WRITTEN QUESTION E-0915/04 by John Bowis (PPE-DE) to the Commission. Directive 2001/83/EC and borderline products.
Date: 2004-03-26
Institutions: European Parliament, Provisional data
Subjects: cosmetic product, foodstuff, legal code, medicinal product, pharmaceutical legislation

3.4.2004

EN

Official Journal of the European Union

C 84 E/913

Answer given by Mr Liikanen on behalf of the Commission

(29 April 2004)

The requirement to give information on a medicinal product in Braille is included in the revision of
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 as agreed by the Parliament and the Council (December
2003-March 2004).

During the discussions for the review of the above-mentioned Directive, Members of the Parliament
pointed out the need to give basic information of medicinal products in Braille as well. As a consequence,
the Council took on board the arguments that partially sighted or blind patients should be in a position to
recognise the medicinal product.

The new provision (Article 56(a) of Directive 2001/83/EC) does not specify in which way the information
must be given, if the information has to be on the container itself or for example on a ‘self-adhesive Braille
label’. Different possibilities could be retained.

Different options could also be considered, in particular, concerning the availability at point of sale or by
request to the distributor of a leaflet in Braille.

The Commission will discuss with the Member States in the context of the Pharmaceutical Committee how
to implement this requirement in the most appropriate manner. Stakeholders will be consulted.

(2004/C 84 E/1009)

WRITTEN QUESTION E-0915/04

by John Bowis (PPE-DE) to the Commission

(26 March 2004)

Subject: Directive 2001/83/EC and ‘borderline products’

Will the Commission clarify what steps it has taken to address the issue of ‘borderline products’, such as
foods, cosmetics and medical devices, within Directive 2001/83/EC (1)?

When will the Commission hold the stakeholders’ meeting announced during the second reading debate
and will a list of invitees be announced before the event?

(1) OJ L 311, 28.11.2001, p. 67.

Answer given by Mr Liikanen on behalf of the Commission

(29 April 2004)

The Honourable Member wonders what steps the Commission has taken to address the implications of the
new Article 2(2) of 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 (‘borderline products’) and when the
Commission will hold a stakeholders’ meeting as announced during the second reading debate in the
Parliament.

The Commission’s opinion is that this provision will clarify, from a legal point of view, the situation of
certain borderline products for which there is currently uncertainty regarding which regulatory system
should be applied. This opinion has been shared by the Parliament and the Council.

The Commission has already started to prepare the organisation of a meeting with all interested parties in
order to discuss practical implementation issues linked to this new provision.

The meeting will take place presumably in June 2004. Stakeholders will be invited to the meeting (different
trade associations) as well as representatives of all Member States.