Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use Basic information Dates Date of document: Date of publication: Date of effect: December 18, 2001 Entry into force - Date pub. + 20 See Art 129 Modified by Modified by: Règlement (CE) n° 1394/2007 du Parlement européen et du Conseil du 13 novembre 2007 concernant les médicaments de thérapie innovante et modifiant la directive 2001/83/CE ainsi que le règlement (CE) n° 726/2004 (Texte présentant de l’intérêt pour l’EEE)
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detail Règlement (UE) 2019/5 du Parlement européen et du Conseil du 11 décembre 2018 modifiant le règlement (CE) no 726/2004 établissant des procédures communautaires pour l’autorisation et la surveillance en ce qui concerne les médicaments à usage humain et à usage vétérinaire, et instituant une Agence européenne des médicaments, le règlement (CE) no 1901/2006 relatif aux médicaments à usage pédiatrique et la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain (Texte présentant de l'intérêt pour l'EEE)
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detail Règlement (CE) n o 1901/2006 du Parlement européen et du Conseil du 12 décembre 2006 relatif aux médicaments à usage pédiatrique, modifiant le règlement (CEE) n o 1768/92, les directives 2001/20/CE et 2001/83/CE ainsi que le règlement (CE) n o 726/2004 (Texte présentant de l'intérêt pour l'EEE)
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detail Directive 2010/84/UE du Parlement européen et du Conseil du 15 décembre 2010 modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain Texte présentant de l'intérêt pour l'EEE
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detail Directive 2011/62/UE du Parlement européen et du Conseil du 8 juin 2011 modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain, en ce qui concerne la prévention de l’introduction dans la chaîne d’approvisionnement légale de médicaments falsifiés Texte présentant de l'intérêt pour l'EEE
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detail Directive 2012/26/UE du Parlement européen et du Conseil du 25 octobre 2012 modifiant la directive 2001/83/CE en ce qui concerne la pharmacovigilance Texte présentant de l'intérêt pour l'EEE
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detail Directive 2009/120/CE de la Commission du 14 septembre 2009 modifiant la directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain en ce qui concerne les médicaments de thérapie innovante (Texte présentant de l'intérêt pour l'EEE)
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detail Directive 2004/24/CE du Parlement européen et du Conseil du 31 mars 2004 modifiant, en ce qui concerne les médicaments traditionnels à base de plantes, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain
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detail Directive 2009/53/CE du Parlement européen et du Conseil du 18 juin 2009 modifiant la directive 2001/82/CE et la directive 2001/83/CE, en ce qui concerne les modifications des termes d’une autorisation de mise sur le marché de médicaments (Texte présentant de l'intérêt pour l'EEE)
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detail Règlement (UE) 2019/1243 du Parlement européen et du Conseil du 20 juin 2019 adaptant aux articles 290 et 291 du traité sur le fonctionnement de l’Union européenne une série d’actes juridiques prévoyant le recours à la procédure de réglementation avec contrôle (Texte présentant de l'intérêt pour l'EEE)
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detail Directive 2004/27/CE du Parlement européen et du Conseil du 31 mars 2004 modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain (Texte présentant de l'intérêt pour l'EEE)
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detail Directive 2002/98/CE du Parlement européen et du Conseil du 27 janvier 2003 établissant des normes de qualité et de sécurité pour la collecte, le contrôle, la transformation, la conservation et la distribution du sang humain, et des composants sanguins, et modifiant la directive 2001/83/CE
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detail Directive 2003/63/CE de la Commission, du 25 juin 2003, modifiant la directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain (Texte présentant de l'intérêt pour l'EEE)
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detail Directive (UE) 2022/642 du Parlement européen et du Conseil du 12 avril 2022 modifiant les directives 2001/20/CE et 2001/83/CE en ce qui concerne les dérogations à certaines obligations relatives à certains médicaments à usage humain mis à disposition au Royaume-Uni en ce qui concerne l’Irlande du Nord ainsi qu’à Chypre, en Irlande et à Malte (Texte présentant de l’intérêt pour l’EEE)
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detail Règlement (UE) 2023/1182 du Parlement européen et du Conseil du 14 juin 2023 relatif à des règles spécifiques concernant les médicaments à usage humain destinés à être mis sur le marché en Irlande du Nord, et modifiant la directive 2001/83/CE (Texte présentant de l’intérêt pour l’EEE)
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detail Règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives du Conseil 90/385/CEE et 93/42/CEE (Texte présentant de l'intérêt pour l'EEE. )
