Changes from report parliamentary committee draft to plenary report

Change 17

RemovedArticle 3 – paragraph 1 – point 15: (15) ‘procurement on behalf of or in the name of the Member States’ means a procurement procedure initiated at the request of Member States and mandating the Commission to act as a central purchasing body on behalf of, or in the name of, the requesting Member States, as provided for in Article 168(3) of Regulation (EU, Euratom) 2024/2509;

AddedArticle 3 – paragraph 1 – point 13 a (new): (13a) ‘contingency stock’ means the quantity of critical medicinal products or, where applicable, medicinal products of common interest that manufacturers and wholesalers might be required to hold under national law in order to have a buffer when shortages or supply disruptions occur, including because of fluctuations in demand or supply;

Change 18

ChangedArticle 3 – paragraph 1 – point 1713 ab (new): (17a)(13b) 'economic‘contingency operator'stock requirement’ means marketingan authorisationobligation holders,imposed suppliers,by manufacturers,a wholesalers,Member State law on manufacturers and otherwholesalers actorsin dealingthe withsupply chain to establish buffer stocks of certain medicinal products into mitigate the risk of shortages or supply chain.disruptions;

Change 19

RemovedArticle 3 – paragraph 1 – point 18: (18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products or medicinal products of common interest, their active substances, key inputs, raw materials and feedstock that is established through a non-binding instrument and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation.

AddedArticle 3 – paragraph 1 – point 13 c (new): (13c) ‘national stockpile’ means the reserves of a quantity of critical medicinal products or medicinal products of common interest established under national law by a Member State for a public health use, such as national strategic reserves;

Change 20

ChangedArticle 3 – paragraph 1 – point 1813 ad (new): (18a) ‘Contingency(13d) stock’‘redistribution’ means the quantitytransfer of critical medicinal products orfrom medicinala productscontingency ofstock commonor interestnational thatstockpile economicfrom operatorsone areor requiredseveral toMember holdStates underto nationalother lawMember inStates orderfollowing toa havedecision aof bufferthe whenCommission shortagesin occur,response includingto becauseshortages ofor fluctuationssupply disruptions in demandone or supply.more Member States;

Change 21

RemovedArticle 3 – paragraph 1 – point 18 b (new): (18b) ‘National stockpile’ means the reserves of a quantity of critical medicinal products or medicinal products of common interest established under national law by a Member State for a public health use, such as national strategic reserves.

AddedArticle 3 – paragraph 1 – point 18: (18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products or its supply chain, their active substances and key inputs that is established through a non-binding instrument and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation;

Change 22

ChangedArticle 3 – paragraph 1 – point 18 ca (new): (18c) ‘Redistribution’ means the(18a) transfer'resilience of critical medicinalsupply productschains' ormeans medicinalthe productsability of common interestthe fromsupply achain contingencyto stockmaintain ora nationalcontinuous stockpileand fromdemand-oriented onesupply orof severalmedicinal Memberproducts, Statesactive tosubstances, otherAPI Memberstarting Statesmaterials, followingand akey decisioninputs ofin the Commission in responseUnion, toeven supplyduring disruptions or shortages in one or more Memberexternal States.shocks;

Change 23

ChangedArticle 3 – paragraph 1 – point 18 db (new): (18d)(18b) 'Resilience'diversification of supply chains' means the abilityexistence of theseveral supplyindependent chainsources toor maintainproduction asites, continuousso andthat demand-orientedthe supply of a medicinal productsproduct, inactive thesubstances, Union,API evenstarting duringmaterials, disruptionsand key inputs does not depend on a single supplier or externalthird shocks.country of supply.

Change 24

RemovedArticle 3 – paragraph 1 – point 18 e (new): (18e) 'Diversification of supply chains' means the existence of several independent sources or production sites, so that the supply of a medicinal product does not depend on a single supplier or third country.

AddedArticle 4 – paragraph 1: 1. The security of supply, availability and affordability of critical medicinal products and, where applicable, medicinal products of common interest, for patients shall be considered a strategic objective of the Union. In order to achieve such an objective, the determination of strategic projects that meet the criteria laid down in Article 5 shall be made in accordance with Article 6.

Change 25

ChangedArticle 4 – paragraph 2: 2. The Member States and the Commission shall work together,together to achieve the strategic objective of the Union referred to in paragraph 1 including by gathering information from healthcare professional organisations, patient organisations and economic operators,operators including marketing authorisation holders, to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures provided for in Sections II and III of this Chapter that take full advantage of the potential of the internal market.market, reflecting the principles of solidarity and coordination between Member States and reducing dependencies on third countries, while ensuring predictability for project promoters.

