S.L. 437.115 Art. 7Veterinary medicinal products obtained for personal use.        S.L. 437.58.

(1) Veterinary medicinal products may be exempted from the requirements provided for in Articles 5, 88 and 99 of

Regulation (EU) 2019/6 when the products are acquired from a Member State or imported for personal use provided that all the following conditions are fulfilled:

(a) the products shall not be sold or re-sold;

(b) the products shall not be transferred to other third parties unless such transfer is notified to the Director;

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

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

(e) a veterinary prescription shall be provided for products classified as requiring such a prescription in the country from where they are obtained, or for similar veterinary medicinal products in the territory of Malta:

Provided that the Director may still require the veterinary prescription when the products are classified as not requiring a veterinary prescription in the country from where they are obtained;

(f) 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, shall be obtained;

(g) only products that do not contain ingredients which are classified as illegal in territory of Malta and which do not have banned indications in the territory of Malta shall be obtained;

(h) only appropriately labelled products which give clear indication of the nature of the ingredients thereof shall be obtained;

(i) food producing animals administered with the veterinary medicinal products authorised in accordance with this regulation may only be consumed by the individual getting the veterinary medicinal products, or by other consenting persons of the same household. The appropriate withdrawal period shall apply, where applicable;

(j) 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 Director in a timely manner; and

(k) the Director’s decision shall be without prejudice to any license or permit that the individual getting the veterinary medicinal products may need to obtain under other regulations or rules.

(2) This regulation shall not be applicable to live or attenuated immunological veterinary medicinal products, 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 the

Measures to monitor certain Substances and Residues thereof in Live

Animals and Animal Products Rules and the substances listed in Table 2 of Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin.

(3) The Director may release, retain or destroy any veterinary medicinal products alone or in feed, active substances or other products intended to be administered to or on animals or given as feed or with feed or water if and when these products are intercepted at the various entry control points throughout the territory of Malta, or in any establishments under his control.

(4) Any expense incurred for the release, retention or destruction of veterinary medicinal products alone or in feed, active substances or other products intended to be administered to, or on animals or given as feed or with feed or water, shall be payable by the person getting the products as determined by the Director.

(5) Pursuant to sub-regulation (3), the Director may keep a record of all instances of release, retention or destruction. These records shall be kept by the Director for a period of not less than fifteen

(15) years.

(6) The Director may issue a list with the requirements needed for obtaining veterinary medicinal products in accordance with this regulation through a notice in the Gazette:

Provided that the provisions of this regulation shall also apply to veterinary medicinal products that are brought in the territory of Malta as a donation for use on animals kept in approved sanctuaries subject to the donations:

Provided further that the Director shall be notified of such request with the name, quantity and nature of the products, the names and addresses of the donor, the recipient and the animal sanctuaries involved.