EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 11.11.2020  
COM(2020) 725 final  
2020/0321 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on a reinforced role for the European Medicines Agency in crisis preparedness and 
management for medicinal products and medical devices  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
• Reasons for and objectives of the proposal  
The unprecedented experience of the COVID -19 pandemic has demonstrated that the 
Union’s ability to coordinate work to ensure the availability of medicinal products 
and medical devices and facilitate their development is currently limited.  
During the COVID -19 crisis, ad hoc solutions needed to be found to contain the risk 
of shortages of medicines and medical devices such as ventilators, surgical masks 
and COVID -19 test kits. The operation of these mechanisms during the emergency 
was made possible by contingent arrangements between the actors involved (the 
Member S tates, the Commission, the European Medicines Agency (‘the Agency’), 
the medicinal product marketing authorisation holders, and the medical device 
manufacturers and authorised representatives). This has in some cases required the 
Commission and the Agency to take on tasks requiring ad hoc working methods. For 
these solutions to become efficient and predictable, the respective roles and 
obligations of the different entities should be clarified and anchored in the relevant 
legislative framework.  
Moreover, fo r, when a number of medicines purported to treat or prevent COVID -19, 
the Agency did not always have access to sufficient health data to formulate 
coordinated recommendations across the Union. The Agency provided scientific 
advice on their development and ability to fight COVID -19 to the utmost of its 
ability, but outside of a formal crisis management structure and without the benefit of 
fast-track scientific advice procedures and obligations on Member States and 
developers to cooperate. In particular, deve lopers indicated a lack of harmonisation 
on aspects related to clinical trials, stemming mainly from the fact that each trial 
needs to be authorised separately in each Member State.  
A suitable framework to support the work of the Expert Panels on medical devices as 
provided for in Regulation (EU) 2017/7451 should also be provided for in order to 
ensure that those panels can efficiently and effectively provide scientific advice 
relevant for crisis preparedness and management, in addition to their core funct ion to 
provide opinions on the verification by notified bodies of the clinical and 
performance assessments for certain high -risk medical devices, including certain in 
vitro  diagnostic devices. This type of advice is essential for crisis preparedness and 
management, for example in the context of the COVID -19 pandemic, repurposing 
production lines for fast production of ventilators with the associated minimal 
technical and safety specifications.  
Therefore, a clear framework for the activities to be deployed by the Agency in 
preparation for and during public health emergencies and other major events should 
be established in order to enhance the Union's capacity to react quickly, efficiently, 
and in a coordinated manner to such emergencies. To be effective and operational in 
                                                 
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (E C) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117, 5.5.2017, p. 1 as 
amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 
amending Regulation (EU ) 2017/745 on medical devices, as regards the dates of application of certain 
of its provisions, OJ L 130, 24.4.2020, p. 18.  EN 2  EN times of public health emergencies, the approach should be based on strong 
preparedness. This preparedness can be achieved with the development of common 
tools and agreed methods for monitoring, reporting and data collection. Gathering 
data on key medicines and medical devices considered the most likely to be impacted 
by a health emergency or other major event is also a key priority. In doing so, the 
proposed Regulation builds on experience from the COVID -19 pandemic so far and 
on ad hoc solu tions set up over the last months as well as the management of 
previous major events in the context of the established incident management plan. As 
part of this plan the  EU Regulatory Network Incident Management Plan for 
medicines for human use was develop ed (Incident Review Network/IRN). 2 This 
structure is used to continuously monitor events and new information, to review their 
public health impact and to take the necessary routine measures to remedy the 
situation. The Incident Review Network will continu e its activities taking into 
account the new management structure in times of crisis provided by the Medicines 
Steering Group established by the proposed Regulation. The proposed Regulation 
will complement and further develop the core tasks already given t o the Agency in 
its founding Regulation3, notably to provide scientific advice and to assess the 
quality, safety and efficacy of medicinal products as part of their authorisation 
process.  
The general objectives of the proposal are to:  
1. ensure a high lev el of human health protection by strengthening the Union’s 
ability to manage and respond to public health emergencies, which have an 
impact on medicinal products and medical devices;  
2. contribute to ensuring the smooth functioning of the internal market for such 
products during public health emergencies.  
