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Table 3 Comprehensive ERA or justification for not submitting ERA studies—HMPs [17, 18, 39]

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. 10 (generic, hybrid, bibliographical, fixed combinations, informed consent, similar biological applications)
Comprehensive ERA Since 2006 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 Not required Adopted guideline:
Usually not required, only if increase in environmental exposure is expected
Draft guideline:
Usually required if there is no access to an earlier ERA for the same API
Required, if the default Fpen was not used in earlier ERA and increase in environmental exposure is expected
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 (–) Adopted guideline:
If no increase in environmental exposure is expected
Draft guideline:
Access to an earlier ERA for the same API in which no default Fpen was used but no increase in environmental exposure is expected
Defined examples for naturally occurring substances:
Vitamins
Electrolytes
Amino acids
Peptides
Proteins
Nucleotides, carbohydrates
Lipids as APIs
Defined examples for an increase:
A new indication which results in an increase in the extent of the use
Defined examples for an increase:
An extension application of an oral medicinal product to include a dermal patch
(–) Defined examples for an increase:
A new indication or a new patient population is added, the maximum daily dose is increased
A new route of administration or a new pharmaceutical form is added
A marketing authorisation is applied for in a member state with a higher prevalence of the disease