S.L. 439.13 Art. 2Interpretation. Cap. 439. Cap. 437.

(1) Unless otherwise stated in these regulations, the definitions in the Act shall apply.

(2) For the purpose of these regulations and unless the context otherwise requires, the following definitions shall apply: "the Act" means the Animal Welfare Act;

"animal experiment" has the same meaning as that provided in the Act;

"animal-welfare body" means a body set up by breeders, suppliers and users in terms of regulation 27 with the aim to carry out tasks as provided in terms of regulation 28; "Animal Welfare Council” means the national committee as established by articles 4, 5 and 6 of the Act for the protection of animals used for scientific purposes in terms of these regulations; "authorisation" means any authorisation which:

*These regulations have been repealed by Legal Notice 138 of 2023.

(a) in relation to competent persons and their activities, may be granted in terms of the Act, to such persons to carry out a procedure or animal experiments, which may only be performed by such competent persons, or under the direct responsibility of such person and may include any licence, warrant, permit, appointment, concession or any decision concerning access to the activity in question, or the exercise thereof; and

(b) in relation to breeders, suppliers, users and their services means a permit, licence, appointment, concession or any decision concerning access to the service activity in question or the exercise thereof, issued to such persons in terms of the Act and for the term stipulated in these regulations;

"breeder" means any natural or legal person breeding animals referred to in Schedule I with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, or breeding other animals primarily for those purposes, whether for economic remuneration or not;

"the Commission" means the European Commission; "expert competent person" means the veterinarians or veterinary surgeons responsible for procedures or any person or officer in charge duly authorised to act on their behalf having adequate knowledge and professional experience in terms of article 43 of the

Veterinary Services Act or as recognised by the Veterinary Surgeons’ Council to exercise his duties and act on behalf of the veterinarian; Provided that competent personnel mentioned in regulation 24 shall, for the purpose of carrying out procedures, be at all times supervised in terms of regulation 24(3) and conform with the requirement set out in regulation 25(1)(c);

"debilitating clinical condition" means a reduction in an animal’s normal physical and psychological ability to function;

"the Department" means the Department for Veterinary Services in Malta as established by article 2 of the Act;

"the Director" has the same meaning as that provided under the Act;

"endangered species" means those species listed in Annex A to Council Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein; "establishment" means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities; "final consumer" means any natural or legal person purchasing animals and animal products subject to trade for his own use and not for resale or retail purposes;

"genetically modified animal" means all animals having their genes artificially added or removed from their DNA; "intra-Community trade" means trade in animals and their products between Member States including commercial activities with the intention to make profit or gain; "live cephalopods" means live animals of the cephalopoda class including inter alia octopuses, squids, cuttlefish and nautiloids; "Member State" means a state which is a member of the European Union; "non-human primates" means all species of the primates order excluding homo sapiens; "non-human vertebrate animals" means all animals with a backbone structure excluding homo sapiens; "overriding reasons relating to public interest" means reasons recognised as such in case law of the Court of Justice of the European Union and which reasons present a justification for the issue of an authorisation and, or the issue of a condition thereto and, or to any other policy decision taken in terms of such authorisation, when such authorisation, and, or condition and, or policy decision thereto could not have been issued or taken under normal circumstances but for such overriding reasons relating to public interest which include the emergency circumstances referred to in regulation 7(4); "procedure" means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues; the severity classification of such procedures is set out in Schedule IX; "project" means a programme of work having a defined scientific objective and involving one or more procedures; "self-sustaining colony" means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans;

"specimen" has the same meaning as that provided under Council Regulation (EC) No 338/97 on the protection of species of wild fauna and flora by regulating trade therein; "supplier" means any natural or legal person, other than a breeder, supplying animals with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, whether for economic remuneration or not;

"TFEU" means the Treaty on the Functioning of the European Union as amended by the Lisbon Treaty, 2009 as may be subject to subsequent amendments; "user" means any natural or legal person using animals in procedures, whether for economic remuneration or not.