Mauritius: Chambers Life Sciences 2017

Last Updated: 11 April 2017
Article by Burty Francois and Ashwin Mudhoo

1. REGULATORY FRAMEWORK

1.1 Key Legislation

The key pieces of legislation governing the authorisation, marketing, sale and supply of pharmaceutical products in Mauritius are the Pharmacy Act 1983 and the Consumer Protection (Price and Supplies Control) Act of 1998.

The term "Pharmaceutical Product" is defined as a drug, medicine, preparation, poison or therapeutic substance.

"Drug" is defined as a substance or ingredient intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in a human being or an animal.

"Medicine" is defined as a chemical product, preparation, biological product or other substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of any ailment, infirmity or injury affecting a human being or animal or for dental treatment.

Poison:

  • means a substance specified in the first, third, fourth and fifth schedules of the Pharmacy Act 1983;
  • subject to paragraph (c), includes any poisonous substance or liquid;
  • does not include:

    1. a substance which is an ingredient in adhesives, anti-fouling compositions, builders' materials, ceramics, distempers, electrical valves, enamels, explosives, fillers, fireworks, fluorescent lamps, glazes, glue, inks, lacquer solvents, loading materials, machine spread plasters, matches, motor fuels and lubricants, paints other than pharmaceutical paints, photographic paper, pigments, plastics, propellants, rubber, surgical dressings, varnishes or vascular plants and their seeds;
    2. a substance specified in the first column of the second schedule and constituted or used in the manner specified in the second column of that schedule;
    3. any article containing barium carbonate or zinc phosphide which has been prepared for the destruction of rats or mice;
    4. cannabis or a cannabis derivative when used as an ingredient in a corn paint.

Preparation means:

  • a solution or mixture, in any physical state, containing a medicine or a therapeutic substance; or
  • a medicine or a therapeutic substance in dosage form.

Therapeutic substance:

  • means a substance whose purity and potency cannot be adequately tested by chemical means; and
  • includes a preparation.

Pharmaceutical products are divided into prescription pharmaceutical products, non-prescription pharmaceutical products and simple medicines.

1.2 Regulatory Bodies

The Pharmacy Board is responsible for the regulation of pharmaceutical products whereas the Minister of Industry, Commerce and Consumer Protection is responsible in terms of pricing.

1.3 Regulations

Medical devices and cosmetics are not regulated under Mauritius laws.

Nutritional products are regulated by the Foods Act 1998 and the Food Regulations 1999 (the "Regulations").

"Food" is defined in the Food Act 1998 as any article or substance meant for human consumption and includes:

  • drinks and bottled water;
  • chewing gum and other products of similar nature and use; and
  • articles and substances used or intended for use as ingredients in the composition or preparation of food,

but does not include:

  • live animals, birds or live fish which are not used for human consumption while they are alive;
  • fodder or feeding stuffs for animals, birds or fish;
  • drugs or medicine as defined in the Pharmacy Act; and
  • hormonal products or veterinary products for use in livestock feed.

No person shall import or manufacture any food, pre-packed food, container or contact material intended to be used for the preparation of any food listed in the third schedule to the Regulations (set out below) unless they have obtained a pre-market approval permit issued by the Permanent Secretary of the Ministry of Health and Quality of Life (the "Permanent Secretary").

List of food, prepacked food, container and contact material requiring pre-market approval

  • any novel food (being any food which has not previously been used for human consumption in Mauritius)
  • artificial sweetener
  • baby feed bottle, teat, nipple and baby feed mug
  • biscuit
  • breakfast cereal
  • canned food for infant and child, infant formula, icing sugar
  • cereal based food for infant and child
  • coffee and chicory blend, cocoa, jam
  • confectionery, snack and cracker, water, chocolate, pastry
  • dry egg powder, liquid egg including egg yolk and egg white
  • edible fat and oil, including shortening, margarine, vanaspati, ghee
  • essence
  • fish product
  • food additive
  • food conditioner
  • food container and contact material
  • formula dietary food
  • frozen confection and related product
  • fruit juice, fruit cordial, soft drink, soft drink powder
  • honey
  • irradiated food
  • low energy food
  • meat product
  • milk and milk product including ice cream, condensed milk, evaporated milk, sterilised milk, UHT milk, tinned cream, cheese, butter
  • mixed spice, pickle, preserved vegetable, preserved egg
  • non-alcoholic beverage
  • nutrient supplement
  • oriental saffron (Jaffran)
  • poultry product
  • refined salt, table salt, iodised salt, low sodium salt, salt for salting fish
  • roasted cereal, nut
  • sauce, vinegar, relish, including salad dressing and mayonnaise, seasoning
  • self-raising flour, baking ingredient
  • special purpose food
  • tomato paste, ketchup, bottled water

A person who applies for a pre-market approval permit must furnish to the Permanent Secretary:

  • an original certificate of analysis from an accredited laboratory from the country exporting the product, certifying the chemical composition and microbiological safety of the product; and
  • such other document or information, or such sample for analysis or examination, as the Permanent Secretary thinks fit.

