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Overview (table of contents) LAW No. 620 of 08/06/2016 Applicable
Publication date: 09-06-2016
Ministry of Health and Elderly
Section I Clinical Trials Show more ...
Chapter 1 Scope of the Act
Omtryk
Section II Clinical Trials of Medicinal Products for Human Use
See reprint note
Chapter 2 Consent to Participation in Trials
Later changes to the regulation
Chapter 3 Science Ethics Drug Committees
LBK No. 1083 of 15/09/2017
Chapter 4 Processing of applications for and conduct of experiments LBK No. 99 of 16/01/2018
LAW No. 314 of 25/04/2018 Section 3
LAW No. 726 of 08/06/2018 § 1
Chapter 5 Prescription Drugs Act No. 557 of 29/05/2018 Section 3
LBK No. 1252 of 31/10/2018
Chapter 6 Monitoring, control and inspection
Section III Clinical Trials of Animal Drugs Change in / cancel
LAW No. 440 of 09/06/2004
Chapter 7 Application and monitoring and control of trials
LAW No. 593 of 14/06/2011
LBK No. 1113 of 07/11/2011
Section IV Final provisions LBK No 506 of 20/04/2013
LBK No. 1202 of 14/11/2014
LBK No. 1188 of 24/09/2016
Chapter 8 Complaint
LBK No. 84 of 17/01/2017
LBK No. 1022 of 28/08/2017
Chapter 9 Financing, etc. LBK No. 191 of 28/02/2018
LBK No. 1286 of 02/11/2018
LBK No. 903 of 26/08/2019
Chapter 10 Remuneration
Chapter 11 Penalty
Links to other EU documents
Chapter 12 Entry into force, etc. 32014R0536 html note
Chapter 13 Amendments to other legislation
Additional documents:
Chapter 14 Faroe Islands and Greenland Regulations, which also relate to
EU document 32014R0536
Bill for this law
The full text All notices etc. and
circulars, etc. to this law
Decisions taken pursuant to this
1) law
Law on Clinical Trials of Medicines Reports by the Ombudsman,
applying this legal regulation
WE MARGRETHE THE SECOND, by the Grace of God the Queen of Denmark, makes wonders:
The Parliament has passed and We, by our consent, upheld the following law:
Section I
Clinical trials
Chapter 1
Scope of the Act
§ 1. The Act applies in the assessment of the Danish Medicines Agency and the scientific ethics committees and
monitoring of clinical trials of human medicines in accordance with the rules of the European Parliament and
Council Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials of medicinal products for human use and on
repeal Directive 2001/20 / EC.
PCS. 2. The Act also applies to the Danish Medicines Agency's assessment and control of clinical trials
medicines on animals.
Section 2. For the purposes of this Act:
1) Regulation: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials with
on medicinal products for human use and repealing Directive 2001/20 / EC.
2) Sponsor: A person, company, institution or organization that assumes responsibility for initiation, management and
organizing the funding of a clinical trial.
3) Investigator: A person responsible for conducting a clinical trial at a clinical trial site.
4) Consent: An informed consent which is a test subject's forced and voluntary expression of his willingness to participate
in a particular clinical trial after being informed of all aspects of the clinical trial that are relevant to
the decision of the test subject to participate or, in the case of minors and test subjects who are without
ability, permission or deputy consent of their legally appointed representative to involve them in the
clinical trials.
5) Legally appointed representative: a natural or legal person or authority or body which, in accordance with the applicable
legislation is authorized to give informed consent on behalf of an investigator (deputy consent) who:
is without acting or underage.
Section II
Clinical trials of drugs in humans
Chapter 2
Consent to participate in trials
§ 3. Deputy consent on behalf of minors shall be given by the custodian
holder, cf., however, section 4 (2). First
PCS. 2. Deputy consent on behalf of subjects under guardianship, including the power to notify
consent to participation in health science research projects, cf. Section 5 (1) of the Guardianship Act. 1, must be given by the guardian.
PCS. 3. Substitute consent on behalf of other test subjects without the ability to act shall be given by the nearest
relatives and probation guardian. The trial guardian is a doctor who is independent of the investigator's interests and interests
the clinical trial of drugs in general.
PCS. 4. The deputy consent shall express the interest of the test subject.
§ 4. A clinical trial may only be conducted on a subject who is 15 years of age and not yet of legal age, if
the test subject and the custodian hold the consent.
PCS. 2. Children between the ages of 5 and 15 should be consulted as far as possible about their participation in a clinical trial.
