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62011CC0535
Opinion of Advocate General Sharpston delivered on 31 January 2013.
Novartis Pharma GmbH v Apozyt GmbH.
Reference for a preliminary ruling: Landgericht Hamburg - Germany.
Reference for a preliminary ruling - Regulation (EC) No 726/2004 - Medicinal products for human use - Procedure for authorisation - Requirement for authorisation - Concept of medicinal products ‘developed’ by means of certain biotechnological processes, as referred to in point 1 of the Annex to that regulation - Repackaging process - Injectable solution distributed in single-use vials containing a larger quantity of the therapeutic solution than that actually used for the purposes of medical treatment - Part of the content of such vials drawn off, on prescription by a doctor, into syringes pre-filled with the prescribed dose, without any modification of the medicinal product.
Case C-535/11.
European Court Reports 2013 Page 00000
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62010CC0221
Opinion of Mr Advocate General Bot delivered on 17 November 2011.
Artegodan GmbH v European Commission et Federal Republic of Germany.
Appeals - Second paragraph of Article 288 EC - Non-contractual liability of the Union - Conditions - Sufficiently serious breach of a rule of law conferring rights on individuals - Decision withdrawing marketing authorisations for medicinal products for human use containing amfepramone.
Case C-221/10 P.
European Court reports 2012 Page 00000
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62005TJ0321
Judgment of the General Court (Sixth Chamber, extended composition) of 1 July 2010.
AstraZeneca AB and AstraZeneca plc v European Commission.
Competition - Abuse of dominant position - Market in anti-ulcer medicines - Decision finding an infringement of Article 82 EC - Market definition - Significant competitive constraints - Abuse of procedures relating to supplementary protection certificates for medicinal products and of marketing authorisation procedures for medicinal products - Misleading representations - Deregistration of marketing authorisations - Obstacles to the marketing of generic medicinal products and to parallel imports - Fines.
Case T-321/05.
European Court Reports 2010 Page II-02805
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62005TJ0429
Judgment of the General Court (Sixth Chamber) of 3 March 2010.
Artegodan GmbH v European Commission.
Non-contractual liability - Medicinal products for human use - Decision requiring the withdrawal of marketing authorisations - Annulment of the decision by a judgment of the Court of First Instance - Sufficiently serious breach of a rule of law conferring rights on individuals.
Case T-429/05.
European Court reports 2010 Page II-00491
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62007CJ0527
Judgment of the Court (First Chamber) of 18 June 2009.
The Queen, on the application of Generics (UK) Ltd v Licensing Authority.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court)- United Kingdom.
Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.
Case C-527/07.
European Court reports 2009 Page I-05259
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62007CC0527
Opinion of Mr Advocate General Mazák delivered on 26 March 2009.
The Queen, on the application of Generics (UK) Ltd v Licensing Authority.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court)- United Kingdom.
Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.
Case C-527/07.
European Court reports 2009 Page I-05259
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62006CJ0452
Judgment of the Court (First Chamber) of 16 October 2008.
The Queen, on the application of Synthon BV v Licensing Authority of the Department of Health.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.
Community code relating to medicinal products for human use - Marketing authorisation - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Grounds for refusal - Liability of a Member State - Serious breach of Community law.
Case C-452/06.
European Court reports 2008 Page I-07681
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62003TJ0273
Judgment of the Court of First Instance (Fifth Chamber) of 31 January 2006.
Merck Sharp & Dohme Ltd and Others v Commission of the European Communities.
Medicinal products for human use - Marketing authorisation for products containing the substance enalapril - Commission decision ordering amendment of the summary of the product's characteristics - Competence.
Case T-273/03.
European Court reports 2006 Page II-00141
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62003TJ0251
Judgment of the Court of First Instance (Fifth Chamber) of 31 January 2006.
Albert Albrecht GmbH & Co. KG and Others v Commission of the European Communities.
Health policy -Veterinary medicinal products - Products containing benzathine benzylpenicillin - Commission decision ordering suspension of marketing authorisations - Competence.
Case T-251/03.
European Court reports 2006 Page II-00016*
summary publication
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62003CJ0074
Judgment of the Court (Second Chamber) of 20 January 2005.
SmithKline Beecham plc v Lægemiddelstyrelsen.
Reference for a preliminary ruling: Østre Landsret - Denmark.
Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Active substance in different forms of salt - Additional documentation.
Case C-74/03.
European Court reports 2005 Page I-00595
