Changes from report parliamentary committee draft to plenary report

AddedArticle 11 – paragraph 1: 1. Upon request of a project promoter, a Member State, with support of the Agency as necessary and through a single point of contact, shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing and Good Distribution Practices inspections for approval of new or extended manufacturing sites or modernisation of the manufacturing sites modernised in the context of the concerned strategic project.

RemovedArticle 12 – paragraph 5: 5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union shall be considered to have an overriding public interest and to serve the interests of public health and safety provided that all the conditions set out in those acts are fulfilled.

AddedArticle 11 – paragraph 2: 2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall, where appropriate, with the support of national competent authorities for medicinal products, provide dedicated advice to assist project promoters, including those developing projects relying on innovative manufacturing processes.

RemovedArticle 12 a (new): Article 12a / Coordination with environmental and chemical legislation / The Commission and Member States shall ensure that the application of this Regulation is coordinated with the application of environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products or medicinal products of common interest. / Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products or medicinal products of common interest, the Commission shall conduct a coordinated impact assessment and consult with the Critical Medicines Group to propose mitigating actions including, where appropriate, legislative proposals.

AddedArticle 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 is applied. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.

RemovedArticle 14: deleted / (deleted) / (deleted) / (deleted)

AddedArticle 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.

RemovedArticle 15 – paragraph 1: 1. Without prejudice to Articles 107 and 108 TFEU, Member States shall prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

AddedArticle 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.

RemovedArticle 15 – paragraph 1 a (new): 1a. Member States may establish contractual arrangements on strategic projects to dedicate a portion of their manufacturing capacity for the production of specific critical medicinal products, their active substances and key inputs or technologies, or categories thereof, in order to address potential or emerging shortages at the request of the Critical Medicines Group within a fixed timeframe.

AddedArticle 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 are available and accessible, including online.

RemovedArticle 15 – paragraph 1 b (new): 1b. The Commission shall adopt guidelines to facilitate the consistent application of this Article by Member States and the granting of State aid to strategic projects that meet the criteria of Article 5. Those State aid guidelines should include specific provisions for financing strategic projects that are aimed to improve the security of supply of medicinal products in the Union, both in terms of capacity (increased manufacturing of medicinal products in the Union) as well as in terms of innovative manufacturing process (improved manufacturing of medicinal products in the Union).

AddedArticle 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.

Change 41

ChangedArticle 1513 – paragraph 12 ca (new): 1c.2a. AnWhere undertakingthe thatdevelopment benefitsof fromStrategic financialProjects supportor fortheir arelated strategicinfrastructure projecthas shallpotential complycross-border withimplications, the obligations laid down in paragraphsMember 2States andconcerned 3.shall Wherecoordinate antheir undertakingplanning failsand toassessment complyprocedures, with those obligations, the financial support granted toof the strategic project may be recovered,Commission, in whole ororder into part,avoid byduplication theof Memberefforts, Stateensure concerned.complementarity, Inand addition,reflect the undertaking shall be subject to a financial penalty or an exclusion fromprinciples fundingof proportionatesolidarity toand thecooperation impactbetween ofMember non-compliance.States.

Change 42

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Change 43

RemovedArticle 16 – paragraph 1: 1. All the Union funding under the Multiannual Financial Framework, including but not limited to regional policy funding programmes, may support strategic projects unless explicitly excluded by the legal basis or the scope of each programme and provided that such support is in line with the objectives set out in the regulations establishing those programmes. / (deleted) / (deleted) / (deleted) / (deleted)

AddedArticle 15 – paragraph 1: 1. Without prejudice to Articles 107 and 108 TFEU, Member States shall prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products, and, where applicable, medicinal products of common interest, identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a). Financial support shall be proportionate to the financing needs of the strategic project and shall be subject to transparency requirements.

RemovedArticle 16 – paragraph 1 a (new): 1a. Subject to relevant acts of Union law, strategic projects under this Regulation may be financed through the general budget of the European Union, including revenues generated from customs duties imposed by the Union on critical medicinal products or medicinal products of common interest in response to tariff or other trade-restrictive measures adopted by third countries.

AddedArticle 15 – paragraph 1 a (new): 1a. Member States may, at the request of the Critical Medicines Group, establish contractual arrangements with economic operators on strategic projects to dedicate a portion of their manufacturing capacity to produce specific medicinal products, their pharmaceutical forms, their active substances and key inputs or technologies, or categories thereof, in order to address current, emerging or potential shortages within a fixed timeframe, determined by the Critical Medicines Group.