The specific objectives of the proposal are to:  
1. monitor and mitigate potential and actual shortages of medicinal products and 
medical devices considered as critical in order to address a given public h ealth 
emergency or, for medicinal products, other major events which may have a 
serious impact on public health;  
2. ensure timely development of high quality, safe and efficacious medicinal 
products with a particular focus on addressing a given public heal th 
emergency;  
3. ensure smooth functioning of expert panels for the assessment of some high -
risk medical devices and avail of essential advice in crisis preparedness and 
management with regard to the use of medical devices.  
• Consistency with existing policy provisions in the policy area  
As part of a package of closely associated measures, the proposal will form part of 
the Union’s overall health response to the COVID -19 pandemic and enhanced crisis 
management framework. The recognition of a public health emergency in accordance 
                                                 
2 https://www.ema.europa.eu/en/documents/other/european -union -regulatory -network -incident -
management -plan-medicines -human -use_en.pdf   
3 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down C ommunity procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1.  EN 3  EN with the p roposed Regulation on Cross -Border Health Threats would trigger the 
activation of the structures provided for within this proposal. The proposed 
monitoring of potential and actual shortages of medicines and medical devices would 
provide a clear evidence ba se, which would inform decisions on the need for medical 
countermeasures as provided for in that proposed Regulation.  
The proposed measures would also complement the considerable body of current 
Union legislation in the fields of medicinal products and me dical devices by 
supporting the continued implementation of that legislation during times of crisis. By 
facilitating the development of medicines, which have the potential to treat, prevent 
or diagnose a disease causing a public health crisis, the proposal  will support the 
implementation of the current legislation on clinical trials. The Agency and Member 
States can use opinions and recommendations on such medicines in regulatory 
procedures leading to their authorisation for use within the EU. By providing a 
permanent structure within the Agency for the functioning of expert panels, the 
proposal will create the ability to quickly provide scientific advice and technical 
support on demand in case of crisis and to support the assessment of certain high -risk 
medical devices.  
While not a central component of the proposed Regulation, it shall also contribute 
indirectly to the EU’s international cooperation priorities in the area of global health. 
Through the work of the Emergency Task Force, the proposed Regulation  will not 
only support Member States but also partner countries, to develop and access 
potential treatments and vaccines during public health crises, thus supporting the 
strengthening of health systems and global health security preparedness and 
response.  
• Consistency with other Union policies  
This proposal is in line with the obligations set out in the Union’s Charter of 
Fundamental Rights and the EU's overarching objectives, including a stronger Health 
Union, a smooth functioning of the internal market, sustainable and resilient health 
systems, and an ambitious research and innovation agenda. In addition, the proposal 
will provide useful input to and synergies with the EU Digital Single Market agenda 
and in the context of the planned European Health Data Space, encouraging and 
supporting innovation and research, facilitating access to and analysis of data and 
information, including real world data (health data generated outside the scope of 
clinical studies), and by including the Agency in the European Hea lth Data Space IT 
infrastructure, with the purpose, inter alia , of monitoring use and shortages of 
medicinal products and medical devices. While this proposal provides for a role for 
the Agency in the European Health Data Space, the details and procedures for 
processing personal data through that IT infrastructure, including the role of the 
Agency as a data controller and/or processor will be set out in the planned legislative 
proposal on that data space.  
The proposal contributes to achieving a high level of human health protection and is 
thus consistent with the Charter of Fundamental Rights in this regard. Where 
personal data is processed to fulfil the provisions of the proposed Regulation, this 
will be done in line with the relevant Union legislation on personal data protection , 
namely  Regulation (EU) 2018/17254 and Regulation (EU) 2016/6795 (the General 
                                                 
4 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, 
 EN 4  EN Data Protection Regulation (GDPR)) and build on existing procedures and processes 
within the Agency which are used to meet such requirements.  
