To the front page of court information.dk
The full text BEK No. 295 of 26/04/2004 Applicable
Publication date: 06-05-2004
Ministry of Health and Elderly
Show more...
Executive Order on Clinical Trials of Drugs on
1) Later amendments to the regulation
people BEK no 903 of 18/08/2006
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
Legislation the regulation concerns
On 28 July 1995, as amended by Law No 382 of 28 May 2003,
LBK No. 99 of 16/01/2018
Field of application
Changes in / cancels
§ 1. This Order covers all clinical trials of medicinal products for human beings for which authorization is sought.
to be implemented in Denmark after 1 May 2004, cf. section 24 of the Medicines Act.
Links to EU directives, cf. note 1
PCS. 2. However, non-intervention trials are not covered by the Order. 32001L0020 html note
Definitions Additional documents:
Regulations implementing the EU
Section 2. For the purposes of this Executive Order, the following terms shall be used in the meanings specified: Directive 32001L0020
All circulars, guides, etc. to
1) Clinical Trials: Any trial of human beings intended to uncover or verify the clinical, pharmacological this Order.
Decisions taken pursuant to this
and / or other pharmacodynamic effects of one or more trial drugs and / or identifying adverse effects in a legal regulation
Reports from the Ombudsman,
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
test drugs to assess safety and / or efficacy.
2) Non-intervention trials: a study in which the drug or drugs are prescribed as usual in
in accordance with the terms of the marketing authorization. The decision to prescribe that person
drug is clearly separate from the decision to include the patient in the study. The treatment itself does not happen
according to an experimental protocol, but follows common practice. No additional diagnostic or
control procedures and epidemiological methods must be used to analyze the data collected.
3) Appropriately designed application: An application containing the information that the Danish Medicines Agency must receive
to subsequently be able to make a professional assessment of the trial as well as the benefits and risk of the participants.
4) Event: any adverse event in a patient or subject in a clinical trial after treatment with a
drug, without necessarily linking this treatment to the adverse event.
5) Side effect: any harmful and undesirable reaction to a trial drug regardless of dose.
6) Unexpected side effect: a side effect whose nature or seriousness does not match the product information (e.g.
investigator's brochure for an unapproved trial drug or, in the case of an approved product,
the SPC).
7) Serious event or serious side effect: an event or side effect that, regardless of dose, results in death
life-threatening, resulting in hospitalization or prolongation of current hospital stay, resulting in persistent or
significant disability or incapacity or being a congenital anomaly or malformation.
8) Personal code number: the patient's trial number.
The Danish Medicines Agency's processing of applications
§ 3. If an application for permission for a clinical trial is not properly designed, the Danish Medicines Agency shall sponsor
notice of this.
PCS. 2. The notification, cf. 1, shall be made as soon as possible upon receipt of the application and shall state the information
that is missing, as well as a deadline for sending them.
Trial protocol changes
§ 4. Before the sponsor makes changes to the trial protocol for an already permitted clinical trial, the sponsor must apply for
The Danish Medicines Agency's permission for this, if the changes can affect:
1) the safety of subjects,
2) the interpretation of the scientific evidence on which the experiment is based;
3) the conduct or conduct of the experiment;
4) the quality or safety of any test drug used in the trial;
or in the case of changes which are otherwise considered to be significant.
PCS. 2. Upon receipt of an application for permission to change the trial protocol, the Danish Medicines Agency
within 35 days sponsor notification of any reasoned objections to the proposed changes.
PCS. 3. If the Danish Medicines Agency notifies the sponsor of a reasoned objection, the sponsor must adapt the planned
amendment accordingly or withdraw its amendment application.
PCS. 4. If the Danish Medicines Agency has no objection, the Board shall authorize the proposed changes and sponsor
must then continue the clinical trial in accordance with the modified trial protocol.
