What changed between the draft committee report and the plenary report

Added:Article 18 – paragraph 2 – subparagraph 2 a (new): Where specific conditions referred to in paragraph 1, point (c), of this Article are not fulfilled within the timeframe given by the Agency or the marketing authorisation holder does not provide duly justified reasons for not fulfilling the conditions, the Commission may suspend, revoke or vary the marketing authorisation by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Removed:Article 17 – paragraph 2 – subparagraph 2: The marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

Added:Article 19 – paragraph 3: 3. Conditional marketing authorisations or a new conditional therapeutic indication, granted pursuant to this Article shall be subject to specific obligations. Those specific obligations, in particular for ongoing or new studies as referred to in paragraph 4, and, where appropriate the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Removed:Article 17 – paragraph 2 – subparagraph 3: Where a renewal application has been submitted, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

Added:Article 19 – paragraph 4: 4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies in accordance with Article 20, with a view to confirming that the benefit-risk balance is favourable.

Removed:Article 17 – paragraph 2 – subparagraph 4: The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation and any subsequent marketing authorisations shall be valid for an additional period of 10 years.

Added:Article 19 – paragraph 7 – subparagraph 1 a (new): Where the specific obligations referred to in paragraph 3 are not complied with within the timeframe stipulated by the Agency or the marketing authorisation holder does not provide duly justified reasons for not complying with the obligations, the Commission may suspend, revoke or vary the marketing authorisation by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Removed:Article 17 – paragraph 2 – subparagraph 4 a (new): Where post-authorisation studies to be performed in accordance with Article 20(1) justify it, the Commission may decide to withdraw a marketing authorisation for a medicinal product based on evidence pointing to a risk to public health.

Added:Article 19 – paragraph 8 – point b: (b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, for adding a new conditional therapeutic indication to an existing marketing authorisation, and for the withdrawal, suspension or revocation of the conditional marketing authorisation.

Change 12

Changed:Article 1819 – paragraph 28 –a subparagraph(new): 28a. aThe (new):Agency Whereshall specificpublish conditionsin the database referred to in paragraphArticle 1,138(1), second subparagraph, point (c),(n), arethe notlist fulfilledof withinconditional themarketing timeframeauthorisations, giventogether bywith the Agencyfollowing orinformation: the/ marketing(a) authorisationspecific holderobligations doesto notbe providecomplied dulywith justifiedby reasonsthe formarketing notauthorisation fulfillingholder; the/ conditions,(b) thetimelines Commissionfor maycompliance suspend,with revokespecific orobligations; vary/ (c) any delays by the marketing authorisation byholder meansregarding ofthe implementingcompliance acts.with Thosespecific implementingobligations actsand shallthe bereasons adoptedfor insuch accordancedelays; with/ (d) any actions on the examinationconditional proceduremarketing referredauthorisation totaken in accordance with Article 173(2).56.

Change 13

Removed:Article 19 – paragraph 1 – subparagraph 2: In emergency situations, as referred to in Article 2(1) of Regulation (EU) 2022/2371, a conditional marketing authorisation or a new conditional therapeutic indication referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.

Added:Article 20 – paragraph 1 – subparagraph 1 – point c a (new): (ca) conducts a post-authorisation treatment optimisation study where the optimal usage of an authorised medicinal product has not been previously established.

Removed:Article 19 – paragraph 3: 3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations, in particular for ongoing or new studies as referred to in paragraph 4 of this Article, the time limit for compliance and penalties in accordance with Article 172 in cases of non-compliance, shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Added:Article 20 – paragraph 1 – subparagraph 3: Where the Agency considers that any of the post-authorisations studies referred to in the first subparagraph, points (a) to (ca), is necessary, it shall inform the marketing authorisation holder thereof in writing, stating the grounds for its assessment and shall include the objectives and timeframe for submission and conduct of the study.

Change 14

Changed:Article 1920 – paragraph 4: 4. AsWhere partthe opinion of the specificAgency obligationsconfirms referredthe toneed infor paragraphany 3,of the marketingpost-authorisation authorisationstudies holderreferred ofto ain conditionalparagraph marketing1, authorisationfirst grantedsubparagraph, pursuantpoints to(a) thisto Article(ca), shallto be requiredcarried toout, completethe ongoingCommission studies,shall orvary tothe conductmarketing newauthorisation, studiesby inmeans accordanceof withimplementing Articleacts, 20,adopted withpursuant ato viewArticle 13 to confirminginclude the safetyobligation andas efficacya condition of the medicinalmarketing product.authorisation Theunless Agencythe shallCommission makereturns relevantthe deadlinesopinion andto criteriathe Agency for ongoingfurther consideration. For obligations under paragraph 1, points (a) and new(b), studiesthe publiclymarketing available.authorisation holder shall update the risk management system accordingly.

Change 15

Removed:Article 19 – paragraph 6: 6. By way of derogation from Article 17(1), an initial conditional marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis for the first three years after granting the authorisation and every two years thereafter. However, where the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) of Regulation (EU) 2022/2371, the marketing authorisation holder shall pursue a marketing authorisation in accordance with Article 5 of this Regulation.