The propos al is a tailored approach for medicine and medical device management 
focusing on public health emergency preparedness. These measures will be 
complemented by additional actions under the Pharmaceutical Strategy for Europe to 
address structural challenges.  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis  
The proposed Regulation would be based on Articles 114 and 168(4)(c) of the Treaty 
on the Functioning of the European Union. Such an approach is based on the general 
and specific objectives of  the proposal, namely to ensure the smooth functioning of 
the internal market, also during times of crisis, and to ensure the quality and safety of 
medicinal products and medical devices developed during such periods. This 
approach is also consistent with the legal basis generally used for Union legislation 
on medicinal products and medical devices6. 
• Subsidiarity   
Public health emergencies of the magnitude of COVID -19 have an impact on all 
Member States, which, on their own are unable to provide a sufficient response. 
Potential or actual shortages of (nationally and centrally authorised) medicines and 
medical device s in times of crises can lead to the risk of disproportionate national 
stockpiling or restrictions to single market movements being placed on such goods. 
Such measures can have a negative impact on the free movement of goods. A 
coordinated response at Unio n-level to monitoring and mitigating the risk of 
shortages can help the Member States to be better prepared for a sudden increase in 
demand, avoid export restrictions within the EU or excessive and uncoordinated 
stockpiling,  resulting in an effective alloc ation of resources at national and Union 
level, maintaining the smooth functioning of the single market and ensuring an 
overall positive impact on public health.  
Providing scientific advice on medicinal products which have the potential to address 
public health emergencies at Union -level can facilitate their market entry, ensure a 
harmonised approach to their use across Member States, and help to ensure such 
products meet harmonised EU standards for their quality, safety and efficacy. 
Scientific advice can  eliminate duplication of efforts and unnecessary research.  
An uncoordinated approach to the development of medicines, which have the 
potential to treat, prevent, or diagnose diseases causing public health emergencies 
can cause delays in their development during periods where time is of the essence. 
Moreover, a lack of clear, Union -level advice on the use of medicines in national 
compassionate use programmes or outside of their authorised indications can lead to 
                                                                                                                                                         
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1 247/2002/EC (OJ L 295, 21.11.2018, p. 39).  
5 Regulation (EU) 2016/769 of the European Parliament and of the Council of 27 April 2016 on the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC, OJ L 119, 4.5.2016, p. 1  
6 For example: Directive 2001/83/EC, Regulation (EC) No 726/2004, Regulation (EU) 2017/745, and 
Regulation (EU) 2017/746  EN 5  EN a fragmented approach across the Union. In ad dition, regulators’ access to EU -wide 
health data is limited and scattered across different partners leading to complex and 
slow analysis, undermining the optimal time window for certain interventions.  
• Proportionality  
The proposal constitutes a proportio nate response to address the problems described 
in section 1. In particular, the proposed requirement of more structured monitoring at 
Union level will avoid duplication and provide a better overview of shortage issues 
of a Union -wide interest.  
The propos al does not interfere with Member States’ competences in decisions on 
the organisation of health care. The proposal does not interfere with notifications sent 
by marketing authorisation holders to the competent authorities when a product 
ceases to be on th e market according to Article 23a of Directive 2001/83/EC7.  
• Choice  of the instrument  
The proposal takes the form of a new Regulation. This type of instrument is 
considered to be the most suitable considering that a key element of the proposal is 
the est ablishment of a framework at Union -level providing for coordinated action to 
address public health emergencies and major events and gives a number of tasks to 
the Agency. The measures do not require the implementation of national measures 
and can be direct ly applicable.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• Ex-post evaluations/fitness  checks  of existing  legislation  
As part of a package of urgent measures based on lessons learnt so far from COVID -
19, the initi ative will be supported by an assessment of data collected and exchanges 
held with public and private stakeholders in the framework of the COVID -19 
pandemic on issues encountered and possible means to address them. Considering 
that the initiative will enla rge the scope of existing legislation, it will not be based on 
an ex post evaluation, as the needs identified were not addressed by the existing 
framework.  
• Stakeholder  consultations  
Shortages of medicines have been a priority for the Member States and Eu ropean 
Parliament for many years as illustrated by several reports from the European 
Parliament as well as Council conclusions and discussions under recent Council 
Presidencies.  
Following the COVID -19 pandemic, coordinating EU health policies, strengtheni ng 
crisis management and increasing EU production of essential medicinal products and 
medical devices have also been identified as a priority by the Council. In addition, 
several Member States have called for coordination to ensure availability of critical  
medicines, including vaccines and medical devices during the COVID -19 and 
potential future health crises.  
