Regulations governing veterinary medicinal products containing genetically modified organisms in the European Community

OIE Revue Scientifique et Technique

Volumn 24, Issue 1, 2005, Pages 101-107

  Moulin, G ^a  

^a Healthy Pigs Production and Experimentation Section   (France)

Author keywords

Biotechnology; European Community; Genetically modified micro organisms; Genetically modified organisms; Marketing authorisation; Procedure; Regulatory aspect; Veterinary medicinal product

Indexed keywords

EID: 23444456320     PISSN: 02531933     EISSN: None     Source Type: Journal    
DOI: 10.20506/rst.24.1.1558     Document Type: Review

References (18)

1. European Communities (EC) (1990). - Council Directive 90/219/EC of 23 April 1990 on the contained use of genetically modified micro-organisms. Off. J. Eur. Communities, L 117, 08/05/1990, 0001-0014.
2. European Communities (EC) (1993). - Council Regulation EC 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. Off. J. Eur. Communities, L 214, 24/08/1993, 0001-0021.
3. European Communities (EC) (1994). - Commission Directive 94/51/EC of 7 November 1994 adapting to technical progress Council Directive 90/219/EC on the contained use of genetically modified micro-organisms. Off. J. Eur. Communities, L 297, 18/11/1994, 0029-0030.
4. European Communities (EC) (1998). - Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EC on the contained use of genetically modified micro-organisms. Off. J. Eur. Communities, L 330, 5/12/1998, 0013-0031.
5. European Communities (EC) (2001). - Commission Directive 2001/28/EC of 20 April 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include KBR 2738 (fenhexamid) as an active substance. Off. J. Eur. Communities, L 113, 24/04/2001, 0005-0007.
6. European Communities (EC) (2001). - Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Off. J. Eur. Communities, L 106, 17/04/2001, 0001-0039.
7. European Communities (EC) (2001). - 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. Off. J. Eur. Communities, L 311, 28/11/2001, 0001-0066.
8. European Communities (EC) (2002). - Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market. Off. J. Eur. Communities, L 280, 18/10/2002, 0062-0083.
9. European Communities (EC) (2003). - Regulation EC No. 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Off. J. Eur. Communities, L 268, 18/10/2003, 0024-0028.
10. European Communities (EC) (2004). - Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP). Off. J. Eur. Communities, L 050, 20/02/2004, 0028-0043.
11. European Communities (EC) (2004). - Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. Off. J. Eur. Communities, L 050, 20/02/2004, 0044-0059.
12. European Communities (EC) (2004). - 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. Off. J. Eur. Communities, L 136, 30/04/2004, 0058-0084.
13. European Communities (EC) (2004). - 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. Off. J. Eur. Communities, L 136, 30/04/2004, 0001-0033.
14. European Medicines Agency (2004). - EMEA/CVMP/ 1151/04: guideline on GMOs: updated notice to applicants guidance. EMEA, London. Website: www.emea.eu.int/pdfs/vet/regaffair/115104en.pdf (accessed on 11 March 2005).
15. European Medicines Agency (2004). - SOP-V-4012 standard operating procedure on GMOs - Article 28 - EMEA/CVMP. EMEA, London. Website: www.emea.eu.int/pdfs/vet/sop/SOPV4012.pdf (accessed on 11 March 2005).
16. Government of France (1995). - Decree No. 95-1173, 6 November 1995 setting specific procedures applying to veterinary medicines containing genetically modified organisms. Journal Officiel, 260, 8 November 1995. Website: www.legifrance.gouv.fr/ (accessed on 5 April 2005).
17. Government of France (2003). - Code de l'environnement (Partie Législative). Livre V : Prévention des pollutions, des risques et des nuisances. Titre III : Organismes génétiques modifiés. Articles L 532 - L 533 (in French). Website: www.legifrance.gouv.fr/ (accessed on 5 April 2005).
18. Government of France. - Code de la santé publique (Nouvelle Partie Réglementaire). Cinquième partie livre Ier. Titre IV : Médicaments vétérinaires. Chapitre I : Dispositions générales. Section 2: Expérimentation, Article R 5141-8 (in French). Website: www.legifrance.gouv.fr/ (accessed on 5 April 2005).