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