The Permanent Secretary may, in deciding whether to grant or refuse an application for a pre-market approval permit, consider among other factors whether the food, pre-packed food, appliance, container or contact material subject matter of the application is:

  • violating any regulation made under the Food Act 1998;
  • restricted for sale in Mauritius;
  • misbranded;
  • improperly labelled; or
  • likely to be hazardous to public health.

The Permanent Secretary may stipulate such conditions as they deem fit in a pre-market approval permit.

In borderline cases and in any event, the Permanent Secretary has the sole discretion to determine whether the pre-market approval will be granted.

The law does not provide any appeal procedure where the initial decisions are unfavourable.

2. CLINICAL TRIALS

2.1 Regulation of Clinical Trials

Clinical trials are regulated in Mauritius by the Clinical Trials Act 2011 and the Clinical Trials (Licence and Fees) Regulations 2011.

2.2 Approval and Authorisation

No person may conduct or cause or permit to be conducted a clinical trial unless that person is the holder of a trial licence ("TL") or an investigator acting on behalf of a sponsor who is the holder of a TL, in relation to that clinical trial. "Investigator" means a medical practitioner, or other health professional acceptable to the Clinical Research Regulatory Council ("CRRC"), who is designated by a sponsor to be responsible for the conduct of a clinical trial. "Sponsor" means a person who assumes responsibility for the initiation, management and financing of a clinical trial.

The CRRC is responsible for the regulation and control of trial licences being issued. An application for a TL should be made in writing to the CRRC accompanied by 25 copies of the following documents together with the application fee of MUR10,000 (approx. USD300):

  • a protocol (being a document that describes the objective, design, methodology, statistical consideration and organisation of a clinical trial);
  • an investigator's brochure (being a compilation of the clinical and non-clinical data on an investigational medicinal product that are relevant to the study of the product in a subject);
  • a brief CV of every investigator;
  • a Certificate of Good Manufacturing Practice and a Certificate of Pharmaceutical Product in relation to every investigational medicinal product from its country of origin; and
  • the separate and different forms to be used for the purpose of patient and subject information, informed consent, recruitment of subjects, adverse event reports and adverse reaction reports.

The sponsor must 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:

    1. sources of funding for the clinical trial and information on the financial or other interests of the sponsor relevant to the clinical trial;
    2. the arrangements for the reimbursement of expenses incurred by the subjects;
    3. 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;
    4. details of any insurance or indemnity to cover the liability of the sponsor and investigator;
    5. summary details of any financial arrangements between:

      1. the sponsor and the investigator; and
      2. 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; and
  • such other information as the CRRC may require.

Where the CRRC receives a complete application, it refers the application with all supporting documents to the Ethics Committee (which advises the CRRC regarding welfare, safety, health and protection of human subjects participating in clinical trials), which gives its opinion.

The Ethics Committee takes such factors as it thinks fit into consideration, including:

  • relevance of the clinical trial and its protocol;
  • suitability of any investigator;
  • anticipated benefits and risks of the clinical trial;
  • adequacy of the measures to be taken for the health, welfare, safety and protection of subjects; and
  • adequacy of the insurance cover to be contracted for the protection of subjects.

It is to be noted that the Ethics Committee is responsible for establishing and following its own standard operating procedures.

The CRRC may, after considering the opinion of the Ethics Committee, grant an application where it is satisfied that:

  • measures to be taken for the health, welfare, safety and protection of subjects are adequate;
  • anticipated benefits of the clinical trial outweigh its risks;
  • insurance cover to be contracted for the protection of subjects is adequate;
  • the investigator is a suitably qualified person;
  • the site for the clinical trial is suitable;
  • the sponsor and the investigator will at all times comply with the Clinical Trials Act 2011 and any regulations made under it; and
  • the clinical trial is to be conducted in compliance with any guidelines issued by the CRRC.

The CRRC may, when considering an application, require the sponsor to furnish such additional information as may be necessary, within such time as it may determine.

On granting an application, the CRRC will issue a trial licence to the sponsor on such terms and conditions as the CRRC thinks fit and on payment of the applicable prescribed licence fee.

2.3 Registration and Publication of Results

It is mandatory to register new clinical trials in a publicly available database and to publish the results of all clinical trials.

DOWNLOAD PDF – CHAMBERS LIFE SCIENCES 2017 – MAURITIUS

Originally published by Chambers Global Practice Guides.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.