Procedure for obtaining authorisation for a clinical trial, study or experiment in Luxembourg

Submit an application dossier

Biomedical research in Luxembourg is regulated. The Law in question stipulates that no 'clinical trial, study or experiment may be carried out on humans for the purposes of developing biological or medical knowledge without prior authorisation from the Minister, and without the opinion of the Health Directorate and the National Research Ethics Committee (Comité national d’éthique de recherche - CNER) having been sought in advance'.

In order to obtain authorisation for a trial, study or experiment, the interested party must submit an application dossier to the Ministry of Health. The Luxembourg Ministry of Health is the sole entity to which applications should be submitted. The Ministry of Health is responsible for forwarding the applications to the Health Directorate and the National Research Ethics Committee.

_{Stages in the application process (with the goal of authorisation)}

2 questions applicants should ask themselves before submitting an application

Content of application dossier

Exhaustive list of documents to be submitted, regardless of project type

Letter of application for authorisation to conduct a clinical trial, study or experiment addressed to the Health Minister
Summary fact sheet (available below)
Application form for a clinical trial
EU number of trial and universal number of trial
Protocol and summary
Updated investigator's brochure (BI) or document replacing it
Dossier on medicinal product(s) being investigated, tested and comparator(s), if applicable
Dossier on auxiliary drug(s), if applicable
Documents relating to GMP, if applicable
Manufacturing and import licence
Labelling of medicinal product being tested
Scientific advice and paediatric investigation plan (PIP), if applicable
Technical file
Case report form (CRF), evaluation grids, questionnaires
Qualification of investigators (CV)
Participant information, informed consent form (French, German)
Proof of membership of an insurance or compensation scheme
Proof of suitable infrastructures
Financing of the study
Other financial provisions (compensation paid to participants, etc.)
Proof of payment of fees
Other useful documents

Important notes

The application dossier must contain all the required documents.
Dossiers with missing documents will be rejected.
The file entitled "Documents to include in the authorisation application file", available below, explains which documents to submit according to study type.

How to name the attached files

Abbreviations
AEC Autorisation d’étude clinique (Clinical study authorisation)
BI Brochure pour l’investigateur (Investigator's Brochure)
BPF Bonnes pratiques de fabrication (Good Manufacturing Practice)
DT Dossier technique (Technical file)
CV Curriculum Vitae
CRF Case Report Form

The files should be named as described below. The dates and versions referred to are those of each relevant document.

Cover letter sent with application:
Protocol code or abbreviated title or acronym of trial followed by _courrierAEC_date(ddmmyyyy)_version (Example: CLEA0122A2403_courrierAEC_02012016_v1)

Trial protocol:
Protocol code or abbreviated title or acronym of trial followed by _protocole_date(ddmmyyyy)_version (Example: CLEA0122A2403_protocole_02012016_v1)

Protocol summary:
Protocol code or abbreviated title or acronym of trial followed by _résumé_date(ddmmyyyy)_version (Example: CLEA0122A2403_résumé_03012016_v1)

Investigator's Brochure:
Protocol code or abbreviated title or acronym of trial followed by_ BI_date(ddmmyyyy)_version (Example: CLEA0122A2403_BI_03012016_v1)

Technical file:
Protocol code or abbreviated title or acronym of trial followed by _dt_date(ddmmyyyy)_version (Example: CLEA0122A2403_DT_03012016_v1)

Insurance

The study sponsor must take out insurance to cover its own liability and that of all those involved in the study.

The insurance for a biomedical research project is a form of liability insurance policy.

It is based on the need to protect participants in clinical trials and is a guarantee of safety for the participants in biomedical research projects.

The object of the insurance must be to cover any potential damage suffered by participants during the biomedical research project itself, as well as any damage that could arise after such a project.

Insurance for a biomedical research project must fulfil two functions:

Indemnify against the civil liability of the sponsor (or investigator) of the medical research. It covers any compensation due in the event of an incident during the research project, and it also covers the liability of all those involved in the research project, including the investigators;
Compensate participants for any loss suffered as a result of their having taken part in a research project. This loss may take the form of bodily injury and/or damage to property.