Added:Article 24 – paragraph 1 – subparagraph 1: In addition to the notification made pursuant to Article 116, the marketing authorisation holder shall notify the Agency without undue delay of any action they take to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with a detailed reasoning for such action.

Removed:Article 19 – paragraph 7 – subparagraph 1 a (new): Where specific conditions referred to in paragraph 3 are not fulfilled within the timeframe given by the Agency or the marketing authorisation holder does not provide duly justified reasons for not fulfilling the conditions, the Commission may suspend, revoke or vary the marketing authorisation by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2).

Added:Article 24 – paragraph 1 – subparagraph 2 – point f a (new): (fa) commercial reasons.

Removed:Article 19 a (new): Article 19a / Revocation of conditional marketing authorisation / The Commission may in justified cases revoke the conditional marketing authorisation that was granted in accordance with Article 19 where the benefit of the immediate availability of the medicinal product on the Union market no longer outweighs the risk due to missing confirming data or non-compliance with the obligations set out in Article 19.

Added:Article 24 – paragraph 3 a (new): 3a. In the cases referred to in paragraph 1, second subparagraph, point (f), the Agency shall immediately inform the Commission. The Commission shall in turn inform the relevant national and Union authorities. Where relevant, national authorities shall forward the information to drinking water and wastewater operators.

Removed:Article 20 – paragraph 1 – subparagraph 1 – introductory part: After the granting of a marketing authorisation, the Agency may at any time consider that it is necessary that the marketing authorisation holder:

Added:Article 24 – paragraph 4 a (new): 4a. The Agency may decide to extend obligations set out in paragraph 4 in justified cases to a specific non-critical medicinal product on a case-by-case basis.

Removed:Article 20 – paragraph 1 – subparagraph 2: If this obligation would apply to several medicinal products, the Agency shall oblige the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study.

Added:Article 24 – paragraph 4 b (new): 4b. The marketing authorisation holder from which the marketing authorisation has been transferred to a third party shall notify the Agency of the transfer as soon as possible. The information regarding the transfer provided shall be made publicly available.

Removed:Article 21 – paragraph 1 a (new): Where a conditional marketing authorisation has been granted in accordance with Article 19, a post-authorisation efficacy study shall always be required in accordance with Article 19(4).

Added:Article 25 – paragraph 1 – subparagraph 3: As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall without undue delay withdraw the initial or duplicate marketing authorisation.

Removed:Article 23 – paragraph 1 a (new): A temporary emergency marketing authorisation granted in accordance with Article 30 shall leave the civil and criminal liability of the manufacturer and marketing authorisation holder unaffected.

Added:Article 26 – paragraph 2: 2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a single or group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, treatment resistant, or causing psychological distress or patients in palliative care, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.

Removed:Article 24 – paragraph 1 – subparagraph 1: In addition to the notification made pursuant to Article 116, the marketing authorisation holder shall notify the Agency without undue delay of any action they take to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with detailed reasoning for such action.

Added:Article 26 – paragraph 3: 3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.

Removed:Article 24 – paragraph 1 – subparagraph 2 – point f: (f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder; in such cases, the Agency shall immediately inform the Commission who is to be responsible for informing the relevant national and Union authorities.

Added:Article 26 – paragraph 4 – subparagraph 2: In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.

Removed:Article 24 – paragraph 1 – subparagraph 2 – point f a (new): (fa) commercial considerations.

Added:Article 26 – paragraph 6: 6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in the database referred to in Article 138(1), second subparagraph, point (n), on its website.

Removed:Article 24 – paragraph 1 – subparagraph 3: Where the action referred to in the first subparagraph is to withdraw a medicinal product from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated with the medicinal product, as well as indicate any potential alternative therapeutic equivalent.

Removed:Article 24 – paragraph 4: 4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on fair and reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC].

Removed:Article 24 – paragraph 4 a (new): 4a. The marketing authorisation holder from which the marketing authorisation has been transferred to a third party shall notify the Agency of the transfer as soon as possible. The information regarding the transfer provided shall be made publicly available.

Removed:Article 25 – paragraph 1 – subparagraph 3: As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall immediately withdraw the initial or duplicate marketing authorisation.

Article 26 – paragraph 10: 10. The Agency shall adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article.

Change 16

Changed:Article 2729 – paragraph 1 a (new): The Committeeapplicable shallperiods alsoof drawregulatory upprotection anshall opinionbe wheneverpublished thereand isupdated disagreementwhere concerningappropriate theby evaluationthe ofCommission medicinalin productsthe throughUnion theRegister mutualof recognitionmedicinal procedure.products.

Change 17

Removed:Article 30 – paragraph 3 a (new): Where a medicinal product receives a temporary emergency marketing authorisation in accordance with this Article, robust transparency measures and standards shall be put in place by the Agency. Those measures shall include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. The public information regarding clinical trials and marketing authorisation decisions shall be published in accordance with Article 17 of Regulation (EU) 2022/123.