PCS. 3. The Minister of Health and Elderly may lay down detailed rules for consultation pursuant to subsection (1). 2nd
§ 5. The requirement for a signature in accordance with Article 29 of the Regulation on informed consent may be fulfilled by the use of one
technique that ensures clear identification of the person signing the document.
PCS. 2. The Minister of Health and the Elderly may lay down detailed rules on the content of the participant information and requirements regarding
the form of the signature.
PCS. 3. The Minister of Health and Elderly may lay down detailed rules on the qualifications of the person giving the
oral information and receives the informed consent of the subject.
PCS. 4. The Minister of Health and Elderly may lay down detailed rules on consent and participation in trials for persons,
which may be subject to particular pressure to participate in a clinical trial of drugs.
Chapter 3
Science ethics drug committees
§ 6. The Minister of Health and the Elderly establishes one or more scientific ethical drug committees.
§ 7. A scientific ethical committee on medicine consists of eight members who are appointed as follows:
1) The Minister of Health and Elderly appoints the chair of the committee.
2) 5 members are appointed by the Minister of Health and Elderly following recommendations from the individual regional councils.
3) 2 members are appointed by the Minister of Health and Elderly following recommendations from organizations representing patients.
PCS. 2. The chairman shall be active in the field of health science research.
PCS. 3. For each region, in accordance with paragraph 1, 1 (2), respectively, appoint a lay person and a person who
is active in health science research. The settings for the Minister of Health and Elderly of persons who are
active in health sciences research, must be made according to recommendations to the individual regional councils from relevant
research forums.
PCS. 4. At the time of appointment, it shall be ensured that, in addition to the chair, the committee has 4 lay persons and 3 members who are
active in the health sciences research.
PCS. 5. A committee shall elect its own Vice-President.
PCS. 6. A committee may set up subcommittees which take decisions and perform the duties of the committees in general.
PCS. 7. The Scientific Medicines Committees draw up a joint proposal for rules of procedure which are approved by
the Minister of Health and Elderly.
PCS. 8. The members of the committees shall be appointed for a term of four years at a time corresponding to the term of office for the regional councils.
Members may be reappointed twice. Alternate members may be appointed.
PCS. 9. The outgoing committee shall continue to operate until new members are appointed and the new committee is constituted.
PCS. 10. The Minister of Health and the Elderly may lay down detailed rules on which forums are relevant research subjects
forums, cf. 4th
PCS. 11. The Minister of Health and Elderly may lay down detailed rules on documentation requirements for the members of
the scientific ethics committee does not have conflicts of interest and that they are independent of the sponsor, rather than the
clinical trials, the investigators involved and the people who fund the clinical trial and that they are not under
other undue influence.
§ 8. Is it in a scientific ethics committee or a subcommittee established pursuant to section 7 (2)? 6, not possible to achieve
If the committee agrees on the assessment of an application or other matters under the regulation or this law, the committee shall decide
however, cf. 2 and 3. The Committee's decision shall be taken on the basis of the recommendations of a majority of its members
the competent committee. In the event of an equality of votes, the chairman's or, in the event of the president's absence, the Vice-President's vote
essential.
PCS. 2. The Chairman or, in the event of the Chairman's absence, the Vice-President shall be part of the majority when the Committee meets.
decision in cases of approval of a trial.
PCS. 3. The chairman of a committee may, on behalf of the committee, decide in cases which are not in doubt.
In addition, the chairman may take a decision when deemed necessary for the safety of the test subjects or for
compliance with the deadlines set in the approval procedures set out in Chapters II and III of the Regulation.
PCS. 4. If the decision is made by the chairman or, in the event of the chairman's absence, the vice-chairman, the committee's
other members as soon as possible thereafter on the decision.
§ 9. The scientific ethical committees on medicine follow research developments in drug trials and work for
understanding the ethical issues that development can bring to the health care system and those
health science research environments.
PCS. 2. The committees shall actively cooperate and coordinate the task with relevant national and international bodies
authorities and organizations, etc.
Chapter 4
Processing of applications for and conducting trials
§ 10. The Danish Medicines Agency and the scientific ethics committees coordinate the processing of applications and
the follow-up to approved trials. The Danish Medicines Agency and the scientific ethics committees must also
cooperation on task fulfillment under the Regulation.
PCS. 2. The Danish Medicines Agency acts as a national point of contact, in accordance with Article 83 of the Regulation.
PCS. 3. When Denmark is a reporting Member State, the Danish Medicines Agency shall carry out all tasks assigned to Denmark as
reporting Member State under the Regulation, except as expressly provided for in this Act or Regulations
provided under this Act.
