Safe use of vaccines and vaccine compliance with food safety requirements

OIE Revue Scientifique et Technique

Volumn 26, Issue 2, 2007, Pages 339-350

  Grein, K ^a   Papadopoulos, O ^b   Tollis, M ^c  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^c Lstituto Superiore di Sanità ^*  (Italy)

Author keywords

Animal; Assessment; Benefit; Consumer; Environment; Health pharmacovigilance; Risk; Safety; User; Vaccine

Indexed keywords

ANIMALIA;

EID: 34548319032     PISSN: 02531933     EISSN: 16080645     Source Type: Journal    
DOI: 10.20506/rst.26.2.1746     Document Type: Article

References (17)

1. Clements D.X., Gear R.N.. Tattersall J.. Carmichael S. & Bennett D. (2004). - Type I immune-mediated polyarthritis in dogs: 39 cases (1997-2002). J. Am. vet. med. Assoc., 224 (8), 1323-1327.
2. Committee for Medicinal Products for Veterinary Use (CVMP) (2003). - CVMP advice on injection-site fibrosarcomas in cats. Vet. Rec, 152 (13), 381-382.
3. European Commission (2006). - EudraLex: - Volume 6 Notice to Applicants. Veterinary Medicinal Products. Available at: http://ec.europa.eu/enterprise/ pharmaceuticals /eudralex/homev6.htm (accessed on 4 July 2007).
4. European Commission (2005). - EudraLex: Volume 8 Notice to Applicants and Note for Guidance. Establishment of maximum residue limits (MRLs) for residues of veterinary medicinal products in foodstuffs of animal origin. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/ homev8.htm (accessed on 4 July 2007).
5. European Council (1990). - Council Regulation (EEC) No. 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 Off. J. Eur. Communities, L 224, 1-8.
6. European Medicines Agency (EMEA) (2006). - Series of guidelines regarding the data requirements and assessment of immunological veterinary medicinal products. Available at: http://www.emea.europa.eu/htms/vet/vetguidelines/immunol ogicals.htm (accessed on 2 June 2007).
7. European Parliament and Council (2004). - Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 (Off. J. Eur. Communities, L 311, 1-66), as amended by Directive 2004/28/EC of the European Parliament and of the Council of the 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medical products. Off. J. Eur. Union, L 136, 58-84. Available at: http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol5/consol_2004/ veterinary_code .pdf (accessed on 2 June 2007).
8. European Parliament and Council (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. Union, L 136, 30.4.2004, 1-33. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-l/reg_2004_726/ reg_2004_726_en.pdf (accessed on 2 June 2007).
9. European Pharmacopoeia (2004). - European Pharmacopoeia 5th Edition & supplements. European Directorate for the Quality of Medicines and Healthcare (EDQM), Council of Europe, Strasbourg.
10. Falcone E., Tollis M. & Conti G. (1999). - Bovine viral diarrhea disease associated with a contaminated vaccine. Vaccine, 18 (5-6), 387-388.
11. Hogenesch H., Azcona-Olivera J., Scott-Moncrieff C., Snyder P.W. & Glickman L.T. (1999). - Vaccine-induced autoimmunity in the dog. In Veterinary vaccines and diagnostics (R. Schultz, ed.). Adv. vet. Med., 41, 733-747.
12. Kass P.H., Barnes WG. Jr, Spangler WL., Chomel B.B. & Culbertson M.R. (1993). - Epidemiologic evidence for a causal relation between vaccination and fibrosarcoma tumorigenesis in cats. J. Am. vet med. Assoc., 203 (7), 1046.
13. Martinod S. (1995). - Risk assessment related to veterinary biologicals: side-effects in target animals. In Risk assessment for veterinary biologicals (E.G.S Osbome & J.W Glosser, eds). Rev. sci. tech. Off. int. Epiz., 14 (4), 979-989.
14. Moore G.E., Guptill L.E, Ward M.R, Glickman N.W, Faunt K.K., Lewis H.B. & Glickman L.T. (2005). - Adverse events diagnosed within three days of vaccine administration in dogs. J. Am. vet. med. Assoc., 227 (7), 1102-1108.
15. Newman S.J., Johnson R., Sears W & Wilcock B. (2002). Investigation of repeated vaccination as a possible cause of glomerular disease in mink. Can. J. vet. Res., 66 (3), 158-164.
16. Spickler A.R. & Roth J.A. (2003). - Adjuvants in veterinary vaccines: modes of action and adverse effects. J. vet. internal Med., 17 (3), 273-281.
17. Téllez S., Casimiro R., Vela A.I., Femández- Garayzábal J.E, Ezquerra R., Latre M.V., Briones V., Goyache J., Bullido R., Arboix M. & Domínguez L. (2006). - Unexpected inefficiency of the European Pharmacopoeia sterility test for detecting contamination in clostridial vaccines. Vaccine, 24 (18), 1710-1715.