What changed between the draft committee report and the plenary report

Added:Article 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 and shall take into account the distinctive characteristics of the supply chains of different medicinal products. These requirements shall be applied in compliance with the Union’s international commitments.

Removed:Article 20 f (new): Article 20f / Reimbursement and replacement / Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20c, it shall be entitled to full reimbursement from the receiving Member State for the value of the medicinal products transferred and the costs of transport and a reasonable mark-up. / The value of the medicinal products transferred shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned or, in the absence of agreement, as determined by the Commission. / The transferring Member State shall be entitled to reimbursement of the determined value within a period not exceeding [60] calendar days from the date of receipt of the critical medicinal products by the receiving Member State. / The Commission shall adopt implementing acts specifying procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 20h(2). / In duly justified circumstances, and in the interest of solidarity, the Commission may authorise the use of Union financial instruments or emergency health funds to support or partially offset the cost borne by the receiving Member State, in accordance with applicable Union law.

Added: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 % 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 thi…

Removed:Article 20 g (new): Article 20g / Union Stockpile / In order to ensure the timely and effective availability of critical medicinal products or medicinal products of common interest with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism. / The Commission is empowered to adopt delegated acts in accordance with Article 30a, to determine: / (a) the categories and specific types of critical medicinal products and medicinal products of common interest to be included in the Stockpile; / (b) the minimum quantities to be stocked for each product, taking into account Union-level risk assessments, supply vulnerabilities, and public health needs; / (c) the logistical, technical and operational arrangements for storage and maintenance of the stockpile; / (d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States. / Should the Commission decide to establish the Union Stockpile, it shall coordinate with national competent authorities to ensure that it does not duplicate national stockpiles or contingency stocks arrangements. The establishment of the Union Stockpile shall be designed and implemented in a way that does not result in any negative impact on availability of medicinal products in other Member States. / The Commission shall further ensure that packaging, labelling, and storage conditions are such as to enable the rapid and safe distribution and use of the medicinal products across th…

Added:Article 18 – paragraph 4: 4. Procurement procedures under this Chapter shall, include additional qualitative criteria, in particular criteria relating to environmental sustainability and the promotion of social rights.

Removed:Article 20 h (new): Article 20h / Committee procedure / 1. The Commission shall be assisted by the Standing Committee on medicinal products for human use established by Article 214 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. / 2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Added:Article 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 the application of those paragraphs would result in a disproportionately high price in a specific procurement procedure. Such derogation shall be accompanied by a written justification specifying the relevant reasons and circumstances, and shall be subject to ex post verification by the competent supervisory authority designated by the Member State.

Removed:Article 20 i (new): Article 20i / Removal of obstacles to implementation / Where Member States identify obstacles to the effective implementation of Section Ia of this Chapter, they shall take all necessary measures to remove such obstacles within one year from the date of application of this Regulation. / To that end, Member States shall, where appropriate, amend or repeal national legislative, regulatory or administrative provisions that are incompatible with the requirements laid down in Section Ia of this Chapter.

Added:Article 18 – paragraph 5 a (new): 5a. To support the implementation of this Article by Member States, the Commission shall develop guidelines for the application of non-price award criteria by ... [18 months from the date of entry into force of this Regulation].

Removed:Article 21 – paragraph 1: 1. Upon a reasoned request of three or more Member States (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EU28 for medicinal products of common interest.

Added:Article 19 – paragraph 1: 1. By 6 months after entry into force of this Regulation each Member State shall establish, after having consulted patient and consumer organisations and healthcare professional organisations, a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. National programmes shall include 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 and shall align reporting and shortage signals with mechanisms operated by MSSG to avoid duplication. Such programmes shall also, where appropriate, 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. Member States may involve their national pricing and reimbursement authorities in the planning and evaluation of such programmes.

Removed:Article 21 – paragraph 5: 5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the involved Member States and provide advice on applicable Union public procurement rules, including on the use of award criteria as set out in Article 18 and on regulatory matters related to medicinal products.

