Changes from report parliamentary committee draft to plenary report

AddedArticle 113 – paragraph 6: 6. The Commission shall adopt delegated acts in accordance with Article 175 to supplement this Regulation by taking a decision on the set up of a regulatory sandbox taking into account the recommendation of the Agency and the sandbox plan pursuant to paragraph 4.

RemovedArticle 118 – paragraph 1 – subparagraph 1: Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 of this Regulation, the information contained in the repositories system referred to in Article 67(2), second subparagraph, point (e), of [revised Directive 2001/83/EC], and the notification made pursuant to Article 116(1), points (a) to (d), of this Regulation, the competent authority concerned as referred to in Article 116(1) of this Regulation shall continuously monitor any potential or actual shortage of those medicinal products.

AddedArticle 113 – paragraph 8 – subparagraph 1 – point b: (b) it is appropriate to protect public health or the environment.

AddedArticle 113 – paragraph 9: 9. Where after the Decision to establish the regulatory sandbox in accordance with paragraph 6, risks to health are identified but these risks can be fully mitigated by the adoption of supplementary conditions, the Commission may, after consultation of the Agency, amend its decision by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by, on the basis of duly justified reasoning and evidence from the Agency, prolonging the duration of a regulatory sandbox.

AddedArticle 114 – paragraph 2: 2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may, upon a justified recommendation by the Agency, be prolonged at the request of the marketing authorisation holder.

AddedArticle 114 – paragraph 3: 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Any derogation from the requirements in context of the sandbox shall ensure that the level of patient safety and protection of public health and ethical principles are upheld. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation.

AddedArticle 115 – paragraph 1 – subparagraph 2: Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. If no effective mitigation plan can be provided, the Agency shall end the sandbox without undue delay.

AddedArticle 115 – paragraph 4: 4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including a breakdown on the number of sandboxes granted, trends on medicinal products eligible for a regulatory sandbox, good practices, difficulties encountered, lessons learnt, reflections on possible future adaptations to the regulatory framework and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports as well as lay summaries shall be made publicly available by the Commission.

AddedArticle 116 – paragraph 1 – introductory part: 1. The marketing authorisation holder of a medicinal product in possession of a centralised marketing authorisation or a national marketing authorisation (‘the marketing authorisation holder’) shall notify and explain the reasons to the competent authority of the Member State where the medicinal product has been placed on the market and, in addition, the Agency for a medicinal product covered by a centralised marketing authorisation (these are referred to in this Chapter as ‘the competent authority concerned’) of the following:

AddedArticle 116 – paragraph 1 – point c: (c) its decision to temporarily suspend the marketing of a medicinal product in that Member State as soon as possible and no less than six months the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;

AddedArticle 116 – paragraph 1 – point d: (d) a foreseeable temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and national competent authorities, where available, as soon as possible and no less than six months before the start of such temporary disruption of supply or, if this is not possible and unforeseeable where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).

AddedArticle 117 – paragraph 1: 1. By ... [18 months from the date of entry into force of this Regulation], the marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available upon request by the Agency or the competent authority of the Member State where the medicinal product has been placed on the market.

AddedArticle 117 – paragraph 2: 2. The Agency shall, in collaboration with the working party referred to in Article 121(1) and after consultation with the Healthcare Professionals' Working Party (HPWP) and the Patients' and Consumers' Working Party (PCWP), draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

AddedArticle 118 – paragraph 1 – subparagraph 1: Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through their national IT surveillance systems or data bases and send the information to the Agency without undue delay.

AddedArticle 118 – paragraph 1 a (new): 1a. On the basis of the information provided pursuant to Article 121(2), point (f), the Agency shall monitor and assess any actions planned or taken by a Member State to mitigate a shortage at national level with regard to their impact on the availability and supply of medicinal products at Union level.

Article 118 – paragraph 2: 2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned shall set a deadline for the submission of the information requested.

Change 41

RemovedArticle 120 – paragraph 1 a (new): 1a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.

AddedArticle 120 – paragraph 1: 1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public shall report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State. In addition, wholesale distributors shall submit regular information on the available stocks of the medicinal products they supply to the competent authority.