                                                 
7 Directive 2001/83/EC of the European Parliament and of the Council of 6 No vember 2001 on the 
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67  EN 6  EN In its resolution on shortages of medicines of 17 September 20208, the European 
Parliament calls on the Commission to implement fast -track and innova tive solutions 
to mitigate medicines shortages and calls on the Commission, the Agency and the 
national regulatory authorities to build on all the pragmatic efforts made during the 
COVID -19 crisis. The proposed Regulation would allow the Agency , to achieve  part 
of the vision outlined in the European Parliament’s resolution.  
Medicinal product interest groups including associations representing respectively 
hospital pharmacists, community pharmacists, consumer associations, wholesale 
distributors, and medica l doctors, have expressed concerns in relation to the recurrent 
problems of shortages of medicines in the EU. Such interest groups have renewed 
long-standing calls for action on this during the COVID -19 pandemic given the acute 
impact it has had on the sup ply of certain medicinal products during the current 
crisis. The COVID -19 pandemic has been extremely challenging for the medical 
devices industry, which has had to adapt to a sharp increase on demand in a climate 
of lack of coordination. Medical Device int erest groups have recurrently requested a 
clearer view of EU demand in order to ensure that production capacity will meet the 
needs of Member States, which is essential to avoid shortages. The lack of EU -wide 
scientific advice on medical devices during the  current crisis has also been 
highlighted as an area that the expert panels can contribute to in future crises.  
• Impact  assessment  
Due to its urgent nature this proposal is not accompanied by an impact assessment.  
The initiative will enlarge the scope of the existing legislation. These changes are 
mainly based on an assessment of the data collected during the first months of the 
pandemic and exchanges held with public and private stakeholders in the framework 
of the COVID -19 pandemic on issues encountered and possible means to address 
them. As regards medical devices, the proposal takes into account the impact 
assessment undertaken in preparation for Regulation (EU) 2017/745 and Regulation 
(EU) 2017/746.   
• Fundamental  rights  
The proposed Regulation contributes to achieving a high level of human health 
protection as set out in Article 35 of the EU Charter of Fundamental Rights. Where 
personal data is processed based on this proposal it will be done in line with the 
relevant Union legislation on person al data protection namely,  Regulation (EU) 
2018/1725 and Regulation (EU) 2016/679 (the General Data Protection Regulation 
(GDPR)).  
4. BUDGETARY  IMPLICATIONS  
The implementation of this proposal has no impact on the current Multiannual 
Financial Framework 2014 -2020.  
The financial impact on the EU budget post -2020 will be part of the next 
Multiannual Financial Framework.  
The budgetary implications are mainly re lated to:  
                                                 
8 European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an 
emerging problem (2020/2071(INI))  EN 7  EN – administrative support  (e.g. to ensure the secretariat of the Executive Steering 
Groups for medicinal products and medical devices, and the Emergency Task 
Force, establish and maintain networks of single points of contacts, provide the 
secretaria t for the medical device expert panels, coordinate independent 
vaccines effectiveness and safety monitoring studies using relevant data held 
by public authorities);  
– scientific support (e.g. provide scientific advice on medicines which have the 
potential to  treat, prevent or diagnose diseases and technical assessments and 
advice on medical devices by expert panels;  
– IT support (e.g. establish, host, and maintain streamlined electronic monitoring 
and reporting tools);  
– remuneration in the form of a special allo wance to national experts involved in 
expert panels on medical devices.  
5. OTHER  ELEMENTS  
• Detailed  explanation  of the specific  provisions  of the proposal  
The proposal aims to complement the measures directed at improving the overall EU 
crisis management framework by addressing the specific issues related to medicinal 
product and medical device sectors and the tasks of the Agency. It would thus 
introduce new rules for the Agency with the objective to provide mechanisms within 
the Agency to:  
– Monitor and mit igate potential and actual shortages of medicinal products and 
medical devices considered as critical in order to address a given public health 
emergency or, for medicinal products, major event;  
– Provide advice on medicinal products, which have the potentia l to treat, 
prevent or diagnose the disease in question. Such advice would cover both 
medicinal products under development, those used under national 
compassionate use programmes, and those already authorised for a different 
indication but with the potenti al to also treat, prevent or diagnose the disease in 
question (repurposed medicines).  
