Executive Steering Group on Shortages and Safety of Medicinal Products
1. The Executive Steering Group on Shortages and Safety of Medicinal Products (the ‘Medicine Shortages Steering Group – MSSG’) is hereby established within the Agency.
The MSSG shall be responsible for fulfilling the tasks referred to in Article 4(3) and (4) and Articles 5 to 8.
The MSSG shall meet regularly and also whenever the situation requires, either in person or remotely, in preparation for or during a public health emergency or when an issue of concern has been raised with the MSSG or when the Commission has recognised a major event in accordance with Article 4(3).
The Agency shall provide the secretariat of the MSSG.
2. The members of the MSSG shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State.
Members of the MSSG may be accompanied to meetings of the MSSG by experts in specific scientific or technical fields.
The list of the members of the MSSG shall be published on the Agency’s web portal.
A representative of the Agency’s Patients’ and Consumers’ Working Party (‘PCWP’) and a representative of the Agency’s Healthcare Professionals’ Working Party (‘HCPWP’) may attend meetings of the MSSG as observers.
3. The MSSG shall be co-chaired by the representative of the Agency and by one of the representatives of the Member States, who shall be elected by and from among the representatives of the Member States in the MSSG.
The co-chairs of the MSSG, on their own initiative or at the request of one or more members of the MSSG, may invite, as observers and to provide expert advice, representatives of national competent authorities for veterinary medicinal products, representatives of other relevant competent authorities and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, wholesale distributors, any other appropriate actor in the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, to attend its meetings, as necessary.
4. The MSSG, in coordination with the national competent authorities for medicinal products, shall facilitate appropriate communication with marketing authorisation holders or their representatives, manufacturers, other relevant actors of the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, with a view to receiving relevant information on actual or potential shortages of medicinal products considered to be critical during a public health emergency or a major event as provided for in Article 6.
5. The MSSG shall establish its rules of procedure, including procedures relating to the working party referred to in paragraph 6 of this Article and procedures for adoption of the critical medicines lists, sets of information and recommendations referred to in Article 8(3) and (4).
The rules of procedure referred to in the first subparagraph shall enter into force once the MSSG has received a favourable opinion from the Commission and the Management Board of the Agency.
6. The MSSG shall be supported in its work by a working party established in accordance with Article 9(1), point (d).
The working party referred to in the first subparagraph shall consist of representatives of the national competent authorities for medicinal products, who shall be the single points of contact in relation to shortages of medicinal products.
7. The MSSG may consult with the Committee for Medicinal Products for Veterinary Use (‘CVMP’) established by Article 56(1), point (b), of Regulation (EC) No 726/2004 whenever the MSSG deems necessary to do so, in particular, in order to deal with public health emergencies or major events related to zoonoses or diseases that only affect animals and that have or may have a major impact on human health or where the use of active substances for veterinary medicinal products may be useful in addressing the public health emergency or major event.
Monitoring of events and preparedness for public health emergencies and major events
1. The Agency, in collaboration with Member States, shall continuously monitor any event that is likely to lead to a public health emergency or major event. As necessary, the Agency shall cooperate with the European Centre for Disease Prevention and Control (‘ECDC’) and, where relevant, other Union agencies.
2. To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency on any event that is likely to lead to a public health emergency or major event, including an actual or potential shortage of a medicinal product in a given Member State. Such reporting shall be based on the reporting methods and criteria pursuant to Article 9(1), point (b).
Where a national competent authority informs the Agency of a shortage of a medicinal product as referred to in the first subparagraph, it shall provide the Agency with any information that it has received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, if that information is not available in the ESMP.
Where the Agency receives a report of an event from a national competent authority for medicinal products, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(6), in order to evaluate the impact of the event in other Member States.
3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall raise the issue of concern with the MSSG.
Following a positive opinion of the MSSG, the Commission may recognise the major event.
The Commission or at least one Member State may raise the issue of concern with the MSSG on its own initiative.
4. The MSSG shall inform the Commission and the Executive Director of the Agency once the MSSG considers that the major event has been sufficiently addressed and considers that its assistance is no longer needed.
On the basis of the information referred to in the first subparagraph or on its own initiative, the Commission or the Executive Director may confirm that the major event has been sufficiently addressed and therefore that the assistance of the MSSG is no longer needed.
