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Fabio Caronna: ECJ 28 Jun 2012

ECJ Medicinal products for human use – Directive 2001/83/EC – Article 77 – Wholesale distribution of medicines – Mandatory special authorisation for pharmacists – Conditions for granting Judges: JN Cunha Rodrigues P Citations: C-7/11, [2012] EUECJ C-7/11 Links: Bailii Statutes: Directive 2001/83/EC 77 European Updated: 03 November 2022; Ref: scu.461894

Bioplus Life Sciences Private Ltd and Others v The Secretary of State for Health: QBD 21 Feb 2020

Claim for Francovich damages relating to the application of the Medicinal Products Directive 2001/83/EC – threshold question whether the provisions of EU law upon which the claimants rely – Articles 6(1), 76(1) and/or 111(1) of the Directive – entail the grant of rights to individuals so as to provide the necessary foundation for the claim. … Continue reading Bioplus Life Sciences Private Ltd and Others v The Secretary of State for Health: QBD 21 Feb 2020

Octapharma France Sas v Agence Nationale De Securite Du Medicament Et Des Produits De Sante and Ministere Des Affaires Sociales et De La Sante: ECJ 7 Nov 2013

ECJ Opinion – Approximation of legislation – Directive 2001/83/EC – Directive 2004/27/EC – Directive 2002/98/EC – Scope of application – Labile blood products – Plasma prepared by a method involving an industrial process – Simultaneous or exclusive application of Directive 2001/83 (as amended by Directive 2004/27) and Directive 2002/98 – Article 168(4) TFEU and Member … Continue reading Octapharma France Sas v Agence Nationale De Securite Du Medicament Et Des Produits De Sante and Ministere Des Affaires Sociales et De La Sante: ECJ 7 Nov 2013

Dhu Arzneimittel (Medicinal Products for Human Use – Labelling and Package Leaflet of Homeopathic Medicinal Products – Judgment): ECJ 23 Apr 2020

References for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Articles 62 and 69 – Particulars on the labelling and package leaflet of homeopathic medicinal products – Exhaustive list of the particulars or possibility to add information that is useful to the patient and is compatible with the summary of … Continue reading Dhu Arzneimittel (Medicinal Products for Human Use – Labelling and Package Leaflet of Homeopathic Medicinal Products – Judgment): ECJ 23 Apr 2020

E I Du Pont De Nemours Co, Inc (Patent): IPO 9 Apr 2009

IPO An application for a paediatric extension of granted certificate SPC/GB/95/010 was filed. The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation (EEC) No. 1768/92 as it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan … Continue reading E I Du Pont De Nemours Co, Inc (Patent): IPO 9 Apr 2009

Commission v Poland: ECJ 29 Sep 2011

ECJ (Approximation Of Laws) Opinion – Failure of a Member State to fulfil obligations – Directive 2001/83/EC – Article 6 – Marketing authorisation – Article 5 – Exclusion from provisions of directive for medicinal products ordered for special needs of individual patient – National legislation allowing importation and placing on the market of equivalent medicinal … Continue reading Commission v Poland: ECJ 29 Sep 2011

Association of The British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency: ECJ 22 Apr 2010

ECJ Free Movement Of Goods – Directive 2001/83/EC Article 94 Financial inducements to medical practices which prescribe certain medicinal products to their patients Public health authorities Doctors Freedom to prescribe Judges: J.-C. Bonichot, President of Chamber and Judges C. Toader, K. Schiemann, P. Kuris and L. Bay Larsen Citations: [2010] EUECJ C-62/09 – O, C-62/09 … Continue reading Association of The British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency: ECJ 22 Apr 2010

Association of The British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency: ECJ 11 Feb 2010

ECJ Opinion – Directive 2001/83/EC Article 94 Financial inducements to medical practices which prescribe certain medicinal products to their patients Public health authorities Doctors Freedom to prescribe. Judges: Jaaskinen AG Citations: C-62/09, [2010] EUECJ C-62/09 Links: Bailii Statutes: Directive 2001/83/EC 94 Cited by: See Also – Association of The British Pharmaceutical Industry v Medicines and … Continue reading Association of The British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency: ECJ 11 Feb 2010

Anklagemyndigheden v Damgaard: ECJ 18 Nov 2008

ECJ Opinion – Human Drugs – Concept advertising – Dissemination of information on a drug by an independent person – Freedom of Expression Judges: Damaso Ruiz-Jarabo Colomer AG Citations: C-421/07, [2008] EUECJ C-421/07 – O Links: Bailii Jurisdiction: European Cited by: Opinion – Anklagemyndigheden v Damgaard ECJ 2-Apr-2009 ECJ Medicinal products for human use Directive … Continue reading Anklagemyndigheden v Damgaard: ECJ 18 Nov 2008

Bios Naturprodukte GmbH v Saarland intervening party: Vertreter des Bundesinteresses beim Bundesverwaltungsgericht (Approximation Of Laws): ECJ 30 Apr 2009