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detail Directive 2008/29/CE du Parlement européen et du Conseil du 11 mars 2008 modifiant la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain, en ce qui concerne les compétences d’exécution conférées à la Commission
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detail Amendment proposed by: Completed by: All documents based on this document: Derogated in: Modifies Repeal: Directive 89/342/CEE du Conseil du 3 mai 1989 élargissant le champ d'application des directives 65/65/CEE et 75/319/CEE et prévoyant des dispositions complémentaires pour les médicaments immunologiques consistant en vaccins, toxines, sérums ou allergènes Directive 89/343/CEE du Conseil du 3 mai 1989 élargissant le champ d'application des directives 65/65/CEE et 75/319/CEE et prévoyant des dispositions complémentaires pour les médicaments radiopharmaceutiques Directive 89/381/CEE du conseil du 14 juin 1989 élargissant le champ d'application des directives 65/65/CEE et 75/319/CEE concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques, et prévoyant des dispositions spéciales pour les médicaments dérivés du sang ou du plasma humains Directive 92/27/CEE du Conseil, du 31 mars 1992, concernant l'étiquetage et la notice des médicaments à usage humain Directive 92/28/CEE du Conseil, du 31 mars 1992, concernant la publicité faite à l'égard des médicaments à usage humain Directive 92/25/CEE du Conseil, du 31 mars 1992, concernant la distribution en gros des médicaments à usage humain Directive 92/26/CEE du Conseil, du 31 mars 1992, concernant la classification en matière de délivrance des médicaments à usage humain Directive 92/73/CEE du Conseil, du 22 septembre 1992, élargissant le champ d'application des directives 65/65/CEE et 75/319/CEE concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux médicaments et fixant des dispositions complémentaires pour les médicaments homéopatiques Directive 65/65/CEE du Conseil, du 26 janvier 1965, concernant le rapprochement des dispositions législatives, réglementaires et administratives, relatives aux spécialités pharmaceutiques Directive 75/318/CEE du Conseil, du 20 mai 1975, relative au rapprochement des législations des États membres concernant les normes et protocoles analytiques, toxico-pharmacologiques et cliniques en matière d'essais de spécialités pharmaceutiques Deuxième directive 75/319/CEE du Conseil, du 20 mai 1975, concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques Affected by case Judgment of the Court (Third Chamber) of 16 July 2015. Abcur AB v Apoteket Farmaci AB and Apoteket AB. Requests for a preliminary ruling from the Stockholms tingsrätt. Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Scope — Articles 2(1) and 3, points 1 and 2 — Medicinal products prepared industrially or manufactured by a method involving an industrial process — Exceptions — Medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient — Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question — Directive 2005/29/EC. Joined Cases C-544/13 and C-545/13. Case C-452/06: Judgment of the Court (First Chamber) of 16 October 2008 (reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen's Bench Division (Administrative Court) (United Kingdom)) — The Queen, on the application of: Synthon BV v Licensing Authority of the Department of Health (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) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 10.1 PT A) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 28 Judgment of the Court (Fourth Chamber) of 8 July 2021. Pharma Expressz Szolgáltató és Kereskedelmi Kft v Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet. Request for a preliminary ruling from the Fővárosi Törvényszék. Reference for a preliminary ruling – Free movement of goods – Medicinal products for human use – Directive 2001/83/EC – Article 5(1), Article 6(1) and Articles 70 to 73 – Medicinal products authorised in one Member State – Classification as medicinal products not subject to medical prescription – Sale in pharmacies of another Member State where the medicinal product does not have a marketing authorisation – National legislation requiring notification to be given to the competent authority and a declaration from that authority concerning the use of that medicinal product – Article 34 TFEU – Quantitative restriction. Case C-178/20. Judgment of the Court (Second Chamber) of 29 February 2024. Doctipharma SAS v Union des Groupements de pharmaciens d’officine (UDGPO) and Pictime Coreyre. Request for a preliminary ruling from the Cour d'appel de Paris. Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 85c – Scope – Distance selling to the general public of medicinal products – Medicinal products for human use not subject to compulsory medical prescription – Persons authorised or entitled to engage in distance selling to the general public of medicinal products – Power of the Member States to impose conditions, justified by the protection of public health, on the retailing, on their territory, of medicinal products sold online – Information society services – Directive 98/34/EC – Directive (EU) 2015/1535 – Service connecting pharmacists and customers for the online sale of medicinal products. Case C-606/21. Judgment of the Court (Fifth Chamber), 23 October 2014. Olainfarm AS v Latvijas Republikas Veselības ministrija and Zāļu valsts aģentūra. Request for a preliminary ruling from the Augstākās Tiesas Senāts. 