Order — ECLI:EU:C:2001:223
Date: 2001-04-11
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Appeals;Protection of personal data
Procedure: Action for annulment;Appeal - successful;Application for interim measures
Origin: Spain;Portugal

Summary of the Order 
1. Appeals — Pleas in law — Plea alleging incorrect appraisal of the facts — Inadmis­
sibility — Review by the Court of Justice of the appraisal of the evidence submitted to 
the Court of First Instance — Possible only where the clear sense of the evidence has 
been distorted 
(Art. 225 EC; EC Statute of the Court of Justice, Art. 51) 
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SUMMARY — CASE C-478/00 P(R) 
2. Appeals — Admissibility —· Assessment in relation to the case at issue 
(EC Statute of the Court of justice, Art. 49) 
3. Approximation of laws — Proprietary medicinal products — Marketing authorisa­
tion — Evaluation of the products — Assessment of their harmfulness and effi­
cacy — Examination in relation to each other — Ongoing nature of the assessment 
(Council Directives 65/65, Art. 5, and 75/318, annex) 
4. Approximation of laws — Proprietary medicinal products — Marketing authorisa­
tion — Withdrawal of authorisation — Discretion of the Community authorities — 
Judicial review —· Limits 
(Council Directives 65/65, Art. 11, and 75/319, Arts 13 and 14) 
1. The Court of First Instance has exclu­
sive jurisdiction to find the facts, save 
where a substantive inaccuracy in its 
findings is attributable to the docu­
ments submitted to it, and to appraise 
those facts. That appraisal thus does 
not, save where the clear sense of the 
evidence has been distorted, constitute 
a point of law which is subject, as such, 
to review by the Court of Justice on 
appeal. 
(see para. 50) 
2. The conditions governing the admissi­
bility of appeals laid down by Arti­
cle 49 of the Statute of the Court of 
Justice are assessed in relation to the 
case at issue and that alone. The fact 
that the grounds of an order of the 
Court of First Instance which has 
become definitive are identical to those 
of an order subject to appeal does not 
prevent the appellant from contesting 
such grounds. 
(see para. 53) 
3. Under Article 5 of Directive 65/65 
relating to proprietary medicinal pro­
ducts, the evaluation of every medic­
inal product relates to its efficacy, its 
harmlessness and its quality. Compli­
ance with those three conditions is 
intended to protect public health. The 
very concept of the protection of public 
health means that the medicinal pro­
duct in question not only must not be 
harmful but also must be effective. The 
degree of harmfulness which the com­
petent authority may regard as accep­
table thus depends on the benefits 
which the medicinal product is consid­
ered to provide. As stated in the 
seventh and eighth recitals in the pre­
amble to Directive 75/318 relating to 
analytical, pharmaco-toxicological and 
clinical standards and protocols in 
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COMMISSION V ROUSSEL AND ROUSSEL IBERICA 
respect of the testing of medicinal 
products, the concepts of 'harmfulness' 
and 'therapeutic efficacy' can only be 
examined in relation to each other. 
Accordingly, the reasons which have 
led a competent authority to preserve a 
marketing authorisation for a medic­
inal product notwithstanding certain 
harmful effects may cease to apply if 
that authority considers that the bene­
fits justifying such an authorisation, 
that is to say the existence of a 
therapeutic effect, are no longer pre­
sent. As stated in the introduction to 
the annex to Directive 75/318, as 
amended by Directive 91/507, after 
issue of the marketing authorisation 
any new data or information are to be 
submitted to the competent authorities 
'in order to monitor the benefit/risk 
assessment'. 
(see paras 62, 65) 
4. Any decision withdrawing a marketing 
authorisation which is adopted in 
accordance with the procedure laid 
down in Articles 13 and 14 of Direc­
tive 75/319 relating to proprietary 
medicinal products must comply with 
the substantive conditions under Arti­
cle 11 of Directive 65/65, which relate 
to the efficacy, safety and quality of the 
medicinal product. This type of deci­
sion is thus the outcome of complex 
assessments in the medico-pharmaco­
logical field. In principle, such assess­
ments are subject to limited judicial 
review. Where a Community authority 
is called upon, in the performance of its 
duties, to make complex assessments, it 
enjoys a wide measure of discretion, 
the exercise of which is subject to a 
limited judicial review in the course of 
which the Community judicature may 
not substitute its assessment of the facts 
for the assessment made by the author­
ity concerned. Thus, in such cases, the 
Community judicature must restrict 
itself to examining the accuracy of the 
findings of fact and law made by the 
authority concerned and to verifying, 
in particular, that the action taken by 
that authority is not vitiated by a 
manifest error or a misuse of powers 
and that it did not clearly exceed the 
bounds of its discretion. 
(see paras 89-90) 
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