Veterinary Medicinal Products (Amendment) Regulations,

L.N. 23 of 2009

VETERINARY SERVICES ACT

(CAP. 437)

Veterinary Medicinal Products (Amendment) Regulations,

IN exercise of the powers conferred by article 30 and 31 of

the Veterinary Services Act, the Minister for Resources and Rural

Affairs, after consulting the Head of the National Veterinary

Laboratory, has made the following regulations:-

(1) The title of these regulations is the Veterinary

Medicinal Products (Amendment) Regulations, 2009 and they

shall be read and construed as one with the Veterinary Medicinal

Products Regulations, 2004, hereinafter referred to as “the principal

regulations”.

(2) The scope of these regulations is to implement the

rules found under European Union Commission Directive 2006/130/

EC amending European Union Council Directive 2001/82/EEC

relating to veterinary medicinal services.

Immediately after subarticle (1) of article 60 of the

principal regulations there shall be added subarticle (2) as follows

“(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 contraindications 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”.

€0.19