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 pre-clinical tests and clinical trials — Article 10 — Generic medicinal products — Concept of ‘reference medicinal product’ — Whether the holder of a marketing authorisation for a reference medicinal product has an individual right to oppose the marketing authorisation of a generic of the reference product — Article 10a — Medicinal products of which the active substances have been in well-established medicinal use within the European Union for at least 10 years — Whether it is possible to use a medicinal product for which authorisation has been granted on the basis of the derogation provided for in Article 10a as a reference medicinal product for the purpose of obtaining a marketing authorisation for a generic product. Case C‑104/13. Judgment of the Court (Third Chamber) of 11 June 2020. ratiopharm GmbH v Novartis Consumer Health GmbH. Request for a preliminary ruling from the Bundesgerichtshof. Reference for a preliminary ruling – Protection of public health – Internal market – Medicinal products for human use – Directive 2001/83/EC – Advertising – Article 96 – Distribution of free samples of medicinal products to persons qualified to prescribe them – Pharmacists excluded from the distribution of free samples of medicinal products – Inapplicability to distribution of free samples of non-prescription medicinal products – Consequences for the Member States. Case C-786/18. Judgment of the Court (First Chamber), 13 March 2014. Octapharma France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Ministère des Affaires sociales et de la Santé. Request for a preliminary ruling from the Conseil d’État (France). Approximation of laws — Directive 2001/83/EC — Directive 2002/98/EC — Scope — Labile blood product — Plasma prepared by means of an industrial process — Simultaneous or exclusive application of the directives — Option for a Member State to provide for a more rigorous regime for plasma than for medicinal products. Case C‑512/12. Judgment of the Court (Second Chamber) of 13 October 2022. M2Beauté Cosmetics GmbH v Bundesrepublik Deutschland. Request for a preliminary ruling from the Verwaltungsgericht Köln. Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 1(2)(b) – Concept of ‘medicinal product by function’ – No scientific study – Scientific knowledge on a structural analogue – Regulation (EC) No 1223/2009 – Cosmetic product – Specific beneficial effects on human health – Direct or indirect beneficial effects – Positive effects on appearance. Case C-616/20. Judgment of the Court (Fourth Chamber), 19 July 2012. Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents. Reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining a supplementary protection certificate — Medicinal product having obtained a valid marketing authorisation — First authorisation — Product successively authorised as a veterinary medicinal product and a human medicinal product. Case C‑130/11. Case C-62/09: Judgment of the Court (Fourth Chamber) of 22 April 2010 (reference for a preliminary ruling from the High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) — United Kingdom) — The Queen, Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency (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) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 94.1 Order of the Court (Eighth Chamber) of 2 March 2017. Criminal proceedings against Juraj Sokáč. Request for a preliminary ruling from the Nejvyšší soud. Reference for a preliminary ruling — Article 99 of the Rules of Procedure of the Court of Justice — Drug precursors — Regulation (EC) No 273/2004 — Article 2(a) — Definition of ‘scheduled substance’ — Exclusion of medicinal products — Directive 2001/83/EC — Article 1(2) — Definition of ‘medicinal product’ — Medicinal product containing ephedrine or pseudoephedrine — Regulation (EC) No 111/2005 — Article 2(a) — Definition of ‘scheduled substance’ — Annex — Inclusion of medicinal products containing ephedrine or pseudoephedrine — No effect on the scope of Regulation (EC) No 273/2004. Case C-497/16. Case C-421/07: Judgment of the Court (Second Chamber) of 2 April 2009 (reference for a preliminary ruling from the Vestre Landsret — Denmark)) — Criminal proceedings against Frede Damgaard (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) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 86 Judgment of the Court (First Chamber) of 15 January 2009. Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg. Reference for a preliminary ruling: Bundesverwaltungsgericht - Germany. Directive 2001/83/EC - Articles 1(2) and 2(2) - Concept of ‘medicinal product by function’ - Product in respect of which it has not been established that it is a medicinal product by function - Account taken of the content in active substances. Case C-140/07. Judgment of the Court (Fifth Chamber) of 17 November 2022. Merck Sharp & Dohme BV and Others v Abacus Medicine A/S and Others. Request for a preliminary ruling from the Sø- og Handelsretten. Reference for a preliminary ruling – Articles 34 and 36 TFEU – Free movement of goods – Intellectual property – Trade marks – Regulation (EU) 2017/1001 – EU trade mark – Article 9(2) – Article 15 – Directive (EU) 2015/2436 – Approximation of the laws of the Member States relating to trade marks – Article 10(2) – Article 15 – Rights conferred