Change 44

ChangedArticle 1615 – paragraph 1 b (new): 1b. Subject to Regulation (EU, Euratom) 2024/2509,The theCommission revenuesshall offacilitate the generalconsistent budgetapplication of thethis EuropeanArticle Unionby mayproviding besufficient usedguidance to support:Member /States (a)on the development,possibilities expansionoffered orunder implementationexisting ofState strategicaid projectsrules aimedfor atthe enhancinggranting manufacturingof capacitiesState of,aid innovationto in,strategic orprojects securitythat meet the criteria of supplyArticle of,5. criticalThis medicinalguidance productsshall orin medicinalparticular productfacilitate the financing of commonstrategic interestprojects withinthat theare Union;aimed /to (b)improve the acquisitionsecurity of criticalsupply of medicinal products andin medicinalthe productsUnion, ofboth commonin interestterms throughof collaborativemanufacturing procurementcapacity proceduresand pursuantin toterms Articlesof 21innovative andmanufacturing 23.processes.

Change 45

RemovedArticle 16 – paragraph 2 a (new): 2a. An undertaking receiving Union financial support under this Article shall comply with any obligations linked to such support. Where an undertaking fails to comply with those obligations, the Union funding may be recovered, in whole or in part, in accordance with the applicable rules. In addition, the Commission may impose a financial penalty or exclusion from future funding proportionate to the impact of the non-compliance.

AddedArticle 15 – paragraph 2: 2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, a project promoter that has benefitted from financial support by a Member State for a strategic project shall prioritise appropriate and continued supply to the Union market so that the needs of patients in the Member State in question are covered and ensure that the critical medicinal product remains available in the Member States where it is being marketed. This paragraph applies mutatis mutandis to medicinal products of common interest.

Change 46

ChangedArticle 1715 – paragraph 1: 1.2 Membera States(new): shall2a. informThe theMember CriticalState Medicinesproviding Groupfinancial referredsupport to ina Articlestrategic 25project ofshall require the intentionbeneficiary economic operator to provideadopt financialmeasures supportthat contribute to strategicthe projectsavailability sufficientlyand inaffordability advanceof tothe allowcritical themedicinal groupproduct toand carrymedicinal outproject itsof coordinationcommon taskinterest asin setthe outUnion market, following guidelines referred to in Article 26.26(2)(ca).

Change 47

ChangedArticle 1715 – paragraph 13 a– (new):subparagraph 1a.1: The CriticalMember MedicinesState Groupthat shallprovided notifyfinancial support to a strategic project may request such project promoter to prioritise and provide the Agencynecessary supplies of strategica projectscritical thatmedicinal benefitedproduct, fromor, financialwhere supportapplicable, atmedicinal Memberproduct Stateof common interest, active substance or key inputs, as applicable, to the Union levelmarket as a priority to avoid shortages in accordanceone withor thisseveral Article.Member States.

Change 48

RemovedArticle 17 – paragraph 2 – subparagraph 1: The Commission shall inform at least once every six months the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

AddedArticle 15 – paragraph 3 – subparagraph 2: Any Member State that encounters a threat of shortages of the critical medicinal product or medicinal product of common interest in question may demand the Member State that provided financial support to submit a request on its behalf. The project promoter shall undertake its very best efforts to supply such products in the requesting Member State.

RemovedArticle 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 implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs in consultation with healthcare professionals, with predictable procurement timelines and minimum binding quantities, and apply procurement requirements other than price-only award criteria. Those requirements shall include award criteria that promote the resilience of supply in the Union, support the diversification of supply sources, and take into account the geographical proximity of manufacturing within the Union. Where justified, such criteria shall be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include an appropriate and predictable mix and weighting of qualitative criteria. Those criteria shall include patient impact and clinical value, innovation, supply chain robustness and agility, the number of diversified suppliers, where appropriate, depending on the product’s indication, clinical and supply chain characteristics, monitoring of supply chains, their transparency upon request of the contracting authority and subject to safeguarding the confidentiality of trade secrets, and contract performance clauses on timely delivery.

AddedArticle 15 – paragraph 3 a (new): 3a. Where a project promoter that receives financial support fails to comply with the obligations in paragraphs 2 and 3, the financial support granted to the strategic project may be suspended, revoked or recovered, in whole or in part, by the Member State concerned. In addition, the project promoter may be subject to an effective, proportionate and dissuasive financial penalty in accordance with national law of the Member State concerned or an exclusion from funding proportionate to the impact and severity of non-compliance.

RemovedArticle 18 – paragraph 1 a (new): 1a. In multiannual contracts or contracts that have been unilaterally prolonged by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

AddedArticle 15 – paragraph 3 b (new): 3b. Where there is a substantiated risk that export of a critical medicinal product or, where applicable, medicinal product of common interest, would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the project promoter benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited and targeted to safeguard public health within the Union.

RemovedArticle 18 – paragraph 2: 2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. Where these requirements are introduced, the contracting authority shall apply multi-winner approaches and shall ensure that significant quantities are purchased from suppliers that manufacture a significant proportion in the Union. Those requirements shall be applied in compliance with the Union’s international commitments.