Change 42

ChangedArticle 120 – paragraph 2:1 2.a For(new): the1a. purposesWhen ofa Articlemarketing 118(1),authorisation whereholder relevant,notifies upona requesttemporary fromdisruption thein competentsupply authorityof concerneda asmedicinal definedproduct, inwholesale Articledistributors 116(1),as entitieswell includingas other marketing authorisationpersons holdersor aslegal definedentities inthat Articleare 116(1),authorised importersor andentitled manufacturersto ofsupply medicinal products orshall activeprovide substancesinformation andupon relevantrequest suppliersin ofa these,timely wholesalemanner distributors,to stakeholderthe representativeAgency, associationsthe orcompetent otherauthority personsin ora legalMember entitiesState thatand arethe authorisedrelevant ormarketing entitledauthorisation toholder supplyon medicinalthe productsreasons tofor the publictemporary shalldisruption providein anysupply relevantof informationthe requestedproduct in a timelyMember manner.State.

Change 43

ChangedArticle 121 – paragraph 1 – point b: (b) publish-a information(new): on(-a) allcollect expectedand orassess actualthe shortagesinformation ofon medicinalpotential products,and theactual reasonshortages forprovided theby shortage,marketing asauthorisation wellholders, asimporters, measuresmanufacturers takenand tosuppliers counterof themedicinal expectedproducts or actual shortage, as soonactive assubstances, thatwholesale competentdistributors, authorityhealthcare hasprofessionals, assessedpatients theand shortageconsumers, and provided clearother recommendationspersons andor possiblelegal alternativesentities tothat healthcareare professionalsauthorised andor patients,entitled onto asupply publiclymedicinal availableproducts andto user-friendlythe website;public;

Change 44

AddedArticle 121 – paragraph 1 – point b: (b) publish information and provide regular updates on actual shortages of medicinal products, that competent authority has assessed the shortage on a publicly available and user-friendly website and ensure such information, including regarding available alternatives, has been actively communicated to representatives of healthcare professionals and patients; competent authorities shall as soon as possible inform the Agency of any measure planned or taken at national level to mitigate the shortage or expected shortage.

AddedArticle 121 – paragraph 1 – point b a (new): (ba) create a system allowing patients to report shortages of medicinal products and request pharmacies supplying hospitals and hospital pharmacies to electronically communicate data on available stock of the medicinal product concerned, in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medicinal product.

AddedArticle 121 – paragraph 1 – point c a (new): (ca) address recommendations to health professionals on the alternative medicinal products to use to pursue treatments in the event of shortages;

AddedArticle 121 – paragraph 1 – point c b (new): (cb) consider the use of appropriate regulatory measures to mitigate the shortage.

Article 121 – paragraph 2 – point f: (f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level without undue delay.

Change 45

AddedArticle 121 – paragraph 2 a (new): 2a. After the expansion of the ESMP referred to in Article 122(6) and for the purpose of Article 118(1) and Article 121(2), point (a), competent authorities of the Member States shall set up national IT systems which are interoperable with the ESMP and allow for the automated exchange of information with the ESMP while avoiding duplication of reporting.

Article 121 – paragraph 5 – point a: (a) report to the Agency on any information received from the marketing authorisation holder as defined in Article 116(1) of the medicinal product concerned or from other actors pursuant to Article 120(1a) and (2);

Change 46

RemovedArticle 122 – paragraph 4 – introductory part: 4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c) and in consultation with relevant patient and consumer organisations:

AddedArticle 121 – paragraph 5 – point d: (d) inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions, without undue delay.

Change 47

ChangedArticle 122121 – paragraph 6: 6. For theThe purposesMember ofStates implementingmay thisrequest Regulation,that the AgencyMSSG shallprovide expandfurther therecommendations, scopereferred ofto thein ESMP.Article The123(4). AgencyWhere shallMember ensure,States thattake dataan isalternative interoperablecourse betweenof theaction ESMP,which Memberis States’not ITin systemsline andwith wherethe relevant,recommendations withof otherthe relevantMSSG ITat systemsnational andlevel, databases,they withoutshall duplicationcommunicate ofthe reporting.reasons Thefor Agencydoing shallso workto towardsthe makingMSSG thein ESMPa fullytimely digitalised.manner.