PCS. 4. The Danish Medicines Agency shall assess whether a trial or activities in a trial fall within the scope of this Act or
Regulation.
Section 11. The Danish Medicines Agency decides whether a clinical trial is approved, whether it is approved under certain conditions or whether
shall be refused approval and shall give the decision in accordance with Article 8 (2). 1 and Article 14 (2). 3, i
the regulation, cf. 6th
PCS. 2. The Danish Medicines Agency declares that Denmark disagrees with the reporting Member State's conclusion in so far as
relates to Part I of the assessment report, cf. Article 8 (2). Article 2 (2) of the Regulation where an application relates only to aspects which are
covered by Part I of the assessment report if either the Danish Medicines Agency or the Scientific Ethics Committee are
disagree with the said conclusion.
PCS. 3. The Scientific Ethics Committee on each application determines whether a clinical trial is approved, whether it
be approved under certain conditions or if approval is refused, in accordance with Article 8 (2). 1 where an application relates only to aspects,
that is covered by Part II of the assessment report and Denmark has not previously disagreed with the reporting
the conclusion of the Member State as regards Part I of the assessment report, cf. 2nd
PCS. 4. The Danish Medicines Agency will assess whether the health aspects of Part I of the assessment report for an application
whether clinical trials of medicinal products for human use have been met, cf. Article 6 (2). 1 of the Regulation.
PCS. 5. The Scientific Medicines Committee assesses the scientific ethical aspects of Part I of
the assessment report has been fulfilled, cf. Article 6 (2). 1 of the Regulation and on the aspects covered by Part II of the assessment report
is fulfilled, cf. Article 7 (2). 1 of the Regulation.
PCS. 6. The Danish Medicines Agency cannot approve a clinical trial or approve a clinical trial under certain conditions, cf.
PCS. 1 if the scientific ethics committee disagrees with the reporting Member State's conclusions in so far as
concerns Part I of the assessment report, of any of the items referred to in Article 8 (2). The grounds or the committee duly stated in paragraph 2 of the Regulation
for justified reasons, consider that the aspects covered by Part II of the assessment report have not been complied with, cf. Article 8 (2). 4, i
Regulation.
§ 12. The Danish Medicines Agency determines whether a substantial change to a trial can be approved, whether the change can be approved
subject to certain conditions or to refusal of approval and to make the decision in accordance with Article 19,
PCS. 1 and Article 23 (1). Without prejudice to paragraph 1 of the Regulation, cf. Third
PCS. 2. The Scientific Medicines Committee shall decide whether a substantial change to a trial is approved
is approved under certain conditions or whether approval is refused when the amendment concerns only one aspect which is
covered by Part II of the Assessment Report and notify the decision in accordance with Article 20 (2). 5 of the Regulation.
PCS. 3. The Danish Medicines Agency cannot approve a significant change to an aspect covered by Part I of
or approve a material change under certain conditions, cf. 1, if the science ethic
the Medicines Committee disagrees with the reporting Member State's conclusions as regards Part I of the assessment report by
any of the items referred to in Article 19 (2); The grounds set out in Article 2 (2) of the Regulation. Similarly, the Danish Medicines Agency cannot approve
significant changes to aspects covered by Part I and Part II of the Assessment Report, or approving significant ones
changes under certain conditions if the SCA disagrees with the reporting Member State
conclusions, as regards Part I of the assessment report, of any of the measures referred to in Article 23 (2). The grounds set out in Article 2 (2) of the Regulation
or the Committee considers that significant aspects covered by Part II of the Assessment Report have not been complied with.
Section 13. The Danish Medicines Agency decides whether to approve a clinical trial or to withdraw the clinical trial
must be suspended and the Danish Medicines Agency may require a sponsor to change any aspect of the clinical
trials pursuant to Article 77 (2). 1 of the Regulation. The Danish Medicines Agency may involve the Scientific Ethics Committee in the assessment of
the basis of the decision. The Scientific Ethics Committee may request the Danish Medicines Agency to consider corrective action
measures after the first paragraph, if the committee deems it necessary.
Section 14. The Minister of Health and the Elderly lays down detailed rules on the aspects of Part I of the assessment report, which also
must be assessed by the scientific ethics committee, including the possible risks to the subjects of the trial.
PCS. 2. The Minister of Health and the Elderly shall lay down detailed rules on administrative cooperation, procedures and
deadlines for the Danish Medicines Agency's and the Scientific Ethics Committee's treatment of clinical applications
trials and follow-up of approved clinical trials.
PCS. 3. The Minister of Health and the Elderly lays down rules on language requirements in clinical trial applications.
