Changes from report parliamentary committee draft to plenary report

AddedRecital 29: (29) The Commission should, after consultation with relevant stakeholders such as patients and consumer organisations, healthcare professionals, public healthcare payers and marketing authorisation holders, issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate.

RemovedRecital 29: (29) The Commission intends to issue guidelines in consultation with patients, healthcare professionals and marketing authorisation holders, designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply if appropriate.

AddedRecital 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 of 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 …

RemovedRecital 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. The programmes should be shared with the Commission and the Critical Medicines Coordination Group (‘the Critical Medicines 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 principles of subsidiarity and proportionality.

AddedRecital 30 a (new): (30a) In view of the increasing vulnerabilities in the supply chains of critical medicinal products and the resulting risks of supply disruptions and shortages that can seriously endanger public health and disrupt the functioning of the internal market, it is necessary to establish a Union coordination mechanism operated by the Commission. That mechanism should serve as a structured, solidarity-based instrument to monitor availability, coordinate responses, and, where necessary, enable medicinal products to be redistributed equitably across the Union. While safeguarding the principle of subsidiarity, the mechanism should only be activated as a measure of last resort when all other national and voluntary Union-level means have been exhausted and where shortages or disruptions in one or more Member States are likely to result in serious harm to patients or affect other Member States. Binding redistribution decisions should be based on objective risk assessments and real-time data and should ensure that the Member States providing assistance retain adequate minimum stock levels. To support timely and informed decisions, Member States should report regularly on their national stockpiles and contingency stocks through a harmonised, digital reporting system. Additionally, fair reimbursement and cost-sharing provisions should ensure that solidarity is matched by equity. In order to ensure uniform conditions for the implementation of reporting obligations in relation to national stoc…

RemovedRecital 31 a (new): (31a) To ensure a coherent and effective Union-wide approach to contingency stocks, the Commission should be empowered to adopt delegated acts to specify and harmonise the conditions applicable to stock requirements. Such delegated acts should allow for flexibility based on product characteristics and market differences, while also enhancing the efficiency of stock management and distribution. Harmonised measures may include quantitative thresholds for contingency stocks, the use of white-label or semi-finished products to allow for agile deployment, and standardised packaging formats to facilitate cross-border supply. In emergency contexts, the package leaflet should be permitted in electronic format only for certain categories of medicinal products, where this facilitates rapid and effective use of contingency stocks.

AddedRecital 30 b (new): (30b) To address vulnerabilities in the supply chains of critical medicinal products and medicinal products of common interest, a Union Stockpile may be established as a last-resort mechanism when other national or Union-level measures, including the voluntary mechanisms provided for in Union legislation, are insufficient. The Commission should be empowered to adopt delegated acts to define the categories of products, minimum quantities, and operational arrangements for storage, maintenance and deployment. The Union Stockpile should be coordinated with Member States to ensure alignment with national stocks and avoid duplication or disruption. It should be possible for Union budgetary support to be provided where appropriate.

Change 9

ChangedRecital 32: (32) Availability30 andc access(new): disparities(30c) existIn fororder criticalto medicinalpromote productssolidarity, andcandidate medicinalcountries productsshould ofbe commonallowed, intereston throughouta thevoluntary Union,basis, disproportionatelyto affectingparticipate somein Memberthe States.procedures Theestablished collaborativeby procurementthis ofRegulation criticalwhere medicinala productsbilateral andagreement ofwith medicinalthe productsUnion ofgoverning commonthe interestrelevant canprocurement beactivities ais powerfulin toolplace. toSuch improveparticipation theirshould securitybe ofwithout supplyprejudice andto accessibility.their Economicaccession operatorsnegotiations participateor into collaborativethe procurementrights proceduresand conductedobligations pursuantreserved to this RegulationMember onStates aunder voluntaryUnion basis.law.

Change 10

RemovedRecital 36: (36) To ensure transparency, legal clarity, and effective coordination, structured agreement between the Member States and the Commission should govern procurement procedures under this Regulation that rely on an active Commission involvement. Such agreement should set out the division of responsibilities, decision-making processes, the information to be shared as relevant to the procurement procedure, including information on Member States’ participation in parallel negotiations through different channels in relation to the same medicinal products or the same active substances as appropriate, and liability provisions, ensuring a fair and efficient framework for participating Member States while preventing market distortions and supply disruptions. This Regulation is without prejudice to and does not prevent the use of joint procurement procedures established under Regulation (EU) 2022/2371 of the European Parliament and of the Council for those critical medicinal products and other medicinal products that also fall within the definition of medical countermeasures as set out in that Regulation. For such medicinal products, the objective of the joint procurement initiative should determine the applicable framework. Where a joint procurement procedure is initiated with the aim of advance purchasing of these medicinal products as medical countermeasures to prepare for and respond to serious cross-border threats to health, such a procurement procedure should be carried out in acc…

AddedRecital 30 d (new): (30d) To improve the functioning of the pharmaceutical market in the Union, Member States and the Commission should, when implementing pricing and public procurement practices, take action to achieve the objectives of the 2019 World Health Assembly Resolution on Improving the transparency of markets for medicines, vaccines, and other health products.