Change 48

AddedArticle 121 a (new): Article121a / National websites on medicines shortages / The website referred to in Article 121( 1), point (b), shall include at least the following information: / (a) trade name of the medicinal product and international non-proprietary name, for interoperability purposes; / (b) the therapeutic indication for the medicinal product of which there is a shortage; / (c) reasons for the shortages and mitigation measures taken to address the shortages; / (d) the start and expected end dates of the shortage; / (e) other relevant information for healthcare professionals and patients, including information about therapeutic alternatives available.

AddedArticle 122 – paragraph 1: 1. For the purposes of Article 118(1) and (1a), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency may set a deadline for the submission of the information requested.

AddedArticle 122 – paragraph 1 a (new): 1a. For the purpose of Article 118(1a) and based on the information provided pursuant to Article 121(1), point (cb), and Article 121(2), the Agency shall assess the actions planned or taken by a Member State to mitigate a shortage at national level with regard to any potential or actual negative impacts of those actions on the availability and security of supply in another Member State and at Union level. The Agency shall inform the Member State concerned and the MSSG, as well as the Member States potentially or actually impacted, of its assessment in a timely manner through the single point of contact working party referred to in Article 3(6) of Regulation (EU) 2022/123. The Agency shall also inform the Commission of its assessment.

AddedArticle 122 – paragraph 2 a (new): 2a. For the purpose of identifying the medicinal products for which the shortage cannot be resolved without Union coordination pursuant to paragraph 2, the Agency may consult market authorisation holders and other relevant stakeholders.

AddedArticle 122 – paragraph 4 – introductory part: 4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c), and in consultation with the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP) and other relevant stakeholders:

AddedArticle 122 – paragraph 6: 6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that data is interoperable between the ESMP and Member States’ IT systems and, where relevant, with other relevant IT systems and databases, without duplication of reporting.

AddedArticle 123 – paragraph 2: 2. The MSSG shall review the status of the critical shortage whenever necessary and shall update the list when it considers that a medicinal product needs to be added or that the critical shortage has been resolved based on the report pursuant to Article 122(5). The MSSG may recommend monitoring forecasts of supply and demand for medicinal products for human use in the Union and monitoring of available stocks in the whole supply chain.

AddedArticle 123 – paragraph 4: 4. The MSSG shall, without undue delay, provide recommendations on measures to resolve or to mitigate the critical shortage in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

AddedArticle 123 – paragraph 4 – subparagraph 1 a (new): Member States, within the MSSG, may decide to activate the ‘Voluntary Solidarity Mechanism for medicines’ to: / (a) notify a critical shortage of a medicinal product at national level to other Member States and the Commission; / (b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States; / (c) organise, with the support of the Agency, meetings with the issuing Member States, the donating party and other relevant parties to discuss operational requirements; / (d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicinal products.

Article 124 – paragraph 2 – subparagraph 2: For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Change 49

ChangedArticle 124 – paragraph 3: 3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available and user-friendly webpage that provides information on all actual critical shortages of medicinal products, including the reasons for the shortages. After assessing the shortages, the Agency shall provide recommendations to healthcare professionals and patients. The webpage shall include the information referred to in Article 121a in addition to the list of Member States affected by each shortage. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b)(b), the ESMP and include, to the extent possible, information from other relevant sources and databases identified by the Agency and include reference to alternative treatment options or products and appropriate communication.

Change 50

RemovedArticle 125 – paragraph 1 – point c: (c) comply with the recommendations referred to in Article 123(4);

AddedArticle 125 – paragraph 1 – point a: (a) provide any additional information that the Agency may request, including regular information on the available stocks of medicinal products;

Article 125 – paragraph 1 – point f: (f) inform the Agency of the end date of the critical shortage without undue delay;

Change 51

RemovedArticle 125 – paragraph 1 – point f a (new): (fa) inform the Agency of the cause of the critical shortage no later than 14 working days after it has been resolved.