AddedArticle 15 – paragraph 3 c (new): 3c. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

RemovedArticle 18 – paragraph 2 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product 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 pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation; / (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 EEA or the Swiss Confederation; / (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation.

AddedArticle 16 – paragraph 1: 1. All the Union funding under the current and future Multiannual Financial Frameworks, including regional policy funding programmes, may support strategic projects unless explicitly excluded by the legal basis or the scope of relevant programmes and provided that such support is in line with the objectives set out in the regulations establishing those programmes. / (deleted) / (deleted) / (deleted) / (deleted)

RemovedArticle 18 – paragraph 3: 3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

AddedArticle 16 – paragraph 1 – subparagraph 1 a (new): Subject to a Council regulation laying down the multiannual financial framework for the years 2028 to 2034 (MFF 2028–2034), strategic projects may be supported by Union funding, including any relevant Union instrument financed within the limits of the ceilings established in the MFF 2028–2034, provided that such support is in line with the objectives set out in the regulations establishing any such relevant instrument. A critical medicines security fund shall be established within the framework of MFF 2028–2034, in coordination with other relevant Union instruments, to support the achievement of the objectives of this Regulation.

RemovedArticle 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 pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation; 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 EEA or the Swiss Confederation; 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) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation; 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 s…

AddedArticle 16 – paragraph 1 – subparagraph 1 b (new): If a project promoter has received financial support for a strategic project from Union funding, it shall prioritise supply to the Union market and shall ensure that the critical medicinal product or, where applicable, medicinal product of common interest, remains available in the Member States where it is being marketed.

RemovedArticle 18 – paragraph 4: 4. Procurement procedures under this Chapter may include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights, insofar as they are linked to the subject-matter of the contract.

AddedArticle 16 – paragraph 2 a (new): 2a. A project promoter receiving Union financial support under this Article shall comply with any obligations linked to such support including any reporting obligations pursuant to Article 57 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final]. Where a project promoter fails to comply with those obligations, the Commission may suspend, revoke or recover the funding, in whole or in part, in accordance with the applicable rules. In addition, the Commission may impose a financial penalty or exclusion from future funding that is proportionate to the impact of the non-compliance, time-limited, and targeted to safeguard public health within the Union.

RemovedArticle 18 – paragraph 5: 5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where such a decision is duly justified on the basis of a documented market analysis, or where application of those provisions would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be supported by a written justification outlining the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

AddedArticle 16 – paragraph 2 b (new): 2b. Where there is a substantiated risk that export of a critical medicinal product would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the project promoter benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited, and targeted to safeguard public health within the Union.

Change 49

ChangedArticle 1816 – paragraph 52 ac (new): 5a.2c. ToThe supportCommission theshall implementationestablish ofa this‘one-stop-shop’ Articleto bycoordinate the Member States, theaward Commissionof shallUnion developfunds guidelinespursuant forto applicationthis ofArticle non-priceand criteriato bysupport ...Member [18States’ monthsauthorities fromwith the dateprioritisation of entryfinancial intosupport forceto ofstrategic thisprojects Regulation].pursuant to Article 15.

Change 50

RemovedArticle 19 – paragraph 1: 1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Each national programme shall include, at a minimum, measures to promote the use of procurement award criteria relating to supply chain resilience and diversification of supply sources in accordance with Article 18. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also, where appropriate and non-discriminatory, include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures as well as review any price freezes, cost containment measures or stockholding obligations applicable.

AddedArticle 16 – paragraph 2 d (new): 2d. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

RemovedArticle 19 – paragraph 2: 2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate an annual structured discussion involving marketing authorisation holders, patient organisations and other relevant economic operators aiming to ensure coordinating and improving national programmes including as regards the application of criteria mentioned in Article 18 and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

AddedArticle 17 – paragraph 1: 1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical Medicines Group’) referred to in Article 25 of the intention to provide financial support to strategic projects sufficiently in advance to allow the group to carry out its coordination task as set out in Article 26. This information shall include a description of how the project meets one or more of the criteria listed in Article 5.

RemovedArticle 20: deleted / (deleted) / (deleted) / (deleted)

AddedArticle 17 – paragraph 2 – subparagraph 1: The Commission shall regularly inform the Critical Medicines Group of the strategic projects that benefited from financial support from the Union including information on how these projects meet the criteria listed in Article 5.

