Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00

Artegodan GmbH and Others

v

Commission of the European Communities

‛Medicinal products for human use — Community arbitration procedures — Withdrawal of marketing authorisations — Competence — Criteria for withdrawal — Anorectics: amfepramone, clobenzorex, fenproporex, norpseudoephedrine, phentermine — Directives 65/65/EEC and 75/319/EEC’

Judgment of the Court of First Instance (Second Chamber, Extended Composition), 26 November 2002   II-4948

Summary of the Judgment

1. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Authorisations ‘granted in accordance with the provisions of Chapter III’ of Directive 75/319 — Definition — National authorisations harmonised under a procedure based on Article 12 of the directive — Not included

   (Council Directive 75/319, Arts 12 and 15a)

2. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Criteria laid down by Directive 65/65 — Exhaustive — Interpretation in accordance with the general principle that protection of public health takes precedence over other considerations

   (Council Directive 65/65, Arts 11 and 21)

3. Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Criteria laid down by Directive 65/65 — Need for new scientific data or information — Scope — Changes in an assessment criterion — Not included

   (Council Directive 65/65, Art. 11)

1.  Article 15a(1) of Directive 75/319 relating to medicinal products provides that the variation, suspension or withdrawal of marketing authorisations ‘granted in accordance with the provisions of [Chapter III]’ of that directive, on the initiative of a Member State with a view to the protection of public health, falls within the exclusive competence of the Commission, when adopting a decision following an opinion of the Committee for Proprietary Medicinal Products in accordance with the procedures laid down in Articles 13 and 14 of that directive. Conversely, the variation, suspension and withdrawal of marketing authorisations which do not fall within the ambit of Article 15a remain, in principle, subject to the exclusive competence of the Member States.

   The concept of a marketing authorisation granted in accordance with the provisions of Chapter III cannot be interpreted as also including authorisations harmonised following consultation of the Committee for Proprietary Medicinal Products under Article 12 of that directive.

   Article 12 sets up, in the field of competence of the Member States, a purely consultative procedure, which is also optional and can, moreover, be initiated not only by the Member States concerned, but also by the Commission, or the applicant or holder of a marketing authorisation. In those circumstances, the principle that the Community is to act within the limits of the powers conferred upon it, precludes an interpretation of Article 15a to the effect that the harmonisation of certain marketing authorisations under a procedure based on Article 12, can have the effect of depriving the Member States concerned of their powers, by triggering the application of the arbitration procedure provided for in Article 15a in respect of the adoption of any subsequent decision regarding the suspension or withdrawal of such authorisations.

   (see paras 121, 150, 155)

2.  The substantive criteria for withdrawal of a marketing authorisation are exclusively governed by Article 11 of Directive 65/65 relating to medicinal products, in accordance with Article 21 of that directive, which provides that an authorisation may not be refused, suspended or revoked except on the grounds set out in that directive. Those criteria must be interpreted in accordance with the general principle that protection of public health must unquestionably take precedence over economic considerations.

   (see paras 171, 173)

3.  The withdrawal of a marketing authorisation pursuant to Article 11 of Directive 65/65 relating to medicinal products is in principle justified only where a new potential risk or the lack of efficacy is substantiated by new, objective, scientific and/or medical data or information. Mere changes in an assessment criterion, even if based on a ‘consensus’ in the medical community, cannot on their own justify the withdrawal of an authorisation where those changes are not based on new scientific data or information.

   (see paras 194, 211)