by a trade mark – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products – Repackaging of the product bearing the mark – New outer packaging – Replacement of the trade mark appearing on the original outer packaging by another product name – Reaffixing of the trade mark of the proprietor specific to the product, to the exclusion of the other distinctive marks or signs appearing on that original outer packaging – Opposition by the proprietor of the mark – Artificial partitioning of the markets between Member States – Medicinal products for human use – Directive 2001/83/EC – Article 47a – Safety features – Replacement – Equivalent features – Delegated Regulation (EU) 2016/161 – Article 3(2) – Anti-tampering device. Case C-224/20. Judgment of the Court (Fifth Chamber), 6 September 2012. Chemische Fabrik Kreussler & Co. GmbH v Sunstar Deutschland GmbH, formerly John O. Butler GmbH. Reference for a preliminary ruling from the Oberlandesgericht Frankfurt am Main. 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’. Case C‑308/11. Judgment of the Court (Grand Chamber) of 22 December 2022. SIA 'EUROAPTIEKA' v Ministru kabinets. Request for a preliminary ruling from the Satversmes tiesa. Reference for a preliminary ruling – Medicinal products for human use – Directive 2001/83/EC – Article 86(1) – Concept of ‘advertising of medicinal products’ – Article 87(3) – Rational use of medicinal products – Article 90 – Prohibited advertising methods – Advertising of medicinal products neither subject to medical prescription nor reimbursed – Advertising on the basis of price – Advertising of special sales – Advertising of bundled sales – Prohibition. Case C-530/20. Judgment of the Court (Third Chamber) of 5 May 2011. Novo Nordisk AS v Ravimiamet. Reference for a preliminary ruling: Tartu Ringkonnakohus - Estonia. Medicinal products for human use - Directive 2001/83/EC - Advertising - Medical journal - Information not included in the summary of product characteristics. Case C-249/09. A87P2 A11 A87P3 A92P2 A92P3 Judgment of the Court (Fourth Chamber) of 22 April 2010. The Queen, on the application of Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency. Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom. 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. Case C-62/09. Judgment of the Court (Second Chamber), 28 June 2012. Fabio Caronna. Reference for a preliminary ruling from the Tribunale di Palermo. Medicinal products for human use — Directive 2001/83/EC – Article 77 — Wholesale distribution of medicines — Mandatory special authorisation for pharmacists — Conditions for granting. Case C-7/11. Judgment of the Court (Second Chamber) of 8 November 2007. Ludwigs - Apotheke München Internationale Apotheke v Juers Pharma Import-Export GmbH. Reference for a preliminary ruling: Landgericht Hamburg - Germany. Free movement of goods - Articles 28 EC and 30 EC - Articles 11 and 13 of the EEA Agreement - Imported medicinal products not authorised in the importing State - Prohibition of advertising - Directive 2001/83/EC. Case C-143/06. Judgment of the Court (Second Chamber) of 14 March 2018. Proceedings brought by Astellas Pharma GmbH. Request for a preliminary ruling from the Korkein hallinto-oikeus. Reference for a preliminary ruling — Directive 2001/83/EC — Medicinal products for human use — Articles 28 and 29 — Decentralised procedure for marketing authorisation for a medicinal product — Article 10 — Generic medicinal product — Data exclusivity period for the reference medicinal product — Power of the competent authorities of the Member States concerned to determine the point in time from which the exclusivity period starts to run — Jurisdiction of the courts of the Member States concerned to review the determination of the point in time from which the exclusivity period starts to run — Effective judicial protection — Charter of Fundamental Rights of the European Union — Article 47. Case C-557/16. 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. Judgment of the Court (Sixth Chamber) of 15 December 2016. LEK Farmacevtska Družba d.d. v Republika Slovenija. Request for a preliminary ruling from the Vrhovno sodišče Republike Slovenije. Reference for a preliminary ruling — Combined Nomenclature — Classification of goods — Food supplements falling under heading 2106 — Active ingredient as the essential component — Possible classification in Chapter 30 of the Combined Nomenclature — Goods presented and marketed as medicinal products. Case C-700/15. Judgment of the Court (Fourth Chamber), 11 April 2013. Novartis Pharma GmbH v Apozyt GmbH. Request for a preliminary ruling from the Landgericht Hamburg. 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. Judgment of the Court (Sixth Chamber) of 14 February 2019. Staat der Nederlanden v Warner-Lambert Company LLC. Request for a preliminary ruling from the Gerechtshof Den Haag. 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. Case C-423/17. Case C-27/08: Judgment of the Court (Fifth Chamber) of 30 April 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht (Germany)) — BIOS Naturprodukte GmbH v Saarland (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) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 1 PT 2 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. Judgment of the Court (First Chamber) of 26 October 2016. Hecht-Pharma GmbH v Hohenzollern Apotheke, Winfried Ertelt. Request for a preliminary ruling from the Bundesgerichtshof. 