S.L. 437.47 Art. 10Exception granted by the Veterinary Services.

(1) The Veterinary Services shall take the necessary measures to ensure that, if there is no authorised veterinary medicinal product in Malta for a condition affecting a non food-

producing species, by way of exception, the veterinary surgeon responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animal concerned with:

(a) a veterinary medicinal product authorised in Malta under these regulations or under European Regulation

(EC) No 726/2004 for use with another animal species, or for another condition in the same species; or

(b) if there is no product as referred to in paragraph (a) -

(i) either a medicinal product authorised for human use in Malta in accordance with European Directive 2001/83/EC of the European Parliament and of the European Council or under European Regulation (EC) No 726/2004,

(ii) or, in accordance with specific national measures, a veterinary medicinal product authorised in another Member State in accordance with these regulations for use in the same species or in another species for the condition in question or for another condition; or

(c) if there is no product as referred to in paragraph (b), and within the limits of the law of Malta, a veterinary medicinal product prepared extemporaneously by a pharmacist or a veterinary surgeon in accordance with the terms of a veterinary prescription.The veterinary surgeon may administer the medicinal product personally or allow another person to do so under the veterinary surgeon’s responsibility.

(2) By way of derogation from regulation 11, the provisions of subregulation (1) hereof shall also apply to the treatment by a veterinary surgeon of an animal belonging to the equidae family provided that it has been declared, in accordance with European Commission Decisions 93/623/EEC and 2000/68/EC, as not being intended for slaughter for human consumption.

(3) In the case of a veterinary medicinal product authorised in another member State, veterinary surgeons shall obtain an authorisation from the Veterinary Services before getting the product for the administration to the animal.

(4) In case the veterinary medicinal products contain restricted substances resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances, consideration should be given to any special requirement that need to be satisfied before the products could be used.

(5) A veterinary medicinal product or a medicinal product supplied for administration under paragraphs (a), (b) and (c) of sub-regulation (1) may only be supplied in accordance with a veterinary prescription from a veterinary surgeon, irrespective of the legal category assigned to the veterinary medicinal product during the Marketing Authorisation procedure.

(6) The veterinary prescription issued under the condition referred to in sub-regulation (5) shall be marked as such. A statement similar to, or stating the equivalent meaning of, the following statement: "This Product has been prescribed in accordance with the Cascade Principle", shall be included on the veterinary prescription.

(7) Unless the veterinary surgeon who prescribed the veterinary medicinal product or medicinal product both supplies the product and administers it to the animal in person, the person supplying it must label it (or ensure that it is labelled) with at least the following information:

(a) the name of the veterinary surgeon who has prescribed the product;

(b) the identification (including the species) of the animal or group of animals;

(c) dosage and administration instructions.

(8) When a veterinary surgeon has recourse to the provisions of regulation 10, the veterinary surgeon shall keep adequate records of the treatment given. The records shall at least contain the particulars mentioned in sub-regulation (7) and shall be available for inspection by the Veterinary Services for a period of not less than three (3) years.

(9) When a veterinary surgeon has recourse to the provisions in paragraphs (a), (b) and (c) of sub-regulation (1), the activity undertaken by the veterinary surgeon is excluded from the scope of the definition of wholesale distribution under a decision to be laid down by the Veterinary Services.