– Provide a well -managed and sustainable structure to coordinate the expert 
panels on medical devices, which will be involved in the assessment of specific 
high-risk medic al devices and device types relevant for health crisis 
management and provide scientific advice essential in crisis preparedness and 
crisis management.  
The proposal also seeks to ensure inter -Agency cooperation during such 
emergencies, most notably with t he European Centre for Disease Prevention and 
Control (ECDC).  EN 8  EN 2020/0321 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on a reinforced role for the European Medicines  Agency in crisis preparedness and 
management for medicinal products and medical devices  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Articles 114 and 168(4)(c) thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
After consulting the European Economic and Social Committee9,  
After con sulting the Committee of the Regions10, 
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union 
(‘TFEU’) and Article 35 of the Charter of Fundamental R ights of the European Union 
the Union is to ensure a high level of human health protection in the definition and 
implementation of all Union policies and activities.  
(2) The unprecedented experience of the COVID -19 pandemic has demonstrated that the 
Union should be more effective in managing the availability of medicinal products and 
medical devices and in developing medical countermeasures to address the threats 
posed to public health. The Union’s ability to do so has been severely impeded by the 
absence o f a clearly defined legal framework for managing its response to the 
pandemic, and also by the limited degree of Union preparedness in case of a public 
health emergency impacting a majority of Member States.  
(3) The often complex supply chains of medicina l products and medical devices, national 
export restrictions and bans, border closures impeding the free movement of those 
goods, and uncertainty related to their supply and demand in the context of the 
COVID -19 pandemic have led to significant impediments  to the smooth functioning of 
the single market and to addressing the serious threats to public health across the 
Union.  
(4) Dealing with the issue of shortages of medicinal products has been a long -standing 
priority for the Member States and European Par liament as illustrated by several 
                                                 
9 OJ C , , p . . 
10 OJ C , , p. .  EN 9  EN reports from the European Parliament11 as well as discussions under recent 
Presidencies of the Council of the European Union.  
(5) The COVID -19 pandemic has exacerbated the problem of shortages for certain 
medicinal product s considered as critical in addressing the pandemic, and has 
highlighted the structural limitations in the Union’s ability to rapidly and effectively 
react to such challenges during public health crises.  
(6) The rapid evolution of COVID -19 and the spread o f the virus led to a sharp increase in 
demand for medical devices such as ventilators, surgical masks, and COVID -19 test 
kits while disruption of production or limited capacity to rapidly increase production 
and the complexity and global nature of the supp ly chain for medical devices, led to a 
negative impact on supply. Those issues resulted in new entities being involved in the 
production of those products, which subsequently resulted in bottlenecks in 
conformity assessment, as well as the prevalence of no n-compliant, unsafe, and in 
some cases counterfeit products. It is therefore appropriate to establish long -term 
structures within an appropriate Union body to ensure monitoring of shortages of 
medical devices resulting from a public health emergency.  
(7) Uncertainty of supply and demand and the risk of shortages of essential medicinal 
products and medical devices during a public health emergency like the COVID -19 
pandemic can trigger export restrictions amongst Member States and other national 
protective m easures, which can seriously impact the functioning of the internal market. 
Furthermore, shortages of medicinal products can result in serious risks to the health 
of patients in the Union due to their lack of availability, which can cause, medication 
error s, increased duration of hospital stays, and adverse reactions caused by the 
administration of unsuitable products used as a substitute for unavailable ones. With 
respect to medical devices, shortages can lead to a lack of diagnostic resources with 
negativ e consequences for public health measures, a lack of treatment or deterioration 
of the disease and may also prevent health professionals from adequately carrying out 
their tasks. Those shortages can also have a significant impact on controlling the 
spread of a given pathogen caused by, for example, an insufficient supply of COVID -
19 test kits. It is therefore important to address the question of shortages and to 
reinforce and formalise monitoring of critical medicinal products and medical devices.  
