Source: EURLEX
Language: en
Format: md

C 101/22 EN Official Journal of the European Union 26.4.2003

Q u e s t i o n 1

Is it compatible with point 8(a)(iii) of Article 4 of the
First Medicinal Products Directive (Directive 65/65/EEC( [1] ), as
amended) for a product to be authorised under the abridged
application procedure when a salt of the active substance in
the product is changed from the one used in the reference
product?

Q u e s t i o n 2

Can the abridged application procedure be used when an
applicant, on its own initiative or at the request of national
health authorities, submits additional documentation in the
form of certain pharmacological or toxicological tests or
clinical trials with a view to demonstrating that the product is
‘essentially similar to’ the reference product?

( [1] ) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (OJ B 22
of 9.2.1965, p. 369).

**Action brought on 19 February 2003 by the Commission**
**of the European Communities against Ireland**

**(Case C-75/03)**

(2003/C 101/36)

An action against Ireland was brought before the Court of
Justice of the European Communities on 19 February 2003 by
the Commission of the European Communities, represented
by Nicola Yerrell, acting as agent, with an address for service
in Luxembourg.

The Applicant claims that the Court should:

(1) find that Ireland has failed in its obligations under the EC
Treaty by failing to adopt the laws, regulations and
administrative provisions necessary to comply with
Council Directive 98/50/EC of 29th June 1998 amending
Directive 77/187/EEC on the approximation of the laws
of the Member States relating to the safeguarding of
employees’ rights in the event of transfers of undertakings,
businesses or parts of businesses ( [1] ), or by failing to
ensure that employers’ and employees’ representatives
have introduced the necessary provisions by agreement,
and/or by failing to inform the Commission thereof; and

(2) condemn Ireland to bear the costs of the procedure.

_Pleas in law and main arguments_

Article 249 EC, under which a directive shall be binding, as to
the result to be achieved, upon each Member State, carries by
implication an obligation on the Member States to observe the
period for compliance laid down in the directive. That period
expired on 17 July 2001 without Ireland having enacted the
provisions necessary to comply with the directive referred to
in the conclusions of the Commission.

( [1] ) OJ L 201 of 17.7.1998, p. 88.

**Action brought on 20 February 2003 by the Commission**
**of the European Communities against the Federal Repub-**
**lic of Germany**

**(Case C-77/03)**

(2003/C 101/37)

An action against the Federal Republic of Germany was
brought before the Court of Justice of the European Communities on 20 February 2003 by the Commission of the European
Communities, represented by Claudia Schmidt, of the European Commission’s Legal Service, acting as Agent, with an
address for service in Luxembourg at the office of Carlos
Gómez de la Cruz, also of the European Commission’s Legal
Service, Wagner Centre C 254, Kirchberg.

The applicant claims that the Court should:

1. declare that, by failing to bring into force the laws,
regulations and administrative provisions necessary to
comply with Directive 98/71/EC( [1] ) of the European
Parliament and of the Council of 13 October 1998 on
the legal protection of designs and/or by failing to inform
the Commission of those provisions, the Federal Republic
of Germany has failed to fulfil its obligations under that
directive;

2. order the Federal Republic of Germany to pay the costs.

_Pleas in law and main arguments_

The period for transposition expired on 28 October 2001.

( [1] ) OJ L 289 of 28.10.1998, p. 28.