Change 26

ChangedArticle 4 – paragraph 3: 3. The Commission shall support the coordinated efforts of the Members States, includingStates byand operatingfoster a coordinationsecure mechanismcross-border forexchange criticalof medicinalrelevant productsinformation and facilitate the distribution of critical medicinal products ofthroughout commonthe interest.Union.

Change 27

RemovedArticle 4 – paragraph 3 a (new): 3a. The Commission shall adopt guidelines establishing a set of objective and transparent criteria for determining when the functioning of the internal market does not sufficiently ensure the availability and accessibility of medicinal products of common interest to patients, in the quantities and presentations necessary to meet patient needs in one or more Member States. Those criteria may include the following: / (a) the absence of clinical trials conducted in the relevant Member State; / (b) the unavailability of the medicinal product under compassionate use programmes; / (c) the failure of the marketing authorisation holder to make the medicinal product available and to ensure its continuous supply in adequate quantities and in the necessary presentations within 12 months from the date of the granting of the marketing authorisation, in response to a duly substantiated request from a Member State.

AddedArticle 5 – paragraph 1 – introductory part: 1. A project located in the Union and related to creating, modernising, increasing or improving manufacturing capacity, as well as decreasing Union dependency in relation to key inputs or otherwise contributing to the security of supply or availability of medicinal products, shall be considered as a strategic project if it meets at least one of the following criteria:

RemovedArticle 4 a (new): Article4a / List of medicinal products with no adequate Union substitute / 1. The Commission shall establish and regularly update a list of medicinal products originating from third countries for which no adequate substitute produced within the Union is available. / 2. The purpose of the list shall be to identify and monitor strategic dependencies and to support the adoption of appropriate measures aimed at ensuring the continuity of supply of medicinal products within the Union.

AddedArticle 5 – paragraph 1 – point a: (a) it creates or increases manufacturing capacity, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or, where applicable, medicinal products of common interest, or for collecting or manufacturing their active substances, or it creates capacity for compounding techniques within pharmacies or hospitals;

RemovedArticle 5 – paragraph 1 – introductory part: A project located in the Union and related to creating or increasing manufacturing capacity as well as decreasing Union dependency in relation to raw materials, feedstock, and key components shall be considered as a strategic project if it meets at least one of the following criteria:

AddedArticle 5 – paragraph 1 – point b: (b) it modernises an existing manufacturing site, including through new technologies and innovative manufacturing processes, for one or more critical medicinal products or where applicable, medicinal products of common interest, their active substances or key inputs to strengthen supply chain resilience, to ensure greater sustainability or increased efficiency;

Change 28

ChangedArticle 5 – paragraph 1 – point a:c: (a)(c) it creates orcreates, increases manufacturing or collectionmodernises manufacturing capacity for one or more critical medicinal products or medicinal products of commonkey interestinputs ornecessary for collecting orthe manufacturing their active substances, or it sets aside a defined portion of manufacturing capacity for the productionone ofor specificmore critical medicinal products,products theiror, activewhere substancesapplicable, ormedicinal categoriesproducts of thosecommon productsinterest, ortheir active substances within a fixed timeframe and at the request of the Critical Medicines Group in order to address potential or emergingkey shortages;inputs;

Change 29

ChangedArticle 5 – paragraph 1 – point b:d: (b)(d) it modernisescontributes anto existingthe manufacturingroll-out siteor fortransfer oneof ora moretechnology criticalthat medicinalplays productsa orkey medicinalrole productsin ofenabling commonthe interestmanufacturing or theirsupply activeof substancesone or keymore inputscritical tomedicinal strengthenproducts, supplyor, chainwhere resilience,applicable, ensuremedicinal greaterproducts sustainabilityof common interest, their active substances or increasedkey efficiency;inputs;

Change 30

ChangedArticle 5 – paragraph 1 – point c: (c) it creates,d increases,a collects(new): or(da) setsit asidereserves a defined portion of manufacturing capacitycapacity, forwithin keya inputsfixed necessarytimeframe, forto theproduce manufacturingspecific ofmedicinal oneproducts oror, morewhere criticalapplicable, medicinal products of common interest, their pharmaceutical forms, their active substances, key inputs, or medicinalenabling productstechnologies, at the request of commonthe interestCritical orMedicines theirCoordination activeGroup, substances;in order to address current, emerging or potential shortages.

Change 31

RemovedArticle 5 – paragraph 1 – point d: (d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products or medicinal products of common interest, their active substances or key inputs;

AddedArticle 5 – paragraph 1 a (new): Notwithstanding paragraph 1, a project shall not receive financial support from the Union pursuant to Article 16 if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances or key inputs within the Union, unless the Critical Medicines Group has assessed the need and such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

RemovedArticle 5 – paragraph 1 – point d a (new): (da) it supports innovative manufacturing processes for one or more critical medicinal products or medicinal products of common interest, or their active substances or key inputs;

AddedArticle 6 – title: Determination of Strategic Projects

RemovedArticle 5 – paragraph 1 – point d b (new): (db) it demonstrably reduces the Union’s dependency on a single supplier country or a limited set of suppliers for one or more critical medicinal products or medicinal products of common interest, or their active substances or key inputs, and thereby contributes to supply chain diversification.

