S.L. 437.47 Art. 4DVeterinary medicinal products obtained from other countries for personal use.

(1)Veterinary medicinal products may be exempted from the provisions in regulations 5 to 8 when the products are procured from a Member State of the European Union or imported from a

Third country under the terms and conditions mentioned in sub-

regulation (2).

(2) The following terms and conditions shall apply:

(a) the products shall not be re-sold for monetary gain;

(b) the products shall not be transferred to other third parties unless such transfer is authorised by the Veterinary Services;

(c) this provision is not applicable to psychotropic drugs, narcotic drugs for all animals and in the case of food producing animals also the substances listed in Group A in Schedule I of Measures to monitor certain Substances and Residues thereof in Live Animals and Animal Products Rules and Table II of Regulation

(EU) 37/2010;

(d) the quantity of products obtained shall be proportional to the dosage regime of the condition it will be used for;

(e) the quantity of products which is allowed entry in Maltese territory shall cover the period indicated as the duration of treatment in the product’s specifications or on the veterinary surgeons ‘s veterinary prescription. However, products intended to be used for recurrent or chronic conditions can be allowed entry in Malta several times a year, provided that cogent evidence that demonstrate the benefits obtained by the regular use of the products can be provided;

(f) the individuals shall be required to provide a veterinary prescription for products classified as requiring such a prescription in the country from where they are obtained or for similar veterinary medicinal products in Malta: Provided that the Veterinary Services may still ask for such a veterinary prescription even if the products are classified as not requiring a veterinary prescription in the country from where they are obtained;

(g) only products that do not contain animal by-products which are derived from high risk areas where certain diseases may be, or suspected to be, present or prevalent, can be obtained;

(h) only products that do not contain ingredients that are classified as illegal in Malta and do not have banned indications in Malta can be obtained;

(i) only appropriately labelled products which give clear indication of the nature of the ingredient/s within can be obtained;

(j) food producing animals administered with the veterinary medicinal products authorised in accordance with this regulation can only be consumed by the person getting the veterinary medicinal products, or by consenting members of the same household. The appropriate withdrawal period shall apply;

(k) before a decision on antimicrobial veterinary medicinal products and products that have a hormonal activity is taken, a risk assessment shall be prepared by the Veterinary Services in a timely manner;

(l) the decision by the Veterinary Service is without prejudice to any license or permit that the person getting the veterinary medicinal products may need to obtain under other regulations of the same or of different department.

(3) The veterinary services shall decide on the release, placing under official control or destruction of veterinary medicinal products, or the products presumed to be veterinary medicinal products, if and when these are intercepted at the various entry control points throughout the territory of Malta.

(4) Pursuant to sub-regulation (3), the Veterinary Services shall keep a record of all the opinions or decisions taken. These records shall be kept by the Veterinary Services for a period of not less than ten (10) years.

(5) The Veterinary Services shall set out the criteria for veterinary medicinal product which can be obtained in accordance with sub-regulation (1) and make them public:

Provided that the provisions of this regulations shall also apply to veterinary medicinal products that are brought in the territory of Malta as a bona fide donation for use on animals kept in the approved sanctuary subject to the donation on condition that the veterinary services is pre-notified of such a request with the name, quantity and nature of the products, and the names and addresses of the donator, the recipient and the animal sanctuary involved.