Chapter 5
Test drugs
§ 15. The Danish Medicines Agency may grant exemptions from Article 92 of the regulation that, as a starting point, test subjects must
have provided free trial drugs, auxiliary drugs and necessary treatment equipment if
(1) the purpose of the experiment is lost if it is provided free of charge; or
2) they are used for an indication covered by the Summary of Product Characteristics of the medicinal product and the subject, regardless of participation in the trial, is in
a treatment with the drug, where the subject himself pays for the drug.
PCS. 2. In tests carried out in a hospital where the subject is already given the drug, etc. free as part of
the treatment at a hospital, the sponsor may enter into an agreement with the hospital that the hospital pays the costs of
the drug, etc. in connection with the trial.
Section 16. The Minister of Health and the Elderly lays down detailed rules on language requirements on labels on trial medicines and
ancillary drugs, as referred to in Article 69 of the Regulation on labeling languages.
Chapter 6
Monitoring, control and inspection
Section 17. The Danish Medicines Agency controls that the obligations for notification of commencement, interruption, etc. of
trials under Articles 36 and 37 of the Regulation are complied with.
Section 18. The Danish Medicines Agency assesses reports of suspected serious unexpected side effects in accordance with the regulation.
Article 42 and the sponsor's annual report on the safety of a trial drug in accordance with Article 43 of the Regulation.
The Danish Medicines Agency joins the scientific ethics committee if, after a health professional assessment, the Danish Medicines Agency
of the report finds grounds for taking corrective measures pursuant to Article 77 of the Regulation, cf. section 13.
PCS. 2. The Danish Medicines Agency and the Scientific Ethics Committee assess serious violations, unexpected incidents and
emergency measures notified in accordance with Articles 52, 53 and 54 of the Regulation.
PCS. 3. The Minister of Health and the Elderly may lay down detailed rules as to what other obligations for reporting
safety information pursuant to Articles 41-44 of the Regulation or the Danish Medicines Agency or the Scientific Ethics Committee
must ensure compliance with.
Section 19. The Danish Medicines Agency may, before, during and after the conduct of a clinical trial of medicines on humans,
including as part of processing an application for marketing authorization under the Medicines Act and as a follow-up to
issuing a marketing authorization, inspecting any business, hospital, clinic and other place performing or
has performed a clinical trial in Denmark or has performed activities related to a clinical trial performed abroad.
The Danish Medicines Agency may order disclosure of all information on the trial, including written material
necessary for the inspection.
PCS. 2. On the basis of a request from a competent authority in another EU or EEA, the Danish Medicines Agency may:
country or from the European Medicines Agency for the assistance of a clinical trial inspection to inspect any establishment,
any hospital, clinic and other places that perform or have performed a clinical trial of drugs or have
conducted activities in connection with a clinical trial conducted abroad. The Board may require the disclosure of all information about
the experiment, including written material necessary for the inspection.
PCS. 3. A scientific ethics committee may request the Danish Medicines Agency to inspect a company, a hospital, a
clinic and other sites conducting a specific clinical trial if the Committee finds it necessary. When the inspection
concerns the approval or follow-up of a clinical trial of medicines, the Danish Medicines Agency and the
science ethics committee decide that the committee participates in the board's inspection in accordance with subsection (1). 1 and 2 and section 20 (2). First
If the scientific ethics committee participates in the inspection, the committee's representatives have the same rights as
The Danish Medicines Agency according to par. 1 and 2 and pursuant to section 20 (2). 1 and 2.
PCS. 4. The Minister of Health and the Elderly shall lay down detailed rules on the Danish Medicines Agency and the scientific ethics
committee co-operation in conducting clinical trial inspections.
PCS. 5. The Minister of Health and the Elderly may lay down further rules on the Danish Medicines Agency's implementation of
inspections in accordance with para. 1-3.
Section 20. As part of the Danish Medicines Agency's inspection pursuant to section 19 (1). 1 and 2, the representatives of the Board of Directors are entitled
access to companies, hospitals, clinics, and other places that are part of the trial without a court order
completion.
PCS. 2. The Danish Medicines Agency has direct access to obtain information in patient records, etc., including electronic
medical records, in order to see information on the health conditions of subjects needed as part of
The Danish Medicines Agency's inspection pursuant to section 19 (1). 1 and 2.
Section 21. A consent given under Chapter V of the Regulation directly provides sponsors and sponsors' representatives and investigator
access to obtain information in patient records, etc., including in electronic records, in order to view information
on the subject's health conditions, which are necessary as part of self-monitoring of the research project, including
quality control and monitoring that these are required to perform.