Added:Article 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 a discussion, involving representatives of marketing authorisation holders, patient and consumer organisations and healthcare professional organisations, and other relevant actors in the supply chain, aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) 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.

Removed:Article 21 – paragraph 6: 6. The facilitation offered by the Commission shall be limited in time and end at the latest upon delivery of the medicinal products of common interest.

Added:Article 20 – paragraph 1: Measures relating to security of supply applied in one or more Member States shall not result in any negative impact on the availability of critical medicinal products and medicinal products of common interest in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for economic operators to hold contingency stocks.

Removed:Article 21 – paragraph 6 a (new): 6a. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements: / (a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions; / (b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such; / (c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product; / (d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

Added:Article 20 – paragraph 2: Member States shall ensure that any national measures or requirements they impose on economic operators in the supply chain to hold contingency stocks are proportionate, targeted, evidence-based and respect the principles of transparency, solidarity and non-discrimination.

Removed:Article 22: deleted

Added:Article 20 – paragraph 2 a (new): Where Member Stats impose contingency stock requirements on economic operators, they shall notify the Commission and the Agency. Member States shall also encourage the implementation of rolling stockpiling systems amongst manufactures.

Removed:Article 23 – title: Joint Procurement and procurement on behalf of Member States

Added:Article 20 – paragraph 2 b (new): All contingency stock requirements and other security of supply measures shall be implemented in a manner that minimises waste and environmental impact, including through effective stock rotation based on the ‘first expired, first out’ system to prevent the destruction of medicinal products.

Removed:Article 23 – paragraph 1: deleted

Added:Article 20 – paragraph 2 c (new): The Commission shall, following a consultation with relevant stakeholders, including patient and consumer organisations, healthcare professional organisations, public healthcare payers, and marketing authorisation holders, issue Union guidelines recommending the establishment of common standards for contingency stocks and national stockpiles to support Member State activities, ensuring predictability for economic operators. Those common standards may include: / (a) the establishment of maximum quantitative thresholds for contingency stocks at both national and aggregated Union level, to be determined in cooperation with economic operators and reviewed periodically in light of evolving risk assessments; / (b) provisions allowing for the holding of contingency stocks in the form of white-label semi-finished or bulk products, where appropriate to ensure flexibility and timely deployment; / (c) the use of harmonised packaging formats, including multi-language or Union-wide packs, with a view to facilitating cross-border supply and reducing relabelling burdens; / (d) practices on sustainable stockpiling, including practices to reduce emissions, improve packing, including leaflet, manager expiry dates, and ensure responsible disposal of unused or obsolete medicinal products.

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Changed:Article 2320 – paragraph 2 –d introductory(new): part:During 2.health Notwithstandingemergencies Articleand 16/(2)crises, andMember (3)States ofauthorities Regulationand (EU,Union Euratom)preparedness 2024/2509,authorities ashall jointclosely procurementcoordinate procedurethe asdistribution providedof forcritical inmedicinal paragraphproducts, 2ain ofparticular thiswith Article,systemic orwholesalers, ain procurementorder byto theensure Commissionequitable onand behalffair ofdistribution. Member States as providedmay foralso inundertake paragraphthe 2bdistribution of this Article, maycritical bemedicinal organisedproducts invia accordancetheir withcivil paragraphspreparedness 4authorities toor 7military ofauthorities thisif Articledeemed ifnecessary itin compliesaccordance with the followingnational requirements:law.

Change 52

Removed:Article 23 – paragraph 2 – point a: (a) the procurement relates to medicinal products belonging to one of the categories below: / (i) critical medicinal products for which a vulnerability evaluation has identified a vulnerability in the supply chains or for which the MSSG has recommended a common procurement initiative; / (ii) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council, or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation including medicinal products intended for the treatment of paediatric cancers, which have been authorised before 12 January 2025.

