Changes from plenary report to adopted text

Added(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 before 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; [Am. 251]

Added(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). [Am. 252]

Added2. For the purposes of the notification made in accordance with paragraph 1, points (a), (b) and (c), the marketing authorisation holder shall provide the information set out in Part I of Annex IV.

AddedFor the purpose of notifications made in accordance with the paragraph 1, point (d), the marketing authorisation holder shall provide the information set out in Part III of Annex IV.

AddedThe marketing authorisation holder shall immediately notify the competent authority concerned, as appropriate, of any relevant changes to the information provided according to this paragraph.

Added3. The Commission is empowered to adopt delegated acts, in accordance with Article 175 in order to amend Annex IV as regards the information to be provided in case of a temporary disruption of supply, information to be provided in case of a suspension or cessation of marketing of a medicinal product or withdrawal of the marketing authorisation of a medicinal product, or the content of the shortage prevention plan referred to in Article 117.

AddedArticle 117 The shortage prevention plan

Added1. 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. [Am. 253]

Added2. The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), shall 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. [Am. 254]

Added3. Where relevant, the marketing authorisation holder as defined in Article 116(1) shall update the shortage prevention plan to include additional information, based on recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (also referred to as the Medicine Shortages Steering Group – ‘MSSG’, established in Article 3(1) of Regulation (EU) 2022/123, in accordance with Articles 123(4) and 132(1).

AddedArticle 118 Shortage monitoring by the competent authority of the Member State or the Agency

Added1. 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. [Am. 255]

AddedThe Agency shall carry out that monitoring in collaboration with the relevant competent authority of the Member State when those medicinal products are authorised under this Regulation.

Added1a. 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. [Am. 256]

Added2. 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 mayshall set a deadline for the submission of the information requested. [Am. 257]

AddedArticle 119 Obligations on the marketing authorisation holder

Added1. The marketing authorisation holder as defined in Article 116(1) shall:

Added(a) submit the information requested in accordance with Article 118(2) or Article 124(2), point (b) to the competent authority concerned as defined in Article 116(1), without undue delay, using the tools, methods of and criteria for the monitoring and reporting established pursuant to Article 122(4), point (b), by the deadline set by that competent authority;

Added(b) provide updates to the information provided in accordance with point (a), where necessary;

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

Added(d) where necessary, submit a request to the competent authority concerned as defined in Article 116(1) for an extension of the deadline set by that competent authority in accordance with point (a), and

Added(e) indicate whether the information provided in accordance with point (a) contains any commercially confidential information, identify the relevant parts of that information having a commercially confidential nature and explain why that information is of such nature.

Added2. To prepare the shortage mitigation plan referred to in Article 118(2), the marketing authorisation holder as defined in Article 116(1) shall include the minimum set of information set out in Part IV of Annex IV and take into account the guidance drawn up by the Agency according to Article 122(4), point (c).

Added3. To prepare a risk assessment of impact of suspension, cessation or withdrawal referred to in Article 118(2), the marketing authorisation holder as defined in Article 116(1) shall include the minimum set of information set out in Part II of Annex IV and take into account the guidance drawn up by the Agency according to Article 122(4), point (c).

Added4. 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.

Added5. The marketing authorisation holder as defined in Article 116(1) shall cooperate with that competent authority and disclose, on their own motion, any relevant information to that authority and update the information as soon as new information becomes available.

AddedArticle 120 Obligations on other actors

Added1. 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 mayshall 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. [Am. 258]

Added1a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors as well as other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information upon request in a timely manner to the Agency, the competent authority in a Member State and the relevant marketing authorisation holder on the reasons for the temporary disruption in supply of the product in a Member State. [Am. 259]

Added2. For the purposes of Article 118(1), 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 requested in a timely manner.

AddedArticle 121 Role of the competent authority of the Member State

Added1. The competent authority of the Member State shall:

Added(-a) collect and assess the information on potential and actual shortages provided by marketing authorisation holders, importers, manufacturers and suppliers of medicinal products or active substances, wholesale distributors, healthcare professionals, patients and consumers, and other persons or legal entities that are authorised or entitled to supply medicinal products to the public; [Am. 260]

Added(a) assess the merits of each confidentiality claim made by the marketing authorisation holder as defined in Article 116(1) in accordance with Article 119(1), point (e), and shall protect information which that competent authority considers to be commercially confidential against unjustified disclosure;

Added(b) publish information and provide regular updates on actual shortages of medicinal products, in cases in which 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; [Am. 261]

Added(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; [Am. 262]

Added(c) report to the Agency, through the single point of contact working party referred to in Article 3(6) of Regulation (EU) 2022/123, any shortage of a medicinal product that it identifies as a critical shortage in that Member State to the Agency without undue delay.

Added(ca) address recommendations to health professionals on the alternative medicinal products to use to pursue treatments in the event of shortages; [Am. 263]

Added(cb) consider the use of appropriate regulatory measures to mitigate the shortage. [Am. 264]

Added2. Following the reporting referred to in paragraph 1, point (c), and to facilitate the monitoring referred to in Articles 118(1), the competent authority of the Member State shall, through the working party referred to in paragraph 1, point (c):

Added(a) submit to the Agency the information referred to in Articles 122(1) or 124(2), point (a), using the tools, methods of and criteria for the monitoring and reporting established pursuant to Article 122(4), point (b), by the deadline set by the Agency;

Added(b) where necessary, provide updates to the information provided in accordance with point (a) to the Agency;

Added(c) justify any failure to provide any of the information referred to in point (a) to the Agency;

Added(d) where necessary, submit a request to the Agency to extend the deadline set by the Agency referred to in point (a);

Added(e) indicate whether the marketing authorisation holder as defined in Article 116(1) has indicated the existence of any commercially confidential information and provide the marketing authorisation holder’s explanation of why that information is of a commercially confidential nature, in accordance with Article 119(1), point (e);

Added(f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level without undue delay. [Am. 265]

Added2a. 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. [Am. 266]

Added3. Where the competent authority of the Member State has any information in addition to the information to be provided pursuant to this Article, it shall immediately provide such information to the Agency through the working party referred to in paragraph 1, point (c).

Added4. Following the addition of a medicinal product on the list of critical shortages of medicinal products referred to in Article 123(1), the competent authority of the Member State shall, through the working party referred to in paragraph 1, point (c), provide any information requested pursuant to Article 124(2), point (a), to the Agency.

Added5. Following any MSSG recommendations provided in accordance with Article 123(4), the competent authority of the Member State shall, through the working party referred to in paragraph 1, point (c):

Added(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(2)120(1a) and (2); [Am. 267]

Added(b) comply and coordinate with any measures taken by the Commission pursuant to Article 126(1), point (a);

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

Added(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. [Am. 268]

Added6. The Member States may request that the MSSG provide further recommendations, referred to in Article 123(4). Where Member States take an alternative course of action which is not in line with the recommendations of the MSSG at national level, they shall communicate the reasons for doing so to the MSSG in a timely manner. [Am. 269]

AddedArticle 121a National websites on medicines shortages

AddedThe website referred to in Article 121(1), point (b), shall include at least the following information:

Added(a) trade name of the medicinal product and international non-proprietary name, for interoperability purposes;

Added(b) the therapeutic indication for the medicinal product of which there is a shortage;

Added(c) reasons for the shortages and mitigation measures taken to address the shortages;