5 Amendments of Nicola PROCACCINI related to 2023/0132(COD)
Amendment 730 #
Proposal for a directive
Article 43 – paragraph 5
Article 43 – paragraph 5
5. The competent authorities of the Member States shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and non-clinical tests, the clinical studies, the risk management system, the environmental risk assessment and the pharmacovigilance system of the medicinal product concerned. For expedited review processes, competent authorities shall agree binding timelines with the applicants to provide a full ERA after receiving the marketing authorisation.
Amendment 743 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h
Article 44 – paragraph 1 – subparagraph 1 – point h
(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;
Amendment 761 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) tThe envirconmtental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant; or timelines of post- authorisation studies to further clarify environmental risk assessment, as required under Article 44, paragraph 1, point (h), cannot be agreed.
Amendment 1358 #
Proposal for a directive
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1
to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobialand/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.
Amendment 1559 #
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).