S.L. 437.47 Art. 60Prescription for dispensing products to the public.

(1) Without prejudice to stricter European Union or national rules relating to dispensing veterinary medicinal products and serving to protect human and animal health, a veterinary prescription shall be required for dispensing to the public the following veterinary medicinal products:

(a) those products subject to official restrictions on supply or use, such as -

(i) the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances,

(ii) the restrictions on the use of veterinary medicinal products resulting from European Union legislation;

(iii) veterinary medicinal products that do not fall within the classification of regulation 6 (1)(a)(i),

(b) and (c) but nonetheless are deemed to require a veterinary prescription for a temporary period.

(aa) veterinary medicinal products for foodproducing animals. However, Malta may grant exemptions from this requirement according to criteria established in accordance with the procedure referred to in Article 89(2) of European Union Council Directive 2004/28/ EC;

(b) those products in respect of which special precautions must be taken by the veterinary surgeon in order to avoid any unnecessary risk to -

(i) the target species,

(ii) the person administering the products to the animal,

(iii) the environment;

(c) those products intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures;

(d) official formula, within the meaning of Article 3(2)(b) of European Union Council Directive 2004/28/EC, intended for food-producing animals. Malta shall take all necessary measures to ensure that, in the case of medicinal products supplied only on prescription, the quantity prescribed and supplied shall be restricted to the minimum amount required for the treatment or therapy concerned. In addition, a prescription shall be required for new veterinary medicinal products containing an active substance that has been authorised for use in a veterinary medicinal product for fewer than five years.

(2) Veterinary medicinal products for food-producing animals may be exempted from the requirement to be dispensed only against veterinary prescription, if all of the following criteria are satisfied:

(a) the administration of veterinary medicinal products is restricted to formulations requiring no particular knowledge or skill in using the products;

(b) the veterinary medicinal product does not present a direct or indirect risk, even if administered incorrectly, to the animal or animals treated, to the person administering the product or to the environment;

(c) the summary of product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use;

(d) neither the veterinary medicinal product nor any other product containing the same active substance has previously been the subject of frequent serious adverse reaction reporting;

(e) the summary of product characteristics does not refer to contra-indications related to other veterinary medicinal products commonly used without prescription;

(f) the veterinary medicinal product is not subject to special storage conditions;

(g) there is no risk for consumer safety as regards residues in food obtained from treated animals even where the veterinary medicinal products are used incorrectly;

(h) there is no risk to human or animal health as regards the development of resistance to antimicrobials or anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly.

(i) veterinary medicinal product classified as prescription only medicines may be exempted from being prescribed and dispensed by a prescription if entirely administered by the veterinary surgeon responsible for the non-food producing animal, who himself provides the veterinary medicinal product, and if the animal owner does not explicitly request a prescription.

(3) Pursuant to sub-regulation (1) there shall be the following four (4) distribution categories of veterinary medicinal product:

(a) Prescription-Only-Medicine, Veterinary surgeon and Pharmacist- abbreviated to POM-VP.

(b) Prescription-Only-Medicine, Veterinary surgeon-abbreviated to POM-V.

(c) Over- the- Counter –Medicine, abbreviated to OTC

(d) General Sales, abbreviated to GS

(4) The supply of veterinary medicinal products for each distribution category shall be made as follows:

(a) POM-VP, shall only be prescribed and/or dispensed by a veterinary surgeon or dispensed by a pharmacist according the terms of a veterinary prescription. Premises from where the products can be supplied are veterinary pharmacies, licensed veterinary establishments, and by the veterinary surgeon during an outcall.

(b) POM-V shall only be prescribed, dispensed and administered by a veterinary surgeon. Premises from where the products can be supplied are licensed veterinary establishments, and by the veterinary surgeon during an outcall.

(c) OTC, may be dispensed without a veterinary prescription. The persons who can dispense this category of veterinary medicinal products are veterinary surgeons, pharmacists and suitably qualified persons under the direction of a pharmacist or a veterinary surgeon. Premises from where the products can be supplied are veterinary pharmacies, licensed veterinary establishments, and by the veterinary surgeon during an outcall.

(d) GS, may be dispensed without a veterinary prescription. The persons who can dispense this category of veterinary medicinal products are veterinary surgeons, pharmacists and suitably qualified persons. Products that fall under this category can be supplied from veterinary pharmacies, veterinary establishments, registered pet shops, registered aquarium fish product retailers and approved feed traders where animal medicated feeds are produced, sold or traded:

Provided that the veterinary services may make requirements to allow products classified in this category to be supplied from premises other those listed above to alleviate supply shortages and facilitate accessibility to treatment that otherwise could be detrimental to animal welfare. Such premises shall not be general retail outlets and must be under the responsibility of a person with an experience of not less than two (2) years in the handling of this category of veterinary medicinal products.

(5) The Veterinary Services shall categorise the distribution category of the veterinary medicinal product when authorising veterinary medicinal products.

(6) When deciding the distribution category of a veterinary medicinal product the Veterinary Services may seek the advice from suitable expert committees and may take in consideration the guidelines of other National, European and International relevant bodies, as may be decided by the Veterinary Services.

(7) Notwithstanding what had been decided during the initial Marketing Authorisation procedure, the Veterinary Services may change the distribution category of a veterinary medicinal product either at the request of the Marketing Authorisation Holder or due to a compulsory variation.

(8) The Veterinary Services shall set out the criteria for the categorisation of a Veterinary Medicinal product and make them public.

(9) Different pack sizes of the same Marketing Authorisation may be assigned a different distribution category.

(10) When the distribution category of the veterinary medicinal product is POM-V or POM-VP this shall be indicated on the immediate and/or outer packaging of the product in legible, undeletable characters.

(11) The legible, undeletable characters citing the distribution category of the veterinary medicinal product may be printed on the immediate and/or outer packaging or made noticeable through an appropriate label.

(12) Both the abbreviated form and the full description of the distribution category of the veterinary medicinal product present on the immediate and/or outer packaging shall be acceptable.

(13) The holders of a wholesale distribution authorisation shall distribute veterinary medicinal products only to the premises authorised to retailed veterinary medical according to these regulations.

(14) The holders of a wholesale distribution authorisation shall distribute to the premises authorised to retailed veterinary medical only the category/categories of veterinary medicinal products that are authorised to be retailed from each type of premises in accordance with these regulations.