Changes from plenary report to adopted text

Added(ba) submit the stewardship and access plan as referred to Article 17(1), point (a), of and Annex I to [revised Directive 2001/83/EC]; [Am. 155]

Added(bb) submit a global access plan to supply third countries in critical need, including through development partners or voluntary licensing. [Am. 156]

AddedWithin 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.

Added4a. The priority antimicrobial shall be added to the list of antimicrobials which are to be reserved for treatment of certain infections in humans and added to the Union list as established by Commission Implementing Regulation (EU) 2022/1255. [Am. 157]

AddedArticle 41 Transfer and use of the voucher

Added1. A voucher may be used to extend the data protection for a period of 6, 9 or 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder. [Am. 158]

AddedA voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection. The voucher shall not be used for a product which already benefited from the maximum regulatory data protection period as set out in Article 81 of [revised Directive 2001/83/EC]. [Am. 159]

AddedA voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

Added2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

Added3. A voucher may be transferred to another marketing authorisation holder once and shall not be transferred further. [Am. 160]

Added3a. The monetary value paid for the transfer of the voucher shall be directed to the Authority, which shall in yearly instalments transfer the amount to the marketing authorisation holder, in order to ensure the manufacturing capacity and supply of the priority antimicrobial. The Commission shall adopt delegated acts in accordance with Article 175 to supplement this Regulation by setting up the framework for the conditions and functioning of annual instalments. [Am. 161]

Added4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.

AddedArticle 42 Validity of the voucher

Added1. A voucher shall cease to be valid in the following cases:

Added(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

Added(b) where it is not used within 5four years from the date it was grantedafter the conditions set out in Article 41 have been fulfilled by the seller. [Am. 162]

Added2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. To protect the buyer from damage resulting from a possible revocation of a voucher after the transfer, seller and buyer shall make contractual liability arrangements. [Am. 163]

Added3. Without prejudice to patent rights, or supplementary protection certificates, if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

AddedArticle 43 Duration of application of Chapter III

AddedThis Chapter shall apply until [Note to OP: insert the date of 15 years after immediately from ... [the date of entry into force of this Regulation] and for 15 years or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest. [Am. 164]

AddedBy ... [five years from the date of entry into force of this Regulation], the Commission shall submit an evaluation report to the European Parliament and to the Council containing a scientific assessment measuring the progress with regard to antimicrobial research and development and the effectiveness of the incentives and rewards in this Chapter. [Am. 165]

AddedCHAPTER IV POST-MARKETING AUTHORISATION MEASURES

AddedArticle 44 Urgent safety or efficacy restrictions

Added1. If, in the event of a risk to public health, the marketing authorisation holder takes urgent safety or efficacy restrictions on their own initiative, the marketing authorisation holder shall immediately inform the Agency.

AddedIf the Agency has not raised objections within 24 hours following receipt of the information, the urgent safety or efficacy restrictions shall be deemed temporarily accepted.

AddedThe marketing authorisation holder shall submit the corresponding application for variation within 15 days following initiation of that restriction in accordance with Article 47.

Added2. In the event of a risk to public health, the Commission may vary the marketing authorisation to impose urgent safety or efficacy restrictions on the marketing authorisation holder.

AddedThe Commission shall take the decision to amend the marketing authorisation by means of implementing acts.

AddedWhere the Commission decision in accordance with this Article imposes restrictions with regard to the safe and effective use of the medicinal product, it may also adopt a decision addressed to the Member States pursuant to Article 57.

AddedWhere the marketing authorisation holder disagrees with the Commission decision, they may provide to the Agency written observations on the variation within 15 days of their receipt of the Commission decision. The Agency shall, based on the written observation, issue an opinion whether an amendment of the variation is required.

AddedIf an amendment of the variation is required, the Commission shall take a final decision in accordance with the examination procedure referred to in Article 173(2).

AddedIf a referral under Article 55 of this Regulation or under Article 95 or 114 of [revised Directive 2001/83/EC] is launched on the same safety or efficacy concern covered by this variation, any written observation provided by the marketing authorisation holder shall be considered in that referral.

AddedArticle 45 Update of a marketing authorisation related to scientific and technological developments

Added1. After a marketing authorisation has been granted in accordance with this Regulation, the marketing authorisation holder shall, in respect of the methods of manufacture and control provided for in Annex I, points (6) and (10), to [revised Directive 2001/83/EC], take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods. The marketing authorisation holder shall apply for approval of corresponding variations in accordance with Article 47 of this Regulation.

