WRITTEN QUESTION E-1613/02 by Avril Doyle (PPE-DE) to the Commission. Traditional herbal medicines.
Date: 2002-06-05
Institutions: European Parliament, Provisional data
Subjects: legal code, medical plant, medicinal product, pharmaceutical legislation, product safety

26.9.2002

EN

Official Journal of the European Communities

C 229 E/219

Does the Commission agree that there is no need for a requirement to produce a residence permit of
3.
indefinite validity as a means of combating speculation by people who are not resident in the Netherlands,
because the rules governing mortgage guarantees also state that a guarantee is valid only if the beneficiary
occupies the dwelling in person and it is his/her permanent principal home, and the guarantee remains
valid only so long as this continues to be the case?

4.
Do the new rules constitute discrimination on grounds of nationality, bearing in mind that people
who wish to settle in the Netherlands for a long period and spouses of Netherlands nationals who
themselves are nationals of another Member State of the EU or the EEA are placed at a disadvantage with
regard to the opportunity to buy a dwelling with the intention of living in it in person?

5. What will the Commission do to put an end to this unequal treatment and discrimination on
grounds of nationality?

Answer given by Mr Bolkestein on behalf of the Commission

(3 July 2002)

The Commission is conducting a detailed investigation of the problem raised by the Honourable Member
and will inform him of the outcome as soon as possible.

(2002/C 229 E/252)

WRITTEN QUESTION E-1613/02

by Avril Doyle (PPE-DE) to the Commission

(5 June 2002)

Subject: Traditional herbal medicines

Could the Commission please clarify why when drafting a definition of what is a traditional medicinal
product it has under Article 16 (c) 1.c of the proposal for a directive, defined ‘it as having a’medicinal
use‘in the Community throughout a period of at least thirty years preceding the date of application’? This
thirty year rule fails to accommodate many traditional medicinal products that cannot provide evidence of
continuous use in Europe for thirty years.

Answer given by Mr Liikanen on behalf of the Commission

(24 June 2002)

The Commission’s proposal for a Directive of the Parliament and of the Council amending the Directive
2001/83/EC as regards traditional herbal medicinal products (1) provides for a simplified registration of
certain herbal medicinal products.

The quality requirements for this category of medicinal products are the same as for all other medicinal
products. The safety and the efficacy of the product, for which the applicant seeks registration, however,
do not need to be proven by new tests and trials or by scientific literature. A simplified registration can be
granted, if data showing the medicinal use of the medicinal product over at least 30 years is sufficient. This
requires in particular that the product has been shown not to be harmful in the specified conditions of use
and that the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-
term use and experience.

Bearing in mind that the information on the product’s traditional use constitutes the basis for assessing the
product’s safety and efficacy, it is of paramount importance to guarantee the validity of this information in
a European context. The safety and the efficacy of a medicinal product can be influenced by regional
factors including availability of other medicines and medical treatments, medical tradition and practice or
physiological particularities. For these reasons it is essential to require that the information on the
traditional use of the product to be registered in one of the Member States relates at least to a certain
degree to its medicinal use in the Community.

C 229 E/220

Official Journal of the European Communities

EN

26.9.2002

At the same time, the Commission has tried to take into account medicinal use outside the Community as
far as possible. Its proposal for a new Article 16c, paragraph 4, 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 (2) requires medicinal use within the Community of at least 15 years. To complete the period of
30 years however,
is allowed to provide information on medicinal use outside the
Community. This provision ensures the necessary validity of the information on traditional use as a basis
for registration in a European context, while at the same time allowing the authorities to profit from
information on non-European medicinal use.

the applicant

(1) OJ C 126 E, 28.5.2002.
(2) OJ L 311, 28.11.2001.