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This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the whole series, please click here.
As part of the revision of the EU pharmaceutical legislative framework, a new directive on medicinal products for human use is proposed, which will repeal Directive 2001/83/EC.[1] One of the objectives of this proposed directive is to reduce the environmental impact of medicinal products. This proposal strengthens the requirements for the environmental risk assessment (ERA) and extends the scope of the ERA to cover new protection goals, including antimicrobial resistance.
Currently, Article 8(3)(g) of Directive 2001/83/EC only requires an environmental risk assessment to be submitted with the application for a marketing authorisation. The accompanying guidelines for the ERA describe how to assess the potential risks of the medicinal product to the environment and prescribe precautionary and safety measures to be considered if environmental risks cannot be excluded.[2] However, under Directive 2001/83/EC, the result of the ERA cannot be a reason to refuse the marketing authorisation.
The proposed directive would have far-reaching implications for the assessment of potential risks as part of the ERA and for its impact on the procedure for obtaining a market authorisation, but also for the period after the market authorisation is granted.
Under the proposed directive, a broader range of risks should be evaluated, including public health risks and antimicrobial resistance risks. Scientific guidelines to specify technical details regarding the ERA requirements will be drawn up by the European Medicines Agency.[3] With regard to antimicrobial medicinal products, the ERA should specify whether the product or any of its components are antimicrobial and include an evaluation of the risk of antimicrobial resistance selection as a result of the manufacture, use and disposal of the medicinal product. Information on risk mitigation measures to limit the development of antimicrobial resistance associated with the use, prescription and administration of the medicine should also be included in the application for market authorisation.
Conducting an ERA is still part of the dossier requirements when applying for a marketing authorisation, but unlike in the current Directive 2001/83/EC, failure to include a sufficient risk assessment or sufficient risk mitigation measures will lead to the refusal of the marketing authorisation application.[4] For generic medicinal products or biosimilars, the marketing authorisation applicant may refer to studies conducted for the reference medicinal product when preparing the ERA.[5]
Moreover, instead of a one-off assessment, the ERA requirements will become an ongoing responsibility and will also apply to already authorised medicinal products. A marketing authorisation holder should, without undue delay, update the ERA with new information to the relevant competent authorities if new information becomes available that may lead to different conclusions of the ERA.[6] For ERAs conducted more than 18 months before the entry into force of the proposed directive, the marketing authorisation holder will be asked to update the ERA if missing information has been identified. For medicinal products authorised before 30 October 2005 that were not subject to an ERA and have been identified as potentially harmful to the environment, an ERA programme will be established.[7]
[1] Proposal for a directive of the European parliament and of the council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, 2023/0132/COD.
[2] Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 corr 2.
[3] Article 22 (5) proposed Directive.
[4] Article 47 (1)(d) proposed Directive.
[5] Article 22 (7) proposed Directive.
[6] Article 22 (6) proposed Directive.
[7] Article 23 (1) proposed Directive.