(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which 
cause public health emergencies, should be developed and made available within the 
Union as soon as possible during such emergencies. The COVID -19 pandemic has 
also highligh ted sub -optimal coordination and decision -making as regards 
multinational clinical trials, and Union -level advice on the use of medicinal products 
in national compassionate use programmes or outside of their authorised indications in 
the Union, causing del ays in the adoption of research outcomes and in the 
development and availability of new or repurposed medicines.  
(9) During the COVID -19 pandemic ad hoc solutions, including contingent arrangements 
between the Commission, the European Medicines Agency (‘th e Agency’), marketing 
authorisation holders, manufacturers and Member States, had to be found to achieve 
the objective of making available safe and efficacious medicinal products to treat 
COVID -19 or prevent its spread, and to facilitate and speed up the d evelopment and 
marketing authorisation of treatments and vaccines.  
                                                 
11 European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an 
emerging problem (2020/2071(INI))  EN 10  EN (10) In order to ensure a better functioning of the internal market of those products and 
contribute to a high level of human health protection, it is therefore appropriate to 
approximate t he rules on monitoring of shortages of medicinal products and medical 
devices, and to facilitate the research and development of medicinal products, which 
may have the potential to treat, prevent, or diagnose diseases that cause public health 
crises.  
(11) This Regulation aims to ensure the smooth functioning of the internal market as 
regards medicinal products and medical devices, with a high level of human health 
protection being fundamental in those aims. Moreover, this Regulation aims to ensure 
the qual ity, safety and efficacy of medicinal products with the potential to address 
public health emergencies. Both objectives are being pursued simultaneously and are 
inseparably linked whilst one not being secondary to the other. As regards Article 114 
TFEU, th is Regulation establishes a framework for the monitoring and reporting on 
shortages of medicinal products and medical devices during public health crises. As 
regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union 
framework ensuri ng the quality and safety of medicinal products and medical devices.  
(12) In order to improve crisis preparedness and management for medicinal products and 
medical devices and increase resilience and solidarity across the Union, the procedures 
and the resp ective roles and obligations of different concerned entities involved should 
be clarified. The framework should build on the ad hoc solutions identified so far in 
the response to the COVID -19 pandemic.  
(13) A harmonised system of monitoring of shortages o f medicinal products and medical 
devices should be established, which will facilitate appropriate access to critical 
medicinal products and medical devices during public health emergencies and major 
events, which may have a serious impact on public health.  That system should be 
complemented with improved structures to ensure appropriate management of public 
health crises and coordinate and provide advice on the research and development of 
medicinal products which may have the potential to address public hea lth 
emergencies. In order to facilitate the monitoring and reporting on potential or actual 
shortages of medicinal products and medical devices, the Agency should be able to ask 
and obtain information and data from the concerned marketing authorisation hol ders, 
manufacturers and Member States through designated points of contact.  
(14) The operational phase of the work of the Steering Groups and Emergency Task Force 
provided for in this Regulation should be triggered by the recognition of a public 
health eme rgency in accordance with Regulation (EU) 2020/[…] on Cross -Border 
Health Threats and, as regards the Medicines Steering Group, the existence of a major 
event. Continuous monitoring of the risk to public health from major events, including 
manufacturing is sues, natural disasters and bioterrorism with the potential to affect the 
quality, safety, efficacy or supply of medicinal products should also be ensured.   
(15) With respect to medicinal products, an executive steering group should be established 
within t he Agency to ensure a robust response to major events and to coordinate 
urgent actions within the Union in relation to the management of issues relating to the 
supply of medicinal products. The Steering Group should establish lists of critical 
medicinal pr oducts to ensure monitoring of those products and it should be able to 
provide advice on the necessary action to take to safeguard the quality, safety, and 
efficacy of medicinal products and ensure a high level of human health protection.  
(16) The Executi ve Steering Group on Shortages and Safety of Medicinal Products should 
benefit from the Agency’s extensive scientific expertise as regards the evaluation and EN 11  EN supervision of medicinal products and should further develop the Agency’s leading 
role in coordina ting and supporting the response to shortages during the COVID -19 
pandemic.  
