Mauritius - Apply for a Medicine Trial Licence or Permit

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Procedure

Apply In-Person

1. To apply for the trial license, you should make your application to the Clinical Research Regulatory Council (CRRC). Please view the CRRC address in the “Office Locations & Contacts” section below.
2. Write a formal application addressed to the CRRC requesting the medical trial license.
3. Prepare the required supporting documents and attach the documents to the application letter in a single file.
4. Submit your application along with all the required documents including the prescribed fees to the CRRC for verification.
5. The CRRC will assess your application and confirm if all the required documents are provided.
6. Upon the assessment process, the CRRC can request you to provide additional information or documents to satisfy the required merits of the application.
7. If your application is complete as required by the CRRC, the CRRC will forward the application and the documents to the Ethics Committee (EC) for approval.
8. The EC will review your application and the provided documents then they will decide to approve or reject the application.
9. After the review by the EC, the CRRC will inform you of the application decision through a written letter.
10. If your application is rejected, you may be requested to provide more information and documents and reapply for the trial license.
11. If your application is approved by the EC and the CRRC, you will be required to pay the license fee.
12. Pay the license fee and then the CRRC will process the license and grant it to you. Note that the license is subjected to terms and conditions prescribed by the EC.
    

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Required Documents

All applications should be accompanied by 25 copies of the following listed document.

• A protocol.
• An investigators brochure.
• A brief C.V of every investigator.
• A Certificate of Good Manufacturing Practice (GMP) and a Certificate of Pharmaceutical Product (COPP) about every investigational medicinal product from its country of origin.
• The separate and different forms are to be used for patient and subject information, informed consent, recruitment of subjects, adverse event reports, and adverse reaction reports.
  

You should also provide:

• information as to the quantity of every investigational medicinal product to be used in the clinical trial.
• information relating to the measures to be taken for the health, welfare, safety, and protection of subjects.
• information relating to financial aspects of the clinical trial, in particular:
  • Sources of funding for the clinical trial and information on the financial or other interests of the sponsor relevant to the clinical trial.
  • The arrangements for the reimbursement of expenses incurred by the subjects.
  • Any provision for compensation in the event of injury or death resulting from the clinical trial, including details of any insurance cover to be contracted for the protection of subjects.
  • Details of any insurance or indemnity to cover the liability of the sponsor and investigator.
  • Summary details of any financial arrangements between:
    • The sponsor and the investigator.
    • The sponsor and the owner or occupier of the site.
• Information relating to the anticipated benefits and risks of the clinical trial.
• Information relating to the location, structure, and amenities of any site where the clinical trial is to be conducted.
• Any other information as the Council may require.
  

Office Locations & Contacts

The Secretary
Clinical Research Regulatory Council
Atchia Building
Suffren Street
Port Louis

Eligibility

Companies and Individuals who wish to conduct a medicine trial in Mauritius are eligible to apply.

Fees

• The application fee is Rs 10,000
• The license fee is Rs 100,000
  

Validity

The license is valid for the period stated in it.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

The application will be processed within 60 days.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

The license is subjected to terms and conditions that should be adhered to, failure to following these terms and conditions may lead to your license being revoked by the CRRC.

Required Information

• Name of trial.
• Duration of trial.
• Contact details.
• Location of trial.
• Particulars of the trial.
• Applicants’ information.
  

Need for the Document

The license proves that you have been permitted to conduct the trial in Mauritius as required by law.

Information which might help

THE CLINICAL TRIALS ACT 2011

Other uses of the Document/Certificate

Please explain what are other uses for obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

EBD

Others

More information which might help people.