WRITTEN QUESTION No. 2825/97 by Ria OOMEN-RUIJTEN to the Commission. Trade in anabolic steroids (SUPPLEMENTARY ANSWER)
Date: 1997-09-01
Institutions: European Parliament, OOMEN-RUIJTEN
Subjects: Netherlands, Spain, approximation of laws, hormone, market approval, marketing, marketing restriction, public health, single market

C 158/14

EN

Official Journal of the European Communities

25. 5. 98

This is not inconsistent with the fact that the Commission, as stated in its Reply to written question E-1705/97 by
the Honourable Member, was unaware of the specific facts behind the Court(cid:146)s statements in the 1994 annual
report. These facts (regions involved, Member States(cid:146) measures and details of actual damage) were not notified
to the Commission, which has asked the Court to provide concrete information (damage, regions, municipalities)
on the points raised in written questions E-1901/96 and E-1902/96 (3). It will pass this information directly to the
Honourable Member.

(1)  OJ C 303, 14.11.1995.
(2)  OJ L 297, 21.11.1996.
(3)  OJ C 60, 26.7.1997.

(98/C 158/18)

WRITTEN QUESTION E-2825/97

by Ria Oomen-Ruijten (PPE) to the Commission

(1 September 1997)

Subject: Trade in anabolic steroids

Is the Commission aware that trade in anabolic steroids, which is allowed in Spain but banned in the Netherlands,
is distorting the internal market and jeopardizing public health protection?

Under what conditions is the trade in Spain permitted (is prescription required, is export allowed)?

What arrangements does the Commission have in mind to bring about uniform European regulations ensuring
comprehensive health protection?

Supplementary answer
given by Mr Bangemann on behalf of the Commission

(10 November 1997)

Available by medical prescription in accordance with the provisions of Council Directive 92/26/EEC concerning
the  classification  for  the  supply  of  medicinal  products  for  human  use (1),  anabolic  steroids  are,  in  Spain,
medicinal products placed on the market with very specific therapeutic indications, such as remedying loss of
muscular  mass  following  severe  malnutrition,  compensating  for  prolonged  treatment  with  high  doses  of
corticoids  or  certain  cancer  treatments,  use  in  conjunction  with  major  surgical  operations  and  treating  burns
patients. All these anabolic agents are available in Spain by virtue of national marketing authorisations granted
by the Spanish authorities and valid only on Spanish territory. To date none of these agents has been the subject
of a mutual recognition procedure, the principle of which is to allow the smooth functioning of the Community
internal market. As for health protection, this is ensured inter alia by the provisions of Directive 92/26/EEC.
Within  the  framework  of  the  mutual  recognition  procedure,  it  is  only  where  discrepancies  appear  between
Member States in the granting of marketing authorisations for the same anabolic agent that, where appropriate,
the Commission could invoke Article 11 of Council Directive 75/319/EEC of 20 May 1975 on the approximation
of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (2)
with a view to harmonising the relevant national marketing authorisations.

(1)  OJ L 113, 30.4.1992.
(2)  OJ L 147, 9.6.1975.