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. Case C-276/15. Judgment of the Court (Fifth Chamber) of 30 April 2009. BIOS Naturprodukte GmbH v Saarland. Reference for a preliminary ruling: Bundesverwaltungsgericht - Germany. 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. Case C-27/08. Judgment of the Court (Second Chamber) of 12 May 2005. Meta Fackler KG v Bundesrepublik Deutschland. Reference for a preliminary ruling: Verwaltungsgericht Berlin - Germany. Medicinal products for human use - Homeopathic medicinal products - National provision excluding from the special, simplified registration procedure a medicinal product composed of known homeopathic substances if its use as a homeopathic medicinal product is not generally known. Case C-444/03. Judgment of the Court (Second Chamber) of 8 November 2007. Gintec International Import-Export GmbH v Verband Sozialer Wettbewerb eV. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Directives 2001/83/EC and 92/28/EEC - National legislation prohibiting advertising of medicinal products by way of statements of third parties or prize draws - Use of generally positive results of a consumer survey and a monthly prize draw to win a pack of the product. Case C-374/05. A90LJ A87P3 A88P6 A90LC A96P1 Judgment of the Court (Fifth Chamber) of 21 September 2023. Apotheke B. v Bundesamt für Sicherheit im Gesundheitswesen (BASG). Request for a preliminary ruling from the Bundesverwaltungsgericht. Reference for a preliminary ruling – Pharmaceutical and cosmetic products – Medicinal products for human use – Directive 2001/83/EC – Article 77(6) – Article 79(b) – Article 80(b) – Guidelines on Good Distribution Practice of medicinal products for human use (GDP) – Pharmaceutical distribution chain – Holder of a wholesale distribution authorisation obtaining medicinal products from persons who are authorised to supply medicinal products to the public but who do not hold a distribution authorisation and are not exempted from the obligation to have such an authorisation – Concepts of ‘sufficient competent staff’ and ‘responsible person’ – Suspension or revocation of the wholesale distribution authorisation. Case C-47/22. A77P3 A79LB A79 A80L1LB A77P6 A80 Judgment of the Court (Second Chamber) of 2 March 2023. Kwizda Pharma GmbH v Landeshauptmann von Wien. Request for a preliminary ruling from the Verwaltungsgericht Wien. Reference for a preliminary ruling – Food safety – Food – Regulation (EU) No 609/2013 – Article 2(2)(g) – Concept of ‘food for special medical purposes’ – Other particular nutritional requirements – Dietary management – Modification of the diet – Nutrients – Use under medical supervision – Ingredients not absorbed or metabolised in the alimentary canal – Distinction in relation to medicinal products – Distinction in relation to food supplements. Case C-760/21. Judgment of the Court (Third Chamber) of 5 May 2011. MSD Sharp & Dohme GmbH v Merckle GmbH. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Medicinal products for human use - Directive 2001/83/EC - Prohibition on the advertising to the general public of medicinal products available only on prescription - Definition of ‘advertising’ - Information communicated to the competent authority - Information accessible on the internet. Case C-316/09. Order of the Court (Eighth Chamber), 14 November 2013. Astrazeneca AB v Comptroller General of Patents, Designs and Trade Marks. Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court). Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 13(1) — Concept of ‘first authorisation to place [a product] on the market in the Community’ — Authorisation issued by the Swiss Institute for Medicinal Products (Swissmedic) — Automatic recognition in Liechtenstein — Authorisation issued by the European Medicines Agency — Period of validity of a certificate. Case C‑617/12. Judgment of the Court (Seventh Chamber) of 19 January 2023. L. GmbH and H. Ltd v Bundesrepublik Deutschland. Requests for a preliminary ruling from the Bundesverwaltungsgericht. Reference for a preliminary ruling – Medical devices – Directive 93/42/EEC – Article 1(2)(a) – Definition – Article 1(5)(c) – Scope – Medicinal products for human use – Directive 2001/83/EC – Article 1(2) – Definition of the concept of ‘medicinal product’ – Article 2(2) – Applicable legal framework – Classification as a ‘medical device’ or as a ‘medicinal product’. Joined Cases C-495/21 and C-496/21. A01PT2LB A01PT2LA A01PT2 A02P2 Judgment of the Court (First Chamber) of 21 November 2018. Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) and Others. Request for a preliminary ruling from the Consiglio di Stato. Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Article 3(1) — Article 6 — Directive 89/105/EEC — Regulation (EC) No 726/2004 — Articles 3, 25 and 26 — Repackaging of a medicinal product for use as a treatment not covered by its marketing authorisation (off-label use) — Reimbursement by the national healthcare insurance system. Case C-29/17. Judgment of the Court (Seventh Chamber) of 7 December 2017. Merck Sharp & Dohme Corporation v Comptroller-General of Patents, Designs and Trade Marks. Reference for a preliminary ruling — Industrial and commercial property — Patent law — Medicinal products for human use — Regulation (EC) No 469/2009 — Article (3)(b) — Supplementary protection certificate — Conditions for obtaining — Article 10(3) — Granting of the certificate or rejection of the application for a certificate — Directive 2001/83/EC — Article 28(4) — Decentralised procedure. Case C-567/16. Judgment of the Court (Fifth Chamber) of 17 November 2022. Bayer Intellectual Property GmbH v kohlpharma GmbH. Request for a preliminary ruling from the Landgericht Hamburg. Reference for a preliminary ruling – Intellectual property – Trade marks – Directive (EU) 2015/2436 – Approximation of the laws of the Member States relating to trade marks – Article 10(2) – Rights conferred by a trade mark – Article 15 – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products – Repackaging of the product bearing the mark – New outer packaging – Opposition by the proprietor of the mark – Artificial partitioning of the markets between Member States – Medicinal products for human use – Directive 2001/83/EC – Article 47a – Safety features – Replacement – Equivalent features – Delegated Regulation (EU) 2016/161 – Article 3(2) – Anti-tampering device – Unique identifier. Case C-204/20. Judgment of the Court (Second Chamber) of 9 December 2004. The Queen, on the application of Approved Prescription Services Ltd v Licensing Authority. Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) - United Kingdom. Medicinal products - Marketing authorisation - Procedures for essentially similar products. Case C-36/03. Case C-527/07: Judgment of the Court (First Chamber) of 18 June 2009 (Reference for a preliminary ruling from the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court) (United Kingdom)) — The Queen, on the application of Generics (UK) Ltd v Licensing Authority (acting through the Medicines and Healthcare products Regulatory Agency) (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 ) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 10.2 PT A) Judgment of the Court (Fourth Chamber), 10 July 2014. Markus D. and G. Request for a preliminary ruling from the Bundesgerichtshof. 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. Joined Cases C‑358/13 and C‑181/14. Judgment of the Court (First Chamber) of 9 June 2005. HLH Warenvertriebs GmbH (C-211/03) and Orthica BV (C-299/03 and C-316/03 to C-318/03) v Bundesrepublik Deutschland. Reference for a preliminary ruling: Oberverwaltungsgericht für das Land Nordrhein-Westfalen - Germany. Free movement of goods - Distinction between medicinal products and food additives - Product marketed as a food additive in the Member State of origin but treated as a medicinal product in the Member State of import - Marketing authorisation. Joined cases C-211/03, C-299/03 and C-316/03 to C-318/03. Judgment of the Court (Fifth Chamber) of 17 November 2022. Novartis Pharma GmbH v Abacus Medicine A/S. Request for a preliminary ruling from the Landgericht Hamburg. Reference for a preliminary ruling – Intellectual property – EU trade mark – Regulation (EU) 2017/1001 – Article 9(2) – Rights conferred by a mark – Article 15 – Exhaustion of the rights conferred by a trade mark – Parallel import of medicinal products – Repackaging of the product bearing the mark – New outer packaging – Opposition by the proprietor of the mark – Artificial partitioning of the markets between Member States – Medicinal products for human use – Directive 2001/83/EC – Article 47a – Safety features – Replacement – Equivalent features – Delegated Regulation (EU) 2016/161 – Article 3(2) – Anti-tampering device – Unique identifier. Case C-147/20. Case C-140/07: Judgment of the Court (First Chamber) of 15 January 2009 (reference for a preliminary ruling from the Bundesverwaltungsgericht — Germany) — Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg (Directive 2001/83/EC — Articles 1(2) and 2(2) — Concept of medicinal product by function — Product in respect of which it has not been established that it is a medicinal product by function — Account taken of the content in active substances) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 1.2 PT B) {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 2.2 Judgment of the Court (Ninth Chamber) of 25 October 2018. Proceedings brought by Boston Scientific Ltd. Reference for a preliminary ruling — Intellectual and industrial property — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Scope — Medical device incorporating as an integral part a substance which, used separately, may be considered to be a medicinal product — Directive 93/42/EEC — Article 1(4) — Concept of ‘administrative authorisation procedure’. Case C-527/17. Judgment of the Court (Second Chamber) of 2 April 2009. Criminal proceedings against Frede Damgaard. Reference for a preliminary ruling: Vestre Landsret - Denmark. 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. Case C-421/07. Judgment of the Court (Eighth Chamber) of 23 April 2020. Deutsche Homöopathie-Union (DHU) Arzneimittel GmbH & Co. KG v Bundesrepublik Deutschland. Requests for a preliminary ruling from the Bundesverwaltungsgericht. 