ECJ Directive 2001/83/EC Article 1(2)(b) Concept of ‘medicinal product by function’ Dosage of the product Normal conditions of use Risk to health Ability to restore, correct or modify physiological functions in human beings. Citations: C-27/08, [2009] EUECJ C-27/08 Links: Bailii Jurisdiction: European European Updated: 24 July 2022; Ref: scu.342018

Chemische Fabrik Kreussler and Co. Gmbh v Sunstar Deutschland Gmbh: ECJ 6 Sep 2012

ECJ Directive 2001/83/EC – Medicinal products for human use – Article 1(2)(b) – Meaning of ‘medicinal product by function’ – Definition of the term ‘pharmacological action’ Citations: C-308/11, [2012] EUECJ C-308/11 Links: Bailii Statutes: Directive 2001/83/EC Jurisdiction: European Health Professions, Licensing Updated: 26 May 2022; Ref: scu.464421

Novartis Europharm v Commission: ECJ 28 Jun 2017

ECJ (Approximation of Laws Public Health : Judgment) Appeal – Medicinal products for human use – Marketing authorisation – Regulation (EEC) No 2309/93 – Centralised procedure at European Union level – Development of a medicinal product that was the subject of a marketing authorisation for other therapeutic indications – Separate marketing authorisation and new trade … Continue reading Novartis Europharm v Commission: ECJ 28 Jun 2017

Warner-Lambert Company (Approximation of Laws – Medicinal Products for Human Use – Judgment): ECJ 14 Feb 2019

Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 11 – Generic medicinal products – Summary of product characteristics – Exclusion of references referring to indications or dosage forms still covered by patent law at the time when the generic medicine was marketed Citations: C-423/17, [2019] EUECJ C-423/17, … Continue reading Warner-Lambert Company (Approximation of Laws – Medicinal Products for Human Use – Judgment): ECJ 14 Feb 2019

Penal procedure against D, G: ECJ 10 Jul 2014

ECJ Medicinal products for human use – Directive 2001/83/EC – Scope – Interpretation of the concept of ‘medicinal product’ – Scope of the criterion based on the capacity to modify physiological functions – Herb and cannabinoid-based products – Not included [2014] EUECJ C-358/13, [2014] PTSR 1217, [2014] WLR(D) 305, ECLI:EU:C:2014:2060 Bailii, WLRD European Citing: Opinion … Continue reading Penal procedure against D, G: ECJ 10 Jul 2014

Hecht-Pharma: ECJ 26 Oct 2016

ECJ Judgment – Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Scope – Article 2(1) – Medicinal products prepared industrially or manufactured by a method involving an industrial process – Point 2 of Article 3 – Officinal formula ECLI:EU:C:2016:801, [2016] EUECJ C-276/15 Bailii Directive 2001/83/EC 2(1) European Health … Continue reading Hecht-Pharma: ECJ 26 Oct 2016

Blue Bio Pharmaceuticals Ltd and Another v Secretary of State for Health and Another: CA 17 Jun 2016

The company appealed against rejection of its challenge to the licensing and classification system applied to its products. Longmore, Lewison, McCombe LJJ [2016] EWCA Civ 554 Bailii Directive 2001/83/EC England and Wales Citing: Appeal from – Blue Bio Pharmaceuticals Ltd and Another, Regina (on The Application of) v Secretary of State for Health (Mhra) Admn … Continue reading Blue Bio Pharmaceuticals Ltd and Another v Secretary of State for Health and Another: CA 17 Jun 2016

Merck Sharp and Dohme Corporation (Patent): IPO 12 Jan 2016

This SPC application concerns the combination of active ingredients, ezetimibe and atorvastatin, found in the medicinal product, ATOZET (RTM). A marketing authorization for ATOZET was being sought under the decentralised procedure (DCP) but, at the date of application for the SPC on 12 September 2014, which was only 1 day before expiry of the patent, … Continue reading Merck Sharp and Dohme Corporation (Patent): IPO 12 Jan 2016

Novartis Europharm v Commission T-67/13: ECFI 15 Sep 2015

ECJ Judgment – Medicinal products for human use – Marketing authorisation for the generic medicinal product Zoledronic acid Hospira – zoledronic acid – Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid – Directive 2001/83/EC – Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 – … Continue reading Novartis Europharm v Commission T-67/13: ECFI 15 Sep 2015

Novartis Europharm v Commission T-472/12: ECFI 15 Sep 2015

Judgment – Medicinal products for human use – Marketing authorisation for the generic medicinal product Zoledronic acid Teva Pharma – zoledronic acid – Regulatory data protection period for the reference medicinal products Zometa and Aclasta, containing the active substance zoledronic acid – Directive 2001/83/EC – Regulation (EEC) No 2309/93 and Regulation (EC) No 726/2004 – … Continue reading Novartis Europharm v Commission T-472/12: ECFI 15 Sep 2015