Added:Article 32 – paragraph 1: 1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned in addition to the evidence submitted in the applicant’s dossier.

Removed:Article 31 – paragraph 1 – point b a (new): (ba) when recognition of the public health emergency has been terminated, the marketing authorisation holder shall be required to apply for a marketing authorisation in accordance with Article 34 without undue delay.

Added:Article 32 – paragraph 2 – subparagraph 1: The Agency shall without undue delay review any new evidence provided by the developer, the Member States or the Commission, or any other additional evidence that comes to its attention, taking into account the evidence submitted by the developer, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.

Change 18

Changed:Article 32 – paragraph 2 – subparagraph3: 1:3. The Agency shall transmit without undue delay reviewto anythe newCommission evidencethe providedscientific byopinion theand developer,its theupdates Memberand Statesany orrecommendations on the Commission,temporary oremergency anymarketing otherauthorisation. evidenceThe thatscientific comesopinion toand itsinformation attention,on inthe particularapplication evidencefor thatthe mightuse influenceof the benefit-risktemporary balanceemergency ofmarketing theauthorisation medicinalshall productbe concerned.made publicly available by the Agency.

Change 19

Removed:Article 34 – paragraph 1: The temporary emergency marketing authorisation shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371 or when sufficient data have been collected in order to grant a conditional marketing authorisation in accordance with Article 19.

Added:Article 33 – paragraph 2: 2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation, after consultation with the applicant or marketing authorisation holder.

Removed:Article 35 – paragraph 1 – point d a (new): (da) a conditional marketing authorisation has been granted.

Added:Article 36 – paragraph 1: The marketing authorisation holder of an authorisation in accordance with Article 33 may submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19 based on the pre-agreed deadlines established with the Agency.

Change 20

Changed:Article 37 – paragraph 1: When the temporary marketing authorisation of a medicinal product is suspended or revoked for reasons other than the safety of the medicinal product, or if that temporary emergency marketing authorisation ceases to be valid, Member States may, in exceptional circumstances, allow for a transitional period, the supply of the medicinal product to patients who are already being treated with it. In such cases, the Member State shall inform the Agency about the application of the transitional period. Conditions for manufacturing, use, supply and safety monitoring and the compliance with the related good manufacturing,manufacturing and pharmacovigilance practices shall continue to apply during that period.

Change 21

Removed:Chapter III – title: ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF PRIORITY ANTIMICROBIALS

Added:Article 39 a (new): Article 39a / Milestone payment reward scheme / 1. An antimicrobial shall be considered a ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with regard to antimicrobial resistance and it has at least one of the following characteristics: / (a) it represents a new class of antimicrobials; / (b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union; / (c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life-threatening infection. / In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level. / 2. The Commission, in consultation with the Agency, shall award milestone payments and support to potential priority antimicrobials addressing the priority pathogens referred to in paragraph 1 of this Article. The milestone payments shall be financed through resource matching by the Commission, including within the framework of Article 12(2), point (b)(i), of Regulation (EU) 2021/695 of the European Parliament and of the Council1a and Regulation (EU) 2021/522 of the European Parliament and of the Council 1b. / The Commission shall adopt delegated acts in accordance with Article 175 to supp…

Removed:Article 40: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 39 b (new): Article 39b / Subscription model for the joint procurement of antimicrobials / 1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council1a with a view to the advance purchase of antimicrobials. / 2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a joint procurement agreement between the parties determining the practical arrangements governing the subscription model system and other procedures, including the length of the subscription contract and the possibility of parallel procurement. / 3. The joint procurement agreement shall take the form of a multi-year subscription and include the following conditions: / (a) delinkage or partial delinkage of funding from the volume of sales of the antimicrobial; / (b) commitment to continuous and sufficient supply in pre-agreed quantities; / (c) commitment to the antimicrobial stewardship and access plans as referred to in Article 17(1), point (a), of [revised Directive 2001/83/EC] ; / (d) commitment to the environmental risk assessment as referred to in Article 22 of [revised Directive 2001/83/EC]; / (e) submission of a global access plan to supply third countries in critical need, including through development partners or voluntarily licensing. / 4. Participation in the joint procurement procedure shall be open to all Member …

Removed:Article 40 a (new): Article 40a / Establishment and role of the European Medicines Facility / 1. The European Medicines Facility ( ‘EMF’) is hereby established. / 2. The main missions and responsibilities of the EMF shall be: / (a) setting out a long-term vision of health priorities in the public interest at a Union level in the form of a strategic roadmap with a number of specific purpose-led R&D projects; in the elaboration of the strategic roadmap, the EMF shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level; / (b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas: / (i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level; / (ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therap…

Added:Article 40 – paragraph 1: 1. Following a request by the applicant for a marketing authorisation, made before the marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in Article 39a(1), under the conditions referred to in paragraph 4 of this Article based on a scientific assessment by the Agency.

Removed:Article 41: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

Added:Article 40 – paragraph 2: 2. The voucher referred to in paragraph 1 shall give the right to its holder to a maximum of additional 12 months of data protection for one authorised medicinal product.

Removed:Article 42: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)