5. Following the recognition of a public health emergency or the recognition of a major event in accordance with paragraph 3 of this Article, Articles 5 to 12 apply as follows:
(a)
where the public health emergency or the major event may affect the quality, safety or efficacy of medicinal products, Article 5 applies;
(b)
where the public health emergency or the major event may lead to shortages of medicinal products in more than one Member State, Articles 6 to 12 apply.
Evaluation of information and provision of recommendations on action in relation to the quality, safety and efficacy of medicinal products related to public health emergencies and major events
1. Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the MSSG shall evaluate information related to the public health emergency or the major event and consider the need for urgent and coordinated action with regard to the quality, safety and efficacy of the medicinal products concerned.
2. The MSSG shall provide recommendations to the Commission and Member States on any appropriate action that it believes needs to be taken at Union level on the medicinal products concerned in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004.
3. The MSSG may consult with the CVMP whenever the MSSG deems necessary to do so, in particular, in order to deal with public health emergencies or major events related to zoonoses or diseases that only affect animals and that have or may have a major impact on human health, or where the use of active substances for veterinary medicinal products may be useful in addressing the public health emergency or the major event.
Lists of critical medicinal products and information to be provided
1. Without prejudice to paragraph 2, the MSSG shall establish a list with the main therapeutic groups of medicinal products that are necessary for emergency care, surgery and intensive care, in order to inform the preparation of the critical medicines lists as referred to in paragraphs 2 and 3 to be used to respond to a public health emergency or major event. The list shall be established by 2 August 2022 and updated annually and whenever necessary.
2. Immediately following the recognition of a major event in accordance with Article 4(3) of this Regulation, the MSSG shall consult the working party referred to in Article 3(6) of this Regulation. Immediately following that consultation, the MSSG shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers to be critical during the major event (the ‘major event critical medicines list’).
The MSSG shall update the major event critical medicines list whenever necessary until the major event has been sufficiently addressed and it has been confirmed that the assistance of the MSSG is no longer needed pursuant to Article 4(4) of this Regulation.
3. Immediately following the recognition of a public health emergency, the MSSG shall consult the working party referred to in Article 3(6) of this Regulation. Immediately following that consultation, the MSSG shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers to be critical during the public health emergency (the ‘public health emergency critical medicines list’). The MSSG shall update the public health emergency critical medicines list whenever necessary until the termination of the recognition of the public health emergency. The public health emergency critical medicines list may be updated to take into account the results of the review process under Article 18 of this Regulation, where appropriate. In such cases, the MSSG shall liaise with the Emergency Task Force referred to in Article 15 of this Regulation (‘ETF’).
4. For the purposes of Article 9(2), the MSSG shall adopt and make publicly available the set of information referred to in Article 9(2), points (c) and (d), that is necessary to monitor the supply of and demand for medicinal products included on the lists referred to in paragraphs 2 and 3 of this Article (the ‘critical medicines lists’) and shall inform the working party referred to in Article 3(6) of that set of information.
5. Following the adoption of critical medicines lists in accordance with paragraphs 2 and 3, the Agency shall immediately publish those lists and any updates to those lists on its web portal as referred to in Article 26 of Regulation (EC) No 726/2004.
6. The Agency shall establish within its web portal a publicly accessible webpage that provides information on actual shortages of medicinal products included in the critical medicines lists in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. The webpage shall provide at least the following information:
(a)
the name and common name of the medicinal product on the critical medicines lists;
(b)
the therapeutic indications for the medicinal product on the critical medicines lists;
(c)
the reason for the shortage of the medicinal product on the critical medicines lists;
(d)
the start and end dates of the shortage of the medicinal product on the critical medicines lists;
(e)
the Member States affected by the shortage of the medicinal product on the critical medicines lists;
(f)
other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.
The webpage referred to in the first subparagraph shall also provide references to national registries on shortages of medicinal products.
Monitoring shortages of medicinal products on the critical medicines lists
Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the MSSG shall monitor the supply of and demand for medicinal products included on the critical medicines lists, with a view to identifying any actual or potential shortages of those medicinal products. The MSSG shall conduct such monitoring using the critical medicines lists and the information and data provided, in accordance with Articles 10 and 11, and available through the ESMP, once it is fully functional.
For the purposes of the monitoring referred to in the first paragraph of this Article, where relevant, the MSSG shall liaise with the Health Security Committee established by Article 17 of Decision No 1082/2013/EU (‘HSC’) and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law and with the ECDC.