PCS. 2. A consent given under Chapter V of the Regulation gives foreign pharmaceutical authorities direct access to
collect information in patient records, etc., including electronic records, in order to view information on
the health conditions of the subject necessary for the quality control of the foreign pharmaceutical authorities as
part of an application for approval of the drug in question.
Section III
Clinical trials on drugs in animals
Chapter 7
Application and monitoring and control of trials
Section 22. A clinical trial of medicinal products on animals may only be carried out when the Danish Medicines Agency has authorized the trial in
according to the rules of this Act.
Section 23. An application for a clinical trial for an animal must be submitted to the Danish Medicines Agency by a sponsor.
PCS. 2. The Minister of Health and the Elderly may lay down detailed rules on time limits on which information an application for
permit for clinical trials with animals must be included and on the Danish Medicines Agency's treatment of such applications.
§ 24. The sponsor or his representative must be domiciled in an EU or EEA country.
§ 25. If the Danish Medicines Agency objects to a clinical trial with animals, the sponsor may change the application once to
take into account the objection. If the application does not change in accordance with the objection, the Board rejects the application.
PCS. 2. The Danish Medicines Agency may impose conditions on the trial against the sponsor and the investigator.
§ 26. If a clinical trial of drugs on animals has begun, the sponsor may only change the trial protocol and
the documentation for the trial drug after approval from the Danish Medicines Agency.
Section 27. Sponsor shall
1) immediately notify the Danish Medicines Agency if unexpected and serious suspicions occur during the trial;
side effects,
2) within 15 days, notify the Danish Medicines Agency if an attempt must be interrupted earlier than planned and give the Board a
justification for the interruption,
(3) compile a list of all serious suspected adverse reactions occurring once a year throughout the trial period;
the trial period, and a report on the safety of the animals and submit them to the Danish Medicines Agency and
4) notify the Danish Medicines Agency not more than 90 days after the end of the trial, that the trial has been completed and as soon as possible and
not later than 1 year submit the test result to the board.
PCS. 2. The Minister of Health and Elderly may lay down detailed rules on the 1 notifications.
PCS. 3. The Minister of Health and the Elderly may lay down detailed rules on the sponsor's duty to notify others, including
responsible for clinical trials and drug authorities in the other EU or EEA countries, on information reported by
PCS. 1, No. 1.
Section 28. If deviations from the approved trial protocol occur during the trial, the Danish Medicines Agency may sponsor a sponsor.
and the investigator may require the trial be amended or paused, or the board may prohibit the trial.
PCS. 2. The Minister of Health and Elderly may lay down detailed rules on the conditions of the Danish Medicines Agency
corrective measures pursuant to para. First
Section 29. Medicines for clinical trials with animals must comply with applicable standards of good manufacturing practice set out in
under the Medicines Act.
PCS. 2. The Danish Medicines Agency shall lay down detailed rules on requirements for the quality and safety of test drugs, including
for their manufacture, and for their control.
Section 30. The Minister of Health and the Elderly may lay down detailed rules on the form requirements for applications and notifications pursuant to
this chapter, including application or notification must be made electronically.
Section 31. The Danish Medicines Agency may, before, during and after the conduct of a clinical trial of medicines on animals,
including as part of the processing of an application for a marketing authorization and as a follow-up to the issuance of a marketing authorization
marketing authorization, controlling any company, etc. that performs or has performed a clinical trial. The Board can
require disclosure of all information, including written material, necessary for the verification.
PCS. 2. On the basis of a request from a competent authority in another EU or EEA, the Danish Medicines Agency may:
country for assistance in the control of a clinical trial, check any company, etc., that performs or has performed a clinical trial
with medicines. The Board may require the disclosure of all information, including written material, which is required
control.
PCS. 3. As part of the Danish Medicines Agency's control, the Agency's representatives are against proper identification and without
court order access to businesses, practices and other places that are part of the conduct of the trial.
PCS. 4. The Danish Medicines Agency's access to control pursuant to subsection (1). 1-3 also includes the Board's compliance with requirements
trial drugs pursuant to section 29 (2). First
Section IV
Final provisions
Chapter 8
Appeals
Section 32. The sponsor may within 30 days of receipt of a decision from the Danish Medicines Agency or the ethics of science
drug committee to appeal to the Ministry of Health and the Elderly as far as legal matters are concerned.
Chapter 9
Financing etc.
Section 33. The Minister of Health and Elderly may lay down rules on the collection and payment of fees from sponsor to cover
of the activities of the Danish Medicines Agency and the scientific ethics committees in accordance with this law and regulations issued in
under the law or regulations issued by the European Union.
