EMEA: Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)
25.03.2009
EMEA:
Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD). This guideline applies to new applications for authorisation of vaccines defined in multi-strain dossiers and variations concerning the addition or replacement of strains of inactivated vaccines intended for use against avian influenza (AI), Bluetongue (BT) and Foot and mouth disease (FMD).
Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD). This guideline applies to new applications for authorisation of vaccines defined in multi-strain dossiers and variations concerning the addition or replacement of strains of inactivated vaccines intended for use against avian influenza (AI), Bluetongue (BT) and Foot and mouth disease (FMD).
The source of the news: http://www.emea.europa.eu/pdfs/vet/iwp/10550607en.pdf
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