S.L. 437.115 Art. 32Administration of veterinary medicinal products and medicinal product to animals.

(1) Any person may administer veterinary medicinal products or medicinal products for human use which require a veterinary prescription without the veterinary prescription in urgent situations to alleviate suffering of the animal or impending spread of disease.

Provided that a visit to the place where the animal is kept by the veterinary surgeon or a visit to the veterinary surgeon with the animal, depending on the best practicable circumstance, shall take place within forty-eight (48) hours of such an administration.

(2) Veterinary surgeons and persons authorised to dispense a veterinary medicinal shall not supply for administration or administer themselves, as may be applicable, veterinary medicinal product unless such product is authorised by the Director.

(3) Products other than authorised veterinary medicinal products whose therapeutic effectiveness is merely anecdotal shall be used with caution. The administration of these products to food producing species shall be subject to the approval of the Director. The Director may ask the animal keeper to provide chemical data, clinical documentation and studies about the possible environmental impact as stipulated in the Gazette before granting his approval.

(4) Before prescribing a veterinary medicinal product or a medicinal product that contain critically important antimicrobials, the prescribing veterinary surgeon may take into account the results of diagnostic laboratory information.

(5) Every registered or licensed establishment where food producing animals are kept and are not excluded from the provisions of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/ 2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012,

(EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/ EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) by the Director, and the establishments where animals are kept for display to the public or for breeding purposes in the territory of Malta shall have an appropriate animal health control programme designed and implemented under the responsibility of a professional registered with the Veterinary Surgeons Council:

Provided that a register of the professionals responsible for each animal health control programme shall be kept by the Director:

Provided further that the Director may, from time to time, publish requirements related to animal health control programmes in the Gazette through a notice.

(6) Veterinary medicinal products and medicinal products for human use that are used in the registered or licensed establishments referred to in sub-regulation (5) shall only be kept in such establishments.

(7) The records referred to in Article 108 of Regulation (EU) 2019/6 shall only be kept in the registered or licensed establishments where food producing animals are kept in accordance with sub-regulation (5).