Chapter 10
reimbursement
§ 34. The sponsor or, if he does not have a court in Denmark, the investigator must pay compensation of DKK 1,350 to
persons who have participated in a project initiated in contravention of Articles 4 or 28 to 35 of the Regulation.
PCS. 2. The amount of the allowance shall be adjusted annually per year. January 1 with 2.0 per cent. plus the adjustment percentage for that person
financial year, cf. the law on a rate adjustment percentage. The resulting amounts are rounded to the nearest 50 divisible
crown amount. The adjustment is made on the basis of the applicable amounts before rounding at the time of adjustment.
PCS. 3. Compensation pursuant to subsection (1). 2. Paragraph 1 shall be determined on the basis of the amounts in force at the time when:
the subject participated in the clinical trial.
PCS. 4. A science ethics drug committee that becomes aware that a test subject may have a claim
allowance pursuant to subsection (1). 1 may order sponsor, sponsor's representative or, if he / she has no jurisdiction in Denmark,
investigator to inform the persons concerned. The Committee may require the form and content of the information. Committee
may also set a time limit for the transmission of the information.
Chapter 11
Punishment
§ 35. Unless stricter punishment is owed under the other legislation, punishable by fine or imprisonment for up to 4 months
that one
1) initiates a clinical trial of drugs in violation of Article 4 or Article 15 of the Regulation or Section 22 of this Act;
2) fails to comply with the obligation to notify under Article 12, Article 36 (2). Article 37 (1), (2) and (3) 1-3, 5 and 6,
Article 38 (2) Article 52 (1) Article 53 (1) 1 and 2, or Article 54 of the Regulation or § 27 (2). 1 of this Act,
(3) fails to comply with security alerts pursuant to Article 42 (2). Article 43 (1) 1 or Article 46 of
Regulation
4) does not comply with Articles 47 or 48 of the Regulation;
5) infringes Article 63 or Article 65 of the Regulation;
6) fails to comply with an order under Article 77 (2). 1 of the Regulation,
7) fails to comply with an injunction or obligation to provide information pursuant to section 19 (1). 1, second paragraph, and par. Section 20 (2), second paragraph. 2, §
21, § 31 (2). 1, second paragraph, and par. 2, second paragraph, or section 34 (2). 4, or
8) the representatives of the supervisory authority refuse access pursuant to section 20 (2). 1, or § 31 (2). Third
Chapter 12
Entry into force, etc.
Section 36. The Minister of Health and the Elderly determines the time for the entry into force of the Act. The Minister may hereby decide,
that different parts of the Act enter into force at different times, cf. 2nd
PCS. 2. § 37 (1), 6-10, 13, 14 and 16, § 38 (1) and (2), and § 40 enter into force on July 1, 2016.
PCS. 3. For up to 3 years after the entry into force of this Act, the Act does not apply to applications that have been notified before the Act
Entry into force, or on applications which, for up to 1 year after the entry into force of the Act, are notified in accordance with the prevailing rules, cf.
Article 98 of the Regulation. For such applications, the rules in force so far apply.
Chapter 13
Amendments to other legislation
Section 37. In Act No. 593 of June 14, 2011 on the scientific ethical treatment of health science research projects, which
amended by Act No. 604 of June 18, 2012 and Section 6 of Act No. 310 of March 29, 2014, the following amendments are made:
1. Everywhere in the Act, the "National Science Ethics Committee" is changed to: "National Science Ethics Committee".
2. § 1, subs. (2) is replaced by the following:
"PCS. 2. The science ethics committee system consists of regional committees, science ethics drug committees and one
National Committee, cf. Chapter 7 and the Act on Clinical Trials on Medicines. '
3. In section 1, the following paragraph is added: 5:
"PCS. 5. The Act does not apply to health science research projects relating to clinical trials of drugs which
notified under Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials with
medicinal products for human use and repealing Directive 2001/20 / EC. '
4. Paragraph 2 (1), second paragraph, is replaced by the following:
'This includes clinical trials of medical devices, cf.
5. Section 2 (2) is repealed.
No. 3-17 then becomes No. 2-16.
6. In section 2, paragraph 9, which becomes paragraph 8, 'incompetent' is replaced by: 'without action'.
7. In section 2, paragraph 11, which becomes paragraph 10, the words "and the practitioner or in the event of the practitioner's decay are deleted"
Health '.