Further details

In the case of research projects carried out within a hospital, the insurance certificate may stipulate that the research project must be authorised in advance by the management of that hospital. Where this applies, a document confirming that the hospital management has given its approval must be submitted to the Ministry of Health.

Where the certificate of insurance makes the principal investigator's cover conditional upon the exclusion of cover under the sponsor's insurance policy, the sponsor's insurance policy should also be attached to the submitted dossier.

Recommendations

It is recommended that the insurance certificate:

refer to the legal framework applicable in Luxembourg;(see box below for legislative texts applicable to biomedical research)
mention the name of the research project;
mention the number of participants;
mention the total amount covered for each research project;
mention the amount covered per participant;
stipulate the territorial coverage of the guarantee;
mention the duration of cover.

The insurance cover must be in place for at least the duration of the research project. It may cover a period longer than the research project to cover any undesirable effects that arise after the end of the study.

How to proceed

Application dossiers addressed to the Health Minister should be sent by email to recherchebiomedicale@ms.etat.lu.
For files bigger than 10 MB, send an email to recherchebiomedicale@ms.etat.lu with the subject heading 'Submission of an application dossier of over 10 MB for a clinical trial, study or experiment (as applicable)'. You will then be emailed an OTX (One-Time Exchange) link that you can use to send your files.

Costs

Since the entry into force of the Law of 8 March 2018 regarding hospitals and hospital planning, the authorisation applications referred to above for the attention of the Ministry of Health are subject to the prior payment of a fee as follows:

Research project: Clinical trial, study or experiment	Fee
Research project submitted to the Minister of Health by an industrial sponsor (or by the investigator).	EUR 1,000
Academic study project submitted to the Minister of Health by a sponsor (or by the investigator).	EUR 500
For any substantial change to a research project as defined in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.	EUR 250

The above fees are payable to the Registration Duties, Estates and VAT Authority, to the bank account:

Important note

Communication of the Health Directorate for the attention of clinical study sponsors and investigators:

Opinion on a notification of a substantial change to a clinical trial, study or experiment initiated before the promulgation of the Law of 8 March 2018 on hospitals and hospital planning.

Pursuant to the Law of 8 March 2018 (Article 27), any clinical trial, study or experiment on humans requires authorisation from the Minister and opinions of the Health Directorate and the National Research Ethics Committee (CNER).

Clinical trials, studies or experiments initiated before the above law do not have ministerial authorisation despite having an opinion from the National Research Ethics Committee. In this context, the Health Directorate is not authorised to assess notifications of substantial changes. Consequently, any new notification of a substantial change is deemed similar to a new study and must be the subject of a request for authorisation in due form within the meaning of Article 27 (1) of the Law.

When to contact the Ministry of Health

Please contact the Ministry of Health by email at recherchebiomedicale@ms.etat.lu:

to submit an application (an application dossier).
when a clinical trial is subject to a substantial change as defined in Article 9 of the Grand-Ducal Regulation of 30 May 2005 on the application of good clinical practice in the conduct of clinical trials on medicinal products for human use.

The sponsor notifies the Minister of the reasons for and the content of the substantial changes and informs the Ethics Committee.

The Ethics Committee gives an opinion within 35 days of the date of receipt of the duly and properly submitted change proposal. If the opinion is not favourable, the sponsor may not change the protocol.

If the opinion of the Ethics Committee is favourable, and if the Minister has not raised any reasoned objections to these substantial amendments, the sponsor will continue to conduct the clinical trial in accordance with the amended protocol. Otherwise, the sponsor must either take heed of the objections and adapt the planned protocol change accordingly or withdraw the change proposal.

To submit notifications of a clinical trial coming to an end and the annual safety reports.
To send a summary of the final report or a summary of the results of clinical trials, studies or experiments.

Publications

Last update 07.01.2026