Olainfarm v Latvijas Republikas Veselibas ministrija: ECJ 23 Oct 2014

ECJ Judgment – Reference for a preliminary ruling – Approximation of laws – Industrial policy – Directive 2001/83/EC – Medicinal products for human use – Article 6 – Marketing authorisation – Article 8(3)(i) – Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials – Derogations relating to … Continue reading Olainfarm v Latvijas Republikas Veselibas ministrija: ECJ 23 Oct 2014

Penal procedure against D, G: ECJ 12 Jun 2014

(Advocate General’s Opinion) Medicinal products for human use – Directive 2001/83 / EC – Scope – Interpretation of the concept of’ medicinal product by function ‘- Scope of the criterion relating to the ability to modify physiological functions – Herbal product And synthetic cannabinoids marketed exclusively for recreational purposes – No medical or therapeutic benefit … Continue reading Penal procedure against D, G: ECJ 12 Jun 2014

Blue Bio Pharmaceuticals Ltd and Another, Regina (on The Application of) v Secretary of State for Health (Mhra): Admn 22 May 2014

The Claimants complained that the Defendant wrongly refused to treat as medicinal products the large number of GCPs (glucosamine-containing product) described as ‘food supplements’. Held: The claim failed. Supperstone J [2014] EWHC 1679 (Admin), CO/6789/2013 Bailii Directive 2001/83/EC Cited by: Appeal from – Blue Bio Pharmaceuticals Ltd and Another v Secretary of State for Health … Continue reading Blue Bio Pharmaceuticals Ltd and Another, Regina (on The Application of) v Secretary of State for Health (Mhra): Admn 22 May 2014

Acino v Commission: ECJ 10 Apr 2014

ECJ Appeal – Medicinal products for human use – Suspension of the marketing and the withdrawal of certain consignments of medicinal products containing the active ingredient Clopidogrel -Variation of marketing authorisations – Prohibition on marketing – Regulation (EC) No 726/2004 and Directive 2001/83/EC – Precautionary principle – Proportionality – Obligation to state reasons A. Borg … Continue reading Acino v Commission: ECJ 10 Apr 2014

Commission v Poland: ECJ 29 Mar 2012

ECJ Failure of a Member State to fulfil obligations – Directive 2001/83/EC – Articles 5 and 6 – Proprietary medicinal products – Medicinal products for human use – Marketing authorisation – Legislation of a Member State exempting medicinal products similar to but cheaper than authorised products from marketing authorisation K. Lenaerts, P [2012] EUECJ C-185/10, … Continue reading Commission v Poland: ECJ 29 Mar 2012

Anklagemyndigheden v Damgaard: ECJ 2 Apr 2009

ECJ Medicinal products for human use Directive 2001/83/EC – Concept of ‘advertising’ – Dissemination of information about a medicinal product by a third party acting on his own initiative C-421/07, [2009] EUECJ C-421/07 Bailii Directive 2001/83/EC Citing: Opinion – Anklagemyndigheden v Damgaard ECJ 18-Nov-2008 ECJ Opinion – Human Drugs – Concept advertising – Dissemination of … Continue reading Anklagemyndigheden v Damgaard: ECJ 2 Apr 2009

Laboratoires Ctrs v European Commission: ECFI 4 Jul 2013

ECFI Medicinal products for human use – Application for authorisation to market the medicinal product Orphacol – Commission decision refusing to grant authorisation – Regulation (EC) No 726/2004 – Directive 2001/83/EC – Well-established medicinal use – Exceptional circumstances T-301/12, [2013] EUECJ T-301/12 Bailii Regulation (EC) No 726/2004, Directive 2001/83/EC European Updated: 15 November 2021; Ref: … Continue reading Laboratoires Ctrs v European Commission: ECFI 4 Jul 2013

Leibniz-Institut Fur Neue Materialien Gemeinnutzige Gmbh (Patent): IPO 29 Jul 2014

EC Design Examination Certificate No. 11870GB411100614, dated 14 June 2010 was filed in support of SPC application SPC/GB/10/051 for ‘Aqueous dispersion of iron oxide nanoparticles’. This product acts through physical means: the nano-sized particles are introduced directly into a cancer tumour and subjected to an alternating magnetic field which causes the particles to heat up … Continue reading Leibniz-Institut Fur Neue Materialien Gemeinnutzige Gmbh (Patent): IPO 29 Jul 2014

Cerus Corporation (Patent): IPO 31 Mar 2014

EC Design Examination Certificate No. G7 02 05 16178 063 was filed in support of SPC application SPC/GB/07/043 for ‘Platelet preparation obtainable by addition, and subsequent photoactivation, of amotosalen or its salt, to a suspension of platelets in plasma’. EC Design Examination Certificate No. G7 06 09 60562 004 was filed in support of SPC … Continue reading Cerus Corporation (Patent): IPO 31 Mar 2014