Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products Basic information CELEX number: 31965L0065Official Journal: JOP_1965_022_0369_004 Form: DirectiveProcedure number: --Languages: Dates Date of document: Date of publication: Date of effect: February 3, 1965 Entry into force - Date notif. Date of transposition: December 31, 1966 See Art 22 ET 366L0454 Art 1 February 3, 1970 Date of end of validity: Modified by Corrected by: Modified by: Directive 89/341/CEE du Conseil du 3 mai 1989 modifiant les directives 65/65/CEE, 75/318/CEE et 75/319/CEE concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques
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detail Deuxième directive 75/319/CEE du Conseil, du 20 mai 1975, concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques
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detail Directive 87/21/CEE du Conseil du 22 décembre 1986 modifiant la directive 65/65/CEE concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques
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detail Directive 83/570/CEE du Conseil du 26 octobre 1983 modifiant les directives 65/65/CEE, 75/318/CEE et 75/319/CEE concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques
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detail Directive 93/39/CEE du Conseil du 14 juin 1993 modifiant les directives 65/65/CEE, 75/318/CEE et 75/319/CEE concernant les médicaments
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detail Directive 66/454/CEE du Conseil, du 28 juillet 1966, modifiant l'article 22 de la directive du Conseil du 26 janvier 1965 concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques
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detail All documents based on this document: Derogated in: Repealed by: Modifies Affected by case Judgment of the Court of 12 November 1996. The Queen v The Medicines Control Agency, ex parte Smith & Nephew Pharmaceuticals Ltd and Primecrown Ltd v The Medicine Control Agency. Reference for a preliminary ruling: High Court of Justice, Queen's Bench Division - United Kingdom. Proprietary medicinal products - Parallel imports - Direct effect of Directive 65/65/EEC - Marketing authorization. Case C-201/94. Judgment of the Court (Fifth Chamber) of 16 April 1991. Upjohn Company and Upjohn NV v Farzoo Inc. and J. Kortmann. Reference for a preliminary ruling: Hoge Raad - Netherlands. Concepts of "medicinal product" and "cosmetic product". Case C-112/89. Judgment of the Court (Fifth Chamber) of 7 December 1993. Pierrel SpA and others v Ministero della Sanità. Reference for a preliminary ruling: Consiglio di Stato - Italy. Directive on medicinal products - Marketing authorization - Lapse. Case C-83/92. Judgment of the Court (Second Chamber) of 20 March 1986. Procureur de la République v Gérard Tissier. Reference for a preliminary ruling: Tribunal de grande instance de Libourne - France. Definition of 'medicinal product'. Case 35/85. Judgment of the Court of 16 December 1999. The Queen, ex parte Rhône-Poulenc Rorer Ltd and May & Baker Ltd v The Licensing Authority established by the Medicines Act 1968 (represented by the Medicines Control Agency). Reference for a preliminary ruling: High Court of Justice, Queen's Bench Division - United Kingdom. Medicinal products - Marketing authorisation - Parallel imports. Case C-94/98. Judgment of the Court (Fifth Chamber) of 21 March 1991. Criminal proceedings against Jean-Marie Delattre. Reference for a preliminary ruling: Tribunal de grande instance de Nice - France. Interpretation of Articles 30 and 36 of the EEC Treaty - Concepts of "disease" or "illness" and "medicinal product" - Pharmacists' monopoly of the right to sell certain products. Case C-369/88. Judgment of the Court (Fifth Chamber) of 21 January 1999. Upjohn Ltd v The Licensing Authority established by the Medicines Act 1968 and Others. Reference for a preliminary ruling: Court of Appeal (England) - United Kingdom. Proprietary medicinal products - Revocation of a marketing authorisation - Judicial review. Case C-120/97. Judgment of the Court (Fifth Chamber) of 3 December 1998. The Queen v The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd, The Wellcome Foundation Ltd and Glaxo Operations UK Ltd and Others. Reference for a preliminary ruling: High Court of Justice, Queen's Bench Division - United Kingdom. Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products. Case C-368/96. Judgment of the Court (Fifth Chamber) of 21 March 1991. Criminal proceedings against Jean Monteil and Daniel Samanni. Reference for a preliminary ruling: Cour d'appel d'Aix-en-Provence - France. Interpretation of Articles 30 and 36 of the EEC Treaty - Concepts of "disease" or "illness" and "medicinal products" - Pharmacists' monopoly of the right to sell certain products. Case C-60/89. 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. Judgment of the Court (Sixth Chamber) of 11 December 2003. Hässle AB v Ratiopharm GmbH. Reference for a preliminary ruling: Bundesgerichtshof - Germany. Council Regulation (EEC) No 1768/92 - Medicinal products - Supplementary protection certificate - Articles 15 and 19 - Validity of Article 19 - Concept of first authorisation to place ... on the market in the Community - Legal effects of non-compliance with the relevant date referred to in Article 19. Case C-127/00. Judgment of the Court (Second Chamber) of 28 July 2011. Generics (UK) Ltd v Synaptech Inc. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Patent law - Medicinal products - Supplementary protection certificate for medicinal products - Regulation (EEC) No 1768/92 - Article 2 - Scope. Case C-427/09. Judgment of the Court (Fifth Chamber) of 28 October 1992. Criminal proceedings against Johannes Stephanus Wilhelmus Ter Voort. Reference for a preliminary ruling: Arrondissementsrechtbank Leeuwarden - Netherlands. Definition of "medicinal product". Case C-219/91. Judgment of the Court (Sixth Chamber) of 29 April 2004. The Queen, on the application of Novartis Pharmaceuticals UK Ltd v The Licensing Authority established by the Medicines Act 1968 (acting by the Medicines Control Agency). Reference for a preliminary ruling: Court of Appeal (England and Wales) (Civil Division) - United Kingdom. Medicinal products - Marketing authorisation - Procedure relating to essentially similar products. Case C-106/01. A04L3PT8LAPTI A04L3PT8LAPTIII Judgment of the Court (Sixth Chamber) of 5 October 1995. The Queen v Licensing Authority of the Department of Health and Norgine Ltd, ex parte Scotia Pharmaceuticals Ltd. Reference for a preliminary ruling: High Court of Justice, Queen's Bench Division - United Kingdom. Medicinal product - Placing on the market - Abridged procedure. Case C-440/93. Judgment of the Court (Sixth Chamber) of 16 October 2003. AstraZeneca A/S v Lægemiddelstyrelsen. Reference for a preliminary ruling: Østre Landsret - Denmark. Medicinal products - Marketing authorisation of a generic medicinal product - Withdrawal of the marketing authorisation of the reference medicinal product - Abridged procedure. Case C-223/01. Judgment of the Court (Third Chamber) of 26 January 1984. SA Clin-Midy and others v Belgian State. Reference for a preliminary ruling: Conseil d'Etat - Belgium. Price control - Proprietary medicinal products. Case 301/82. Judgment of the Court (Fifth Chamber) of 30 November 1983. Criminal proceedings against Leendert van Bennekom. Reference for a preliminary ruling: Arrondissementsrechtbank Amsterdam - Netherlands. Concept of "Medicinal products" - "Medicinal preparations". Case 227/82. Judgment of the Court of 7 February 1984. Duphar BV and others v The Netherlands State. Reference for a preliminary ruling: Arrondissementsrechtbank 's-Gravenhage - Netherlands. Health-care scheme - Compatibility with the Treaty of restrictions on access to certain medicinal preparations. Case 238/82. Judgment of the Court (Fifth Chamber) of 3 December 1998. The Queen v The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd, The Wellcome Foundation Ltd and Glaxo Operations UK Ltd and Others. Reference for a preliminary ruling: High Court of Justice, Queen's Bench Division - United Kingdom. Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products. Case C-368/96. Legal basis TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, PART THREE - POLICY OF THE COMMUNITY, TITLE I - COMMON RULES, CHAPTER 3: APPROXIMATION OF LAWS, ARTICLE 100 EuroVoc Vocabulary Internal market - Principles Industry Approximation of laws Technical barriers Health and safety Approximation of laws Marketing Proprietary medicinal products Labelling Pharmaceutical product