AddedArticle 126 – paragraph 2 a (new): 2a. The Commission shall take the appropriate steps to address any concerns raised by the assessment of the Agency referred to in Article 122(1a).

Change 52

ChangedArticle 127 – paragraph 1: 1. The competent authority of the Member State shall, after consultation with healthcare professionals and national patient and consumer organisations, identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).

Change 53

RemovedArticle 127 – paragraph 4: 4. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information from other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public. Those actors shall state whether the information provided to the competent authority of the Member States contains any commercially confidential information, provide a justification for that statement and indicate the information in question.

AddedArticle 128 – paragraph 2: 2. The marketing authorisation holder as defined in Article 116(1) shall be responsible for providing correct, not misleading, and complete information as requested by the competent authority concerned as defined in Article 116(1) and shall have the duty to cooperate and to disclose on their own motion any relevant information without undue delay to that competent authority and to update the information as soon as that information becomes available.

Change 54

ChangedArticle 129 – paragraph 1: For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information pro-actively whereby theythe deemdeadline itset necessaryby orthe asAgency requestedand inprovide aupdates timelywhenever manner.necessary.

Change 55

ChangedArticle 130 – paragraph 1 – subparagraph 1 – introductorypoint part:a: The(a) Agencydevelop shall,a incommon collaborationmethodology withto identify critical medicinal products, including the workingevaluation partyof referredvulnerabilities and the availability of appropriate alternatives with respect to inthe Articlesupply 121(1),chain pointof (c)those andmedicines, afterin consultation with patientthe organisations,Patients’ ensureand Consumers’ Working Party (PCWP) and the following:Healthcare Professionals’ Working Party (HCPWP), as well as other relevant stakeholders;

Change 56

ChangedArticle 130 – paragraph 12 – subparagraph 1 – point a: (a)b: develop(b) athe commonmarketing methodologyauthorisation toholder identifyof criticalthe medicinal products,product, including the evaluation of the therapeutic indication,shortage vulnerabilitiesprevention and the availability of appropriate alternativesmitigation withplan, respectreferred to the supply chain of those medicines, in consultation withArticle patient117 and consumer organisations, as well as other relevantArticle stakeholders;119(2);

Change 57

RemovedArticle 131 – paragraph 1: 1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and patient and consumer organisations, as well as other relevant stakeholders as set out in Article 162 of this Regulation. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

AddedArticle 130 – paragraph 5: 5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall assess any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8 and report on that information to the MSSG.

AddedArticle 130 – paragraph 6 a (new): 6a. Following the request by a Member State to use the Voluntary Solidarity Mechanism referred to in Article 132(1a), the Agency shall provide assistance to the MSSG and may: / (a) confirm that the conditions are met to launch the Voluntary Solidarity Mechanism; / (b) notify the members of the MSSG of the launch of the Voluntary Solidarity Mechanism; / (c) request from the members of the MSSG relevant information within a specific time limit; / (d) put the issuing country in contact with those Member States able to support them; / (e) organise meetings with the issuing Member States, the donating party and other relevant concerned parties; / (f) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicinal products.

AddedArticle 131 – paragraph 1: 1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and the Patients’ and Consumers’ Working Party (PCWP), the Healthcare Professionals’ Working Party (HCPWP) and the Industry Standing Group (ISG). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Article 131 – paragraph 2: 2. The MSSG shall propose updates to the Union list of critical medicines to the Commission, where necessary.

Change 58

ChangedArticle 132 – paragraph 1: 1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on manufacturing capacity, on reorganisation of manufacturing capacity, diversification of suppliers, inventory managementmanagement, andestablishment of minimum safety stock and, if necessary, redistribution of available stock among Member States under the Voluntary Solidarity Mechanism to address urgent needs, as well as pricing and procurement mechanisms and cost-containmentmeasures measures.and, where appropriate, the use of regulatory flexibilities without lowering safety and efficacy standards.

Change 59

RemovedArticle 133 – paragraph 1 – point c: (c) comply with the recommendations referred to in Article 132(1);

AddedArticle 132 – paragraph 1 a (new): 1a. The MSSG shall coordinate the Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicinal product during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.