S.L. 437.47 Art. 11Records and furtherdetailstobe kept by veterinary surgeon.

(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 food-

producing species, by way of exception, the veterinary surgeon responsible may, under his direct personal responsibility and in particular to avoid causing unacceptable suffering, treat the animals concerned on a particular holding 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), either -

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

(ii) a veterinary medicinal product authorised in another Member State in accordance with these regulations for use in the same species or in another food-producing 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) Subregulation (1) shall apply provided that pharmacologically active substances included in the medicinal product are listed in Annex I, II or III to European Regulation

(EEC) No 2377/90, and that the veterinary surgeon specifies an appropriate withdrawal period. Unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than:

- 7 days for eggs, - 7 days for milk, - 28 days for meat from poultry and mammals including fat and offal, - 500 degree-days for fish meat.

(3) With regard to homeopathic veterinary medicinal products in which active principles figure in Annex II to European Regulation (EEC) No 2377/90, the withdrawal period referred to in the second paragraph of subregulation (2) shall be reduced to zero.

(4) When a veterinary surgeon has recourse to the provisions of subregulations (1) and (2), he shall keep adequate records of the date of examination of the animals, details of the owner, the number of animals treated, the diagnosis, the medicinal products prescribed, the doses administered, the duration of treatment and the withdrawal periods recommended, and shall make these records available for inspection by the Veterinary Services for a period of at least five years.

(5) Without prejudice to the other provisions of these regulations, Malta shall take all necessary measures concerning the import, distribution, dispensing of and information on the medicinal products which they permit for administration to food-producing animals in accordance with subregulation (1)(b)(ii).

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

(7) 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 shall be given to any special requirement that need to be satisfied before the products could be used.

(8) 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 prescription from a veterinary surgeon, irrespective of the legal category assigned to the veterinary medicinal product in accordance with regulation 60.

(9) The prescription issued under the condition referred to in sub-regulation (8) 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 Cascade Principle", shall be included on the veterinary prescription.

(10) Unless the veterinary surgeon who prescribed the veterinary medicinal product or the 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 name and address of the animal owner;

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

(d) the date of supply;

(e) dosage and administration instructions;

(f) the withdrawal period, if relevant.

(11) When a veterinary surgeon has recourse to the provisions in sub-regulation (1) the activity undertaken by the veterinary surgeon is excluded from the scope of the definition of wholesale distribution.