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Published by: eurolex on Nov 29, 2010
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Reference for a preliminary ruling from High Court of Justice (England & Wales), Queen's Bench Division (Admin-istrative Court) (United Kingdom) made on 28 November2007
Generics (UK) Ltd, Regina v Licensing Authority(acting via the Medicines and Healthcare productsRegulatory Agency)(Case C-527/07)
(2008/C 22/64)
Language of the case: English
Referring court
High Court of Justice (England & Wales), Queen's Bench Divi-sion (Administrative Court)
Parties to the main proceedings
Generics (UK) Ltd, Regina
Licensing Authority (acting via the Medicines andHealthcare products Regulatory Agency)
Questions referred
(1) Where a medicinal product falling outside the scope of theAnnex to Regulation 2309/93 (
) has been placed on themarket in a Member State, (Austria) under its nationalauthorisation procedure prior to the accession of thatMember State to the EEA or the EC and:(a) that Member State has subsequently acceded to the EEAand then the EC, and as part of the conditions of itsaccession it has transposed into its national law theauthorisation provisions of Directive 65/65 (now Direc-tive 2001/83 (
)), no transitional provisions applying inthis respect;(b) the product in question has remained on the market inthat Member State for some years after its accession tothe EEA and the EC;(c) following the accession of that Member State to the EEAand the EE, the marketing authorisation for the productin question has been varied by adding a new indication,and the variation was considered by the authorities of that Member State to be consistent with the require-ments of Community law;(d) the dossier of the product in question was not updatedin accordance with Directive 65/65 (now Directive2001/83) after that Member State's accession to theEEA and the EC; and(e) a product containing the same active ingredient hassubsequently been authorised under Article 6 of Direc-tive 2001/83 and placed on the market in the EC;is the medicinal product to be considered to be
a referencemedicinal product which is or has been authorised under Article 6
in a Member State
within the meaning of Article 10(1) of Directive 2001/83, and if so which of theabove conditions is/are decisive in this respect?(2) In circumstances where the competent authority of a refer-ence Member State erroneously refuses an application for amarketing authorisation made under Article 10(1) of Direc-tive 2001/83 in the context of the decentralised procedureprovided for in that Directive, on the ground that the medic-inal product referred to in Question 1 above was not a
reference medicinal product
within the meaning of Article10(1), what guidance, if any, does the Court of Justice thinkit appropriate to provide as to which circumstances thenational court ought to take into consideration when itcomes to determine whether the breach of Community law is a sufficiently serious breach within the meaning of thejudgment in Brasserie du Pecheur and Factortame?
) OJ L 214 p. 1.(
) OJ L 311 p. 67.
Appeal brought on 29 November 2007 by Association dela presse internationale ASBL (API) against the judgment of the Court of First Instance (Grand Chamber) delivered on12 September 2007 in Case T-36/04: Association de lapresse internationale ASBL (API) v Commission of theEuropean Communities(Case C-528/07 P)
(2008/C 22/65)
Language of the case: English
Association de la presse internationale ASBL (API)(represented by: S. Völcker, Rechtsanwalt, F. Louis, avocat and C.O'Daly, Solicitor)
Other parties to the proceedings:
Commission of the EuropeanCommunities26.1.2008C 22/36 Official Journal of the European Union

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