C 192/26 EN 8.7.2000 Official Journal of the European Communities
Product or Service: Products in Class 3 of the Nice Pleas in law and main arguments
Agreement (in particular, washing
and bleaching preparations for— Adipex Retard capsules are placed on the market solely onlaundry use; cleaning prep-the basis of a national Austrian authorisation, for thearations, preparations for thegrant of which the mutual recognition procedure underwashing of dishes, soaps, per-Chapter III of Directive 75/319 (1) was not applied. Thefumery, essential oils, cosmetics,defendant was therefore not competent to adopt thehair lotions, dentifrices)contested decision.
Contested decision Refusal of registration by the— The Commission wrongly based its decision on Article 15abefore the Board of examinerof Directive 75/319 and the criteria in Article 5 of DirectiveAppeal:65/65 (2). In fact only Article 11 of Directive 65/65/EEC is
material, however.
Grounds for appeal: Infringement of Article 7(1)(b) of
Regulation 40/94.— The conditions for withdrawal of authorisation are not
satisfied. It has not been sufficiently established either thatphentermin is harmful or that it lacks therapeutic effect if
correctly used.
(1) Second Council Directive 75/319/EEC of 20 May 1975 on the
approximation of provisions laid down by law, regulation oradministrative action relating to proprietary medicinal products(OJ 1975 L 147, p. 13).
(
2) Council Directive 65/65/EEC of 26 January 1965 on the approxi-Action brought on 17 May 2000 by Gerot Pharmazeutikamation of provisions laid down by law, regulation or administrat-GmbH against the Commission of the European Com- ive action relating to proprietary medicinal products (OJ, English
munities Special Edition 1965-1966, p. 20).
(Case T-132/00)
(2000/C 192/49)
Action brought on 22 May 2000 by Cambridge Healthcare (Language of the case: German)
Supplies Limited against the Commission of the European
Communities
An action against the Commission of the European Communi-
ties was brought before the Court of First Instance of the(Case T-137/00)European Communities on 17 May 2000 by Gerot Pharmazeu-
tika GmbH, of Vienna, represented by Dr Karl Grigkar,
Rechtsanwalt, Vienna. (2000/C 192/50)
The applicant claims that the Court should:(Language of the case: English)
— annul Commission Decision K (2000) 452 of 9 March
An action against the Commission of the European Communi- 2000 on withdrawal of authorisation of medicinal prod-
ties was brought before the Court of First Instance of the ucts for human use which contain the substance phen-
European Communities on 22 May 2000 by Cambridge termin, in particular with respect to the medicinal product
Healthcare Supplies Limited, represented by David Vaughan, Adipex Retard capsules authorised for the applicant; in
Q.C., Kelyn Bacon, Barrister, and Simon Davis, Solicitor, eventu
Clifford Chance, London.
— annul the Commission’s decision in so far as Article 1 in
The applicant claims that the Court should: conjunction with Annex I thereof requires the Member
State Austria to withdraw the authorisation for the appli-
cant’s medicinal product containing phentermin, namely — annul Commission Decision C(2000)452, of 9 March
Adipex Retard capsules; 2000;
— order the Commission to pay the applicant’s costs. — order the Commission to pay the applicant’s costs.
8.7.2000 EN C 192/27 Official Journal of the European Communities
Pleas in law and main arguments CPMP and the procedure of the Commission in adopting
the decision;
The contested decision requires the Member States to withdraw— the decision infringes the tests in Directives 65/65/EEC (2)the marketing authorisations of Phentermine containing med-and 75/319/EEC for the withdrawal of a marketingicinal products.authorisation; and the duty, in Article 253 EC, to state the
reasons on which it was based;
The applicant is a Marketing Authorisation Holder in the— the evaluation by the CPMP and Commission of both theUnited Kingdom for 15mg and 30mg strength Ionaminsafety and efficacy aspects of Phentermine is not supportedcapsules, which are medicinal products containing Phentermi-by any reliable scientific evidence, and is in fact contradict-ne. It seeks the annulment of the decision on the followinged by overwhelming evidence provided by both thegrounds:applicant and the CPMP itself.
— the referral of Phentermine to the Committee for Pro-(1) Second Council Directive 75/319/EEC of 20 May 1975 on theprietary Medicinal Products (CPMP), under Article 15a ofapproximation of provisions laid down by Law, Regulation orDirective 75/319/EEC (1), was invalid; further the CPMP inAdministrative Action relating to proprietary medicinal productsits opinion went outside the scope of the referral; thus the(OJ L 147 p. 13).Commission was not competent to take action;(2) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
mation of provisions laid down by Law, Regulation or Adminis-
— the decision is flawed by the infringement of essential trative Action relating to proprietary medicinal products (OJ
1965, 22, p. 369). procedural requirements, both in the procedure before the