RemovedRecital 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 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, the European Medicines Agency (‘the Agency) and patient organisations with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. 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.

AddedRecital 31: (31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these obligations should be designed taking into consideration the principles of proportionality, transparency and solidarity and non-discrimination. The Member States should give due consideration to forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks. Effective coordination mechanisms at Union level are therefore necessary to address possible conflicts and to ensure that national measures do not delay patient access, distort supply chains, or fragment the internal market.

RemovedRecital 38: (38) To ensure coordinated implementation of this Regulation, the Critical Medicines Group should enable exchanges of information related to funding of strategic projects and facilitate the strategic orientation of financial support for strategic projects. The Critical Medicines Group should also facilitate the exchange of information on national programmes, including on the approach to contingency stock requirements in public procurement contracts. When relevant, the Critical Medicines Group should facilitate the coordination of national programmes. The Critical Medicines Group should furthermore facilitate discussions on the need to launch a collaborative procurement initiative and the need to prioritise the vulnerability evaluation for specific critical medicinal products. In order to ensure solidarity and an effective Union-level response to shortages or supply disruptions of critical medicinal products or medicinal products of common interest, it is necessary to establish a clear decision-making process for the redistribution of such products. To that end, the Member States should be included in the decision-making process through the Critical Medicines Group established under this Regulation.

AddedRecital 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 medicines 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.

RemovedRecital 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. Those partnerships should be identified through a structured methodology, distinguishing between those reinforcing existing cooperation and those aiming to reduce strategic dependencies. They should also address trade and regulatory barriers, promote regulatory cooperation, and facilitate cross-border movement of critical medicinal products or medicinal products of common interest, in compliance with international obligations.

AddedRecital 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) 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.

RemovedRecital 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. 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. The Commission should continuously monitor the application of this Regulation and assess its impact on competition and the functioning of the internal market. Where such monitoring or a comprehensive evaluation reveals that the application of this Regulation leads to significant distortions of competition or serious disruptions to the internal market, the Commission should take appropriate correc…

AddedRecital 38: (38) To ensure coordinated implementation of this Regulation, the Critical Medicines Group should enable exchanges of information related to funding of strategic projects and facilitate the strategic orientation of financial support for strategic projects. The Critical Medicines Group should also facilitate the exchange of information on national programmes, including on the approach to contingency stock requirements in public procurement contracts. When relevant, the Critical Medicines Group should facilitate the coordination of national programmes. The Critical Medicines Group should furthermore facilitate discussions on the need to launch a collaborative procurement initiative and the need to prioritise the vulnerability evaluation for specific critical medicinal products. In order to ensure solidarity and an effective Union-level response to shortages or supply disruptions of critical medicinal products, it is necessary to establish a clear decision-making process for the redistribution of such products. To that end, the Member States should be included in the decision-making process through the Critical Medicines Group established under this Regulation.

RemovedRecital 41 a (new): (41a) In order to supplement this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the specification and harmonisation of the conditions applicable to Member States’ contingency stock requirements, as well as the determination of the categories, types and quantities of critical medicinal products and medicinal products of common interest to be included in the Union Stockpile, the determination of the specific arrangements for storage and maintenance of such Stockpile, and the criteria and procedures for the deployment of the stockpiled products. In order to amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distorsions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making* . In particular, to ensure equal participation in the preparation of deleg…

AddedRecital 38 a (new): (38a) In order to strengthen the Union’s preparedness and ensure an inclusive, needs-driven, transparent and coordinated approach to future challenges in the supply of critical medicinal products, the Critical medicines group, after consultation with the Commission, the Agency and the Critical Medicines Alliance, should establish a strategic foresight process. This process should identify and assess potential strategic projects, taking into account long-term trends, vulnerabilities, and opportunities for enhancing the resilience and sustainability of supply chains within the Union, specifically based on unmet medical needs.

RemovedArticle 1 – paragraph 1: 1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection, maintaining patient safety and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products, including both critical medicinal products and medicinal products of common interest.

AddedRecital 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) and their starting materials in the scope of international partnerships.

