What changed between the plenary report and the adopted text

Changed:Article 5 – paragraph 1 – point d a (new): (da) it reserves a defined portion of manufacturing capacity, within a fixed timeframe, to produce specific critical medicinal products or, where applicable, medicinal products of common interest, their pharmaceutical forms, their active substances, key inputs, or enabling technologies, at the request of the Critical Medicines Coordination Group, in order to address current, emerging or potential shortages.

Changed:Article 15 – paragraph 2 a (new): 2a. The Member State providing financial support to a strategic project shall require the beneficiary economic operator to adopt measures that contribute to the availability and affordability of the critical medicinal product and medicinal projectproduct of common interest in the Union market, following guidelines referred to in Article 26(2)(ca).

Changed:Article 18 – paragraph 3 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a medicinal product of common interest shall be considered to take place within the Union if at least one of the following conditions is met: / (a) at least 50 % of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation; / (c) at least 50 % ofessential themanufacturing valuesteps, ofincluding the final medicinalsynthesis productor resultsbiological fromproduction manufacturingof oractive processingsubstances, operationsare carried out within the Union or, where appropriate, the EFTA countries; or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of thi…this Re…

Changed:Article 22 – paragraph 1 – introductory part: 1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where five or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission shall initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below:

Changed:Article 27 – paragraph 1 a (new): The Commission shall endeavour to incorporate health security aspects into strategic partnerships. Such aspects may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies and to foster regulatory convergence and cooperation in the pharmaceutical sector. The Commission shall endeavour the inclusionto ofinclude access to active substances and API starting materials within strategic partnerships, in order to ensure timely availability of critical medicinal products under this mechanism.

Changed:Recital 17: (17) Certain projects and technology can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products, improve efficiencies in the production of those products, and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects, inlcludingincluding cross-border strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should be provided with adequate resources to ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, whilst upholding the highest social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information. To ensure the efficient use of resources and strategic coherence at Union level, the designation of strategic projects should avoid unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs, unless such duplication is justified by clearly demonstr…demonstra…

Changed:Recital 37: (37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health, the European Medicines Agency (‘the Agency)Agency’) and representatives from patient organisations and healthcare professional organisations. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Changed:Article 26 – paragraph 2 – point d j (new): (dj) issue a recommendation concerning the applicability of any of the provisions referred to in Article 2 (2a)2(2a) to medicinal products of common interest.

Removed:SHORT JUSTIFICATION

Removed:The amendments proposed by the rapporteur in his opinion on the proposal for a Regulation of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products, as well as the availability and accessibility of medicinal products of common interest, and amending Regulation (EU) 2024/795, aim to boost EU manufacturing of critical medicines by fast-tracking permits, simplifying environmental assessments, and supporting strategic projects. The proposal also promotes better coordination among Member States and introduces limited reporting obligations.

Removed:To avoid unintended disruptions resulting from overlapping environmental and chemical legislation, a balanced, data-driven approach is needed, one that safeguards the availability of medicines while upholding high environmental standards. The rapporteur believes that coordination between pharmaceutical, environmental, and chemical legislation is essential to prevent negative impacts on patient access to medicines and to ensure the sustainability and competitiveness of the European pharmaceutical and healthcare sectors.

Removed:To ensure transparency, all data related to environmental assessments, authorisations, and planning should be easily accessible (including online) and presented clearly through a centralised portal. These procedures must be efficient, time-bound, and must not create undue financial or administrative burdens, aligned with international conventions.

Removed:Rapid timelines for activating strategic projects should be maintained, especially when urgent action is needed to respond to shortages of critical medicines.

Removed:AMENDMENTS

Removed:The Committee on the Environment, Climate and Food Safety submits the following to the Committee on Public Health, as the committee responsible:

Removed:Recital 4: (4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, upholding social, health and environmental standards, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

Removed:Recital 4 a (new): (4a) The 2019 Commission Strategic Approach to Pharmaceuticals in the Environment acknowledges that pharmaceuticals may pose risks to the environment and human health and highlights the need for a comprehensive and proportionate strategy, consistent with the Union’s commitment to the One Health approach.

Removed:Recital 17: (17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, upholding social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Removed:Recital 18 a (new): (18a) It is essential to ensure that the production of pharmaceutical products within the Union is conducted in a safe, responsible and sustainable manner over the long term, such as by reducing environmental pollution by manufacturing waste, this form of pollution may contribute to the spread of antimicrobial resistance, impact ecosystems and biodiversity, and thereby create possible risks for public health.

Removed:Recital 19: (19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, without undermining the quality and robustness of the assessments and while not lowering the level of health and environmental protection.

Removed:Recital 24: (24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include an appropriate and predictable balance of qualitative criteria including product quality measured by patient impact and clinical value, environmental sustainability, such as the use of sustainable and innovative manufacturing technologies and the minimisation of active substance emissions during production, pharmaceutical innovation for patients, and the society, in addition to stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Removed:Recital 39: (39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Any such partnership should support a high level of safety, environmental protection, quality, and efficacy.