8. Section 2 (12), which becomes No. 11, is replaced by the following:
'11) Trial Guardian: A doctor who is independent of the interests of the probation officer and of interests in trial projects in
moreover, may give the deputy consent on behalf of the subject for participation in a health science
research project. The probation guardian must protect the interests of the probation officer. "
9. In section 3, subs. 2. In paragraph 2 (3), 'incompatible' is replaced by 'without action'.
10. § 3, subs. (3) is replaced by the following:
"PCS. 3. The consent gives the sponsor and sponsor's representatives and investigator direct access to obtain information in
patient records, etc., including electronic records, for the purpose of viewing information about the subject
health conditions that are necessary as part of self-monitoring of the research project, including quality control and
monitoring which they are required to carry out. "
11. In section 3, subs. 5, "§§ 8-12" is amended to: "§§ 8-11".
12. In section 4, subs. 1, the following is inserted after 'holder': 'cf., however, section 4 a'.
13. § 4, subs. (3) is replaced by the following:
"PCS. 3. Substitute consent on behalf of other test subjects without the ability to act shall be given by the nearest
relatives and probation guardian. "
14. In section 4 (2). 5. In Article 5 (5), 'A practitioner' is changed to: 'Trial guard'.
15. The following is inserted after section 4:
§ 4 a. A clinical trial may only be conducted on a subject who is 15 years of age, but is not yet of legal age, if
the test subject and the holder of the custody authority give consent to this, cf. 1. '
16. In section 5, par. 2, first paragraph, 'incompetent' is replaced by: 'without action'.
17. In section 9, para. Paragraph 1, first paragraph, is inserted after "informed consent": ", cf. section 4 a".
18. In section 11, par. (B) paragraph 1 shall be deleted "not relating to clinical increases in medicinal products";
19. Section 12 is repealed.
20. Section 13 (1). (2) is replaced by the following:
"PCS. 2. involves a research project clinical trial of medical devices to be approved by
The Danish Medicines Agency is authorized by the committee system to carry out the project subject to the necessary permission according to
Medical Devices Act. '
21. In section 15, para. Paragraph 1, first paragraph, is inserted after 'work': ', cf. 3 '.
22. In section 15, par. Paragraph 2, second paragraph, is inserted after 'work': ', cf. 3 '.
23. In section 15, the following paragraph is inserted: 2 as a new paragraph:
"PCS. 3. Clinical trials on medicinal products shall be reported to the scientific ethics committees. '
PCS. 3 then becomes paragraph. 4th
24. In section 19, para. 2 and 3, is deleted 'and does not relate to the notified health science research project with clinical trials
drugs'.
25. In section 21, para. Paragraph 1 is deleted "relating to clinical trials of medicines covered by the Medicines Act".
26. In section 23, para. 2. In paragraph 2, 'gene therapy, somatic cell therapy or drugs' is changed to: 'gene therapy or somatic cell therapy'.
27. In section 23, para. (C) Paragraph 5 is deleted 'which does not include clinical trials of medicinal products'.
28. In section 26, para. Paragraph 1, first paragraph, is inserted after 'regional committee': 'or a scientific ethics committee'.
29. In section 26, para. Paragraph 1, second paragraph, is inserted after 'regional committee': 'or a scientific ethics committee'.
30. In section 27, para. Paragraphs 1, 2, 2, "clinical trials of drugs or" and "Law on medicines respectively" are deleted.
31. In section 28 (2). Paragraph 1, first paragraph, shall be deleted "not relating to clinical trials of medicinal products".
32. Section 28 (2). Paragraph 1, second paragraph, is repealed, and the following is inserted:
'The Regional Committee or the Medical Ethics Committee, which has granted authorization for the implementation of a
research project, oversees that an approved health science research project is carried out in accordance
with this law. If the authorization is granted by the national committee, the supervision shall be exercised by the national committee. '
33. In section 28, para. (3) is deleted "which does not apply to clinical trials of medicines covered by the Medicines Act".
34. Section 30 (2). Paragraph 1, second paragraph, is replaced by the following:
"The obligation to notify also includes serious incidents."
35. In section 30, para. 2. In the first subparagraph of paragraph 2, 'serious unexpected adverse reactions' is replaced by: 'serious adverse reactions'.
36. Section 30 (2). Paragraph 2, second paragraph, is replaced by the following:
"The duty to provide information and information also includes serious incidents."
37. In section 32, para. (B) paragraph 1 is inserted after 'the regional committees': 'and the scientific ethics committees'.