AddedArticle 6 – paragraph 1 – subparagraph 1: Within three months of the entry into force of this Regulation, each Member State shall designate an authority (‘the designated authority’) to be in charge of assessing and verifying whether or not a project meets at least one of the criteria set out in Article 5 and is therefore to be considered a strategic project.

RemovedArticle 5 – paragraph 1 a (new): Notwithstanding the first paragraph, a project shall not be considered strategic if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs within the Union, unless such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

AddedArticle 6 – paragraph 1 – subparagraph 2: A promoter may request the designated authority to assess whether a project constitutes a strategic project.

Change 32

ChangedArticle 6 – paragraph 1 – subparagraph 1:3: EachAny Member State shall as soon as possible, and in any event not later than ... [90authority daysmay fromrequest the date of entry into force of this Regulation], designate an authority (‘the designated authority’) that shall assessauthority andto verify whetherits ordetermination notof a project meets at least one of the criteria set out in Article 5 and therefore constitutesas a strategic project.

Change 33

ChangedArticle 6 – paragraph 3: 3. The Commission shall provide a simple, easilyaccessible, accessibleand user-friendly webpage serving as the central hub for project promoters on which at least the following informationelements shall be clearly listed: / (a) the contact details and other relevant information on the Member States’ designated authorities; and / (b) details of the opportunities for financial support from the Union.

Change 34

ChangedArticle 6 – paragraph 3 a (new): 3a. The– designatedpoint authoritya shall(new): assess(a) the project promoter’s request referred tocontact indetails paragraphand 1,other secondrelevant subparagraph,information withinon 6the monthsMember ofStates’ thatdesignated request.authorities;

Change 35

RemovedArticle 6 – paragraph 5 a (new): 5a. In order to promote a consistent and coordinated approach across the Union and to ensure legal certainty for project promoters, the Commission shall adopt guidelines setting out common criteria and procedural principles for the assessment and recognition of projects as strategic projects for critical medicinal products and medicinal products of common interest.

AddedArticle 6 – paragraph 3 – point b (new): (b) information on available administrative or financial support from the Union; and

RemovedArticle 6 – paragraph 5 b (new): 5b. The guidelines referred to in paragraph 5a shall, in particular, specify: / (a) objective criteria for the assessment of strategic relevance, including the project's potential to address supply vulnerabilities, enhance manufacturing capacity or resilience, ensure security of supply, or contribute to Union-wide public health preparedness; / (b) procedural aspects, including timelines, transparency requirements, and modalities for submission and evaluation of applications; / (c) mechanisms for cooperation and exchange of information between the Commission and the designated authority to ensure consistent application of the guidelines.

AddedArticle 6 – paragraph 3 – point c (new): (c) a standard template for the project promoter’s request available in all official languages of the Union.

RemovedArticle 6 – paragraph 5 c (new): 5c. Member States shall take due account of the guidelines when assessing and recognising strategic projects.

AddedArticle 6 – paragraph 3 – subparagraph 1 a (new): The Commission shall adopt implementing acts to provide for a standard template for the project promoter’s request referred to in point (c) of the first subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20e(2).

Change 36

ChangedArticle 6 – paragraph 5 d (new): 5d. Prior to the determination of3 a project(new): as3a. strategic,The thedesignated Commissionauthority shall assess whether the project would result in a significant duplication of existing or planned manufacturing capacities within thepromoter’s Union.request Thereferred Commissionto shallin carryparagraph out1, thatsecond assessmentsubparagraph, within onethree monthmonths of receiving a complete application. If the Commission does not complete the assessment within that period, it shall be presumed that the project does not result in significantsubmitted duplication.request.

Change 37

RemovedArticle 7 – paragraph 1: Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public and patient interests.

AddedArticle 6 – paragraph 5: 5. Where the verification whether a project constitutes a strategic project has been performed by a designated authority in accordance with this Article, any other authority shall rely on that verification.

RemovedArticle 7 – paragraph 2: The Member States’ authorities shall ensure that the relevant permit granting and regulatory support processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law.

AddedArticle 6 – paragraph 5 a (new): 5a. In order to promote a consistent and coordinated approach across the Union and to ensure legal certainty for project promoters, the Commission shall adopt guidelines setting out common criteria and procedural principles for the assessment and determination of projects as strategic projects for critical medicinal products and, where applicable, medicinal products of common interest. Designated authorities shall take into consideration those guidelines, as appropriate, when assessing and determining projects as strategic

RemovedArticle 7 – paragraph 2 a (new): The Commission shall establish a ‘one-stop-shop’ to coordinate the award of Union funds pursuant to Article 16 and to support Member States’ authorities with the prioritisation of financial support to strategic projects pursuant to Article 15.

