Table 4 Comprehensive ERA or justification for not submitting ERA studies—VMPs [19, 24, 40]
New marketing authorisation | Variation application | Extension application | Renewal | Application under Art. 13 (generic, hybrid, bibliographical, informed consent) | |
|---|---|---|---|---|---|
Comprehensive ERA | Since 1998 (phase I) or 2005 (phase I + II) usually required | Usually not required, only type II, only if increase in environmental exposure is expected, and addressing only the change | Usually not required, only if increase in environmental exposure is expected and addressing only the change | Usually not required, only if A potential risk to the environment is identified on basis of existing information And/or Data have become available indicating a potential problem arising from the presence in the environment of an active substance related to the use of a veterinary medicinal product and in relation to the inherent ecotoxicity of the active substance and/or its metabolite(s) | Similar to new marketing authorisation (usually required) |
Justification for not submitting ERA studies | If no environmental risk is expected, because the active substance is a naturally occurring substance | If no increase in environmental exposure is expected | If no increase in environmental exposure is expected | (–) | Similar to new marketing authorisation |
Defined examples for naturally occurring substances: Vitamins Electrolytes Amino acids Peptides Proteins Nucleotides Carbohydrates Lipids as APIs | Defined examples for an increase: Increase in dose rate for an existing food producing species Addition of an indication for an existing food producing species | Defined examples for an increase: Change or addition of a new route of administration Change or addition of food producing species | (–) |