S.L. 458.43 Art. 3Definitions.

In these regulations, unless the context otherwise requires -

"adverse event" means any untoward medical occurrence in a patient or clinical trial subject who is administered a medicinal product and which does not necessarily have a causal relationship with this treatment; "adverse reaction" means all untoward and unintended responses to an investigational medicinal product related to any dose administered;

"Agency" means the European Medicines Agency established by Council Regulation (EC) No 726/2004;

"clinical trial" means any investigation in human subjects intended to discover or verify the clinical, pharmacological and, or other pharmacodynamic effects of any investigational medicinal product and, or to identify any adverse reactions to any investigational medicinal product and, or to study absorption, distribution, metabolism and excretion of any investigational medicinal product with the object of ascertaining its safety and, or efficacy. This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State; "the Ethics Committee" means an independent body, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to recruit and inform trial subjects and obtain their informed consent; "good clinical practice" means a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well being of trial subjects are protected and that the results of the clinical trials are credible;

"informed consent" means a decision, which must be written in one of the official languages of Malta or in a language understandable to the clinical trial subject and, or his legal representative, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative[ if such person is unable to write, oral consent may be given in the presence of at least one witness; "inspection" means the act by the Licensing Authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources deemed to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and, or contract research organisation’s facilities, or at other establishments which the Licensing Authority sees fit to inspect; "investigational medicinal product" means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form;

"investigator" means a doctor or a person who is suitably qualified approved by the Licensing Authority for investigations because of the scientific background and the experience in patient care such investigation requires. The investigator is responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator;

"investigator’s brochure" means a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects; "multi-centre clinical trial" means a clinical trial conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the trial sites may be located in a single Member State, in a number of Member States and, or in Member States and third countries; "non-interventional trial" means a study where a medicinal product is, prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data; "protocol" means a document that describes the objective or objectives, design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments; "serious adverse" event or "serious adverse reaction" means any untoward medical occurrence or effect where any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect; "sponsor" means an individual, company, institution or organisation or its legal representative who must be established in the Community and who takes responsibility for the initiation, management and, or financing of a clinical trial;

"subject" means an individual who participates in a clinical trial as either a recipient of the investigational medicinal product or a control; "unexpected adverse reaction" means an adverse reaction, the nature or severity of which is not consistent with the relevant product information (e.g. investigator ’s brochure for an unauthorised investigational product or summary of product characteristics for an authorised product).