies
p.(None): one has closed the browser. If you accept cookies, courtsinformation.dk saves this choice and whether you have one
p.(None): used simple search or field search of a cookie, which always expires after 12 months. Read more
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None): in accordance with the terms of the marketing authorization. The decision to prescribe that person
p.(None): drug is clearly separate from the decision to include the patient in the study. The treatment itself does not happen
p.(None): according to an experimental protocol, but follows common practice. No additional diagnostic or
p.(None): control procedures and epidemiological methods must be used to analyze the data collected.
p.(None): 3) Appropriately designed application: An application containing the information that the Danish Medicines Agency must receive
p.(None): to subsequently be able to make a professional assessment of the trial as well as the benefits and risk of the participants.
p.(None): 4) Event: any adverse event in a patient or subject in a clinical trial after treatment with a
p.(None): drug, without necessarily linking this treatment to the adverse event.
p.(None): 5) Side effect: any harmful and undesirable reaction to a trial drug regardless of dose.
p.(None): 6) Unexpected side effect: a side effect whose nature or seriousness does not match the product information (e.g.
p.(None): investigator's brochure for an unapproved trial drug or, in the case of an approved product,
p.(None): the SPC).
p.(None): 7) Serious event or serious side effect: an event or side effect that, regardless of dose, results in death
p.(None): life-threatening, resulting in hospitalization or prolongation of current hospital stay, resulting in persistent or
p.(None): significant disability or incapacity or being a congenital anomaly or malformation.
p.(None): 8) Personal code number: the patient's trial number.
p.(None): The Danish Medicines Agency's processing of applications
p.(None): § 3. If an application for permission for a clinical trial is not properly designed, the Danish Medicines Agency shall sponsor
p.(None): notice of this.
p.(None): PCS. 2. The notification, cf. 1, shall be made as soon as possible upon receipt of the application and shall state the information
p.(None): that is missing, as well as a deadline for sending them.
p.(None): Trial protocol changes
p.(None): § 4. Before the sponsor makes changes to the trial protocol for an already permitted clinical trial, the sponsor must apply for
p.(None): The Danish Medicines Agency's permission for this, if the changes can affect:
p.(None): 1) the safety of subjects,
p.(None): 2) the interpretation of the scientific evidence on which the experiment is based;
p.(None): 3) the conduct or conduct of the experiment;
p.(None): 4) the quality or safety of any test drug used in the trial;
p.(None): or in the case of changes which are otherwise considered to be significant.
p.(None): PCS. 2. Upon receipt of an application for permission to change the trial protocol, the Danish Medicines Agency
p.(None): within 35 days sponsor notification of any reasoned objections to the proposed changes.
p.(None): PCS. 3. If the Danish Medicines Agency notifies the sponsor of a reasoned objection, the sponsor must adapt the planned
p.(None): amendment accordingly or withdraw its amendment application.
p.(None): PCS. 4. If the Danish Medicines Agency has no objection, the Board shall authorize the proposed changes and sponsor
p.(None): must then continue the clinical trial in accordance with the modified trial protocol.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| criminal | criminal |
| disability | Mentally Disabled |
| drug | Drug Usage |
| incapacity | Incapacitated |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input