RemovedArticle 20 a (new): Article 20a / Safeguards relating to national contingency stock requirements and Union-level coordination measures to ensure security of supply / 1. Measures adopted by Member States to safeguard the security of supply of critical medicinal products and medicinal products of common interest shall not adversely affect the availability of such products in other Member States or compromise the functioning of the internal market. / In particular, Member States shall: / (a) refrain from introducing or maintaining requirements on economic operators in relation to the holding of contingency stocks that could result in disproportionate or discriminatory effects on the supply of such products in other Member States; / (b) ensure that any obligations they impose on economic operators in relation to the holding of contingency stocks are proportionate, non-discriminatory, and consistent with the principles of transparency and solidarity; / (c) take due account of any guidelines on improving the security of supply to and avoiding supply shortages that have been issued by the Commission pursuant to Article 134 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final], including those on facilitating the fulfilment of Member State’s obligations pursuant to points (a) and (b) of this subparagraph; (d) take due account of the guidelines referred to in point (c) of this subparagraph when establishing national programmes in accordance with Article 19 of this Regulatio…

AddedArticle 17 – paragraph 2 – subparagraph 2: The Commission shall inform the Critical Medicines Group of its intention to propose the establishment of funding possibilities to support strategic projects. It shall also inform the Critical Medicines Group of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

RemovedChapter IV – Section I a (new): SECTION Ia / UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS AND MEDICINAL PRODUCTS OF COMMON INTEREST

AddedArticle 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 implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs and the size of the patient population in consultation with healthcare professionals, with predictable procurement timelines and predictable mix and weighting of qualitative criteria, and shall apply procurement requirements other than price-only award criteria. Those requirements shall include award criteria that promote the resilience of supply in the Union, support the diversification of supply sources, and take into account the distance between manufacturing sites and points of delivery within the Union. Such criteria shall form the main basis for award decisions and shall, in any case, be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and may also include innovation, supply chain robustness, the number of diversified suppliers, obligations on the monitoring of supply chains, transparency of supply chains upon request of the contracting authority and contract performance clauses on timely delivery.

RemovedArticle 20 b (new): Article 20b / Establishment of a Union coordination mechanism for critical medicinal products and medicinal products of common interest / A Union coordination mechanism for critical medicinal products and medicinal products of common interest is hereby established. It shall be operated by the Commission. Through that coordination mechanism the Commission shall: / (a) monitor the availability and distribution of critical medicinal products and medicinal products of common interest across the Union; / (b) ensure effective and equitable redistribution in cases of shortage or supply disruption in one or more Member States having a negative impact in the internal market or in other Member States.

AddedArticle 18 – paragraph 1 a (new): 1a. In contracts which provide for the possibility of unilateral prolongation by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

RemovedArticle 20 c (new): Article20c / Redistribution decisions / Where, for a critical medicinal product or medicinal product of common interest, a shortage or supply disruption is identified in one or more Member States, the Commission shall, upon request of the Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring a redistribution from a national stockpile or a contingency stock. Such a decision shall: / (a) be based on an objective risk assessment and real-time data establishing both the shortage or supply disruption resulting in serious harm or risk of serious harm to patients and the negative impact in the internal market or in other Member States; / (b) specify the quantities to be transferred, the timeframe for delivery, and any logistical arrangements; / (c) ensure that the transferring Member States retain adequate minimum levels of the relevant medicinal product.

AddedArticle 18 – paragraph 2: 2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicinal products. Those requirements shall be applied in compliance with the Union’s international commitments.

RemovedArticle 20 d (new): Article20d / Stockpile information and reporting obligations / The Commission shall establish and maintain a digital reporting system that enables real-time updates on the status of national stockpiles and contingency stocks where they are established under national law. / Each Member State shall report to the Commission at least once per month, and immediately upon any significant change in stock levels. The Member States’ reports shall contain, at a minimum, the following information: / (a) a list of medicinal products for which contingency stocks or a national stockpile are held; / (b) the quantities of such stocks; / (c) the measures in place to ensure proper stock management, including rotation and the prevention of expiry. / For the purposes of this Article, the Commission shall make use of existing Union data infrastructures and reporting mechanisms, including but not limited to the Technical Regulation Information System (TRIS), the European Medicines Verification System (EMVS), the European Shortages Monitoring Platform (ESMP), EudraGMDP, the Industry Single Point of Contact (iSPOC) network, and relevant instruments established under the Union Civil Protection Mechanism. The Commission shall be granted timely access to data held by the Agency, and by the competent authorities of the Member States, to the extent necessary to support its mandate in the areas of situational awareness, risk assessment, and the coordination under this Chapter. / The Commission may adopt i…

AddedArticle 18 – paragraph 2 – subparagraph 1 a (new): For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product 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; / (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; / (c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EFTA countries.

RemovedArticle 20 e (new): Article 20e / Obligations of Member States / Member States shall: / (a) comply with binding redistribution decisions adopted pursuant to Article 20c; / (b) cooperate fully with the Commission in the implementation of this Regulation. / The Commission may initiate an infringement procedure against a Member State in the event of non-compliance with the obligations laid down in this Regulation.