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Table 4 Comprehensive ERA or justification for not submitting ERA studies—VMPs [19, 24, 40]

From: The accessibility of data on environmental risk assessment of pharmaceuticals: Is the marketing authorisation procedure in conflict with the international right of access to environmental information?

  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
(–)