Case C-117/07: Judgment of the Court (Eighth Chamber) of 27 September 2007 — Commission of the European Communities v Czech Republic (Failure of a Member State to fulfil its obligations — Directive 2005/28/EC — Principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use — Requirements for authorisation of the manufacturing or importation of these medicinal products — Failure to transpose within the prescribed period)
Date: 2007-11-24
Institutions: Court of Justice
Subjects: Czechia, European Commission, action for failure to fulfil an obligation, experiment on humans, medical research, medicinal product, national implementing measure, pharmaceutical industry

24.11.2007

EN

Official Journal of the European Union

C 283/5

Operative part of the judgment

Operative part of the judgment

1. By failing to adopt, within the prescribed period, the laws, regula-
tions and administrative provisions necessary to comply with Direc-
tive 2003/35/EC of the European Parliament and of the Council
of 26 May 2003 providing for public participation in respect of
the drawing up of certain plans and programmes relating to the
environment and amending with regard to public participation and
access to justice Council Directives 85/337/EEC and 96/61/EC,
the Kingdom of Belgium has failed to fulfil its obligations under
that Directive;

1. By failing to adopt, within the prescribed period, the laws, regula-
tions and administrative provisions necessary to comply with Direc-
tive 2004/27/EC of the European Parliament and of the Council
of 31 March 2004 amending Directive 2001/83/EC on the Com-
munity code relating to medicinal products for human use, the
Czech Republic has failed to fulfil its obligations under Article 3 of
that directive;

2. The Czech Republic is ordered to pay the costs.

2. The Kingdom of Belgium is ordered to pay the costs.

(1) OJ C 95, 28.4.2007.

(1) OJ C 95, 28.4.2007.

Judgment of the Court (Sixth Chamber) of 27 September
the European Communities v
2007 — Commission of

Czech Republic

(Case C-115/07) (1)

(Failure of a Member State to fulfil its obligations — Directive
2004/27/EC — Proprietary medicinal products — Medicinal
products for human use — Failure to transpose within the
prescribed period)

Judgment of the Court (Eighth Chamber) of 27 September
the European Communities v
2007 — Commission of

Czech Republic

(Case C-117/07) (1)

(Failure of a Member State to fulfil its obligations — Directive
2005/28/EC — Principles and detailed guidelines for good
clinical practice as regards investigational medicinal products
for human use — Requirements for authorisation of the
manufacturing or importation of these medicinal products —
Failure to transpose within the prescribed period)

(2007/C 283/07)

Language of the case: Czech

(2007/C 283/08)

Language of the case: Czech

Parties

Parties

Applicant: Commission of the European Communities (repre-
sented by: B. Stromsky and M. Šimerdová, Agents)

Defendant: Czech Republic (represented by: T. Boček, Agent)

Applicant: Commission of the European Communities (repre-
sented by: B. Stromsky and M. Šimerdová, Agents)

Defendant(s): Czech Republic (represented by: T. Boček, Agent)

Re:

Failure of a Member State to fulfil obligations — Failure to
adopt, within the prescribed period, all the provisions necessary
the European
to comply with Directive 2004/27/EC of
Parliament and of the Council of 31 March 2004 amending
Directive 2001/83/EC on the Community code relating to
medicinal products for human use (OJ 2004 L 136, p. 34)

Re:

Failure of a Member State to fulfil obligations — Failure to
adopt, within the prescribed period, all the provisions necessary
to comply with Commission Directive 2005/28/EC of 8 April
2005 laying down principles and detailed guidelines for good
clinical practice as regards investigational medicinal products for
human use, as well as the requirements for authorisation of the
manufacturing or importation of such products (OJ 2005 L 91,
p. 13)

C 283/6

EN

Official Journal of the European Union

24.11.2007

Operative part of the judgment

1. By failing to adopt, within the prescribed period, the laws, regula-
tions and administrative provisions necessary to comply with
Commission Directive 2005/28/EC of 8 April 2005 laying down
principles and detailed guidelines
for good clinical practice as
regards investigational medicinal products for human use, as well as
the requirements for authorisation of the manufacturing or impor-
tation of such products, the Czech Republic has failed to fulfil its
obligations under Article 31(1) of that directive;

2. The Czech Republic is ordered to pay the costs.

(1) OJ C 95, 28.4.2007.

Reference for a preliminary ruling from the Landgericht
Mannheim (Germany) lodged on 12 July 2007 — Criminal
proceedings against Karl Schwarz

(Case C-321/07)

(2007/C 283/09)

Language of the case: German

Referring court

Landgericht Mannheim

Party to the main proceedings

Karl Schwarz

Questions referred

drive, which was issued earlier, also no longer requires to be
recognised after accession of the foreign Member State, even
where the period of
the ban imposed in Germany has
expired?

(1) Council Directive 91/439/EEC of 29 July 1991 on driving licences

(OJ 1991 L 237, p. 1).

Reference for a preliminary ruling from Supreme Court
(Ireland) made on 6 August 2007 — Nicole Hassett and
Cheryl Doherty/The Medical Defence Union Limited and
MDU Services Limited v Raymond Howard and Brian
Davidson

(Case C-372/07)

(2007/C 283/10)

Language of the case: English

Referring court

Supreme Court, Ireland

Parties to the main proceedings

Applicants: Nicole Hassett and Cheryl Doherty/The Medical
Defence Union Limited and MDU Services Limited

Defendants: Raymond Howard and Brian Davidson

Questions referred

1. Is it — contrary to Article 7(5) of Directive 91/439/EEC (1)
— possible under Community law for a citizen of the EU to
hold a valid German right to drive and a second right to
drive issued by another Member State, both of which were
obtained before the accession to the EU of
the foreign
Member State and — if so —

2. Does the withdrawal — before the entry into force of the
Regulation on the right to drive (Fahrerlaubnisverordnung;
‘FeV’) of 1 January 1999 — of the later second German right
to drive as a consequence of a drunkenness offence mean
that the validity in Germany of the first foreign right to

Where medical practitioners form a mutual defence organisation
taking the form of a company, incorporated under the laws of
one Member State, for the purpose of providing assistance and
indemnity to its members practising in that and another
Member State in respect of their professional practice, and the
provision of such assistance or indemnity is dependant on the
making of a decision by the Board of Management of that
company, in accordance with its Articles of association, in its
absolute discretion, are proceedings in which a decision refusing
assistance or indemnity to a medical practitioner practising in
the other Member State pursuant to that provision is challenged
by that medical practitioner as involving a breach by the
company of contractual or other legal rights of the medical