Opinion of the Economic and Social Committee on the 'Proposal for a European Parliament and Council Directive on the Community code relating to medicinal products for human use (codified version)'
Date: 1999-10-20
Institutions: European Economic and Social Committee
Subjects: approximation of laws, code of conduct, drug surveillance, medicinal product, pharmaceutical legislation

20.12.1999

EN

Official Journal of the European Communities

C 368/3

Opinion of the Economic and Social Committee on the ‘Proposal for a European Parliament and
Council Directive on the Community code relating to medicinal products for human use (codified
version)’

(1999/C 368/02)

On 4 October 1999 the Council decided to consult the Economic and Social Committee, under
Article 262 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for the Single Market, Production and Consumption, which was responsible for preparing
the Committee’s work on the subject, adopted its opinion on 7 October 1999. The rapporteur was Mr
Braghin.

At its 367th plenary session (meeting of 20 October 1999) the Economic and Social Committee adopted
the following opinion by 105 votes to one with three abstentions.

1.

Introduction

adoption of the codified legislation, so that the Directive can
enter into force on 1 January 2000 as laid down in Article 131.

1.1.
The proposed directive under consideration is designed
to codify and thus to supersede the various directives on the
approximation of provisions laid down by law, regulation or
administrative action relating to medicinal products, from
Council Directive 65/65/EEC of 26 January 1965 onwards.
The purpose of codification is to simplify and clarify Com-
munity law so as to ensure transparency and correct interpret-
ation, in accordance with the Commission’s decision of 1 April
1987 and the Conclusions of the Presidency of the Edinburgh
European Council (December 1992).

1.2.
The new directive, which is intended to codify the rules
expressly mentioned in Annex II, Part A, containing the list of
repealed directives, with their successive amendments, must
be adopted in full compliance with the normal Community
legislative procedure as laid down in Article 251 of the Treaty,
and must respect the substance of the codified texts, confining
itself to collating them with only such formal amendments as
are required by codification itself.

1.3.
The Commission has also taken account of the fact
that the European Agency for the Evaluation of Medicinal
Products has been set up by Council Regulation (EEC) No
2309/93 (OJ L 214 of 24.8.1993) and that in parallel Directive
93/39/EEC (ibidem) has laid down the framework for European
regulatory procedures.

1.4.
The codification proposal concerning medicinal prod-
ucts for human use was drawn up in parallel with the
codification proposal
for directives relating to veterinary
medicinal products, which are not covered by the text under
consideration.

2. General comments

2.2.
The codification in question is complete insofar as it
also covers the directives and specific provisions relating
to immunological medicinal products, radiopharmaceuticals,
medicinal products derived from human blood or human
plasma, and homeopathic medicinal products, as well the
directives on wholesale distribution, classification,
labelling
and package leaflets, and advertising. The final part of the text
is Annex I entitled ‘Analytical, Pharmacotoxicological and
Clinical Standards and Protocols in respect of the Testing of
Medicinal Products’.

2.3.
The codified text mostly retains the terminology used
in the original directives and does not reflect developments
which have occurred in the meantime, particularly as a result
of the work of the International Conference on Harmonisation
(ICH), which seeks to define standards applicable in the EU
and the rest of the world. The Committee suggests the addition
of another annex in which the technical terms which should
be replaced by those finally adopted by the ICH are indicated.

international

The development of

terminology
2.3.1.
should in particular be reflected in the updating of
the
definitions in Article 1 in those languages where traditional
terms no longer current internationally have remained in use
(e.g. in Italian: ‘effetto collaterale negativo’ rather than ‘reazione
avversa’). The Committee feels that
the incorporation of
changes approved by the appropriate international organis-
ations should be facilitated when transposing directives into
national law.

The Committee warmly welcomes this codification
2.1.
effort, which constitutes an essential reference point for the
relevant authorities of the Member States. The proposed
codification, reflecting a need felt for years, was finally included
in the Commission’s 1998 work programme and has now
reached the proposal stage. The Committee hopes that the
accelerated procedure, endorsed by the interinstitutional agree-
ment of 20 December 1994, will make possible the rapid

2.3.2.
The Committee also hopes that, for those few terms
which in certain languages can be expressed in slightly different
forms without changing the meaning, a single term could
always be used (e.g. in English: ‘marketing authorisation holder’
instead of ‘applicant’, ‘holder’ or ‘authorisation holder’), unless
it is necessary in a specific context to bring out shades of
meaning.

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Official Journal of the European Communities

20.12.1999

2.3.3.
The text of Annex I includes a series of amendments
as to the terms used, with some discrepancies between the
different languages. It would be desirable to point out and
justify these amendments in notes or in a specific annex, given
the technical nature of the points and their importance for
correct preparation of the registration dossier.

2.4.
The various language versions do not always match,
probably because of imperfect translation from the original
stages of the document. The Committee suggests that the
the present codification
Commission could make use of
exercise to amend the articles and take appropriate steps where
they are inaccurately translated from the reference language.

2.5.
Title IX tackles the subject of pharmacovigilance, a
field in which debate is under way with a view to drawing
up proposed amendments to Directive 75/319/EEC. The
Committee hopes that these proposals will be put forward and
discussed soon, in the interests of increasingly effective public
health protection.

the importance of

The Committee, aware of

2.6.
this
codification to harmonisation of the rules governing the
pharmaceutical sector, and of early transposition of
the
directive into national legislation, recommends that the Com-
mission set up a panel of experts, if possible representing all
the official languages of the EU, in order to standardise the use
of technical terms, verify that they reflect official ICH findings
and, where compatible, current usage, and compare the
language versions to ensure that changes are standard.