Added:Chapter IV – Section I a (new): Ia UNION COORDINATION MECHANISM FOR CRITICAL MEDICINAL PRODUCTS

Removed:Article 23 – paragraph 2 – point b: (b) the procurement procedure helps to improve the security of supply and availability of critical medicinal products in the Union or to ensure the availability and accessibility of medicinal products of common interest, as applicable. / (deleted)

Added:Article 20 a (new): Article 20a / Establishment of a Union coordination mechanism for critical medicinal products / A Union coordination mechanism for national stockpiles and contingency stocks of critical medicinal products is hereby established. It shall be operated by the Commission in collaboration with the Agency and the Critical Medicines Coordination Group. Through that coordination mechanism, the Commission shall: / (a) monitor the availability and distribution of critical medicinal products across the Union; (b) enable effective and equitable redistribution in cases of a shortage or a supply disruption in one or more Member States that has a negative impact on the internal market or on other Member States.

Removed:Article 23 – paragraph 2 a (new): 2a. Unless otherwise provided for in this Article, the procurement procedure shall be carried out in accordance with Article 168(2) and (3) of Regulation (EU, Euratom) 2024/2509.

Added:Article 20 b (new): Article20b / Redistribution decisions / 1. Where a shortage or a supply disruption of a critical medicinal product is identified in one or more Member States, the Commission shall, as a last resort and only after all other measures have been exhausted, including the voluntary mechanisms provided for in Union legislation, and upon a justified and substantiated request of one or more Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring redistribution from a national stockpile or a contingency stock. / 2. Any distribution decision as referred to in the first paragraph shall: / (a) be based on an objective risk assessment and regularly updated 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; / (b) specify the quantities to be transferred, the timeframe for delivery, and any other necessary logistical arrangements; / (c) ensure that transferring Member States retain adequate minimum levels of the relevant medicinal product. / 3. A distribution decision adopted pursuant to this Article shall specify the date at which it takes effect and shall be notified by the Commission to the Member States concerned without delay/within ... [and at least 20 days before its date of application].

Removed:Article 23 – paragraph 2 b (new): 2b. At the Commission’s initiative, the Commission and at least nine Member States with a similar epidemiological or economic situation may engage, as contracting parties, in a joint procurement procedure as provided for in Article 168(2) of Regulation (EU, Euratom) 2024/2509, if the requirements laid down in paragraph 2 of this Article are fulfilled. Such a joint procurement procedure shall be conducted in accordance with paragraphs 4 to 7 of this Article.

Added:Article 20 c (new): Article 20c / Appeal mechanism / 1. A Member State concerned by a redistribution decision adopted and notified pursuant to Article 20b may submit a reasoned request for a review of the decision referred to in that Article. Such a request shall be submitted to the Commission within 10 days of the notification referred to in that Article and shall state in detail the reasons for which that Member State considers that the decision does not comply with the conditions laid down in that Article or that its application would pose a disproportionate risk to public health. / 2. Following consultation of the Critical Medicines Coordination Group, the Commission shall adopt a review decision within 10 days of receipt of the reasoned request referred to in paragraph 1. That decision shall confirm, amend or revoke the distribution decision adopted and notified pursuant to Article 20b and shall state the reasons on which it is based. / 3.The submission of a request for review shall not suspend the application of the distribution decision adopted and notified pursuant to Article 20b, unless the Commission, on duly justified grounds, decides to grant a suspension pending the outcome of the review.

Removed:Article 23 – paragraph 2 c (new): 2c. Where nine or more Member States consider it appropriate to mandate the Commission to act as a central purchasing body, those Member States may jointly request the Commission to procure on their behalf, or in their name, as a mandated contracting authority, in a procurement procedure on behalf of Member States as provided for in Article 168(3) of Regulation (EU, Euratom) 2024/2509. If the requirements laid down in paragraph 2 of this Article are fulfilled, the Commission may initiate such a procurement procedure in accordance with paragraphs 4 to 7 of this Article.

