Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)
Date: 2000-06-05
Institutions: European Commission
Subjects: EU Member State, approximation of laws, pharmaceutical legislation, veterinary drug

10.6.2000

EN

Official Journal of the European Communities

L 139/25

COMMISSION DIRECTIVE 2000/37/EC

of 5 June 2000

amending Chapter VIa ‘Pharmacovigilance’ of Council Directive 81/851/EEC on the approximation
of the laws of the Member States relating to veterinary medicinal products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 81/851/EEC of 28
September 1981 on the appriximation of the laws of the
Member States relating to veterinary medicinal products (1), as
last amended by Directive 93/40/EEC (2), and in particular
Article 42i thereof;

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

In order to ensure the continued safety of veterinary
medicinal products in use, it is necessary to ensure that
pharmacovigilance
in the Community are
continually adapted to take account of scientific and
technical progress.

systems

For public health protection, relevant data on adverse
effects in humans related to the use of veterinary medi-
cines should be collected and evaluated.

The pharmacovigilance systems should consider
available data on lack of efficacy.

the

In addition, collection of information on adverse reac-
tions due to off-label use, investigations of the validity of
the withdrawal period and on potential environmental
problems may contribute to improve regular monitoring
of good usage of veterinary medicines.

It is necessary to take account of changes arising as a
result of
international harmonisation of definitions,
terminology and technological developments in the field
of pharmacovigilance.

The increasing use of the mutual recognition procedure
that
established by Directive 81/851/EEC requires
current procedures for reporting and dissemination of
suspected adverse reactions be amended to ensure better
co-ordination between Member States.

The increasing use of electronic means of communi-
cation of information on adverse reactions to veterinary
medicinal products marketed in the Community is
intended to allow a single reporting point for adverse
reactions, at the same time ensuring that this informa-
tion is shared with the competent authorities in all
Member States.

(1) OJ L 317, 6.11.1981, p. 1.
(2) OJ L 214, 24.8.1993, p. 31.

(8)

(9)

It is necessary to further define terms currently used
within the veterinary pharmacovigilance systems.

It is the interest of the Community to ensure that the
centrally
veterinary pharmacovigilance
authorised medicinal products and those authorised by
other procedures are consistent.

systems

for

(10) Holders of marketing authorisations should additionally
be proactively responsible for ongoing pharmacovigi-
lance of the veterinary medicinal products they place on
the market.

(11)

The measures provided for in this Directive are in
conformity with the opinion of the Standing Committee
on veterinary medicinal products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Chapter VIa ‘Pharmacovigilance’ of Directive 81/851/EEC is
hereby amended as follows:

1. Article 42a,

is hereby replaced by the following text:

‘Article 42a

In order to ensure the adoption of appropriate regulatory
decisions concerning the veterinary medicinal products
authorised within the Community, having regard to infor-
mation obtained about suspected adverse reactions to veter-
inary medicinal products under normal conditions of use,
the Member States shall establish a veterinary pharmacovigi-
lance system. This system shall be used to collect informa-
tion useful in the surveillance of veterinary medicinal prod-
ucts, with particular reference to a dverse reactions in
animals and in human beings related to the use of veter-
inary medicinal products, and to evaluate such information
scientifically.

Such information shall be collated with available data on
the sale and prescription of veterinary medicinal products.

This system also takes into account any available informa-
tion related to the lack of expected efficacy, off-label use,
investigations of the validity of the withrawal period and on
potential environmental problems, arising from the use of
the product, interpreted in accordance with the Commission
guidelines referred to in Article 42g, which may have an
impact on the evaluation of their benefits and risks.’

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EN

Official Journal of the European Communities

10.6.2000

2. Article 42b,

is hereby replaced by the following:

4. Article 42d,

is hereby replaced by the following text:

‘Article 42b

For the purpose of this Directive, the following definitions
shall apply:

(a) “adverse reaction” means a reaction which is harmful
and unintended and which occurs at doses normally
used in animals for the prophylaxis, diagnosis or treat-
ment of disease or the modification of physiological
function,

(b) “human adverse reaction” means a reaction which is
noxious and unintended and which occurs in a human
being following exposure to a veterinary medicine,

(c) “serious adverse reaction” means an adverse reaction
is life-threatening, results in
which results in death,
significant disability or
is a congenital
incapacity,
anomaly/birth defect, or which results in permanent or
prolonged signs in the animals treated;

(d) “unexpected adverse reaction” means an adverse reac-
tion, the nature, severity or outcome of which is not
consistent with the summary of the product characteris-
tics,

(e) “periodic safety update reports” means the periodical
reports containing the records referred to in Article 42d;

(f)

“post-marketing surveillance studies” means pharmacoe-
pidemiological study or a clinical trial carried out in
accordance with the terms of the marketing author-
isation, conducted with the aim of identifying and inves-
tigating a safety hazard relating to an authorised veter-
inary medicinal product,

(g) “off-label use” means the use of a veterinary medicinal
product that is not in accordance with the summary of
including the misuse and
the product characteristics,
serious abuse of the product.

For the interpretation of
the definitions and principles
outlined in this chapter, the marketing authorisation holder
and the competent authorities shall refer to the detailed
guidance referred to in Article 42g.’