Reporting and recommendations on shortages of medicinal products
1. For the duration of a public health emergency, or following the recognition of a major event as referred to in Article 4(3) until it has been confirmed that the major event has been sufficiently addressed pursuant to Article 4(4), the MSSG shall regularly report the results of the monitoring referred to in Article 7 to the Commission and the single points of contact referred to in Article 3(6), and, in particular, shall signal any actual or potential shortages of medicinal products included on the critical medicines lists or any event that is likely to lead to a major event.
The reports referred to in the first subparagraph may also be made available to other actors in the supply chain for medicinal products, where appropriate, in accordance with competition law.
2. Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), the MSSG shall provide aggregated data and demand forecasts to support its findings and conclusions. In that regard, the MSSG shall:
(a)
use data from the ESMP, once it is fully functional;
(b)
liaise with the ECDC to obtain epidemiological data, models and development scenarios to help forecast medicinal product needs; and
(c)
liaise with the Executive Steering Group on Shortages of Medical Devices referred to in Article 21 (‘MDSSG’) where medicinal products included on the critical medicines lists are used jointly with a medical device.
The aggregated data and demand forecasts referred to in the first subparagraph may also be made available to other actors in the supply chain for medicinal products, where appropriate, in accordance with competition law, with a view to better preventing or mitigating actual or potential shortages of medicinal products.
3. As part of the reporting referred to in paragraphs 1 and 2, the MSSG may provide recommendations on measures that the Commission, Member States, marketing authorisation holders and other entities, including representatives of healthcare professionals and of patients, could take to prevent or mitigate actual or potential shortages of medicinal products.
Member States may request the MSSG to provide recommendations on measures referred to in the first subparagraph.
For the purposes of the second subparagraph, the MSSG shall liaise, as relevant, with the HSC and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law.
4. The MSSG, on its own initiative or at the request of the Commission or a Member State, may provide recommendations on measures that the Commission, Member States, marketing authorisation holders, representatives of healthcare professionals and other entities could take to ensure preparedness for dealing with actual or potential shortages of medicinal products caused by public health emergencies or major events.
5. Where requested by the Commission, the MSSG may coordinate measures taken by the national competent authorities, the marketing authorisation holders and other entities, including representatives of healthcare professionals and of patients, as relevant, to prevent or mitigate actual or potential shortages of medicinal products in the context of a public health emergency or major event.
Working methods and provision of information on medicinal products
1. In order to prepare for the fulfilment of the tasks referred to in Articles 4 to 8, the Agency, shall:
(a)
specify the procedures and criteria for establishing and reviewing the critical medicines lists;
(b)
specify the methods of and criteria for the monitoring, data collection and reporting provided for in Articles 4, 7 and 8, with a basic minimum data set;
(c)
develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with other existing IT systems and IT systems under development until the ESMP is fully functional, on the basis of data fields that are harmonised across Member States;
(d)
establish the working party referred to in Article 3(6) and ensure that each Member State is represented on that working party;
(e)
establish and maintain a list of single points of contact for marketing authorisation holders for all medicinal products authorised in the Union, through the database provided for in Article 57(1), point (l), of Regulation (EC) No 726/2004;
(f)
specify the methods for the provision of recommendations referred to in Article 5(2) and Article 8(3) and (4) and for the coordination of measures referred to in Article 8(5);
(g)
publish information covered by points (a), (b) and (f) on a dedicated webpage on its web portal.
For the purposes of the first subparagraph, point (a), Member States, marketing authorisation holders, other relevant actors in the supply chain for medicinal products and representatives of healthcare professionals, of patients and consumers, may be consulted as necessary.
2. Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the Agency shall:
(a)
establish a list of single points of contact for the marketing authorisation holders for the medicinal products included on the critical medicines lists;
(b)
maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency or major event;
(c)
request relevant information on medicinal products on the critical medicines lists from the single points of contact referred to in point (a) and set a deadline for the submission of that information, if that information is not available in the ESMP;
(d)
request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.
