Guideline on the environmental risk assessment (ERA) of medicinal products for human use / EMA

Guideline on the environmental risk assessment (ERA) of medicinal products for human use / Ed. EMEA 2006 - EMA 2024

ID 25455 | 03.02.2026

It is mandatory for a marketing authorisation application (MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological, and fate properties of its active substance(s).

This guideline describes how to perform this ERA and how to evaluate potential risks to the environment arising from the use of the medicinal product, with the aim of protecting aquatic and terrestrial ecosystems including surface water, groundwater, soil, species at risk of secondary poisoning and the risk for the microbial processes in sewage treatment plants (STPs). Furthermore, the identification of potential hazards of the active substance of a medicinal product is described. The guideline also includes consideration of potential precautionary and risk mitigation measures and provides guidance on how to report the findings in an Environmental Risk Assessment Report.

1. Introduction (background)
The purpose of this guideline is to describe the assessment of the potential environmental risks and hazards of HMP. It outlines general considerations and the recommended stepwise procedure of assessment.

2. Scope and legal basis

An ERA is required for all new MAAs for a medicinal product submitted through a centralised, mutual recognition, decentralised or national procedure.

For type II variations, the ERA dossier should be updated if there is an anticipated increase in the environmental exposure, e.g. a new indication which results in an increase in the extent of the use. For
extension applications according to Annex II of Commission Regulation (EC) No 1085/2003, an ERA is also required if there is an anticipated increase in the environmental exposure, e.g. an extension
application of an oral medicinal product to include a dermal patch. The environmental data previously submitted in the original dossier of the same marketing authorisation holder (MAH)1 may serve as a basis for the revised ERA for the variation or extension application, or for a new MAA with the same active substance.

An ERA is not required for renewals of marketing authorisations. If new data emerge in the postauthorisation phase that require an update to the ERA, the updated ERA shall be submitted as a type
IB C.I.z variation. For further details, please refer to the EMA pre-authorisation guidance, Q&A No 3.4.2 (EMA, 2023).

Directive 2001/83/EC, as amended, relates to those risks to the environment arising from the use, storage and disposal of medicinal products and not to risks arising from the synthesis or manufacture of medicinal products. This guideline is focused on environmental risks associated with the use of HMPs.

This guideline does not apply to medicinal products consisting of genetically modified organisms (GMOs). For further details on those, please refer to the Agency’s pre-authorisation guidance Q&A 3.4.3

For MAAs for radio-pharmaceutical precursors for radiolabelling, and for radiopharmaceuticals, additional requirements on emission standards for radiation set by Council Directives 2013/59/Euratom
should be taken into account.

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the potential environmental risks  posed by the use of medicinal products shall be evaluated and, on a case-by-case basis, specific
arrangements to limit this risk shall be considered. Under the current requirements, the outcome of the ERA should not constitute a criterion for refusal of a marketing authorisation.

According to Directive 2001/83/EC, applicants are required to submit an ERA irrespective of the legal basis (see Figure 2 Q2a-d and Figure 3 Q2a-b).

The environmental risk assessment should be provided in Module 1.6 of the MAA (see section 9). Any missing data or studies should be justified by the applicant. In the interest of animal welfare, the principles of 3Rs (Replacement, Reduction and Refinement) in accordance with Directive 2010/63/EU should be implemented whenever possible.
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	Descrizione	Lingua	Dimensioni	Downloads
	Guideline on the environmental risk assessment (ERA) of medicinal products for human use EMA 2024	EN	1138 kB	3
	Guideline on the environmental risk assessment (ERA) of medicinal products for human use Guideline on the environmental risk assessment (ERA) of medicinal products for human use	EMEA 2006	155 kB	3