THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
An alternative approach is acceptable for inactivated vaccines in line with VICH GL44 ‘Target Animal Safety for Veterinary Live and Inactivated Vaccines: for vaccines that require a single lifetime dose or primary vaccination series only, the primary vaccination regimen should be used. For vaccines that require a single dose or primary vaccination series followed by booster vaccination, the primary vaccination regimen plus an additional dose should be used. The vaccine used shall be formulated to contain the maximum permitted payload and number of antigens are recommended to be conducted. The animals are observed at least daily for local and systemic reactions to vaccination for no fewer than 14 days after each injection. Any undue reaction attributable to the vaccine should be assessed and may prevent acceptance of the vaccine by the National Regulatory Authority. 3.B.2. Field studies/Field use Generally, the results of laboratory safety trials should be supplement by data from field studies to confirm the safety of the vaccine under normal conditions of use. However, due to the particular challenges of conducting field trials with FMD vaccines, the absence of field safety studies from the PSF may be acceptable provided that comprehensive laboratory data on safety is supplied. Nevertheless, all additional data generated from the use of the vaccine in the field (publications, reports, pharmacovigilance data, …) shall be provided to supplement results of laboratory studies in line with Section 3.E.1. 3.B.3. Impact of the vaccine on reproductive performances and lactation The impact of the vaccine on lactation and reproductive performances (sterility, abortion, teratogenic effect on the progeny, …) shall be investigated with the recommended dose and by the most sensitive route of administration. If such studies are not performed, relevant warnings should be given in the product information. 3.B.4. User safety Risks resulting from the nature of the product, its preparation, its use and its risks resulting from particular characteristics of the user e.g. pregnant women, immunocompromised individuals should be investigated. Where necessary, recommendations to minimise exposure of the product user during administration and, where relevant, during preparation of the product for administration should be given in the product information.
3.B.5. Consumer safety Consideration shall be given to the possibility of any residue remaining in the foodstuffs. The components of the vaccine must be in accordance with Maximum Residue Limits (MRL) (also termed Tolerance Levels) regulations in operation in which the vaccine is authorised. A proposal for a withdrawal period shall be made, even where this period if proposed as 0 days, and its adequacy shall be discussed in relation to any residue studies, which have been undertaken.
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