3. The information referred to in paragraph 2, point (c), shall include at least:
(a)
the name of the marketing authorisation holder of the medicinal product;
(b)
the name of the medicinal product;
(c)
the identification of active manufacturing sites for finished products and active substances of the medicinal product;
(d)
the Member State in which the marketing authorisation is valid and the marketing status of the medicinal product in each Member State;
(e)
details of the actual or potential shortage of the medicinal product, such as actual or estimated start and end dates and suspected or known cause;
(f)
sales and market share data of the medicinal product;
(g)
available stocks of the medicinal product;
(h)
the forecast of supply for the medicinal product, including information on potential vulnerabilities in the supply chain, quantities already delivered and projected deliveries;
(i)
demand forecasts for the medicinal product;
(j)
details of available alternative medicinal products;
(k)
shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity and approved production sites of the finished medicinal product and of active substances, potential alternative production sites and minimum stock levels of the medicinal product.
4. In order to supplement the shortage prevention and mitigation plans for critical medicinal products referred to in paragraph 3, point (k), the Agency and national competent authorities for medicinal products may request information from wholesale distributors and other relevant actors regarding any logistical challenges incurred in the wholesale supply chain.
Obligations on marketing authorisation holders
1. Marketing authorisation holders for medicinal products authorised in the Union shall provide the information for the purposes of Article 9(1), point (e), of this Regulation by 2 September 2022, in the form of an electronic submission to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004. Those marketing authorisation holders shall provide updates when necessary.
2. In order to facilitate the monitoring referred to in Article 7, the Agency may request marketing authorisation holders for medicinal products included on the critical medicines lists to submit the information referred to in Article 9(2) point (c).
The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (b), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.
3. The marketing authorisation holders referred to in paragraphs 1 and 2 shall justify any failure to provide any requested information and any delays in providing requested information by the deadline set by the Agency.
4. Where the marketing authorisation holders referred to in paragraph 2 indicate that the information that they submitted at the request of the Agency or the national competent authorities for medicinal products contains information of a commercially confidential nature, they shall identify the relevant parts of that information having such nature and explain why that information is of a commercially confidential nature.
The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.
5. Where the marketing authorisation holders referred to in paragraph 2 or other relevant actors in the supply chain for medicinal products have any information in addition to that required under paragraph 2, second subparagraph, which provides evidence of an actual or potential shortage of medicinal products, they shall immediately provide such information to the Agency.
6. Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), the marketing authorisation holders referred to in paragraph 2 shall:
(a)
provide any comments they have to the Agency;
(b)
take into account any recommendations referred to in Article 8(3) and (4) and any guidelines referred to in Article 12, point (c);
(c)
comply with any measures taken at Union or Member State level pursuant to Articles 11 and 12;
(d)
inform the MSSG of any measures taken and report on the monitoring and results of those measures, including providing information on the resolution of the actual or potential shortage of medicinal products.
Role of Member States in the monitoring and mitigation of shortages of medicinal products
1. In order to facilitate the monitoring referred to in Article 7, unless the information concerned is available on the ESMP, the Agency may request a Member State to:
(a)
submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;
(b)
indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 10(4);
(c)
indicate any failure to provide requested information, and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 10(3).
Member States shall comply with the Agency’s request by the deadline set by the Agency.
2. For the purposes of paragraph 1, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products included on the critical medicines lists to the public shall provide that Member State with relevant information and data, including information and data on the levels of stock of those medicinal products at the request of that Member State.
3. Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6) of this Regulation.
4. Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), Member States shall:
(a)
take into account any recommendations and guidelines referred to in Article 12, point (c), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);
(b)
inform the MSSG of any measures taken and report on the results of the actions referred to in point (a), including providing information on the resolution of the actual or potential shortage of medicinal products.
For the purposes of the first subparagraph, points (a) and (b), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MSSG in a timely manner.
The recommendations, guidelines and actions referred to in the first subparagraph, point (a), and a summary report of the lessons learned, shall be made publicly available via the web portal referred to in Article 14.
Role of the Commission regarding the monitoring and mitigation of shortages of medicinal products
The Commission shall take into account the information from and recommendations of the MSSG referred to in Article 8(1) and (2) and in Article 8(3) and (4), respectively, and shall:
(a)
take all necessary action within the limits of the powers conferred on the Commission, with a view to mitigating actual or potential shortages of medicinal products included on the critical medicines lists;
(b)
facilitate the coordination between marketing authorisation holders and other relevant entities to address demand surges, where necessary;
(c)
consider the need for guidelines and recommendations to be addressed to Member States, marketing authorisation holders, and other entities, including relevant entities from the supply chain for medicinal products, where relevant;
(d)
inform the MSSG of any measures taken by the Commission and report on the results of those measures;
(e)
request the MSSG to provide recommendations or coordinate measures as provided for in Article 8(3), (4) and (5);
(f)
consider the need for medical countermeasures in accordance with Decision No 1082/2013/EU and other applicable Union law;
(g)
liaise with third countries and relevant international organisations, as appropriate, to mitigate actual or potential shortages of medicinal products included on the critical medicines lists or their active substances, where those medicinal products or active substances are imported into the Union and where such actual or potential shortages have international implications, and report on any related actions as well as the results of those actions to the MSSG, where relevant.
