Cap. 458 Art. 2Interpretation.

In this Act, unless the context otherwise requires -

"adverse reaction" means a response to a medicinal product which is noxious and unintended;

"advertising" in relation to medicinal products includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products and without prejudice to the generality of the foregoing in particular includes:

(a) the advertising of medicinal products to the general public;

(b) the advertising of medicinal products to persons qualified to prescribe or supply them;

(c) visits by medical or sales representatives to persons qualified to prescribe medicinal products;

(d) the supply of samples;

(e) the provision of inducements to prescribe or supply medicinal products, by way of a gift, offer or promise of any benefit or bonus, whether in money or in kind, except when the intrinsic value of such an inducement is minimal;

(f) sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products;

(g) sponsorship of any scientific congress attended by persons qualified to prescribe or supply medicinal products and in particular where payment of their travelling and accommodation expenses is offered in connection therewith; but shall exclude:

(i) the labelling and the accompanying package leaflets, as may be specified in accordance with the provisions of Part III, Title I of this Act;

(ii) correspondence, even if accompanied by material of a non-promotional nature, which is in reply to a specific question about a particular medicinal product;

(iii) factual, informative, announcement or reference material relating to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues, price lists and other material of a similar nature provided that such material does not include any product claim;

(iv) any statement relating to human health or disease, provided there is no reference, whether direct or indirect, to a medicinal product; "active substance" means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis; "analysis" includes testing of a medicinal product or any of its constituents, both active or inactive, in respect of their chemical, physical, pharmaceutical, biological, toxicological or pharmacological properties; "assemble", in relation to a medicinal product, means to enclose the product in a container which is labelled before the product is sold or supplied, or, where the product is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and shall also include the act of introducing approved information in or on the container and "assembly" shall be construed accordingly;

"authorised officer" in relation to the Medicines Authority means any officer or employee of the Authority or any other person authorised by the Authority to act on its behalf and in relation to the Licensing Authority means any officer or employee of the Department as referred to in article 5 of the Department of Health

(Constitution) Ordinance authorised by the Licensing Authority to act on its behalf; "brokering of medicinal products" means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person; "business" means any economic activity whether carried out by the individual or by a body of persons, whether corporate or unincorporate and includes the exercise of a profession;

"clinical trial" means any investigation in human subjects intended to discover or verify, the clinical, pharmacological and, or other pharmacodynamic effects of one or more investigational medicinal products, and, or to identify any adverse reactions to one or more investigational medicinal products, and, or to study the absorption, distribution, metabolism and excretion of one or more investigational products with the object of ascertaining their safety and, or efficacy. This includes clinical trials carried out in either one site or multiple sties, whether in one or more than one Member State; "common name" means the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name;

"composition" in relation to a medicinal product, means the ingredients constituting it and the proportions, and the degrees of strength, quality and purity, in which those ingredients are respectively contained in it and as may be established in a recognised pharmacopoeia; "container" in relation to a medicinal product, means the immediate packaging or outer packaging; "cosmetic product" shall have the same definition as found under the Product Safety Act; "dental practitioner" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance or any other law replacing the same;

"designated Minister" means the Minister who is designated by the Prime Minister as being responsible for the Medicines Authority;

"disease" includes any injury, ailment or adverse condition, whether of body or mind;

"dispensing" means the sale or supply of medicinal products from a pharmacy;

"excipient" means any constituent of a medicinal product other than the active substance and the packaging material;

"falsified medicinal product" means any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

(c) its history, including the records and documents relating to the distribution channels used, but excludes unintentional quality defects and is without prejudice to infringements of intellectual property rights; "foodstuff" shall have the same meaning as that under the Food

Safety Act; "good practice" in relation to manufacturing practice, laboratory practice, distribution practice, clinical practice and dispensing practice means the standards for the proper execution of the relative activity as established by or under this Act; "herbal medicinal product" means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations; "herbal preparations" means preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates; "herbal substances" means all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author);

"homeopathic medicinal product" means any medicinal product prepared form substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contian a number of principles; "immediate packaging" means the container or other form of packaging immediately in contact with the medicinal product; "immunological medicinal product" means any medicinal product consisting of vaccines, toxins, serums or allergen products, where -

(a) vaccines, toxins and serums shall cover in particular:

(i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;

(ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;

(iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;