2.6.1.
need for consistent and uniform use of concepts such as:

The Committee would draw special attention to the

— adverse reactions / negative collateral effects

— medicine / medicinal product / medicinal speciality

— holder of marketing authorisation / holder / authorisation

holder / applicant

2.7.
As shown in the final part of the Commission com-
munication on the Community marketing authorisation pro-
cedures for medicinal products (OJ C 229 of 22 July 1998),
there are still diverging interpretations by national adminis-
trations, a certain reluctance to trust scientific assessments
from other Member States, and lengthy national administrative
procedures - all factors which have prevented full use of
the advantages of the new authorisation procedures. The
Committee hopes that the Commission will take advantage of
the overall reassessment of the registration system due in 2001
to introduce the necessary adjustments to the present texts,
assisted in this by the considerable and welcome effort of
codification currently in progress.

3. Specific comments

3.1.
The Committee would draw the Commission’s atten-
tion to a number of specific points in which it has identified
discrepancies, so that
the excellent work of codification
presented can be further improved.

The adaptation in whereas clause (14) would appear to
3.2.
alter the meaning of the second sentence slightly compared to
the original version.

3.3.
In the Italian language version of whereas clause (45),
the verb ‘puo` ’ is missing before ‘incidere’ (i.e. ‘could’ before
‘affect’).

3.4.
Article 1 is of particular importance, since it defines
the terms used. The various versions differ at several points,
those of particular relevance being 11 (effet indésirable; adverse
reaction; effetto collaterale negativo), 12, 13, 14 (specifications
of point 11), 17 (professionnel habilité à cet effet; professional
person qualified to make such a prescription; professionista
autorizzato a prescrivere medicinali) and 26 (tout risque; all
risks; un rischio: the Italian version is closest to the original
texts).

— active substance / active ingredients / components

— method of preparation / method of manufacture

A discrepancy running throughout the text is that in
3.4.1.
the English version the terms ‘side effects’ and ‘undesirable
effects’ have been replaced with the now universally used
‘adverse reactions’, while this has not been done for the other
language versions.

— competent authorities / Member States

— Agency (EMEA) / Committee (CPMP).

3.5.
Article 11(2) does not contain specific reference to the
international common term recommended by the World
Health Organisation, which provided technical clarification for
the original text.

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Official Journal of the European Communities

C 368/5

3.6.
The English language version of Article 19(2) is the
sole language version which does not contain the phrase ‘the
basic ingredients and, if need be, its intermediate products or
other constituent materials’.

The English language version of Article 36(1) incor-

3.7.
rectly refers to ‘products’ instead of ‘procedures’.

3.8.
The term ‘agent’ used in a number of articles [42(1);
46(d); fifth line of 51(3)], and the expression ‘persons respon-
sible for inspecting them’ [80(a)], should be replaced by the
technically correct term ‘inspector’.

3.9.
The phrase ‘person authorised or entitled’ to supply
medicinal products to the public (Article 82) is truncated in a
number of language versions, which refer solely to a ‘person
authorised’.

3.10.
The English term ‘guidelines’ is not translated by the
usual ‘linee guida’, but in some languages the phrase ‘linee
direttrici’ is employed, which may give the wrong impression
that they can be imposed from above.

3.11.
The English version of Article 85 wrongly talks of
distribution of medicinal products to the public ‘for pro-
‘for non-
motional purposes’. The meaning must be
promotional purposes’.

3.12.
The English version of Article 96(b) employs the term
‘prescribing agent’: it would be more appropriate to use the
term ‘prescriber’, which reflects both the reference text and
current usage.

term employed is that currently used in the different Member
States to describe this professional function.

The English language version of Article 112 uses the
3.14.
term ‘person responsible for marketing a medicinal product’
instead of ‘marketing authorisation holder’ as employed in the
reference text.

3.15.
There is a typing error in the English version of
Annex I, Part 2.D.1, third paragraph, giving ‘method or prep-
aration’ instead of the correct ‘method of preparation’.

The Italian version of Annex I, Part 4.B.1.2, second
3.16.
paragraph, still uses the term ‘procedure di attuazione’
(‘implementation procedures’) instead of ‘tecniche adottate’
(‘technical application’) as in the other updated language
versions.

3.17.
Annex I (Part 4.F.1) talks of ‘treatment of the control
groups’. The Italian version wrongly uses the phrase ‘controllo
delle prove’ (‘control of the samples’). It should be ensured that
the correct phrase is used in all language versions.

In some language versions, other articles contain
3.18.
incorrect references. For instance,
the English version of
Article 33 refers to 34 instead of 32, and the Italian version of
Article 55 refers to 55 instead of 54. The entire directive
should be formally checked.

Some language versions only give ‘or’

3.19.
instead of
‘and/or’, for instance Articles 41(a), 59(a), the third indent of
71(1), and 115 in the Italian version. This may change the
meaning and the subsequent transposition to national law.
The entire directive should be formally checked for this aspect.

In Article 103(a), some language versions fail

3.13.
to
provide an accurate description of the function of ‘medical
representatives’. The Commission is asked to check that the

3.20.
missing.

Lastly, reference to Article 12(3) of Directive 92/28 is

Brussels, 20 October 1999.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI