S.L. 437.47 Art. 2Definitions.

For the purposes of these regulations, the following terms shall have the following meanings -

"active substance" means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product and that product, when used in its production, becomes an active ingredient of that product; "advertising of veterinary medicinal products" means the making of a representation in any form in connection with veterinary medicinal products in order to promote the supply, distribution, sale, prescription or use of veterinary medicinal products and comprising also the supply of samples and sponsorships;

*These regulations have been repealed by Legal Notice 335 of 2024. "Agency" means the European Medicines Agency established by Regulation (EC) No 726/2004; "Adverse reaction" means a reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function; "the Commission" means the Commission in accordance with Council Decision 1999/468/EC of 28th June, 1999; "Director for Veterinary Services" means the Director for Veterinary Services as defined in the Veterinary Services Act, and includes, to the extent of the authority given, to any officer authorised by him, in writing, to act on his behalf for any of the purposes mentioned in the Veterinary Services Act. Whenever in the text the words "Veterinary Services" are used these should be construed as referring to the "Director for Veterinary Services";"; and immediately thereafter there shall be added the following new definitions:

"dispensing" means the sale or supply of veterinary medicinal products. The products are sold or supplied from a veterinary pharmacy or by a veterinary surgeon in licensed veterinary establishments or during out calls; "European Union" means the European Union as referred to in the Treaty; "Committee for Veterinary Medicinal Products" hereinafter referred to as "the Committee" means part of the Agency set up to facilitate the adoption of common decisions on the authorisation of veterinary medicinal products on the basis of the scientific criteria of quality, safety and efficacy. This Committee shall be appointed in accordance with article 31 of European Union Council Directive 2001/82/EC; "Common name" means the international non-proprietary name recommended by the World Health Organisation, or, if one does not exist, the usual common name; "the Community" means the European Community as established under the Treaty establishing the European Community; "food" shall have the same meaning as assigned to it in the Food Safety Act;

"Homeopathic veterinary medicinal product" means any veterinary medicinal product prepared from 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 Member States. A homeopathic veterinary medicinal product may contain a number of principles; "Human adverse reaction" means a reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine;

"Immediate packaging" means the container or any other form of packaging that is in direct contact with the medicinal product;

"Immunological veterinary medicinal product" means a veterinary medicinal product administered to animals in order to produce active or passive immunity or to diagnose the state of immunity; "imported veterinary medicinal products" means veterinary medicinal products obtained from a source outside the EU; "licensed veterinary establishment" has the same meaning as assigned to it in the Private Veterinary Establishments (Licensing) Regulations;

"Labelling" means information on the immediate or outer packaging; "Medicated feeding stuffs" means any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a veterinary medicinal product; Medicinal products" shall have the same meaning as is assigned to in the Medicines Act; "Member State" means a State which is a member of the European Union; ""Metaphylactic" means the administration of a veterinary medicinal product or a medicinal product to a group of animals after a diagnosis of clinical disease in part of the group has been established, with the aim of treating the clinically sick and controlling the spread of the disease to animals in close contact and at risk and which may already be sub clinically infected; "Name of veterinary 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 trademark or the name of the marketing authorisation holder; "Narcotic drugs" means the substances present on the Yellow List prepared by the International Narcotics Control Board in accordance with the Single Convention on Narcotic Drugs, 1961, Protocol of 25 March 1972 amending the Single Convention on Narcotic Drugs, 1961; "Off-label use" means the use of a veterinary medicinal product when such use is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product;

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

"Package leaflet" means the leaflet containing information for the user that accompanies the medicinal product;

"Periodic safety update reports" means the periodical reports containing the records referred to in regulation 68. "Pharmacist" means a person who is enlisted in the Register of Pharmacists kept by the Pharmacy Council in terms of article 17 of the

Health Care Professions Act;

"placing under official control" means the detaining of any article by the Director for Veterinary Services in order to permit the accomplishment of any of its functions; "Post-marketing surveillance studies" means the pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product; "Premix for medicated feeding stuffs" means any veterinary medicinal product prepared in advance with a view to the subsequent manufacture of medicated feeding stuffs; "prescribing" means the act of preparing a veterinary prescription by a veterinary surgeon being it on paper or electronic media; "preventive use of an antimicrobial agents" means the administration of antimicrobial agents to healthy animals to prevent infections to compensate for inadequate good farming practice;

"procurement" means the act of acquiring, for profit or not, a veterinary medicinal product, or part thereof, from a Member State of the European Union; "prophylactic administration of antimicrobials" means the administration of a veterinary medicinal product or a medicinal product to an animal or group of animal before clinical signs of a disease, in order to prevent the occurrence of disease or infection: "psychotropic drugs" means the substances listed in the Third schedule to the Medical and Kindred Professions Ordinance and those substances listed on the Green List prepared by International

Narcotics Control Board in accordance with the Convention on Psychotropic Substances of 1971; "Representative of the marketing authorisation holder" means the person, commonly known as local representative, designated by the marketing authorisation holder to represent him in Malta; "Risk/benefit balance" means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the risks as defined above;

"Risks relating to use of the product" means: - any risk relating to the quality, safety and efficacy of the veterinary medicinal products as regards animal or human health; - any risk of undesirable effects on the environment;

"Serious adverse reaction" means an adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly and, or birth defect, or which results in permanent or prolonged signs in the animals treated; "source country" means a Member State of the EU or a country in the European Economical Area from where the veterinary medicinal products referred to in regulation 7 can be procured;

"Strength" means the content of 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 which may be -

(a) human, e.g. human blood and human blood products;

(b) animal, e.g. micro organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;

(c) vegetable, e.g. micro organisms, plants, parts of plants, vegetable secretions, extracts;

(d) chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis; "Suitably Qualified Persons" means that person who has a qualification in a veterinary science and included in one of the para-veterinary professions mentioned in the Act;

"Third Country" means a State which is not a Member within the European Community;

"Unexpected adverse reaction" means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics; "Veterinary medicinal product" means:

(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis; "veterinary surgeon" means a person as described and regulated by article 43 of the Act and whose name is entered in the Register of Veterinary Surgeons’ Register, or that person, coming from any other Member State of the European Union, whose name is entered in the relevant register kept by the relevant body of that Member State which regulates the profession of Veterinary surgeons. In the latter case the provisions of the Mutual Recognition of Qualifications Act and the Services (Internal Market) Act shall apply;

"Veterinary prescription" means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law. "Veterinary Services" means the competent authority within the territory of Malta as established under article 2 of the Veterinary Services Act; "veterinary wholesale dealer" means that person authorised to carry out wholesale distribution of veterinary medicinal products; "Withdrawal period" means the period necessary between the last administration of the veterinary medicinal product to animals, under normal conditions of use and in accordance with the provisions of these regulations, and the production of foodstuffs from such animals, in order to protect public health by ensuring that such foodstuffs do not contain residues in quantities in excess of the maximum residue limits for active substances laid down pursuant to European Union Regulation (EEC) No 2377/90; "Wholesale dealing in veterinary medicinal products" means any activity which includes the purchase, sale, import, export, or any other commercial transaction in veterinary medicinal products, whether or not for profit, except for -

(a) the supply by a manufacturer of veterinary medicinal products manufactured by himself, or,

(b) retail supplies of veterinary medicinal products by persons entitled to carry out such supplies in accordance with regulation 59.