Added2. The marketing authorisation holder shall without undue delay provide the Agency, the Commission and the Member States with any new information which might entail the amendment of the particulars or documentation referred to in Annex I, Articles 11, 28, 41 or 62 of [revised Directive 2001/83/EC], in Annex II to that Directive, or in Article 12(4) of this Regulation.

AddedThe marketing authorisation holder shall without undue delay inform the Agency and the Commission of any prohibition or restriction imposed on the marketing authorisation holder or any entity in contractual relationship with the marketing authorisation holder by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned. The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.

Added3. The marketing authorisation holder shall ensure that the product information and the terms of the marketing authorisation including the summary of product characteristics, the labelling and package leaflet are kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal set-up in accordance with Article 104.

Added4. The Agency may at any time request the marketing authorisation holder to submit data demonstrating that the benefit-risk balance remains favourable. The marketing authorisation holder shall answer fully and promptlywithin the time limit set for any such request. The marketing authorisation holder shall also respond fully and within the time limit set to any such request of a competent authority regarding the implementation of any measures previously imposed, including risk minimisation measures. [Am. 166]

AddedThe Agency may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file. The marketing authorisation holder shall submit that copy at the latest seven days after receipt of the request.

AddedThe marketing authorisation holder shall also respond fully and within the time limit set to any request of a competent authority regarding the implementation of any measures previously imposed with regard to risks to the environment or public health, including antimicrobial resistance.

AddedArticle 46 Update of risk management plans

Added1. The marketing authorisation holder of a medicinal product referred to in Articles 9, and 11 of [revised Directive 2001/83/EC] shall submit to the Agency a risk management plan and a summary thereof, where the marketing authorisation for the reference medicinal product is withdrawn but the marketing authorisation for the medicinal product referred to in Articles 9 and 11 of [revised Directive 2001/83/EC] is maintained.

AddedThe risk management plan and the summary thereof shall be submitted to the Agency within 60 days of the withdrawal of the marketing authorisation for the reference medicinal product by means of a variation in accordance with Article 47.

Added2. The Agency may impose an obligation on a marketing authorisation holder for a medicinal product referred to in Articles 9, 10, 11 and 12 of [revised Directive 2001/83/EC] to submit a risk management plan and summary thereof where:

Added(a) additional risk minimisation measures have been imposed concerning the reference medicinal product; or

Added(b) it is justified on pharmacovigilance grounds.

Added3. In the case mentioned referred to in paragraph 2, point (a), the risk management plan shall be aligned with the risk management plan for the reference medicinal product.

Added4. The imposition of the obligation referred to in paragraph 3, shall be duly justified in writing, notified to the marketing authorisation holder and shall include the deadline for submission of the risk management plan and the summary by means of a variation in accordance with Article 47.

AddedArticle 47 Variation of marketing authorisation

Added1. An application for variation of a centralised marketing authorisation by the marketing authorisation holder shall be made electronically in the formats made available by the Agency, unless the variation is an update by the marketing authorisation holder of their information held in a database. The electronic format shall include a baseline sequence in relations to the Common Technical Document (CTD). [Am. 167]

Added2. Variations shall be classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicinal product concerned. Those categories shall range from changes to the terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon and to administrative changes.

Added3. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the Agency. Such procedures may also include updates by the marketing authorisation holder of their information held in a database.

Added4. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by establishing the following:

Added(a) the categories referred to in paragraph 2 in which variations shall be classified;

Added(b) procedures for the examination of applications for variations to the terms of marketing authorisations, including procedures for updates through a database;

Added(c) the conditions for submission of a single application for more than one change to the terms of the same marketing authorisation and for the same change to the terms of several marketing authorisations;

Added(d) specifying exemptions to the variation procedures where the update of information in the marketing authorisation referred to in Annex I may be directly implemented;

Added(e) the conditions and procedures for cooperation with competent authorities of third countries or international organisations on examination of applications for variations to the terms of marketing authorisation.

AddedArticle 48 Scientific opinion on data submitted from not-for-profit entities for repurposing of authorised medicinal products

Added1. An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non-clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need. [Am. 168]