Case C-115/07: Judgment of the Court (Sixth Chamber) of 27 September 2007 — Commission of the European Communities v Czech Republic (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)
Date: 2007-11-24
Institutions: Court of Justice
Subjects: Czechia, European Commission, action for failure to fulfil an obligation, legal code, medicinal product, national implementing measure, pharmaceutical legislation, public health

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)