WRITTEN QUESTION E-0506/03 by Salvador Garriga Polledo (PPE-DE) to the Commission. Understanding package leaflets.
Date: 2003-02-21
Institutions: European Parliament, Provisional data
Subjects: EU Member State, consumer information, consumer protection, marketing, official language, packaging, pharmaceutical product, public health, use of languages

C 280 E/58

Official Journal of the European Union

EN

21.11.2003

(2003/C 280 E/060)

WRITTEN QUESTION E-0503/03

by Joan Vallvé (ELDR) to the Commission

(21 February 2003)

Subject: Catalan on the Commission’s website

Paragraph 4 of Parliament’s resolution of 11 December 1990 on languages in the Community and the
situation of Catalan (1) called on the Commission to take action to guarantee, inter alia, the use of Catalan
for disseminating public information concerning the European institutions in all the media.

It should be borne in mind that Parliament’s website is already available in the 12 languages of the
candidate countries for enlargement (in addition to the 11 current official languages), and that many of
these languages are less widely spoken than other languages of the European Union. This is the case with
Catalan, which is an official language of three regions with legislative powers and more than 11 million
inhabitants and which is spoken by 8 million people, placing it in front of Swedish, Finnish, Danish,
Bulgarian, Slovene, Slovak, Lithuanian, Latvian, Estonian and Maltese and making it comparable, as far as
Europe is concerned, to Portuguese or Czech.

Catalan belongs to a group of European languages which are official languages in their respective regions
of the Member States but which receive no official recognition at EU level.

the Commission introduce these languages on its website,

Will
Parliament’s resolution?

in line with the request made in

(1) OJ C 19, 28.1.1991, p. 42.

Answer given by Mr Prodi on behalf of the Commission

(7 March 2003)

Since the Union’s Europa website was launched in 1995, the Commission has applied the general principle
of publishing material in electronic form in all the Union’s official languages.

In addition to official documents, Europa (http://europa.eu.int) makes a large amount of non-official
information available to the general public. Here,
to technical
constraints and human and budgetary resources, is to maximise efforts in order that the general public can
access the official language of its choice. This objective will still be a priority for the next enlargement.

the Commission’s objective, subject

It is for the Member States to decide on its official languages.

(2003/C 280 E/061)

WRITTEN QUESTION E-0506/03

by Salvador Garriga Polledo (PPE-DE) to the Commission

(21 February 2003)

Subject: Understanding package leaflets

In view of the recommendations heard in television commercials concerning the necessary precautions
when taking the pharmaceutical products being advertised, it is surprising that in many EU Member States
the package leaflets accompanying medicinal products are published only in the language of the country of
consumption.

This prevents citizens of other EU countries who for whatever reason (work, tourism, etc.) are in a country
other
than their home country from being able to understand the explanations given by such
pharmaceutical package leaflets, particularly as regards contra-indications.

21.11.2003

EN

Official Journal of the European Union

C 280 E/59

Does the Commission believe that it should propose the adoption of corresponding Community legislation
requiring that all pharmaceutical package leaflets be published in three languages, so as to enable citizens
from the remaining EU countries who consume the products concerned to understand what is indicated in
the leaflet and prevent the health risks for consumers which may arise from possible contra-indications?

Answer given by Mr Liikanen on behalf of the Commission

(22 April 2003)

The essential aim of the Community rules governing the production, distribution and use of medicinal
products is to safeguard public health. The information supplied to users has to provide a high degree of
consumer protection, in order that medicinal products may be used correctly on the basis of full and
comprehensible information.

Article 59 of Directive 2001/83/EC (1) requires that the package leaflet shall be drawn up in accordance
with the summary of the product characteristics. For products authorised by the Community, there is a
single product characteristics agreed at Community level that forms part of the Community decision, and
the text of the package leaflet is the same throughout the Union.

In accordance with Article 63(2) of this Directive, the package leaflet must be presented at least in the
official language or languages of the Member State(s) where the product is placed on the market. When
more than one language is used, then all the text must be in each language, and the overall readability of
the label should not be adversely affected. The content of all language versions must be identical.

At the moment, the package leaflet translation into three or more languages is only an option for the
marketing authorisation holder.

The Commission supports any initiative to improve patient information on medicines. Our proposal to
review Directive 2001/83/EC and Regulation 2309/93/EC (2) includes various important suggestions related
to this area. In December 2002, the Commission accepted some Parliament amendments with regard to
increasing the transparency in this field and to make more and better information accessible to patients.
However, no amendment was included by the Parliament regarding the languages of the package leaflet.

(1) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating

to medicinal products for human use (cid:1) OJ L 311, 28.11.2001.

(2) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (cid:1) OJ L 214, 24.8.1993.

(2003/C 280 E/062)

WRITTEN QUESTION E-0513/03

by Alexander de Roo (Verts/ALE) to the Commission

(24 February 2003)

Subject: Scrap wood and dioxin in meat

The incineration of scrap wood in a drying plant in Erfurt (Germany) appears to be the cause of the
presence of dioxin in cattle transport and meat.

A great deal of wood and wood products are treated and impregnated to increase their durability. For this
purpose chlorinated hydrocarbons are often used.

When the treated wood (building waste and scrap wood) is burnt, dioxin is produced.

Is the Commission prepared to curb the incineration of scrap wood and impregnated wood and to permit
this incineration method only in specialised treatment plants, thus prohibiting it from having an effect on
the food chain?