Volume 5 of the publications "The rules governing medicinal products in the European Union" compiles the body of European Union legislation in the pharmaceutical sector for medicinal products for veterinary use.
Directives
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Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products (OJ L 168, 30.6.2009, p. 33-34). |
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Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (OJ L 44, 14.2.2009, p. 10-61). |
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Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription (OJ L 349, 12.12.2006, p. 15-16). |
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Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1-66 - Consolidated version : 18/7/2009). |
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Amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58-84). |
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Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70-73). |
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Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ L 92, 7.4.1990, p. 42-48).
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Regulations
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Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11-22). |
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Council Regulation (EC) No 1308/1999 of 15 June 1999 amending Regulation (EC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 156, 23.6.1999, p. 1-3). |
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| EEC/2377/90 (Consolidated) |
Consolidated version of the Council Regulation (EEC) N° 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits for veterinary medicinal products in foodstuffs of animal origin (Consolidated version : 16/08/2008). This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents.
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Commission Regulation (EC) No 478/2009 of 8 June 2009 amending Annexes I and III to Council 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, as regards monepantel (OJ L 144, 9.6.2009, p. 17-19). |
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| EC/485/2009 |
Commission Regulation (EC) No 485/2009 of 9 June 2009 amending Annex II to Council 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, as regards tiludronic acid and iron fumarate (OJ L 145, 10.6.2009, p. 31-33). |
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Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ L 214, 24.8.1993 p. 1-21; Finnish special edition: Chapter 13, Volume 24, p. 158; Swedish special edition: Chapter 13, Volume 24, p. 158). |
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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolidated version : 20/04/2009, Lithuanian consolidadted version : 30/12/2008). |
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Amended by Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission (OJ L 81, 20.3.2008, p. 51-52 ). |
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Amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny - Part Two (OJ L 87, 31.3.2009, p. 109-154, especially p. 116-118, Annex 2.9, where Regulation (EC) No 726/2004 is adapted). |
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Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1-5).
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Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 345, 19.12.1998, p. 3-8). |
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Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products (OJ L 073, 19.3.2003, p. 6-7). |
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Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency (OJ L 340, 13.11.2005 p. 1-9). |
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Commission Regulation (EC) No 312/2008 of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate (OJ L 93, 4.4.2008, p. 8-10). |
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Commission Regulation (EC) No 249/2009 of 23 March 2009 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate (OJ L 79, 25.3.2009, p. 34-36). |
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Commission Regulation (EC) No 540/95, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93 (OJ L 55, 11.3.1995, p. 5-6). |
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Commission Regulation (EC) No 1662/95, of 7 July 1995, laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use (OJ L 158, 8.7.1995, p. 4-5).
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Commission Regulation (EC) No 2141/96, of 7 November 1996, concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93 (OJ L 286, 8.11.1996, p. 6-8). |
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Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (OJ L 159, 27.6.2003, p. 1-23). |
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Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (OJ L 159, 27.6.2003, p. 24-45). |
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Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae was published in the Official Journal on 22 December 2006 (OJ L 367, 22.12.2006, p. 33-45). |
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Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 155, 15.6.2007, p. 10-19). |
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Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p. 7-24). |
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Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 209, 4.8.2012, p. 4-14). |
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Regulation (EC) No 470/2009 of the European Parliament and the Councilof 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11-22). The new regulation will enter into force on the twentieth day following its publication in the Official Journal. |
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Commission Regulation (EU) N° 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1-72). |
Miscellaneous
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Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee (OJ L 147, 9.6.1975, p. 23; Spanish special edition: Chapter 13, Volume 4, p. 102; Portuguese special edition: Chapter 13, Volume 4, p. 102; Finnish special edition: Chapter 13, Volume 4, p. 108; Swedish special edition: Chapter 13, Volume 4, p. 108).
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Council Directive 78/25/EEC, of 12 December 1977, on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (OJ L 11, 14.1.1978, p. 18-20; Finnish special edition: Chapter 13, Volume 8, p. 39; Greek special edition: Chapter 13, Volume 7, p. 34; Swedish special edition: Chapter 13, Volume 8, p. 39; Spanish special edition: Chapter 13, Volume 8, p. 86; Portuguese special edition: Chapter 13, Volume 8, p. 86).
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Council Directive 90/219/EEC, of 23 April 1990, on the contained use of genetically modified micro-organisms (OJ L 117, 8.5.1990, p. 1-14; Finnish special edition: Chapter 15, Volume 9, p. 198; Swedish special edition: Chapter 15, Volume 9, p. 198).
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Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (O L 330, 5.12.1998, p. 13-31).
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Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate releasse into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1-39).
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Council Regulation No (EEC) 1768/92, of 18 June 1992, concerning the creation of a supplementary protection certificate for medicinal products (OJ L 182, 2.7.1992, p. 1-5; FI and SV special editions: Chapter 13, Volume 23, p. 78; CS, ET, HU, LT, LV, MT, PL, SK and SL special editions: Chapter 13, Volume 11, p. 200-204). |
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Commission Communication 94/C 82/04 on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993 (OJ C 82, 19.3.1994, p. 4). |
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Commission communication on the Community marketing authorisation procedures for medicinal products (OJ C 229, 22.7.1998, p. 4-17). |
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Guideline on the definition of a potential serious risk to human or animal health or for the environment in the context of Article 33(1) and (2) of Directive 2001/82/EC (OJ C 132, 7.6.2006, p. 32-35). |
