Order — ECLI:EU:T:2000:248
Date: 2000-10-31
Language of the case: German
Court formation: President of the Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Application for interim measures: suspension of operation of the contested measure and other interim measures
Procedure: Action for annulment;Application for interim measures - successful
Origin: Austria;Belgium;Germany;Spain;France;United Kingdom;Italy

Summary publication) 
Bruno Farmaceutici SpA and Others 
v 
Commission of the European Communities 
(Proceedings for interim relief — Withdrawal of marketing authorisations for 
medicinal products for human use containing the substance 'amfepramone' — 
Directive 75/319/EEC — Urgency — Balancing of interests) 
Order of the President of the Court of First Instance, 31 October 2000 . . II - 3560 
Summary of the Order 
1. Applications for interim measures — Suspension of operation of a measure — 
Conditions for granting — Urgency — Serious and irreparable damage — Decision 
withdrawing marketing authorisation for a medicinal product 
(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104(1) and (2)) 
2. Applications for interim measures — Suspension of operation of a measure — 
Conditions for granting — Balancing of all the interests involved — Decision 
withdrawing marketing authorisation for a medicinal product 
(Art. 242 EC; Rules of Procedure of the Court of First Instance, Art. 104 (1) and (2)) 
II - 3557 
SUMMARY — CASE T-76/00 R 
1. The damage which might be occa­
sioned by the immediate operation of 
a decision of the Commission concern­
ing the withdrawal of marketing 
authorisations for certain medicinal 
products is serious and irreparable, 
for the holder of a marketing author­
isation for a medicinal product con­
cerned, where it is shown, first, that the 
complete withdrawal from the market 
of the medicinal product in question 
entails the risk that substitute medic­
inal products will very probably take 
its place and that it will be impossible 
for the holder of the authorisation to 
restore confidence in the product even 
if the statements that the product 
withdrawn presents a danger to 
patients are subsequently disproved 
and, second, that if the decision were 
to be annulled by the court hearing the 
main application, the financial damage 
suffered by the holder because of a fall 
in sales as a result of loss of confidence 
in the product could not be quantified 
sufficiently completely. 
(see paras 42-44) 
2. Where, on an application for suspen­
sion of the operation of a measure, the 
judge hearing the application balances 
the various interests involved, he must 
determine whether later annulment of 
the contested measure by the Court 
when ruling on the main application 
would allow the situation which would 
have been brought about by the 
immediate operation of the measure 
to be reversed, and, conversely, whe­
ther suspension of operation of the 
measure would prevent it from being 
fully effective in the event of the main 
application being dismissed. 
In the context of an application for 
suspension of the operation of a Com­
mission decision concerning the with­
drawal of marketing authorisation for 
certain medicinal products, while the 
requirements of the protection of pub­
lic health must unquestionably be given 
precedence over economic considera­
tions when balancing the competing 
interests, mere reference to the protec­
tion of public health cannot exclude an 
examination of the circumstances of 
the case, in particular of the relevant 
facts. 
The balance of interests favours sus­
pension of the operation of such a 
decision where, first, it appears highly 
probable that its operation would 
entail the definitive loss of the appli-
II - 3558 
BRUNO FARMACEUTICI AND OTHERS V COMMISSION 
cant's position in the market even if the 
court hearing the main application 
were to annul the decision and, second, 
the Commission has not been able to 
show why the protective measures 
contained in a previous decision based 
on identical data, and consisting solely 
in a change to the compulsory infor­
mation which must be included in 
national authorisations, have proved 
to be insufficient to protect public 
health. 
(see paras 46-51) 
II - 3559