RemovedArticle 1 – paragraph 1 a (new): 1a. It is also an objective of this Regulation to support the competitiveness of the Union’s pharmaceutical sector as a strategic asset and to promote targeted, evidence-based measures that avoid unintended consequences for the continuity of supply of critical medicinal products and for the accessibility of medicinal products of common interest to patients.

AddedRecital 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. 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. When an evaluation reveals a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission should conduct a coordinated, evidence-based assessment and, where appropriate, propose proportionate mitigating measures in consultation with Member States and relevant stakeholders to safeguard continuous supply.

RemovedArticle 1 – paragraph 2 – point c: (c) leverage the aggregated demand of participating Member States through collaborative procurement procedures,

AddedRecital 42 a (new): (42a) In order to supplement this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the specification and harmonisation of the conditions applicable to the determination of the categories, types and quantities of critical medicinal products to be included in the Union Stockpile, the determination of the specific arrangements for storage and maintenance of such Stockpile, and the criteria and procedures for the deployment of the stockpiled products. The exercise of these delegated powers should fully respect the principles of subsidiarity and proportionality. In order to amend this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of a temporary suspension of specific provisions of this Regulation, in the case of urgent and significant distortions of competition or serious disruptions of the functioning of the internal market, until appropriate corrective measures are adopted. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparatio…

RemovedArticle 1 – paragraph 2 – point d: (d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships,

AddedArticle 1 – paragraph 1: 1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby reducing its dependency on third countries and thereby ensuring a high level of public health protection, maintaining patient safety and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the accessibility and affordability of medicinal products.

Change 11

ChangedArticle 1 – paragraph 21 –a point(new): d1a. aStrengthening (new):manufacturing (da)capacities strengthenand the resilience andof promotesupply thechains, sustainableas accesswell toas competitiveness, strategic autonomy and supplyinnovation ofin rawthe materialsUnion’s andpharmaceutical feedstocksector, essentialis foralso thean manufactureobjective of medicinal products;this andRegulation.

Change 12

RemovedArticle 1 – paragraph 2 – point d b (new): (db) coordinate contingency stocks and national stockpiles for critical medicinal products and medicinal products of common interest.

AddedArticle 1 – paragraph 2 – introductory part: 2. To achieve the objectives set out in paragraphs 1 and 1a, the Regulation sets out a framework to:

RemovedArticle 2 – paragraph 2: 2. Chapter III, Chapter IV and Article 26(2), point (c), also apply to medicinal products of common interest.

AddedArticle 1 – paragraph 2 – point a: (a) facilitate, support and incentivise investments in new manufacturing capacity and strengthen existing manufacturing capacity for critical medicinal products and, where applicable, medicinal products of common interest, their active substances and other key inputs in the Union with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain, by making available any accelerated permit granting processes related to the strategic projects that exist in applicable Union and national law;

RemovedArticle 2 – paragraph 2 a (new): 2a. Articles 20g and Article 23 apply to investigational medicinal products.

AddedArticle 1 – paragraph 2 – point b a (new): (ba) prevent shortages and strengthen availability of medicinal products by facilitating the adoption of common standards governing contingency stocks and national stockpiles of critical medicinal products and medicinal products of common interest, and by enhancing transparency and coordination among Member States in this regard;

RemovedArticle 3 – paragraph 1 – introductory part: For the purposes of this Regulation, the definitions laid down in Article 4 of Directive (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] and in Article 2 of Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall apply. For the purpose of this Regulation, the following definitions shall apply:

AddedArticle 1 – paragraph 2 – point c: (c) leverage the aggregated demand of participating Member States through collaborative procurement procedures;

AddedArticle 1 – paragraph 2 – point d: (d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships with a priority given to medicinal products that can become critical if vulnerabilities affect their supply chain;

AddedArticle 1 – paragraph 2 – point d a (new): (da) facilitate investments in critical distribution infrastructure capacity for critical medicinal products ensuring security of supply, availability and accessibility in the Union; and

AddedArticle 1 – paragraph 2 – point d b (new): (db) strengthen the resilience of supply chains and promote the sustainable access to and supply of active substances of critical medicinal products, their API starting materials, and other key inputs within the Union insofar as they are used for the manufacture of critical medicinal products.

AddedArticle 2 – paragraph 1: 1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product’s supply chain.

AddedArticle 2 – paragraph 1 a (new): 1a. Chapter III also applies to active substances of critical medicinal products, their starting materials, and other key inputs within the Union, insofar as they are used for the manufacture of critical medicinal products.

