Case C-387/99

Commission of the European Communities

v

Federal Republic of Germany

(Failure of a Member State to fulfil obligations – Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC) – Directive 65/65/EEC – Food preparations containing three times more vitamins than the recommended daily amount – Preparations lawfully marketed as food supplements in the Member State of exportation – Preparations classified as medicinal products in the Member State of importation – ‘Medicinal product’ – Obstacle – Justification – Public health – Proportionality – Admissibility of the application)

Summary of the Judgment

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Administrative practice classifying as medicinal products certain vitamin preparations containing three times more than the recommended daily amount – Justification – Protection of public health – Absence – Requirement for detailed assessment on a case-by-case basis

(EC Treaty, Arts 30 and 36 (now, after amendment, Arts 28 EC and 30 EC; Council Directive 65/65, Art. 1)

A Member State has failed to fulfil its obligations under Article 30 of the Treaty (now, after amendment, Article 28 EC) when it automatically classifies as medicinal products vitamin preparations lawfully manufactured or marketed as food supplements in other Member States where they contain three times more vitamins, other than vitamins A and D, than the daily amount recommended by the national food association.

Since such a classification, which is based solely on the recommended daily amount, does not fully satisfy the requirement for a classification on the basis of the pharmacological properties of each vitamin preparation and, consequently, it does not necessarily follow that all preparations concerned come within the definition of a ‘function’ medicinal product for the purposes of Directive 65/65 relating to proprietary medicinal products, that practice creates a barrier to trade, in so far as vitamin preparations lawfully marketed or produced in other Member States as food supplements cannot be marketed in the Member State in question until they have been subject to the marketing authorisation procedure for medicinal products.

That practice cannot be justified for reasons of protection of the health and life of humans referred to in Article 36 of the Treaty (now, after amendment, Article 30 EC), since it does not make a distinction by reference to the different vitamins added or, in particular, to the level of risk to public health which their addition could entail and, consequently, the automatic nature of that practice does not make it possible to identify and assess a real risk to public health, which requires a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question could entail.

(see paras 62, 65, 78-79, 83, operative part)

JUDGMENT OF THE COURT (Sixth Chamber) 29 April 2004 (1)

(Failure of a Member State to fulfil obligations – Articles 30 and 36 of the EC Treaty (now, after amendment, Articles 28 EC and 30 EC) – Directive 65/65/EEC – Food preparations containing three times more vitamins than the recommended daily amount – Preparations lawfully marketed as food supplements in the Member State of exportation – Preparations classified as medicinal products in the Member State of importation – ‘Medicinal product’ – Obstacle – Justification – Public health – Proportionality – Admissibility of the application)

In Case C-387/99,

applicant,

v

defendant, supported by

and by and byand by

interveners,

APPLICATION for a declaration that, by classifying as medicinal products vitamin and mineral preparations which are lawfully produced or marketed as food supplements in the other Member States where they contain three times more vitamins and minerals than the daily amount recommended by the Deutsche Gesellschaft für Ernährung, the Federal Republic of Germany has failed to fulfil its obligations under Article 30 of the EC Treaty (now, after amendment, Article 28 EC),

THE COURT (Sixth Chamber),,

composed of: V. Skouris, acting as the President of the Sixth Chamber, J.N. Cunha Rodrigues, R. Schintgen, F. Macken (Rapporteur) and N. Colneric, Judges,

Advocate General: L.A. Geelhoed,

after hearing oral argument from the parties at the hearing on 21 February 2002,

after hearing the Opinion of the Advocate General at the sitting on 16 May 2002,

gives the following

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products [OJ 1993 L 214, p. 1] …’

‘The authorisation provided for in Article 3 shall be refused if, after verification of the particulars and documents listed in Article 4, it proves that the medicinal product is harmful in the normal conditions of use, or that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant, or that its qualitative and quantitative composition is not as declared.

Authorisation shall likewise be refused if the particulars and documents submitted in support of the application do not comply with Article 4.’

Admissibility

Substance

On those grounds,

THE COURT (Sixth Chamber)

hereby:

Skouris

Cunha Rodrigues

Schintgen

Macken

Colneric

Delivered in open court in Luxembourg on 29 April 2004.

R. Grass

V. Skouris

Registrar

President