8 Amendments of Stanislav POLČÁK related to 2023/0132(COD)
Amendment 198 #
Proposal for a directive
Recital 31
Recital 31
(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or, lasting harm or death to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. _________________ 43[1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 314 #
Proposal for a directive
Recital 69
Recital 69
(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50[1]), the Environmental Quality Standard Directive (2008/105/EC51[2]) the Groundwater Directive (2006/118/EC52[3]), the Urban Wastewater Treatment Directive (91/271/EEC53[4]), the Drinking Water Directive (2020/218454) and[5]), the Industrial Emissions Directive (2010/75/EU55). _________________ 50 Directive 2000/60/EC of the European Parliament) and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19). 53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40). 54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1). 55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17Waste Framework Directive (2008/98/EC18a).
Amendment 560 #
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available, or where the results of animal studies previously carried out by the applicant or others may be used for the medicinal product.
Amendment 621 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. It will also focus on the risks associated with the inappropriate handling of a medicinal product that has become waste and include measures to minimise these risks. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 657 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
This programme shall be made publicly available by the Agency and, if necessary, updated.
Amendment 664 #
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency within the time limit set for the medicinal product in the programme. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.
Amendment 1552 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission mayshall suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder.
Amendment 1560 #
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.Does not affect the English version.)