Removed:Recital 41: (41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. At the same time and to safeguard the availability and security of supply of critical medicinal products, all market actors, competent authorities, Member States and the Commission should ensure that all barriers, such as regulatory, economic and market-based, are identified and evaluated as part of the Commission’s assessment on the achievement of the objectives of this Regulation. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.

Removed:Recital 41 a (new): (41a) This Regulation should be implemented in line with existing Union legislation. Where the evaluation has identified that such legislation has the possibility to impact in an adverse manner on the accessibility, availability or affordability of medicinal products, the Commission should carry out comprehensive, evidence-based assessments and, where appropriate, propose proportionate mitigating measures to safeguard supply, availability and affordability of medicinal products and to support the Union's competitiveness.

Removed:Article 3 – paragraph 1 – point 13: (13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, yield improvements or other chemistry or biotechnology process that contribute to increasing the level of security, energy efficiency and environmental performance of the production, Artificial Intelligence, platform techniques, 3D manufacturing and sustainable manufacturing methods;

Removed:Article 5 – paragraph 1 – point b: (b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater environmental sustainability, overall sustainability or increased efficiency, such as innovative processes that improve production quality, resilience, or reliability;

Removed:Article 7 – paragraph 2: The Member States’ authorities shall ensure that the relevant permit granting processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring compliance with the highest social, health and environmental standards.

Removed:Article 12 – paragraph 1 – subparagraph 1: A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 ,Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint procedure fulfilling the requirements of those Union legislative acts are applied. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.

Removed:Article 12 – paragraph 2: 2. Member States shall ensure that the competent authorities issue the reasoned conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact assessment within 45 days of receiving all necessary information pursuant to Articles 5, 6 and 7 of that Directive and after completing the consultations referred to in Articles 6 and 7 of that Directive, with a possibility of extension by a maximum of 45 days in duly justified cases.

Removed:Article 12 – paragraph 5 a (new): 5a. Member States shall ensure that their competent authorities and other authorities designated pursuant to Article 6(1) of Directive 2011/92/EU have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary to fulfil their obligations under this Article.

Removed:Article 13 – paragraph 1: 1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data is available and accessible, including online.

Removed:Article 13 – paragraph 2: 2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23, the combined assessment shall also cover those impacts. The fact that assessments are combined pursuant to this paragraph shall not affect their content or quality or robustness of the assessment.

Removed:Article 14 – paragraph 2: 2. All decisions adopted pursuant to the Articles in this section shall be made publicly available in an easily understandable manner, including online, and all decisions concerning one project shall be available on the same website.

Removed:Article 18 – paragraph 1: 1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall wherever feasible implement multi-winner procurements, which scope is designed based on clinical needs in consultation with healthcare professionals and relevant experts, with predictable procurement timelines. Contracting authorities in the Member States shall apply procurement requirements, other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include several qualitative criteria, such as patient impact and clinical value, environmental sustainability, innovation, diversity and robustness of supply chain, may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority, and contract performance clauses on timely delivery.

Removed:Article 18 – paragraph 4: 4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability, and social rights. In order to safeguard the integrity of the Single Market, the Commission shall support coordination and the exchange of best practices between Member States.

Removed:Article 19 – paragraph 1 – subparagraph 1 a (new): Member States shall aim to ensure that the design and periodic review of such programmes involve health professionals and patient organisations, as well as environmental expertise, to balance public health needs, affordability and sustainability.

Removed:Article 20 – paragraph 2 a (new): Stockpiling management system shall apply a “first in, first out” principle and promote the use of shelf-life extension studies, in order to reduce expiry-related waste. The Commission, in cooperation with the Member States and the relevant agencies, shall adopt guidelines on sustainable stockpiling, including measures to reduce emissions, improve packaging, manage expiry dates, and ensure the environmentally sound disposal of unused or obsolete medicinal products.

Removed:Article 26 – paragraph 2 – point d a (new): (da) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of procurement programmes, ensuring proportionality and avoiding duplication.

Removed:Article 27 – paragraph 1: Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. Such partnership shall support a high level of safety, environmental protection, quality, and efficacy.

Removed:Article 30 – paragraph 1: 1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall within its evaluation assess the impact of other relevant Union legislation on this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Removed:Article 30 – paragraph 2 a (new): 2a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.

Added:Recital 1: (1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in all Union policies and activities. The availability of safe, efficacious and high-quality medicinal products, underpinned by a resilient and competitive pharmaceutical industry and secure, reliable supply chains forming the backbone of the supply of medicinal products, is vital to achieving this objective and to safeguarding public health across the Union and improving the preparedness and the Union’s overall security.

Removed:Recital 1: (1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in all Union policies and activities. The availability of safe, efficacious and high-quality medicinal products, underpinned by a resilient and competitive pharmaceutical industry and secure, reliable supply chains forming the backbone of the supply of medicine, is vital to achieving this objective and to safeguarding public health across the Union and improving the preparedness and the Union’s overall security.