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 product characteristics –Dosage schedules for homeopathic medicinal products. Joined Cases C-101/19 and C-102/19. Judgment of the Court (Fifth Chamber) of 5 February 2015. Miguel M. and Others. Requests for a preliminary ruling from the Bundesgerichtshof. Request for a preliminary ruling — Drug precursors — Monitoring of trade between the Member States — Regulation (EC) No 273/2004 — Monitoring of trade between the European Union and third countries — Regulation (EC) No 111/2005 — Trade in medicinal products containing ephedrine or pseudoephedrine — Definition of ‘scheduled substance’ — Composition — Exclusion of all medicinal products or only those containing scheduled substances and the composition of which does allow those substances to be readily extracted — Directive 2001/83/EC — Definition of ‘medicinal product’. Joined Cases C-627/13 and C-2/14. Judgment of the Court (First Chamber) of 20 September 2007. Staat der Nederlanden v Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg and Others. Reference for a preliminary ruling: Hoge Raad der Nederlanden - Netherlands. Community code relating to medicinal products for human use - Articles 28 EC and 30 EC - Registration and marketing authorisation - Anthroposophic medicinal products. Case C-84/06. Judgment of the Court (Fourth Chamber) of 15 July 2021. DocMorris NV v Apothekerkammer Nordrhein. Request for a preliminary ruling from the Bundesgerichtshof. Reference for a preliminary ruling – Medicinal products for human use subject to a medical prescription – Directive 2001/83/EC – Scope – Advertising by a mail-order pharmacy intended to influence not the customer’s choice of a particular medicinal product, but the choice of pharmacy – Prize competition – Free movement of goods – National legislation – Prohibition on offering, advertising or granting advantages and other promotional gifts in the field of therapeutic products – Selling arrangements falling outside the scope of Article 34 TFEU. Case C-190/20. Judgment of the Court (Fourth Chamber), 3 October 2013. Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto. Request for a preliminary ruling from the Korkein hallinto-oikeus. Reference for a preliminary ruling — Approximation of laws — Medical devices — Directive 93/42/EEC — Medicinal products for human use — Directive 2001/83/EC — Right of the competent national authority to classify as a medicinal product for human use a product marketed in another Member State as a medical device bearing a CE marking — Applicable procedure. Case C‑109/12. Judgment of the Court of 11 December 2003. Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval. Reference for a preliminary ruling: Landgericht Frankfurt am Main - Germany. Articles 28 EC and 30 EC - Directives 92/28/EEC and 2000/31/EC - National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member State - Doctor's prescription required for supply - Prohibition on advertising the sale of medicinal products by mail order. Case C-322/01. Case C-649/18: Request for a preliminary ruling from the Cour d’appel de Paris (France) lodged on 15 October 2018 — A v Daniel B, UD, AFP, B, L Case C-47/22: Request for a preliminary ruling from the Bundesverwaltungsgericht (Austria) lodged on 21 January 2022 — Apotheke B. v Bundesamt für Sicherheit im Gesundheitswesen (BASG) article 77 paragraph 6 article 80 article 79 article 79 point (b) article 80 point (g) article 80 point (b) article 77 paragraph 2 article 77 paragraph 3 Case C-102/19: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 11 February 2019 — Deutsche Homöopathie-Union (DHU) Arzneimittel GmbH & Co. KG v Bundesrepublik Deutschland article 14 paragraph 1 article 62 article 69 Case C-557/16: Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 4 November 2016 — Astellas Pharma GmbH article 28 paragraph 5 article 10 article 29 paragraph 1 Case C-190/20: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 5 May 2020 — DocMorris NV v Apothekerkammer Nordrhein title (subdivision) VIII article 87 paragraph 3 Case C-178/20: Request for a preliminary ruling from the Fővárosi Törvényszék (formerly the Fővárosi Közigazgatási és Munkaügyi Bíróság (Hungary)) lodged on 7 April 2020 — Pharma Expressz Szolgáltató és Kereskedelmi Kft v Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet article 73 article 72 article 70 article 71 Case C-423/17: Request for a preliminary ruling from the Gerechtshof Den Haag (Netherlands) lodged on 13 July 2017 — Staat der Nederlanden v Warner-Lambert Company LLC article 21 paragraph 3 article 11 article 10 article 6 Case C-179/16: Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 25 March 2016 — F. Hoffmann-La Roche AG, La Roche SpA, Novartis AG and Novartis Farma SpA v Autorità Garante della Concorrenza e del Mercato Case C-589/23, Cassella-med and MCM Klosterfrau: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 25 September 2023 — Cassella-med GmbH & Co. KG, MCM Klosterfrau Vertriebsgesellschaft mbH v Verband Sozialer Wettbewerb e.V. article 1 point 2 point (b) Case C-147/20: Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 23 March 2020 — Novartis Pharma GmbH v Abacus Medicine A/S article 47a paragraph 1 point (b) article 47a article 54 point (o) Case C-567/16: Reference for a preliminary ruling from High Court of Justice (Chancery Division) (United Kingdom) made on 10 November 2016 — Merck Sharp v Comptroller-General of Patents, Designs and Trade Marks Case C-224/20: Request for a preliminary ruling from the Sø- og Handelsretten (Denmark) lodged on 29 May 2020 — Merck Sharp & Dohme B.V., Merck Sharp & Dohme Corp., MSD DANMARK ApS, MSD Sharp & Dohme GmbH, Novartis AG, FERRING LÆGEMIDLER A/S