(b) "allergen product" shall mean any medicinal product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent;

"importation" means any one or more of the following activities: procuring, holding, selling and release of imported medicinal products in any part of Malta notwithstanding any provisions in any other Act, but does not include imported medicinal products that are in transit where the whole consignment of the said products remains fully intact and its status is not changed for free circulation; "ingredient" in relation to the manufacture or the preparation of a substance, includes anything which is the sole active ingredient of the substance as manufactured or prepared; "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 authorization 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;

"kit" means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration; "labelling" means any information on the immediate or outer packaging; "licence" means a licence issued under the provisions of this Act;

"licensee" means any person who is the holder of a licence for a particular activity granted under this Act;

"magistral formula" means any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient; "manufacture", in relation to a medicinal product, includes any process carried out in the course of manufacturing the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it; "medical practitioner" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance or any other law replacing same; "medicinal prescription" means any medicinal prescription issued by a professional person qualified to prescribe medicinal products by or under this Act;

"medicinal product" means any substance or combination of substances -

(a) presented as having properties for treating or preventing disease in human beings; or

(b) which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; "medicinal products derived from human blood or human plasma" means medicinal products based on blood constituents which are prepared industrially by public or private establishments, such medicinal products including, in particular, albumin, coagulating factors and immunoglobulins of human origin; "medicinal purpose" includes any one or more of the following purposes:

(a) the treating or preventing disease;

(b) the diagnosing of disease or ascertaining the existence, degree or extent of a physiological condition;

(c) contraception;

(d) inducing anaesthesia;

(e) the prevention or interference with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function or in any other way.

"Medicines Authority" means the Authority established under article 4;

"Medicines Review Board" means the Board established under article 14;

"Minister" means the Minister responsible for public health; "name of the medicinal product" means the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorisation holder; "officinal formula" means any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by such pharmacy;

"outer packaging" means the packaging into which the immediate packaging is placed;

"package", in relation to any medicinal product, means any box, packet or other article in which one or more container of the product are, or are intended to be, enclosed, and, where any such box, packet or other article is, or is to be itself enclosed in one or more other boxes, packets or articles, includes any of the said boxes, packets or articles; "package leaflet" means a leaflet containing information for the user which accompanies the medicinal product; "pharmacist" means a person who is authorised to exercise such profession under the Medical and Kindred Professions Ordinance, or any other law replacing the same; "pharmacy technician" means a person authorised to act as such under the Medical Kindred and Profession Ordinance or any other law replacing the same;

"post-authorisation safety study" means any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures;

"prescribed" means prescribed by regulations made by the Minister under this Act;

"qualified person" means any person who is a qualified person in relation to a manufacturer’s licence as provided in article 38 (1)(e);

"radionuclide generator" means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceutical; "radionuclide precursor" means any radionuclide not being a radiopharmaceutical, radionuclide generator or kit which is produced for the radio-labelling of another substance prior to administration; "radiopharmaceutical" means any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose;

"recognised laboratory" means any laboratory recognised as such by the Licensing Authority for the purposes of this Act;

"recognised pharmacopeia" means a pharmacopeia recognised by rules for the purpose of this Act;

"responsible person" means any person who is a responsible person in relation to a wholesale dealer's licence as provided in article 55(1)(d); "risk-benefit balance" means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined in paragraph (a) of the definition "risks related to use of the medicinal product";

"risks related to use of the medicinal product” means -

(a) any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health;

(b) any risk of undesirable effects on the environment

"rules" means rules made by the Licensing Authority under the provisions of this Act;

"serious adverse reaction" means an adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect

"strength of the medicinal product" means the content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form; "substance" means any matter irrespective of origin be it human (including human blood and human blood products), animal (including micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products), vegetable (including micro-organisms, plants, parts of plants, vegetable secretions, extracts), or chemical (including elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis); "Superintendent of Public Health" has the same meaning as is assigned to it by article 4 of the Department of Health (Constitution) Ordinance; "unexpected adverse reaction" means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics; "veterinary surgeon" means a person who is authorised to exercise such profession under the Veterinary Services Act, or any other law replacing the same; "wholesale distribution", in relation to a medicinal product and active substances, includes any one or all activities consisting of procuring, holding, supplying or exporting medicinal products and active substances, apart from supplying medicinal products to the public.