Section 2: Interpretation

2. Interpretation In this Act— “administer” means give or apply a substance or test article, in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle, to a human being— (a) orally, by injection, by introduction into the body or in any other way; or (b) by external application, whether by direct contact with the body or not; “adverse event” means any untoward medical occurrence in a patient or a subject to whom a medicinal product is administered, or on whom a medical device is tested, which does not necessarily have a causal relationship with the treatment; “adverse reaction” means any untoward and unintended response to an investigational medicinal product administered in any dose to a subject or to a medical device tested on a subject; “Certificate of Good Manufacturing Practice (GMP)” means a certificate which purports to show that a manufacturer has effectively implemented a set of international standards aimed at ensuring that an investigational medicinal product, medicinal product or medical device is consistently manufactured and controlled to the quality standards appropriate to their intended use; “Certificate of Pharmaceutical Product (COPP)” means a certificate issued in a format recommended by the World Health Organisation by a drug regulatory authority and purporting to— (a) indicate that a manufacturer has submitted its manufacturing site to regular GMP inspections; and (b) provide details about the product and its manufacture, including, but not limited to, the marketing authorisation holder, the active ingredients and excipients, the manufacturing and packaging sites and whether or not the product is placed on the market in the country of origin; “clinical trial” means an investigation in a subject intended to— (a) discover or verify the clinical or pharmacological effect of an investigational medicinal product; (b) identify any adverse reaction to such a product; or (c) study the absorption, distribution, metabolism and excretion of such a product, for the purpose of ascertaining the safety or efficacy of the product, after its administration to the subject; [Issue 10] C25A – 2 Revised Laws of Mauritius “conditions and principles of good clinical practice” means the conditions and principles having their origin in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects; “Council” means the Clinical Research Regulatory Council referred to in section 3; “Ethics Committee” means the Ethics Committee referred to in section 7; “guidelines”— (a) means guidelines which the Council considers applicable to the conduct of clinical trials in Mauritius; and (b) includes, but is not limited to, existing international standards such as the good clinical practice guideline (ICH E6) of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use; “health personnel” includes any person who works in a technical or scientific capacity in a hospital, dispensary, clinic, laboratory or medical research centre; “investigational medicinal product”— (a) means the pharmaceutical form of a substance, test article or placebo being tested or used as a reference in a clinical trial; and (b) includes a medicinal product, the importation of which is permitted in an authorised form and which— (i) is used, formulated or packaged in a different way; n Use; “health personnel” includes any person who works in a technical or scientific capacity in a hospital, dispensary, clinic, laboratory or medical research centre; “investigational medicinal product”— (a) means the pharmaceutical form of a substance, test article or placebo being tested or used as a reference in a clinical trial; and (b) includes a medicinal product, the importation of which is permitted in an authorised form and which— (i) is used, formulated or packaged in a different way; (ii) is used for an unauthorised indication; or (iii) is used to gain further information about the authorised form; “investigator” means a medical practitioner, or other health professional acceptable to the Council, who is designated by a sponsor to be responsible for the conduct of a clinical trial; “investigator’s brochure” means a compilation of the clinical and non-clinical data on an investigational medicinal product or a medical device which are relevant to the study of the product in, or the device on, a subject; “law practitioner” has the same meaning as in the Law Practitioners Act; “manufacture” has the same meaning as in the Pharmacy Act; “medical device”— (a) means an instrument, apparatus, appliance, material or other article, whether used alone or in combination with any software necessary for its proper application, which— C25A – 3 [Issue 10] Clinical Trials Act (i) is intended by the manufacturer to be used on a subject for the purpose of— (A) diagnosis, prevention, monitoring, treatment or alleviation of any disease; (B) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap; (C) investigation, replacement or modification of the anatomy or of a physiological process; or (D) control of conception; and (ii) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means; and (b) includes a device intended to administer a medicinal product or which incorporates as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device; “medical practitioner” means a person registered as a general practitioner or a specialist under the Medical Council Act; “medicinal product” means a substance which is manufactured, sold, supplied, imported or exported for use, wholly or mainly, in any of the following ways— (a) by being administered to a human being for a medicinal purpose; (b) as an ingredient in the preparation of a substance or article which is to be administered to a human being or an animal for a medicinal purpose; "medicinal purpose" means— (a) treating or preventing disease; (b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition; (c) contraception; (d) inducing anaesthesia; or (e) preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way; “Minister” means the Minister to whom responsibility for the subject of health is assigned; “nursing officer” means a person registered as a general nurse or a mental health nurse under the Nursing Council Act; [Issue 10] C25A – 4 Revised Laws of Mauritius “officer”— (a) means an officer of the Council designat ogical function, whether permanently or temporarily, and whether by terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way; “Minister” means the Minister to whom responsibility for the subject of health is assigned; “nursing officer” means a person registered as a general nurse or a mental health nurse under the Nursing Council Act; [Issue 10] C25A – 4 Revised Laws of Mauritius “officer”— (a) means an officer of the Council designated under section 6; and (b) includes the Secretary; “pharmacist” has the same meaning as in the Pharmacy Act; “pharmacovigilance” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems; “Pharmacovigilance Committee” means the Pharmacovigilance Committee referred to in section 9; “protocol” means a document which describes the objective, design, methodology, statistical consideration and organisation of a clinical trial; “Register” means the register of clinical trials referred to in section 29; “Secretary” means the Secretary of the Council designated under section 6; “serious adverse event” or “serious adverse reaction” means any adverse event or adverse reaction which— (a) results in death; (b) is life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation; (d) results in persistent or significant disability or incapacity; or (e) consists of a congenital anomaly or birth defect; “site” means a place approved by the Council for the conduct of a clinical trial; “sponsor” means a person who assumes responsibility for the initiation, management and financing of a clinical trial; “subject” means a human being to whom an investigational medicinal product is administered, or on whom a medical device is tested, for the purposes of a clinical trial; “supervising officer” means the supervising officer of the Ministry responsible for the subject of health; “test article” means any drug (including a biological product for human use), human food additive, colour additive or other substance intended for administration to a human being; “Trade and Therapeutics Committee” has the same meaning as in the Pharmacy Act; “trial licence” means a licence issued under section 13; “trial master file” means the file referred to in section 23. [S. 2 amended by s. 9 (a) of Act 10 of 2017 w.e.f. 1 October 2017.] C25A – 5 [Issue 10] Clinical Trials Act PART II – CLINICAL RESEARCH REGULATORY COUNCIL