# C_2005057EN.01000701.xml

| 5.3.2005 | EN | Official Journal of the European Union | C 57/7 |
| --- | --- | --- | --- |

5.3.2005

EN

Official Journal of the European Union

C 57/7

---

JUDGMENT OF THE COURT

JUDGMENT OF THE COURT

(Second Chamber)

of 20 January 2005

in Case 74/03 (reference for a preliminary ruling by the Østre Landsret): SmithKline Beecham plc v Lægemiddelstyrelsen (1)

1

(Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Active substance in different forms of salt - Additional documentation)

(2005/C 57/12)

Language of the case: Danish

In Case 74/03: reference for a preliminary ruling under Article 234 EC by the Østre Landsret (Denmark), made by decision of 14 February 2003, received at the Court on 19 February 2003, in the proceedings between SmithKline Beecham plc and Lægemiddelstyrelsen, interveners: Synthon BV and Genthon BV – the Court (Second Chamber), composed of C.W.A. Timmermans, President of the Chamber, C. Gulmann (Rapporteur), J.-P. Puissochet, N. Colneric and J.N. Cunha Rodrigues, Judges; F.G. Jacobs, Advocate General; M. Múgica Arzamendi, Principal Administrator, for the Registrar, has given a judgment on 20 January 2005, in which it has ruled:

| 1. | Article 4.8(a)(iii) of 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, as amended by Council Directives 87/21/EEC of 22 December 1986, 89/341/EEC of 3 May 1989 and 93/39/EEC of 14 June 1993, must be interpreted as not preventing an application for marketing authorisation in respect of a medicinal product from being handled under the abridged procedure under that provision where that product contains the same therapeutic moiety as the reference product but combined with another salt. |
| --- | --- |

1.

Article 4.8(a)(iii) of 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, as amended by Council Directives 87/21/EEC of 22 December 1986, 89/341/EEC of 3 May 1989 and 93/39/EEC of 14 June 1993, must be interpreted as not preventing an application for marketing authorisation in respect of a medicinal product from being handled under the abridged procedure under that provision where that product contains the same therapeutic moiety as the reference product but combined with another salt.

| 2. | In support of an application under Article 4.8(a)(iii) of Directive 65/65 as amended, an applicant may, either spontaneously or at the request of the competent authority of a Member State, supply additional documentation in the form of certain pharmacological and toxicological tests or clinical trials in order to demonstrate that his product is essentially similar to the reference product. |
| --- | --- |

2.

In support of an application under Article 4.8(a)(iii) of Directive 65/65 as amended, an applicant may, either spontaneously or at the request of the competent authority of a Member State, supply additional documentation in the form of certain pharmacological and toxicological tests or clinical trials in order to demonstrate that his product is essentially similar to the reference product.

---

(1)  OJ C 101 of 26.04.2003.

1

---