AddedArticle 2 – paragraph 2: 2. Chapter III, Articles 5 to 15, Chapter IV with the exception of its Section Ia new, and Article 26(2), point (c), also apply to medicinal products of common interest, where the Critical Medicines Coordination Group has issued a positive recommendation pursuant to Article 26(2)(dj). / Articles 16 and 17 apply, mutatis mutandis, to medicinal products of common interest subject to the condition that the Union funding allocation under Article 16 exceeds EUR 500 million.

AddedArticle 3 – paragraph 1 – introductory part: For the purposes of this Regulation, relevant definitions laid down in Article 4 of Directive (EU) …/… [reference to be added after adoption cf. COM(2023) 192 final] and in Article 2 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall apply mutatis mutandis. The following definitions shall also apply:

Article 3 – paragraph 1 – point 1: deleted

Change 13

ChangedArticle 3 – paragraph 1 – point 2: (2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including primary packaging materials, excipients, solvents,solvents and reagents, raw materials, feedstock and starting materials;

Article 3 – paragraph 1 – point 3: deleted

Article 3 – paragraph 1 – point 4: deleted

Change 14

RemovedArticle 3 – paragraph 1 – point 5: (5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or which meets at least one of the following criteria: / (a) it is designated as orphan medicinal product pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products; / (b) it is a novel antimicrobial medicinal product which: / (i) contains an active substance with a new chemical structure or a new mechanism of action not previously authorised within the Union for the treatment or prevention of infections; / (ii) is intended for the treatment or prevention of infections caused by pathogens which are resistant to existing antimicrobial agents; or / (iii) addresses an unmet medical need in accordance with Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final];

AddedArticle 3 – paragraph 1 – point 4 a (new): (4a) ‘substance of human origin’ or ‘SoHO’ means ‘substance of human origin’ or ‘SoHO’, as defined in Regulation (EU) 2024/19381a; / 1a Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC.

Change 15

ChangedArticle 3 – paragraph 1 – point 7:5: (7)(5) ‘vulnerability‘medicinal evaluation’product meansof thecommon evaluationinterest’ ofmeans thea supplymedicinal chainsproduct, ofother than a critical medicinal products toproduct, identifyfor theirwhich vulnerabilities,in takingthree intoor considerationmore shortagesMember ofStates thosethe productsfunctioning inof the two years precedingmarket thedoes evaluation,not assufficiently wellensure asthe theiravailability, complexitiesaffordability and specificaccessibility characteristics,to performedpatients byin the MSSGquantities inand consultationpresentations withnecessary theto respectivecover marketingthe authorisationneeds holdersof patients in accordancethose withMember RegulationStates (EU)or …/…is ofdesignated theas Europeanorphan Parliamentmedicinal andproduct pursuant to Article 67 of theRegulation Council14(EU).../... [reference to be added after adoption cf. COM(2023) 193 final] and in compliance with the Union’s international commitments;final)];

Change 16

RemovedArticle 3 – paragraph 1 – point 8: deleted

AddedArticle 3 – paragraph 1 – point 5 a (new): (5a) 'API starting material’ means a raw material, an intermediate product, or an active substance that is used in the production of an active pharmaceutical ingredient (API) and that is incorporated as a significant structural fragment into the structure of the API;

AddedArticle 3 – paragraph 1 – point 5 b (new): (5b) ‘systemic wholesaler’ means a wholesaler of medicinal products that holds a wholesale distribution authorisation and fulfils all obligations laid down in Article 166 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final]. They wholesale and continuously distribute either the full range of prescription medicines, meaning more than the 80%, or above 20% of the total market share of prescription medicines, available for retail sale in a Member State market;

AddedArticle 3 – paragraph 1 – point 6: (6) ‘vulnerability in the supply chains’ means structural and non-structural risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, and the specific features of the supply chains of each product, that compromise the continuous supply of such medicinal products to patients in the Union;

AddedArticle 3 – paragraph 1 – point 10: (10) ‘strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation;

AddedArticle 3 – paragraph 1 – point 10 a (new): (10a) ‘cross-border strategic project’ means a strategic project identified pursuant to the criteria set out in Article 5 of this Regulation, which may be carried out by a minimum of two Member States;

AddedArticle 3 – paragraph 1 – point 11 a (new): (11a) ‘economic operator’ means an economic operator as defined in Directive 2014/24/EU;

AddedArticle 3 – paragraph 1 – point 12: (12) ‘permit granting process’ means a process covering all relevant permits to build, expand, convert and operate a strategic project, including building, chemical and grid connection permits and environmental assessments and authorisations where those are required and encompassing all applications and procedures;

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, automation, yield improvements or other chemistry or biotechnology process that contribute to increase the level of security, energy and environmental performance of the production, and use of Artificial Intelligence, platform technologies or 3D technologies in manufacturing;