38. In section 34, the following is inserted after "the regional committees": ", the scientific ethics drug committees".
39. In section 41, para. (B) in paragraph 1, point 4 is deleted 'or'.
40. In section 41, para. (B) in paragraph 1, point 5, the word '.' Is replaced by: ', or'.
41. In section 41, para. 1, the following point 6 is added:
'6) fails to comply with an order under section 42 (2). 2. '
42. In section 42, para. 1, the words 'and § 12' are deleted.
43. In section 42, the following paragraph is inserted: 1 as a new paragraph:
"PCS. 2. A scientific ethics committee, which becomes aware that a test subject may be entitled to a claim for compensation
according to para. 1, may order a sponsor or, if he / she has no jurisdiction in Denmark, the person responsible for the trial to inform the
affected persons. The Committee may require the form and content of the information. The Committee may also set a deadline
dissemination of the information. "
PCS. 2-4 becomes paragraph 2. 3-5.
Section 38. In the Medicines Act, cf. Statutory Order No. 506 of 20 April 2013, as amended by section 1 of Act No. 518 of 26 May
2014 and section 2 of Act No. 542 of April 29, 2015, the following amendments are made:
1. In section 89, the following paragraph is inserted: 2 as a new paragraph:
"PCS. 3. A consent given under the Personal Data Act directly grants sponsor and sponsor representatives and investigator
access to obtain information in patient records, etc., including in electronic records, in order to view information
on the subjects' health conditions which are necessary as part of the implementation of the research project, including
quality control and monitoring which they are required to carry out. '
PCS. Subsection 3 and 4 then become paragraphs. 4 and 5.
2. Section 90 (2). (5) is replaced by the following:
"PCS. 5. The Danish Medicines Agency has direct access to obtain information in patient records, etc., including electronic
medical records, in order to see information on the health conditions of subjects needed as part of
The Danish Medicines Agency's inspection in accordance with para. 2-4. "
3. In section 104 (1). Paragraph 1 (4) is inserted after '§ 89 (2). 2 ':' or 3 ', and after' section 90 (2). 2, second paragraph, par. 3. the following paragraph 3 is added:
5 '.
Section 39. In the Health Act, cf. Statutory Order No. 1202 of November 14, 2014, as last amended by § 1 of Act No. 383 of
On April 27, 2016, the following change is made:
1. In section 46 (2). 1, the Act on a Scientific Ethics Committee System and the Treatment of Biomedical Research Projects is amended to:
»Act on the Scientific Ethical Treatment of Health Sciences Research Projects and the Act on Clinical Trials with
drugs'.
Section 40. In Act No. 440 of June 9, 2004 on the Council of Ethics, as amended by section 16 of Act No. 545 of June 24, 2005, Section 45 of Act No. 593
of June 14, 2011, § 2 of Act No. 559 of June 18, 2012 and § 2 of Act No. 601 of June 18, 2012, is amended as follows:
1. In section 9, subs. 1. In the first subparagraph of paragraph 1, the words "National Science Ethics Committee" shall be replaced by: "National Science Ethics Committee".
§ 41. In the Act on access to complaints and compensation within the healthcare system, cf. Statutory Order No. 1113 of 7 November
2011, as last amended by section 18 of Act No. 395 of 2 May 2016, is amended as follows:
1. In section 19, subs. Paragraph 2 (1) is inserted after 'trial': 'including clinical trials of medicinal products'.
Chapter 14
Faroe Islands and Greenland
Section 42. The Act does not apply to the Faroe Islands and Greenland, but may be implemented in whole or in part by royal decree for
Faroe Islands with the changes that the Faroese conditions indicate.
Given at Christiansborg Castle, June 8, 2016
Under Our Royal Hand and Seal
MARGRETHE R.
/ Sophie Løhde
Official notes
1. The Act incorporates certain provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical
trials of medicinal products for human use and repealing Directive 2001/20 / EC, Official Journal 2014, No L 158, page 1. Pursuant to Article 288 TFEU,
The Treaty applies directly to a regulation in each Member State. The reproduction of these provisions in the Act is thus solely based on
for practical reasons and does not affect the immediate validity of the regulation in Denmark.
Omtryksnote
13-07-2016:
Act No. 620 of June 8, 2016 on clinical trials of medicines has been reprinted because of an error in section 36 (1). 2nd
The wording is corrected from »Paragraph. 2. Sections 37 (1), 6-10, 12, 13 and 15, 38 (1) and (2), and 40 shall enter into force on 1 July 2016. '
to » 2. Sections 37 (1), 6-10, 13, 14 and 16, 38 (1) and (2), and 40 shall enter into force on 1 July 2016. '
Section 36 (2). 2, is now in accordance with the wording in the Folketing's reprint of Bill No. L 142 2015-16 as
adopted.
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