§ 5. If the sponsor or investigator becomes aware of circumstances that could pose a risk to one
sponsor or investigator must immediately take the necessary measures to protect
subject.
PCS. 2. The sponsor shall immediately notify the Danish Medicines Agency of these new circumstances and the measures taken,
cf. First
Investigators reporting incidents
Section 6. Investigators must immediately report all serious incidents to the sponsor, with the exception of the serious
events which in the trial protocol or investigator's brochure are designated as events that do not require immediate
reporting. The report must be followed up by a detailed written report and in the immediate report as well as in the report.
In the subsequent report, the investigator must identify the subjects with a personal code number.
PCS. 2. Investigator shall also report to the sponsor events and / or abnormal analysis results which in
The trial protocol is listed as being critical to the safety of the subjects. Reporting must be done in
in accordance with the rules and deadlines set out in the Protocol.
PCS. 3. When reporting deaths, the investigator must provide any additional information that the sponsor may request.
Section 7. The sponsor must keep detailed records of all incidents reported by an investigator. These
records must be submitted to the Danish Medicines Agency upon request.
Sponsor's reporting of serious side effects
Section 8. The sponsor must ensure that all information about unexpected and serious suspected adverse reactions that are fatal or
life-threatening, registered and reported to the Danish Medicines Agency.
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
side effect.
PCS. 3. Not later than 8 days after the report, the sponsor must notify the Danish Medicines Agency of all relevant information
sponsors and investigators' follow-up to the report.
PCS. 4. All unexpected and serious suspected adverse reactions other than those referred to in para. 1 shall be reported to
The Danish Medicines Agency no later than 15 days after the sponsor became aware of these.
PCS. 5. The sponsor must notify all relevant investigators of the adverse reactions mentioned above.
§ 9. The Danish Medicines Agency shall ensure that all unexpected and serious suspected adverse reactions that are reported
The Danish Medicines Agency will be notified, registered.
Order to change or stop clinical trials
§ 10. If the Danish Medicines Agency during the trial gets a basis for assuming that the trial is not carried out in
in accordance with the application or permit, or if there are other circumstances which give rise to doubt
regarding the safety and scientific aspects of the trial, the Danish Medicines Agency may require the trial
changed or paused, or the board may prohibit the trial.
PCS. 2. Before the Danish Medicines Agency makes a decision pursuant to subsection (1). 1, the Board requests a sponsor and / or investigator
on an opinion which must be communicated to the Board within 7 days.
PCS. 3. The Danish Medicines Agency may fail to obtain an opinion, cf. 2, if the Board considers that a postponement
of the decision may pose a security risk to the subjects.
PCS. 4. In the event of a decision to suspend or prohibit a trial, the Danish Medicines Agency shall immediately notify its decision
as well as the rationale for the Scientific Ethics Committee concerned, the European Medicines Agency,
Commission and other EU / EEA countries.
penalty provisions
§ 11. Unless higher penalties are imposed under other legislation, penalties are imposed on those who
1) violates § 4 (1). 1 and 4, 5, 6, 7 or 8 of this Order, or
2) fails to comply with orders issued pursuant to section 10 (2). First
PCS. 2. Companies may be imposed, etc. (legal persons) criminal liability in accordance with the rules of Chapter 5 of the Criminal Code.
Effective Determination
Section 12. The Order shall enter into force on 7 May 2004.
Ministry of the Interior and Health, 26 April 2004
Lars Løkke Rasmussen
/ Paul Schüder
Official notes
1. The Order contains provisions implementing Council Directive 2001/20 / EEC of 4 April 2001, Official Journal L121, p. 34.
rettinformation.dk always uses a temporary cookie (session cookie) on all pages. A session cookie expires when Accept cookies
one has closed the browser. If you accept cookies, courtsinformation.dk saves this choice and whether you have one
used simple search or field search of a cookie, which always expires after 12 months. Read more
about Legal Information's use of cookies on the Cookie Policy Accept Session Cookies page