3. Article 42c is hereby amended as follows:

(a)

in the first paragraph, the words ‘person responsible for
placing the veterinary medicinal product on the market’
are changed to ‘marketing authorisation holder’;

(b) in point (a) of the second paragraph, the words ‘at a
single point’ are changed to ‘in order to be accessible at
least at one point within the Community’;

(c)

in point (b) of the second paragraph the words ‘relevant
national or Community guidance’ are changed to
‘guidance referred to in Article 42g’;

(d) to the second paragraph the following point

(d)

is

added:

‘d)

the provision to the competent authorities, of any
other information relevant to the evaluation of the
benefits and risks afforded by a veterinary medicinal
product, including appropriate information on post-
marketing surveillance studies.’

‘Article 42d

The marketing authorisation holder shall be required
1.
to maintain detailed records of all suspected adverse reac-
tions occurring either in the Community or in a third
country.

2.
The marketing authorisation holder shall be required
to record and to report all suspected serious adverse reac-
tions and human adverse reactions related to the use of
veterinary medicinal products, of which he can reasonably
be expected to have knowledge, or which are brought to his
attention,
immediately to the competent authority of the
Member State in whose territory the incident occured, and
in no case later than 15 calendar days following the receipt
of the information.

3.
The marketing authorisation holder shall ensure that
the suspected serious and unexpected adverse reactions and
human adverse reactions, occuring in the territory of a third
country, are reported immediately in accordance with the
guidance referred to in Article 42g, so that they are avail-
able to the Agency and to the competent authorities in the
Member State(s) where the veterinary medicinal product is
authorised, and in no case later than 15 calendar days
following the receipt of the information.

4.
In the case of veterinary medicinal products which
have been considered within the scope of Directive 87/
22/EEC, or which have benefited from the procedures of
mutual recognition under Articles 8, 8a and 17(4) and
veterinary medicinal products for which there has been a
referral to the procedures under Articles 21 and 22 of this
Directive, the marketing authorisation holder shall addition-
ally ensure that all suspected serious adverse reactions and
human adverse reactions, occurring in the Community, are
reported in the format and at intervals to be agreed with the
reference Member State or a a competent authority desig-
nated as reference Member State, in such a way so as to be
accessible to the reference Member State.

5.
Unless other requirements have been laid down as
condition of the granting of authorisation, records of all
adverse reactions shall be submitted to the competent
authorities in the form of a periodic safety update report,
either immediately upon request or periodically as follows:
six monthly for the first
two years after authorisation,
annually for the subsequent two years, and at the time of
the first renewal. Thereafter,
the periodic safety update
reports shall be submitted at five-yearly intervals together
with the application for renewal of the authorisation. The
periodic safety update report shall include a scientific evalu-
ation of the benefit and risks afforded by the veterinary
medicinal product.

6.
Following the granting of a marketing authorisation,
the marketing authorisation holder may request the amend-
ment of the periods referred to in this Article according to
the procedure laid down by the Commission Regulation
(EC) No 541/95 (*),

if applicable.

(*) OJ L 55, 11.3.1995, p. 7.’

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Official Journal of the European Communities

L 139/27

5. A new second paragraph is added to Article 42e:

8. Article 42h is replaced by the following text:

‘The Member States may impose specific requirements on
veterinary practitioners and other health care professionals
in respect of the reporting of suspected serious or unex-
pected adverse reactions and human adverse reactions, in
particular where such reporting is a condition of
the
marketing authorisation.’

6. Article 42f,

is replaced by the following text:

‘Article 42f

The Agency,

1.
in collaboration with the Member
States and the Commission shall set up a data-processing
network to facilitate the exchange of pharmacovigilance
information regarding medicinal products marked in the
Community.

2. Making use of
the network foreseen in the first
paragraph, Member States shall ensure that reports of
suspected serious adverse reactions and human adverse
reactions, in accordance with the Standing Committee on
veterinary medicinal products guidance referred to in
Article 42g, that have taken place on their territory are
immediately made available to the Agency and the other
Member States, and in any case within 15 calendar days
of their notification, at the latest.

shall ensure that

The Member States

3.
reports of
suspected serious adverse reactions and human adverse
reactions,
that have taken place on their territory are
immediately made available to the marketing authoriation
holder, and in any case within 15 calendar days of their
notification, at the latest.’

7. Article 42g is amended as follows:

‘Article 42g

(a)

in

consultation with

to facilitate the exchange of

In order
information
about pharmocovigilance within the Community, the
Commission,
the Agency,
Member States and the interested parties, shall draw
up guidance on the collection, verification and presen-
tation of adverse reaction reports,
including technical
for electronic exchange of veterinary
requirements
pharmacovigilance
information in accordance with
internationally agreed terminology.

‘Article 42h

considers

Where, as a result of the evaluation of veterinary pharma-
covigilance data,
a
a Member State
marketing authorisation should be suspended, withdrawn
or varied to restrict the indications or availability, amend
the posology, add a contraindication or add a new
precautionary measure,
forthwith inform the
Agency,
the other Member States and the marketing
authorisation holder.

shall

that

it

In case of urgency,
the Member State concerned may
suspend the marketing authorisation of a veterinary medi-
cinal product, provided the Agency, the Commission and
the other Member States are informed at the latest on the
following working day.’

Article 2

Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive no later than 5 December 2001.

the provisions set out

in
When the Member States adopt
paragraph 1, they shall contain a reference to this Directive
or shall be accompanied by such reference at the time of
their official publication. The procedure for such references
shall be adopted by the Member States. The Member States
shall communicate to the Commission the provisions of
national
law which they adopt in the field covered by this
Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 5 June 2000.

(b) This guidance shall be published in Volume 9 of the
Rules governing medicinal products in the European
Union and shall take account of international harmo-
nisation work carried out in the field of pharmacovi-
gilance.’

For the Commission

Erkki LIIKANEN

Member of the Commission