Legal documents

Date	Description and links
29 July 2020	Questions and answers document on regulatory and legal issues concerning homeopathic medicinal products in the European framework, Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies
08 Jun 2011	Directive 2011/62/EU preventing entry into the legal supply chain of falsified medicinal products
15 Dec 2010	Directive 2010/84/EU and Directive 2012/26/EU providing legislation on pharmacovigilance
18 Jun 2009	Directive 2009/53/EC introducing rules on varations to the terms of marketing authorisations for medicinal products
20 Dec 2006	Regulation (EC) No 1901/2006 on medicinal products for paediatric useand amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
31 Mar 2004	Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
31 Mar 2004	Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
31 Mar 2004	Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
16 Aug 2003	Consolidation of Regulation (EEC) No 2377/90 Laying down a Community Procedure for the Establishment of Maximum Residue Limits of Veterinary Medicinal Products in Foodstuffs of Animal Origin
6 Nov 2001	Directive 2001/83/EC on the Community code relating to medicinal products for human use
6 Nov 2001	Directive 2001/82/EC on the Community code relating to veterinary medicinal products
22 Sep 1992	Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products
22 Sep 1992	Council Directive 92/73/EEC widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and establishing complementary provisions for homeopathic medicinal products
26 Jun 1990	Regulation (EEC) No 2377/90 Laying down a Community Procedure for the Establishment of Maximum Residue Limits of Veterinary Medicinal Products in Foodstuffs of Animal Origin
28 Sep 1981	Directive 81/851/EEC on the approximation of laws of the Member States relating to veterinary medicinal products
20 May 1975	Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products
20 May 1975	Second Council Directive on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products
26 Jan 1965	Council Directive 65/65/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products