Changes from plenary report to adopted text

Added(d) the start and expected end dates of the shortage;

Added(e) other relevant information for healthcare professionals and patients, including information about therapeutic alternatives available. [Am. 270]

AddedArticle 122 Role of the Agency concerning shortages

Added1. 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. [Am. 271]

Added1a. 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. [Am. 272]

Added2. On the basis of Article 118(1), the Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall identify the medicinal products for which the shortage cannot be resolved without EU coordination.

Added2a. 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. [Am. 273]

Added3. The Agency shall inform the MSSG of the shortages of the medicinal products that have been identified pursuant to paragraph 2.

Added4. 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: [Am. 274]

Added(a) set the criteria to adopt and review the list of critical shortages referred to in Article 123(1);

Added(b) specify the tools, including the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, once the scope is expanded pursuant to paragraph 6, the methods of and criteria for the monitoring and reporting provided for in Articles 119(1), point (a), and 121(2), point (a);

Added(c) draw up guidance to allow marketing authorisation holders as defined in Article 116(1) to put in place the risk assessment of impact of suspension, cessation or withdrawal and the shortage mitigation plan as referred to in Article 118(2);

Added(d) specify the methods for the provision of recommendations referred to in Article 123(4);

Added(e) publish information covered by points (a) to (d) on a dedicated webpage on its web-portal referred to in Article 104.

Added5. For the duration of the critical shortage and until the MSSG considers it to be resolved, the Agency shall regularly report on the results of the monitoring referred to in Article 124 to the Commission and the MSSG, and in particular, it shall report any event that is likely to lead to a major event, as defined in Article 2 of Regulation (EU) 2022/123. Where a public health emergency is recognised in accordance with Regulation (EU) 2022/2371 or an event is recognised as a major event, in accordance with Regulation (EU) 2022/123, that Regulation applies.

Added6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, 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. [Am. 275]

AddedArticle 123 Role of the MSSG and the list of critical shortages of medicinal products

Added1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG shall adopt a list of critical shortages of 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 co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).

Added2. 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. [Am. 276]

Added3. In addition, the MSSG shall amend its rules of procedure, and the rules of procedure of the working party referred to in Article 121(1), point (c), in accordance with the roles set out in this Regulation.

Added4. The MSSG mayshall, 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. [Am. 277]

Added4.a Member States, within the MSSG, may decide to activate the ‘Voluntary Solidarity Mechanism for medicines’ to:

Added(a) notify a critical shortage of a medicinal product at national level to other Member States and the Commission;

Added(b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States;

Added(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;

Added(d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicinal products. [Am. 278]

AddedArticle 124 Management of the critical shortage

Added1. Following the addition of a medicinal product to the list of critical shortages pursuant to Article 123, paragraphs 1 and 2, and based on the continuous monitoring carried out in accordance with Article 118(1), the Agency, in coordination with the competent authority of the Member State, shall continuously monitor the critical shortage of that medicinal product.

Added2. For the purposes of paragraph 1, where that information is not already available to the Agency, the Agency may request relevant information on that critical shortage from:

Added(a) the competent authority of the Member State concerned through the working party referred to in Article 121(1), point (c);

Added(b) the marketing authorisation holder as defined in Article 116(1);

Added(c) the other actors listed in Article 120(2).

AddedFor the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested. [Am. 279]

Added3. 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 in cases in which, including the reasons for the shortages. After assessing the shortages, the Agency has assessed the shortage and has providedshall 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), 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. [Am. 280]

AddedArticle 125 Obligations on the marketing authorisation holder in case of a critical shortage

Added1. Following the addition of a medicinal product to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2, or recommendations provided in accordance with Article 123(4), the marketing authorisation holder as defined in Article 116(1) and subject to those recommendations shall:

Added(a) provide any additional information that the Agency may request, including regular information on the available stocks of medicinal products; [Am. 281]

Added(b) provide additional relevant information to the Agency;

Added(c) take into account the recommendations referred to in Article 123(4);

Added(d) comply with any measures taken by the Commission pursuant to Article 126(1), point (a), or actions taken by the Member State pursuant to Article 121(5), point (d);

Added(e) inform the Agency of any measures taken pursuant to points (c) and (d) and the report on results of such measures;

Added(f) inform the Agency of the end date of the critical shortage. without undue delay. [Am. 282]

AddedArticle 126 Role of the Commission

Added1. The Commission shall, where it considers it appropriate and necessary:

Added(a) take into account the MSSG recommendations and implement relevant measures;

Added(b) inform the MSSG of those measures taken by the Commission.

Added2. The Commission may request the MSSG to provide recommendations referred to in Article 123(4).

Added2a. The Commission shall take the appropriate steps to address any concerns raised by the assessment of the Agency referred to in Article 122(1a). [Am. 283]

AddedSection 2 Security of supply

AddedArticle 127 Identification and management of critical medicinal products by the competent authority of the Member State

Added1. The competent authority of the Member State shall, after consultation with healthcare professionals and patient organisations, identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a). [Am. 284]

Added2. The competent authority of the Member State acting through the working party referred to in Article 121(1), point (c), shall report to the Agency the critical medicinal products in that Member State identified pursuant to the paragraph 1, as well as the information received from the marketing authorisation holder as defined in Article 116(1).

Added3. 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 including the shortage prevention plan referred to in Article 117 from the marketing authorisation holder as defined in Article 116(1).

Added4. 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.

Added5. The competent authority of the Member State shall assess the merits of each confidentiality claim made by the marketing authorisation holder pursuant to Article 128(1), point (e), and shall protect any information that is commercially confidential against unjustified disclosure.

Added6. For the purposes of the adoption of the Union list of critical medicinal products pursuant to Article 131, each Member State shall, through the competent authority of the Member State concerned:

Added(a) submit to the Agency the information referred to in Article 130(2), point (a), using the tools, methods of and criteria for the monitoring and reporting established pursuant to Article 130(1), point (c), by the deadline set by the Agency;

Added(b) provide any relevant information to the Agency, including information on measures that have been taken by the Member State to strengthen the supply of that medicinal product;

Added(c) provide updates to the information provided in accordance with points (a) and (b) to the Agency where necessary;

Added(d) justify any failure to provide any of the requested information;