Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/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 medicinal products (Text with EEA relevance)
Date: 1999-09-08
Institutions: European Commission
Subjects: European Medicines Agency, animal disease, approximation of laws, marketing, pharmaceutical product, public health

15. 9. 1999

EN

Official Journal of the European Communities

L 243/7

COMMISSION DIRECTIVE 1999/82/EC

of 8 September 1999

amending the Annex to Council Directive 75/318/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 medicinal products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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 medicinal products;

Having regard to Council Directive 75/318/EEC of 20 May
1975 on the approximation of the laws of the Member States
relating to analytical, pharmacotoxicological and clinical stand-
ards and protocols in respect of the testing of medicinal prod-
ucts (1), as last amended by Directive 93/39/EEC (2), and in
particular Article 2(a)(1) thereof,

(6) Whereas, the Note for Guidance on Minimising the Risk
of Transmitting Animal Spongiform Encephalopathy
Agents via Medicinal Products will have to be regularly
updated and modified by the Committee for Proprietary
Medicinal Products of
the European Agency for the
Evaluation of Medicinal Products, taking into account
the latest scientific developments;

(1) Whereas Commission Decision 97/534/EC of 30 July
1997 on the prohibition of
the use of material
presenting risks as regards transmissible spongiform
encephalopathies (3) defines
specified risk materials,
provides for their elimination at source and prohibits
their import into the Community;

(7) Whereas the Note for Guidance on Minimising the Risk
of Transmitting Animal Spongiform Encephalopathy
Agents via Medicinal Products and its updates are
published by the European Commission in Volume 3 of
its publication ‘The rules governing medicinal products
in the European Union’;

(2) Whereas, prior to being marketed, all medicinal prod-
ucts, whether they originate in the Community or are
imported from third countries, are subject
to an
approval procedure in the context of which the treat-
is evaluated,
ment process of any raw material
in
the Annex to
conformity with the provisions of
Directive 75/318/EEC;

(3) Whereas this approval procedure applies to all medicinal
products to be placed on the market in the Community,
notwithstanding the origin of the product or the raw
materials
the
compliance with Community law of medicinal products,
starting materials and intermediate products which are
imported into the Community to be used in the manu-
facture of medicinal products is systematically controlled
and checked;

contained therein; whereas,

thereby,

(4) Whereas on 21 April 1999, the Committee for Propri-
etary 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
Medicinal Products;

(5) Whereas, in drafting this updated Note for Guidance, the
Committee for Proprietary Medicinal Products of the
European Agency for the Evaluation of Medicinal Prod-
the
ucts took into account all relevant Opinions of

(8) Whereas this Note for Guidance is considered to be
adequate to assure that the risk of transmitting Animal
Spongiform Encephalopathy via medicinal products is
minimised since manufacturers of medicinal products
are obliged under Directive 75/318/EEC to take into
account the relevant Community guidelines in assem-
bling the dossier for application for marketing author-
isation;

(9) Whereas it contributes to the clarity of the legal situa-
tion and ensures the highest reasonable level of protec-
tion of public health to amend the Annex to Directive
75/318/EEC to expressly make compliance with the
above Note for Guidance binding with regard to all
marketing authorisations for medicinal products and to
provide for an appropriate phasing-in period for already
existing marketing authorisations;

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

in conformity with the opinion of
Committee for Medicinal Products for Human Use,

HAS ADOPTED THIS DIRECTIVE:

Article 1

(1) OJ L 147, 9.6.1975, p. 1.
(2) OJ L 214, 24.8.1993, p. 22.
(3) OJ L 216, 8.8.1997, p. 95.

The Annex to Directive 75/318/EEC is hereby amended as
shown in the Annex.

L 243/8

EN

Official Journal of the European Communities

15. 9. 1999

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 medicinal
products lodged as from 1 July 2000 comply with the
criteria set out in the Annex to this Directive,

— all marketing authorisations for medicinal products meet
the criteria of the Annex to this Directive not later than 1
March 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.

The Member States shall communicate to the Commis-
4.
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.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 8 September 1999.

For the Commission

Karel VAN MIERT

Member of the Commission

ANNEX

A new paragraph C.a is inserted in Part 2 of the Annex to Directive 75/318/EEC:

‘C.a Specific measures concerning the prevention of

the transmission of animal spongiform encephalopathies

The applicant must demonstrate that the medicinal product is manufactured in accordance with the Note for
Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal
Products and its updates, published by the European Commission in Volume 3 of its publication “The rules
governing medicinal products in the European Union”.’