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.
- 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:
- 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;
- 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;
- any article containing barium carbonate or zinc phosphide which has been prepared for the destruction of rats or mice;
- cannabis or a cannabis derivative when used as an ingredient in a corn paint.
- 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.
- 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.
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
- 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
- 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
- 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;
- 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:
- 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
- the sponsor and the investigator; and
- 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.
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.