Added:Article 20 d (new): Article 20d / Stockpile information and reporting obligations / 1. 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 such national stockpiles or contingency stocks are established under national law. Each Member State shall report to the European Commission at least quarterly on the status of their national stockpiles and contingency stocks, and immediately upon any significant change in stock levels. / 2. The report referred to in paragraph 1 shall include the following information: / (a) a list of critical 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. / 3. 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 in accordance with national law, to the extent…

Removed:Article 23 – paragraph 3: deleted

Added:Article 20 e (new): Article 20e / Committee procedure / 1. The Commission shall be assisted by the Standing Committee on medicinal products for human use established by Article 214 of Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final]. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. / 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Removed:Article 23 – paragraph 4: 4. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request referred to in paragraph 2c, through the Critical Medicines Group, and invite them to join the procedure.

Added:Article 20 f (new): Article 20f / Obligations of Member States / Where the Commission adopts a redistribution decision pursuant to Article 20b, Member States shall: / (a) comply with that redistribution decision; / (b) notify, without undue delay, the Commission and the Agency if they impose contingency stocks requirements on economic operators; / (c) cooperate fully and without delay and, where necessary, provide mutual support to any other Member State that has requested assistance pursuant to Article 20b(1), with a view to preventing or mitigating shortages of critical medicinal products.

Removed:Article 23 – paragraph 5: 5. The Commission shall assess the utility, the necessity and proportionality of the request referred to in paragraphs 2b and 2c and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

Added:Article 20 g (new): Article 20g / Reimbursement and replacement / 1. Where a Member State or economic operator transfers critical medicinal products in accordance with a binding decision adopted pursuant to Article 20b, it shall be entitled to full reimbursement from the receiving Member State for the value of the critical medicinal products transferred and the costs of transport and a reasonable mark-up. / 2. The value of the medicinal products shall be determined on the basis of their wholesale acquisition cost or an equivalent fair market value, as agreed between the Member States concerned. / The transferring Member State or economic operator shall be entitled to reimbursement of the determined value as soon as possible, but not later than 30 day from the date of receipt of concerned medicinal product by receiving Member State. / The Commission is empowered to adopt delegated acts in accordance with Article 30a, to supplement this Regulation by laying down procedures for reimbursement or replacement, and for cost-sharing mechanisms between Member States where appropriate.

Removed:Article 23 – paragraph 8: deleted

Added:Article 20 h (new): Article 20h / Union Stockpile / 1. In order to ensure the timely and effective availability of critical medicinal products with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism to be activated in situations where the Union coordination mechanism for critical medicinal products indicates the existence of a recurrent or persistent shortage in national stockpiles and contingency stocks. / 2. The Commission is empowered to adopt delegated acts in accordance with Article 30a to supplement this Regulation by establishing: / (a) the categories and specific types of critical medicinal products to be included in the Union Stockpile; / (b) the minimum quantities to be stocked for each product, taking into account Union-level risk assessments, supply vulnerabilities, and public health needs; / (c) the logistical, technical and operational arrangements for storage and maintenance of the Union stockpile; / (d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States. / 3. In the event that the Commission decides to establish a Union Stockpile for critical medicinal products with identified vulnerabilities in accordance with paragraphs 1 and 2, it shall: / (a) coordinate with national competent authorities to ensure alignment and ensure that the Union stockpile does not duplicate national contingency stock arrangements: / (b) design and implement the measures to be taken in…

Removed:Article 23 – paragraph 8 a (new): 8a. The Commission shall ensure that any procurement procedure under this Article applies, to the greatest extent possible, the award criteria and requirements referred to in Article 18(1) to (4), including those on supply chain resilience, diversification and innovation.

Added:Article 21 – paragraph 1: 1. Upon a reasoned request of three or more Member States (‘the request’), the Commission shall act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive 2014/24/EC of the European Parliament and of the Council for medicinal products of common interest. / (deleted)

Removed:Article 23 – paragraph 8 b (new): 8b. The Commission shall ensure that any procurement procedure under this Article complies with the following requirements: / (a) contracting authorities from the participating Member States agree to minimum binding quantities and to take the necessary steps to ensure that a product is promptly made available to cover patient needs in their jurisdictions; / (b) commercially sensitive contractual terms and conditions are considered as trade secrets under applicable law and are protected as such; / (c) the relevant medicinal product is exempted from any other renegotiations or other measures of an economic nature on the marketing of such product; / (d) permanent regulatory flexibilities are granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating countries do not engage in any parallel procurement or negotiation activities related to the critical medicinal product or medicinal product of common interest that is the subject of such procurement procedure.

