Commission Directive 1999/104/EC of 22 December 1999 amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (Text with EEA relevance)
Date: 1999-12-22
Institutions: European Commission
Subjects: approximation of laws, drug surveillance, pharmaceutical legislation, pharmacology, toxicology, veterinary drug

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EN

Official Journal of the European Communities

6. 1. 2000

COMMISSION DIRECTIVE 1999/104/EC

of 22 December 1999

amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the
Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in
respect of the testing of 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 81/852/EEC of 28
September 1981 on the approximation of the laws of the
Member States relating to analytical, pharmacotoxicological
and clinical standards and protocols in respect of the testing of
veterinary medicinal products (1), as last amended by Directive
93/40/EEC (2), and in particular Article 2a(1) thereof,

(1) Whereas Commission Decision 987/534/EC of 30 July
1997 on the prohibition of
the use of material
presenting risks as regards transmissible spongiform
encephalopathies (3), as amended by Council Decision
98/745/EC (4), defines specified risks materials, provides
for their elimination at source and prohibits their import
into the Community;

products, whether

(2) Whereas, prior to being marketed, all veterinary medi-
cinal
the
Community or are imported from third countries, are
to an approval procedure in the context of
subject
is
which the treatment process of any raw material
evaluated,
the
Annex to Directive 81/852/EEC;

in conformity with the provisions of

originate

they

in

(3) Whereas this approval procedure applies to all veter-
inary medicinal products to be placed on the market in
the
the Community, notwithstanding the origin of
product or the raw materials contained therein; whereas,
thereby, the compliance with Community law on veter-
inary medicinal products, starting materials and inter-
mediate products which are
into the
Community to be used in the manufacture of veterinary
medicinal products
systematically controlled and
checked;

imported

is

(4) Whereas on 17 June 1999, the Committee for Veter-
inary Medicinal Products of the European Agency for the
Evaluation of Medicinal Products adopted an updated
Note for Guidance on minimising the risk of transmit-
ting animal spongiform encephalopathy agents via veter-
inary medicinal products.

(5) Whereas, in drafting this updated Note for Guidance, the
Committee for Veterinary Medicinal Products of
the
European Agency for the evaluation of medicinal prod-
ucts took into account all relevant opinions of
the
Scientific Committee on Medicinal Products and Medical
Devices, as well as the Scientific Steering Committee and
additional scientific considerations which apply to the
specific field of veterinary medicinal products;

transmitting animal

(6) Whereas, the Note for Guidance on minimising the risk
of
spongiform encephalopathy
agents via veterinary medicinal products will have to be
regularly updated and modified by the Committee for
Veterinary Medicinal Products of the European Agency
for the evaluation of medicinal products, taking into
account the latest scientific developments;

transmitting animal

(7) Whereas the note for Guidance on minimising the risk
spongiform encephalopathy
of
agents via veterinary medicinal products and its updates
are published by the European Commission in Volume 7
of its publication ‘The rules governing medicinal prod-
ucts in the European Union’;

(8) Whereas this Note for Guidance is considered to be
adquate to assure that the risk of transmitting animal
spongiform encephalopathy via veterinary medicinal
products is minimised since manufacturers of veterinary
medicinal products are obliged under Directive 81/
852/EEC to take into account the relevant Community
guidelines in assembling the dossier for application for
marketing authorisation;

(9) Whereas it contributes to the clarity of the legal situa-
tion and ensures the highest reasonable level of protec-
tion of animal and human health to amend the Annex
to Directive 81/852/EEC to expressly made compliance
with the above Note for Guidance binding within regard
to all marketing authorisations for veterinary medicinal
products and to provide for an appropriate phasing-in
period for already existing marketing authorisations;

(1) OJ L 317, 6.11.1981, p. 16.
(2) OJ L 214, 24.8.1993, p. 31.
(3) OJ L 216, 8.8.1997, p. 95.
(4) OJ L 358, 31.12.1998, p. 113.

(10) Whereas the measures provided for in this Directive are
the Standing

in conformity with the opinion of
Committee for Veterinary Medicinal Products,

6. 1. 2000

EN

Official Journal of the European Communities

L 3/19

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annex to Directive 81/852/EEC is hereby amended as
shown in the Annex.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive no later than 1 January 2000.

take the necessary measures to

2. Member States shall
ensure that:
— applications for marketing authorisations for veterinary
medicinal products lodged as from 1 October 2000 comply
with the criteria set out in the Annex to this Directive;
— all marketing authorisations for veterinary medicinal prod-
ucts meet the criteria of the Annex to this Directive not
later than 1 June 2001.

3. When the Member States adopt the provisions set out in
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.

4.
The Member States shall communicate to the Commis-
sion 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 third 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, 22 December 1999.

For the Commission

Erkki LIIKANEN

Member of the Commission

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Official Journal of the European Communities

6. 1. 2000

ANNEX

A new paragraph C.(a) is inserted in Title I Part 2 and Title II Part 6 of the Annex to Directive 81/852/EEC.

‘C.(a) Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies

The applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for
Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal
products and its updates, published by the European Commission in Volume 7 of its publication “The rules governing
medicinal products in the European Union”.’