European shortages monitoring platform
1. The Agency shall set up, maintain, and manage an IT platform to be known as the European shortages monitoring platform (‘ESMP’), which shall be linked to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004.
The ESMP shall be used to facilitate the collection of information on shortages of, supply of, and demand for medicinal products, including information on whether the medicinal product is placed or ceases to be placed on the market in a Member State.
2. The information collected through the ESMP shall be used to monitor, prevent, and manage:
(a)
actual or potential shortages of medicinal products on the critical medicines lists during public health emergencies and major events; and
(b)
actual or potential shortages of medicinal products that are likely to lead to a public health emergency or a major event in accordance with Article 4(2).
3. For the purposes of paragraph 2, during public health emergenciesand major events:
(a)
marketing authorisation holders shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(2), point (a), in accordance with Articles 9 and 10;
(b)
Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.
The reporting referred to in the first subparagraph, point (b), shall include information in addition to that referred to in that point received from marketing authorisation holders and wholesale distributors, or other persons or legal entities that are authorised or entitled to supply to the public medicinal products included on the critical medicines lists, where relevant.
4. For the purposes of paragraph 2, and as regards ensuring preparedness for public health emergencies and major events:
(a)
marketing authorisation holders shall use the ESMP to report to the Agency:
(i)
the information referred to in Article 13(4) of Regulation (EC) No 726/2004 for authorisations granted in accordance with that Regulation;
(ii)
information based on the categories set out in Article 9(3) that relate to actual or potential shortages of medicinal products that are likely to lead to a public health emergency or major event, where appropriate;
(b)
Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).
5. The reporting referred to in paragraph 4, point (b):
(a)
shall include the information referred to in Article 23a of the Directive 2001/83/EC that was reported to national competent authorities for medicinal products for authorisations granted in accordance with that Directive;
(b)
may include additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public.
6. To ensure the optimal use of the ESMP, the Agency shall:
(a)
develop the technical and functional specifications of the ESMP, including the data exchange mechanism for exchanging with the existing national systems and the format for electronic submissions, in collaboration with the MSSG;
(b)
require that data submitted to the ESMP comply with the standards developed by the International Organization for Standardization for the identification of medicinal products and be based on the domains of master data in pharmaceutical regulatory processes, namely substance, product, organisation, and referential data, where relevant;
(c)
develop standardised reporting terminology to be used by marketing authorisation holders and Member States when reporting to the ESMP, in collaboration with the MSSG;
(d)
establish relevant guidance for reporting through the ESMP, in collaboration with the MSSG;
(e)
ensure that data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without any duplication of reporting;
(f)
ensure that the Commission, the Agency, national competent authorities and the MSSG have appropriate levels of access to the information contained in the ESMP;
(g)
ensure that commercially confidential information submitted to the system is protected against unjustified disclosure;
(h)
ensure the ESMP is fully operational by 2 February 2025 and draw up a plan for the implementation of the ESMP.
Communication regarding the MSSG
1. The Agency shall provide information to the public and interest groups with regard to the work of the MSSG in a timely manner and shall respond to disinformation targeting the work of the MSSG as appropriate, via a dedicated webpage on its web portal and other appropriate means, in cooperation with national competent authorities.
2. Proceedings of the MSSG shall be transparent.
The summaries of the agenda and of the minutes of the meetings of the MSSG, as well as its rules of procedure referred to in Article 3(5) and recommendations referred to in Article 8(3) and (4), shall be documented and made publicly available on a dedicated webpage on the Agency web portal.
Where the rules of procedure referred to in Article 3(5) allow members of the MSSG to have divergent opinions recorded, the MSSG shall make such divergent opinions, and the grounds on which they are based, available to national competent authorities for medicinal products at their request.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