Added:Article 21 – paragraph 3: 3. The Commission shall assess the request in light of the objectives of this Regulation. The Commission shall communicate to the requesting Member States its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request. It shall inform the European Parliament thereof.

Removed:Article 24 – title: Agreement concerning procedures under Article 23

Added:Article 21 – paragraph 5: 5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the interested Member States and provide advice on applicable Union public procurement rules, including on the use of award criteria as set out in Article 18 and on regulatory matters related to medicinal products.

Removed:Article 25 – paragraph 2: 2. The Member States, the Agency and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed national permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of the MSSG as permanent representatives. The Critical Medicines Group shall appoint two permanent representatives from patient organisations.

Added:Article 21 – paragraph 6: 6. The facilitation offered by the Commission shall be limited in time and end, unless otherwise requested by the requesting Member States, upon signature of the procurement contract by the participating contracting authorities. Where requested by requesting Member States, the facilitation offered by the Commission shall end upon delivery of the medicinal products of common interest.

Removed:Article 25 – paragraph 3: 3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the relevant marketing authorisation holders and other relevant stakeholders and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group and the MSSG may organise joint meetings. For discussions where input from the industry perspective is necessary, the Critical Medicines Group shall consult the relevant marketing authorisation holders and/or trade associations including through the organisation of structured joint meetings as required.

Added:Article 21 – paragraph 6 a (new): 6a. The Commission shall act as a facilitator under this Article subject to the acceptance of the following conditions by the requesting Member States: / (a) contracting authorities from the participating Member States agree to procure minimum binding quantities based on individual Member States needs and to take the necessary steps to ensure that a product is promptly made available to cover patients needs in their territory; / (b) commercially sensitive information is treated in accordance with Directive (EU) 2016/943 and with applicable Union and national law on the protection of trade secrets, and is protected as such; / (c) participating Member States, for the duration of the contract, refrain from unilateral renegotiation of the agreed commercial terms, except where this is explicitly provided for in the contract; / (d) regulatory flexibilities available under applicable Union law are applied to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes, and labelling flexibilities; / (e) participating Member States refrain, for the duration of the joint procurement procedure and resulting contract, from conducting separate negotiations or procurements for the same product.

Removed:Article 25 – paragraph 4: 4. The Commission shall organise regular meetings and coordinate the work of the Critical Medicines Group by means of the Secretariat.

Added:Article 21 – paragraph 7 a (new): 7a. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein and with which the Union has entered into a bilateral agreement governing the facilitation of cross-border procurement, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law. The participation of candidate countries shall not affect the need for three or more Member States to initiate the procedure.

Removed:Article 25 – paragraph 6 a (new): 6a. The Critical Medicines Group shall have biannual meetings, and additional meetings when needed, to consult with the Critical Medicines Alliance.

Added:Article 22 – paragraph 1 – introductory part: 1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where five 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:

Removed:Article 26 – paragraph 1: 1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission and inform the relevant marketing authorisation holder, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Added:Article 22 – paragraph 2: 2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply, availability and affordability of critical medicinal products in the Union or to ensure the availability, accessibility and affordability of medicinal products of common interest, as applicable.

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Changed:Article 2622 – paragraph 2 –3: introductory3. part:The 2.participation Inin orderthe toprocurement attainprocedure theshall objectivesbe referredopen to in paragraph 1,all theMember CriticalStates. MedicinesThe GroupCommission shall perform the following tasks in compliance with theinform necessaryall guaranteesMember toStates safeguardingof the confidentiality ofjoint traderequest secretsreferred andto in consultationparagraph with1, through the marketingCritical authorisationMedicines holdersGroup, and otherinvite relevantthem economicto operators:join the procedure.

Change 54

Removed:Article 26 – paragraph 2 – point a: (a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union, as well as to ensure that the public health and patient safety implications are explicitly assessed and taken into account in all related decisions;