Authorisation within the European Union of vaccines against antigenically variable viruses responsible for major epizootic diseases

OIE Revue Scientifique et Technique

Volumn 26, Issue 2, 2007, Pages 421-428

  Mackay, D K J ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Authorisation; Avian influenza; Bluetongue; European Union; Foot and mouth disease; Licensing; Vaccine

Indexed keywords

ANIMALIA; AVES; OVIS ARIES;

EID: 34548348707     PISSN: 02531933     EISSN: 16080645     Source Type: Journal    
DOI: 10.20506/rst.26.2.1750     Document Type: Article

References (7)

1. European Commission (2003) - 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. Off. J. Eur. Union, L 159, 1-23. Available at: http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-1/reg_2003_1084/reg_2003_1084_en.pdf (accessed on 14 January 2007).
2. European Commission (2003). - 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. Off. J. Eur. Union, L 159, 24-45. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2003_1085/ reg_2003_1085_en.pdf (accessed on 14 January 2007).
3. European Medicines Agency (EMEA) (2004). - Position Paper on Requirements for Vaccines against Foot-and-Mouth Disease (adopted by the Committee for Medicinal Products for Veterinary Use [CVMP] June 2004). EMEA/CVMP /775/02. Available at: http://www.emea.europa.eu/pdfs/vet/press/pp/077502en.pdf (accessed on 14 January 2007).
4. European Medicines Agency (EMEA) (2004). - Guideline on Requirements for Vaccines for Use in Birds against Avian Influenza. EMEA/CVMP/222624/06. Available at: http://www.emea.europa.eu/pdfs/vet/iwp/22262406en.pdf (accessed on 14 January 2007).
5. European Parliament (2001). - Consolidated 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, 1-66)
6. as amended by Directive 2004/28/EC (Off. J. Eur. Union, L 136, 58-841. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol5/consol_2004/veterinary_code.pdf (accessed on 14 January 2007).
7. European Parliament (2004). - Regulation (ECI 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, 1-33. Available at: http://ec.europa.eu/ enterprise/pharmaceuticals/eudralex/vol1/reg_2004_726/reg_2004_726_en.pdr (accessed on 14 January 2007).