WRITTEN QUESTION E-0647/03 by Jules Maaten (ELDR) to the Commission. Obligation to register homeopathic medicines.
Date: 2003-03-05
Institutions: European Parliament, Provisional data
Subjects: EU Member State, application of EU law, approximation of laws, homeopathic product, legal code, market approval, marketing standard, medicinal product, pharmaceutical legislation

14.8.2003

EN

Official Journal of the European Union

C 192 E/213

(2003/C 192 E/255)

WRITTEN QUESTION E-0647/03

by Jules Maaten (ELDR) to the Commission

(5 March 2003)

Subject: Obligation to register homeopathic medicines

Is the Commission aware that because of the different registration requirements in the Member
1.
States, homeopathic remedies can be sold in pharmacies in the Germany, while this has been forbidden in
the Netherlands since 1 June 2002?

Does the Commission take the view that a company can market homeopathic products in the

2.
Netherlands that are registered in Germany, although they are not registered in the Netherlands?

3.
If not, is a company also forbidden to put a product on the market in the Netherlands if it has
demonstrated that the product meets European safety requirements? The reason for this question is that
registration is very expensive, and difficult for small companies and importers to obtain.

4.
Dutch patients have to order most of the German homeopathic remedies prescribed by their doctors
themselves, and collect them from Germany. This is because the Netherlands is the only Member State to
have applied, since 1 June 2002, the European registration requirements. Medicines produced in Germany
meet the German registration requirements, but do not yet meet the European ones (which will not be
introduced in Germany until 2008). Is the Commission aware of this practical problem, and how does it
intend to solve it?

In the opinion of the Commission, does this situation not constitute an unacceptable barrier to the

5.
European single market?

6.

Does the Commission intend to remedy this situation?

Answer given by Mr Liikanen on behalf of the Commission

(9 April 2003)

1.
The Commission is aware of differences that exist between the national rules on the registration and
distribution of homeopathic medicinal products in various Member States. The reason for these differences
is that the European legislation does not fully harmonise this area. Homeopathic medicinal products
covered by a registration or an authorisation granted under national law on or before 31 December 1993
are excluded, according to Article 13 paragraph 1 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 (1),
from the harmonised registration requirements of that Directive. In addition, the rules on the retail trade
and in particular whether medicinal products have to be sold in pharmacies, are not covered by the
existing European legislation.

2.
Article 6 paragraph 1 of Directive 2001/83/EC provides that no medicinal product may be placed on
the market of a Member State unless a marketing authorisation has been issued by the competent
authorities of that Member State in accordance with that Directive or an authorisation has been granted in
accordance with 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 (2). This provision applies to all
medicinal products including homeopathic medicinal products. Hence a homeopathic medicinal product
may not be marketed in the Netherlands,
if it has not obtained a national marketing authorisation/
registration in the Netherlands or a Community marketing authorisation.

3.
The requirement set out in Article 6 paragraph 1 of Directive 2001/83/EC is a strict and necessary
condition for the marketing of a medicinal product. Therefore, the answer given to the second question
applies, irrespective of whether European safety requirements are met.

C 192 E/214

Official Journal of the European Union

EN

14.8.2003

The situation described in the fourth question is not correct according to the information that is
4.
available to the Commission. The harmonised legislation for the authorisation and registration of
homeopathic medicinal products as set out in Directive 2001/83/EC is applied in all Member States
including Germany. However, as explained in the answer to the first question, this legislation is obligatory
only for authorisations/registrations after 31 December 1993. For authorisations or registrations that were
existing at that date, the European legislation does not contain obligatory provisions. It is up to the
Member States therefore to decide what rules to apply to such authorisations or registrations. The
Commission does not have the competence to impose any binding rules in this area.

As a result of Article 6 of Directive 2001/83/EC, there is no entirely free circulation of nationally
5.
approved medicines as a separate approval
is needed for each Member State where the product is
marketed. However, it is one of the key objectives of that Directive to facilitate the free movement of the
medicinal products concerned,
recognition of marketing
authorisations. For authorisations or
registrations granted before 31 December 1993, Article 13
paragraph 1 of Directive 2001/83/EC obliges the Member States to take due account of such approvals,
when an authorisation or registration for the same product is sought in another Member State. This system
promotes the Single Market while taking account of existing divergences between the Member States.

in particular by providing for a mutual

As the answers given to the other questions indicate, the Commission is not entitled to stipulate how
6.
the Member States should deal with the authorisations or registrations for homeopathic medicinal products
existing on the 31 December 1993. For authorisations and registrations granted after that date, the
European legislation provides for largely harmonised rules. No specific problems with the application of
these rules have been brought to the attention of the Commission. It is not foreseen, therefore, to take any
particular measure in this area.

(1) OJ L 311, 28.11.2001.
(2) OJ L 214, 24.8.1993.

(2003/C 192 E/256)

WRITTEN QUESTION E-0693/03

by Konstantinos Hatzidakis (PPE-DE) to the Commission

Subject: Refusal of Dikatsa in Greece to recognise a European degree

(7 March 2003)

Since 1991 the European Union has been funding the European Association of Environmental
Management Education involving universities of international repute, such as the National and Capodis-
trian University of Athens, the Université Libre de Bruxelles, the Ecole polytechnique Fédérale de Lausanne,
Geneva University, Trier University and Erasmus University.

The Union provides financial support for the Masters degree in Environmental Management which is
recognised in all EU Member States, apart from Greece. Following an appeal by an interested party to the
Greek Council of State, the Supreme Court has invalidated the decision by Dikatsa (the Greek body
responsible for recognising degrees) not to recognise the above post-graduate degrees.

Despite this, both the Greek Ministry of Education and the Dikatsa, acting on its behalf, refuse to recognise
these degrees on various pretexts.

Is the Commission aware of this curious state of affairs? What action does it intend to take to solve this
specific problem?

Answer given by Mr Bolkestein on behalf of the Commission

(7 April 2003)

The information provided for by the Honourable Member is not sufficiently detailed for the Commission
to establish whether the non-recognition of the master degree in question amounts to an infringement of
Community law.