Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription   (Text with EEA relevance)
Date: 2006-12-11
Institutions: European Commission
Subjects: animal product, derogation from EU law, drug surveillance, public health, veterinary drug

12.12.2006

EN

Official Journal of the European Union

L 349/15

COMMISSION DIRECTIVE 2006/130/EC

of 11 December 2006

implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the
establishment of criteria for exempting certain veterinary medicinal products for food-producing
animals from the requirement of a veterinary prescription

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/82/EC of
Parliament and of the Council of 6 November 2001 on the
Community code relating to veterinary medicinal products (1),
and in particular point (aa) of the first paragraph of Article 67
thereof,

Whereas:

(5)

(6)

Inappropriate storage conditions may seriously affect the
quality,
safety and efficacy of veterinary medicinal
products. Therefore, products whose quality, safety and
efficacy can be guaranteed only when stored under
special conditions should not be granted an exemption.

products

veterinary medicinal

Exempted
should
furthermore contain only active substances that do not
cause a risk for consumer safety as regards residues in
food obtained from treated animals and they should have
no potential
for causing a risk to human or animal
health by developing resistance to antimicrobials or
anthelmintics, if used incorrectly.

in this Directive are in
The measures provided for
accordance with
Standing
the
the
Committee on Veterinary Medicinal Products,

opinion

of

(1)

(2)

Pursuant to Article 67 of Directive 2001/82/EC, in the
cases covered by the first and third paragraphs thereof,
veterinary medicinal products may be dispensed to the
public only against prescription. However, as certain
substances, contained in veterinary medicinal products
for food-producing animals, do not present a risk to
to the
human or
environment,
requirement may be
exemptions
granted in accordance with point
the first
paragraph of Article 67. Such exemptions are without
prejudice to the application of any other provision of
the first and third paragraphs of that Article.

animal health or
from that general

(aa) of

Consequently it is appropriate to establish criteria on the
basis of which Member States may grant exemptions
from the general rule, provided for in point (aa) of the
first paragraph of Article 67 of Directive 2001/82/EC,
requiring a prescription for dispensing to the public
veterinary medicinal products
food producing
animals.

for

(3) Where the veterinary medicinal products concerned are
easy to administer and, even if administered incorrectly,
do not present a risk either to the animal being treated
or to the person administering the product, it should be
possible for those products to be made available without
the need for a veterinary prescription. On the other hand,
it should not be possible to grant an exemption for
products that feature an unfavourable pharmacovigilance
profile or harm the environment.

(1) OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive establishes the criteria on the basis of which
Member States,
the first
in accordance with point
paragraph of Article 67 of Directive 2001/82/EC, may grant
to dispense veterinary
requirement
exemptions
medicinal products intended for food-producing animals to
the public only against prescription.

from the

(aa) of

Article 2

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

if all of

(a)

the administration of veterinary medicinal products
restricted
requiring
knowledge or skill in using the products;

formulations

is
particular

no

to

(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;

L 349/16

EN

Official Journal of the European Union

12.12.2006

(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
serious adverse reaction
reporting;

frequent

Article 4

1. Within six months of the notification referred to in Article
3, Member States shall bring into force the laws, regulations and
administrative provisions necessary
to comply with this
Directive. They shall forthwith communicate to the Commission
the text of those provisions and a correlation table between
those provisions and this Directive.

(e)

the summary of product characteristics does not refer to
contraindications
related to other veterinary medicinal
products commonly used without prescription;

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

(f)

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

(g) there is no risk for consumer safety as regards residues in
the

food obtained from treated animals
veterinary medicinal products are used incorrectly;

even where

(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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 5

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

Article 6

Article 3

This Directive is addressed to the Member States.

1. Where Member States decide to provide for the granting
of exemptions pursuant to this Directive, they shall notify the
Commission thereof.

If a notification in accordance with paragraph 1 has not
2.
been made by 31 March 2007 at
the national
exemptions referred to in point (aa) of the first paragraph of
Article 67 of Directive 2001/82/EC shall cease to apply.

the latest,

Done at Brussels, 11 December 2006.

For the Commission

Günter VERHEUGEN
Vice-President