and H. Lundbeck A/S v Abacus Medicine A/S, Paranova Danmark A/S, 2CARE4 ApS article 47a paragraph 1 point (b) article 47a article 47a paragraph 1 point (b) point (ii) article 54 point (o) Case C-517/23, Apothekerkammer Nordrhein: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 10 August 2023 — Apothekerkammer Nordrhein v DocMorris NV article 87 paragraph 3 article 86-100 title (subdivision) VIII title (subdivision) VIIIa Case C-530/20: Request for a preliminary ruling from the Satversmes tiesa (Latvia) lodged on 20 October 2020 — SIA EUROAPTIEKA v Ministru kabinets annex VIII article 87 paragraph 3 article 90 Case C-276/15: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 June 2015 — Hecht-Pharma GmbH v Hohenzollern Apotheke, owned by Winfried Ertelt article 3 point 2 article 3 point 1 Case C-451/24, Kwizda Pharma II: Request for a preliminary ruling from the Verwaltungsgericht Wien (Austria) lodged on 26 June 2024 – Kwizda Pharma GmbH article 2 paragraph 2 article 2 paragraph 1 Case C-527/17: Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 5 September 2017 — LN Case C-296/15: Request for a preliminary ruling from the Državna revizijska komisija za revizijo postopkov oddaje javnih naročil (Slovenia) lodged on 18 June 2015 — Medisanus d.o.o. v Splošna Bolnišnica Murska Sobota Case C-165/21: Request for a preliminary ruling from Københavns Byret (Denmark) lodged on 11 March 2021 — Orion Corporation v Lægemiddelstyrelsen article 6 paragraph 1 article 10 paragraph 2 point (a) article 28 Case C-616/20: Request for a preliminary ruling from the Verwaltungsgericht Köln (Germany) lodged on 19 November 2020 — M2Beauté Cosmetics GmbH v Federal Republic of Germany article 1 paragraph 2 point (b) Case C-786/18: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 14 December 2018 — ratiopharm GmbH v Novartis Consumer Health GmbH article 96 paragraph 2 article 96 paragraph 1 Case C-417/22: Request for a preliminary ruling from the Verwaltungsgerichtshof (Austria) lodged on 21 June 2022 — AB v Disziplinarrat der Österreichischen Apothekerkammer article 87 paragraph 3 article 90 Case C-118/24, Laboratoires Eurogenerics and Theramex France: Request for a preliminary ruling from the Conseil d’État (France) lodged on 14 February 2024 - EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS v Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Biogaran SAS article 29 article 28 article 10 article 29 paragraph 1 article 10 paragraph 1 Case C-29/17: Request for a preliminary ruling from the Consiglio di Stato (Italy) lodged on 19 January 2017 — Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) article 6 article 5 recital 2 article 3 paragraph 1 article 3 Case C-204/20: Request for a preliminary ruling from the Landgericht Hamburg (Germany) lodged on 13 May 2020 — Bayer Intellectual Property GmbH v kohlpharma GmbH article 54 point (o) article 47a Case C-497/16: Request for a preliminary ruling from the Nejvyšší soud České republiky (Czech Republic) lodged on 16 September 2016 — Criminal proceedings against Juraj Sokáč Case C-618/23, SALUS: Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 6 October 2023 — SALUS Haus Dr. med Otto Greither Nachf. GmbH & Co. KG v Astrid Twardy GmbH article 16a article 1 point 29 Case C-606/21: Request for a preliminary ruling from the Cour d’appel de Paris (France) lodged on 30 September 2021 — Doctipharma SAS v Union des Groupements de pharmaciens d’officine (UDGPO), Pictime SAS operating under the name ‘Coreyre’ Case C-101/19: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 11 February 2019 — Deutsche Homöopathie-Union (DHU) Arzneimittel GmbH & Co. KG v Bundesrepublik Deutschland article 14 paragraph 1 article 62 article 69 Case C-496/21: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 August 2021 — H. Ltd. v Federal Republic of Germany article 1 point 2 point (a) article 2 paragraph 2 Case C-589/24, Almirall: Request for a preliminary ruling from the Hoge Raad der Nederlanden (Netherlands) lodged on 11 September 2024 – Almirall BV, Almirall SA v Infinity Pharma BV, Pharmaline BV article 6 article 3 point 2 article 40 article 40 paragraph 2 unnumbered paragraph 2 Case C-495/21: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 August 2021 — L. GmbH v Federal Republic of Germany article 1 point 2 point (a) article 2 paragraph 2 Case T-109/23: Action brought on 23 February 2023 — UY v Commission annex I part IV point 2.1 sentence Case T-108/23: Action brought on 22 February 2023 — UY v Commission annex I part IV point 2.1 sentence Legal basis Treaty establishing the European Community (Amsterdam consolidated version) Part Five: Institutions of the Community Title I: Provisions governing the institutions Chapter 2: Provisions common to several institutions Article 251 Article 189b - EC Treaty (Maastricht consolidated version) Treaty establishing the European Community (Amsterdam consolidated version) Part Three: Community policies Title VI: Common rules on competition, taxation and approximation of laws Chapter 3: Approximation of laws Article 95 Article 100a - EC Treaty (Maastricht consolidated version) EuroVoc Vocabulary Public health Internal market - Principles Single market Approximation of laws Pharmaceutical legislation Medicinal product Proprietary medicinal products Industry Public health Medicinal products Technical barriers Approximation of laws Legal code