Changed:Recital 4 a (new): (4a) While medicine shortages can occur for any type of product, they disproportionately affect older, off-patent, and generic medicinal products, primarily due to their low profit margins, which reduce incentives for investment in robust manufacturing capacity. Older, off-patent, and generic medicinal products make up the majority of the medicinal products placed on the Union List of Critical Medicinal Products, due to low profit margins that limit investment in manufacturing. Many off-patent and generic medicinal products suppliers have outsourced manufacturing or relocated production of finished products outside the Union, and frequently source their APIsactive pharmaceutical ingredients (APIs) from third countries. Consequently, the Union relies on a limited number of API suppliers and manufacturers, many located outside its borders.

Changed:Recital 8: (8) As the Union market for medicinal products remains fragmented, there is a need for better coordination between Member States to leverage in full the Union’s potential to strengthen the security of supply of medicinal products, without calling into question Member States’ responsibilities for the organisation and delivery of health services and medical care, and enhance patient’s access to the medicinal products they need. Uncoordinated national measures risk disrupting the internal market, fail to address broader supply chain issues, and are insufficient to resolve cross-border issues, including the Union's dependency on third countries. The regulatory framework for medicinal products therefore needs to be complemented by targeted actions providing for further harmonisation, while avoiding duplication or overlap of existing structures. Furthermore, existing data infrastructures and databases should be fully leveraged in order to reduce reporting burdens, streamline the monitoring of medicinal product supply chains, and improve the efficiency of data exchangeexchanges between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

Changed:Recital 9: (9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available and accessible to patients in some Member States. This may be caused by a variety of factors, including administrative and budgetary barriers, product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States increasing inequalities between patients in the Union and undermining the Union's commitment to achieving universal access to essential medicinemedicinal products by 2030 in line with the United Nations sustainable development goal 3.8. This Regulation aims at strengthening the resilience of supply chains, addressing concrete security-of-supply vulnerabilities, and reducing such inequalities among Member States, ensuring more equitable access to medicinal products across the Union, so that patients enjoy the same level of access regardless of their country of residence.

Changed:Recital 16 b (new): (16b) The Commission should establish and regularly update a list of medicinal products originating from third countries for which no adequate substitute produced within the Union is available, in order to identify and monitor dependencies and to support measures aimed at ensuring the continuity of supply of medicinal products.

Changed:Recital 25: (25) Inconsistent use of procurement requirements in public procurement procedures may have negative impact on the internal market as it creates obstacles to cross-border participation and a lack of predictability for bidders. In order to avoid such negative outcomes, the use of MEAT criteria should be mandatory. To minimise market fragmentation and create certainty and predictability for both public health system payers as well as for pharmaceutical manufacturers, the Commission should coordinate and maintain a catalogue of such MEAT criteria, as well as relevant best practices tofor using them in public procurement, for use by the Member States.

Changed:Recital 30: (30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for outpatient sector where they are often not purchased through public procurement, these programmes may also encompass measures to strengthen supply chain resilience and sustainability through measures related to pricing and reimbursement, where appropriate. Such programmes should take into account the economic viability of critical medicines, and recommend relevant measures, including exemptions of specific categories of critical medicines, such as products derived offrom substances of human origin (SoHO), from national cost containment measures. The programmes should be shared with the Commission and the Critical Medicines Coordination Group, established by this Regulation, to facilitate the exchange of best practices and coordination between the Member States. This cooperation should enhance the overall effectiveness of the various measures put forward to secure the supply of critical medicinal products, while respecting the …th…

Changed:Recital 32: (32) Availability and access disparities exist for critical medicinal products and medicinal products of common interest throughout the Union, disproportionately affecting some Member States. The collaborative procurement of critical medicinal products and of medicinal products of common interest can be a powerful tool to improve their security of supply and accessibility including medicinesmedicinal products for rare diseases, antimicrobials, and other innovative, high-cost, or specialised treatments across various therapeutic areas, such as oncology. Economic operators participate in collaborative procurement procedures conducted pursuant to this Regulation on a voluntary basis.

Changed:Recital 39: (39) The Union should further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union should, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. As part of these partnerships, the Commission should promote a collaborative innovation ecosystem that integrates small and medium-sized enterprises, start-ups and deep-tech innovators alongside established pharmaceutical companies in order to enhance resilience, foster technological advancement and boost the competitiveness of the Union’s pharmaceutical sector. The Commission should specifically consider the inclusion of access to active pharmaceutical ingredients (API)APIs and their starting materials in the scope of international partnerships.

Changed:Article 26 – paragraph 2 – point d a (new): (da) facilitate discussion and exchange among members of the Critical Medicines Group and, where appropriate, coordinate and exchange with the EU stockpiling network, as established by the Commission with Member States, in relation to Article 20 ,20, specifically sharing best practices in stock management, including real-time tracking, condition monitoring, expiry alerts, stock rotation, shelf-life and waste management, including waste reduction facilities, and evaluations where necessary;