AddedArticle 6 – paragraph 5 b (new): 5b. The guidelines referred to in paragraph 5a shall, in particular, specify: / (a) measurable criteria for the assessment of strategic relevance, including the project's potential to address supply vulnerabilities, enhance manufacturing capacity or resilience, ensure security of supply, or contribute to Union-wide public health preparedness; / (b) indicative timelines for operational readiness, transparency requirements, and steps for submission and assessment of requests; / (c) available mechanisms for cooperation and exchange of information between the Commission and the designated authority to allow for consistent application of the guidelines.

AddedArticle 6 – paragraph 5 c (new): 5c. The Commission shall act as a coordinator for cross-border strategic projects and shall ensure effective cooperation between the designated authorities of the Member States concerned, to avoid duplication of efforts in bordering Member States and to promote complementarity and efficiency in the implementation of such projects.

AddedArticle 6 – paragraph 5 d (new): 5d. Prior to the determination of a project as strategic, the designated authority shall notify the Critical Medicines Coordination Group of its intention to make such a determination. Within one month of receipt of such notification, the Critical Medicines Coordination Group shall assess whether the project would result in a significant duplication of existing or planned manufacturing capacities within the Union. Where the Critical Medicines Coordination Group does not complete the assessment within that period, the project shall be presumed not to result in significant duplication. / Where the Critical Medicines Coordination Group considers that the project would result in a significant duplication of existing or planned manufacturing capacities within the Union, it shall inform the designated authority thereof. Such projects shall not be eligible to receive financial support from the Union pursuant to Article 16.

AddedArticle 7 – paragraph 1: Strategic projects shall be considered as contributing to the security of supply of critical medicinal products, or where applicable, medicinal products of common interest, in the Union and, therefore, to be in the public interest as serving the objectives of public health, safety and the protection of patients’ interests.

AddedArticle 7 – paragraph 2: The Member States’ authorities shall ensure that the relevant permit granting processes and corresponding certification and inspection processes related to strategic projects are fast tracked, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring the quality and robustness of assessments and upholding the relevant environmental, health and work safety standards.

Article 8 – title: Administrative and technical support

Change 38

RemovedArticle 8 – paragraph 2 a (new): 2a. Each Member State shall provide all necessary administrative and technical support to any strategic project located within its territory, for the purpose of mitigating unplanned interruptions in the supply of energy, gas or heat that are essential for establishing or increasing manufacturing capacity.

AddedArticle 8 – paragraph 1 – point b: (b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project and, where relevant, facilitating required consultations of local communities, organisations and social partners;

RemovedArticle 8 a (new): Article 8a / Other supportive measures / Member States may provide for other supportive measures, in particular to ensure that employees whose roles are essential to the implementation of a strategic project aimed at creating or increasing manufacturing capacity remain available in case of supply chain vulnerabilities or disruptions that need to be addressed, especially in times of national emergency or mobilisation. In particular, they may provide for measures such as: / (a) (a) exempting those employees from active military service; / (b) assigning those employees mobilisation duties within the strategic project itself.

AddedArticle 8 – paragraph 2: 2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs), small mid-cap enterprises (SMCs), as well as to entities not engaged in an economic activity and, where appropriate, establish a dedicated channel for communication with them to provide guidance and respond to queries related to the implementation of this Regulation.

Change 39

ChangedArticle 118 – paragraph 1:2 1.a Upon(new): request2a. ofMember aStates projectshall promoter,ensure that a Memberstrategic State,project withlocated supportwithin ofits theterritory Agencyis asprovided necessary,with shallthe provideadministrative regulatoryand technical support necessary to aprevent strategicor projectmitigate locatedunplanned oninterruptions itsin territory,the includingsupply byof prioritisingenergy, Goodgas Manufacturingor Practicesheat inspectionsrequired for approval ofthe newestablishment or extendedexpansion of manufacturing sitescapacity, orincluding modernisationfacilitating oftimely theaccess manufacturingto sitesrelevant innetwork connections and capacity, and coordinating with the contextcompetent ofnetwork operators to ensure the concernedstability strategicand project.continuity of supply.

Change 40

RemovedArticle 11 – paragraph 2: 2. Upon request of a project promoter, the Agency shall provide dedicated advice to assist project promoters in accordance with Article 5, including those promoters developing projects relying on innovative manufacturing processes.

AddedArticle 8 – paragraph 2 b (new): 2b. Member States shall ensure that their authorities providing administrative support and authorities involved in the permit-granting process have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary for the effective performance of their tasks under this Regulation.

RemovedArticle 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 30 days of receiving all necessary information.