S.L. 437.115 Art. 2Interpretation. Cap. 437.  Cap. 449.   S.L. 437.106.  Cap. 458.    Cap. 464.   Cap. 31.

(1) In these regulations, unless the context otherwise requires:

"Act" means the Veterinary Services Act;

"Agency" means the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

"applicant" means the person who applies with the Director to obtain any kind of authorisation as the case may be;

"broker" means a person who acts as an intermediary in arranging sale of veterinary medicinal products between two (2) or more parties who are authorised to distribute veterinary medicinal products by means of a wholesale distribution authorization, without the veterinary medicinal products being transported or stored by him; "brokering" means the activity of the broker in relation to the sale or purchase of veterinary medicinal products, except for wholesale distribution, which do not include physical handling of the veterinary medicinal product by the broker, and which consist of negotiating independently and on behalf of another person;

"country of source" means a Member State of the European Union or a country in the European Economic Area;

"Director" means the Director Veterinary Services who shall be a warranted veterinary surgeon or an officer nominated by him;

"electronic veterinary prescription" means a veterinary prescription making use of the technology framework made available by the Director that allows veterinary surgeons to issue veterinary prescriptions through electronic media and that is available to those persons who are authorized to dispense veterinary medicinal products;

"food" shall have the same meaning as assigned to it in the Food Safety Act;

"imported" means the act of acquiring veterinary medicinal product or part thereof, whether for the purposes of profit or non-profit, from a third country;

"investigational veterinary 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 which is different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form;

"licensed veterinary establishment" shall have the same meaning as that assigned to it in the Private Veterinary

Establishments (Licensing) Regulations;

"medicinal products for human use" shall have the same meaning as that assigned to it in the Medicines Act;

"Member State" means a State which is a member of the European Union;

"narcotic drugs" means the substances present on the Yellow List established by the International Narcotics Control Board in accordance with the Protocol of 25 March 1972 amending the Single Convention on Narcotic Drugs, 1961;

"pharmacist" means a person who is enlisted in the

Register of Pharmacists kept by the Pharmacy Council in accordance with article 17 of the Health Care Professions Act;

"premises" means the premises used for, or in connection with, any premises authorised or licensed by the Director, as the case may be;

"prescribing" means the act of preparing a veterinary prescription by a veterinary surgeon whether on paper or through electronic media;

"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 the International Narcotics Control Board in accordance with the Convention on Psychotropic Substances of 1971, as amended;

"Regulation (EU) 2019/6" means Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

"responsible person" means the technically competent person referred to in Article 101 of Regulation (EU) 2019/6;

"Single Convention" means the Single Convention on Narcotic Drugs adopted at New York on the 30th March 1961, as subsequently amended by the Protocol adopted in Geneva on the 25th March, 1972;

"suitably learned person" means any person included in the Register of the Professions and Trades Supplementary to the Veterinary Profession provided for in the Act who may dispense veterinary medicinal products of category OTC under the supervision of a veterinary surgeon or pharmacist and dispense others of category GS without this supervision;

"veterinary pharmacy" means any premises licensed in accordance with article 62 of the Act in which any veterinary medicinal product is kept, or from where it is sold, dispensed or supplied directly to the public by retail, but shall not include dispensing of treatments from veterinary establishments and dispensing during out calls by veterinary surgeons;

"veterinary surgeon" means a person who has a warrant granted in accordance with article 43 of the Act;

"wholesale distributor of veterinary medicinal products" means the holder of a valid wholesale distribution authorisation referred to in Article 99(1) of Regulation (EU) 2019/6.

(2) Unless the context otherwise requires, words and phrases used in these regulations which are not herein defined shall have the same meaning assigned to them in the Act:

Provided that words and phrases used in these regulations which are neither defined in these regulations nor in the Act shall have the same meaning assigned to them in Regulation (EU) 2019/6.