(17) In order to ensure that safe, high quality, and efficacious medicinal products, which 
have the potential to address public health emergencies, can be developed and made 
avail able within the Union as soon as possible during public health emergencies, an 
emergency task force should be established within the Agency to provide advice on 
such medicinal products. The Emergency Task Force should provide advice free of 
charge on scien tific questions related to the development of treatments and vaccines 
and on clinical trial protocols, to those organisations involved in their development, 
such as marketing authorisation holders, clinical trial sponsors, public health bodies, 
and academi a, irrespective of their exact role in the development of such medicinal 
products.  
(18) The work of the Emergency Task Force should be separate from the work of the 
scientific committees of the Agency and should be carried out without prejudice to the 
scientific assessments of those committees. The Emergency Task Force should 
provide recommendations with regard to the use of medicinal products in the fight 
against the disease that is responsible for the public health crisis. The Committee for 
Medicinal Pro ducts for Human Use should be able to use those recommendations 
when preparing scientific opinions on compassionate or other early use of a medicinal 
product prior to marketing authorisation.  
(19) The establishment of the Emergency Task Force should build  on the support provided 
by the Agency during the COVID -19 pandemic, notably as regards scientific advice 
on clinical trials design and product development as well as the ‘rolling’ review i.e. on 
an on -going basis, of emerging evidence to allow a more effi cient assessment of 
medicinal products including vaccines during public health emergencies.  
(20) Individual research entities may agree together, or with another party, to act as a 
sponsor in order to prepare one harmonised Union -wide clinical trial protocol, yet 
experience during the COVID -19 pandemic has shown that initiatives to set up large 
multinational trials struggle to materialise due to the lack of a single entity that can 
undertake all the responsibilities and activities of a sponsor within the Union, while 
interacting with multiple Member States. It is therefore appropriate for the Agency to 
identify and facilitate such initiatives by giving advice on the possibilities to act as a 
sponsor or, where applicable, to define respective responsibi lities  as co -sponsors in 
accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would 
strengthen the research environment in the Union, and promote harmonisation and 
avoid subsequent delays in integrating the results of research to a mark eting 
authorisation. A Union sponsor could benefit from Union research funding available at 
the time of the public health emergency as well as existing clinical trial networks to 
facilitate the development, application, submission, and running of the trial . This may 
be particularly valuable for trials established by Union or international public health or 
research organisations.  
(21) With respect to  medical devices, an executive steering group on medical devices 
should be established to coordinate urgent ac tions within the Union in relation to the 
management of supply and demand issues of medical devices, and to establish a list of 
critical devices in the case of a public health emergency.  
(22) This Regulation also provides the Agency with a role to support  the expert panels on 
medical devices designated under Commission Implementing Decision (EU) EN 12  EN 2019/139612 to provide independent scientific and technical assistance to the Member 
States, the Commission, the Medical Device Coordination Group (MDCG), notified 
bodies and manufacturers.  
(23) In addition to their role in clinical evaluation assessments and performance evaluations 
of certain high risk medical devices and in vitro  diagnostic medical devices in 
accordance with Regulation (EU) 2017/74513 and Regulation (EU) 2017/74614 
respectively, as well as providing opinions in response to consultation by 
manufacturers and notified bodies, the expert panels should play an essential role in 
the preparedness for and management of public health crises for medical devices, 
including those devices which have the potential to address public health emergencies. 
The panels are to provide scientific, technical, and clinical assistance to the Member 
States, the Commission, and the Medical Device Coordination Group  (MDCG). In 
particular the panels are to contribute to the development of guidance on a number of 
points including clinical and performance aspects for specific devices, categories, or 
groups of devices or specific hazards related to a category or group of  devices, develop 
clinical evaluation and performance evaluation guidance in line with the state of the 
art, and contribute to the identification of concerns and emerging issues on safety and 
performance.  
(24) Given the Agency’s long -standing and proven re cord of expertise in the field of 
medicinal products and considering the Agency’s experience from working with a 
multitude of groups of experts, it is appropriate to establish the appropriate structures 
within the Agency to monitor potential shortages of m edical devices in the context of a 
public health emergency and to provide the Agency with a mandate to host the expert 
panels on medical devices. This would allow for long -term sustainability for the 
functioning of the panels and provide clear synergies wi th related crisis preparedness 
work for medicinal products. Those structures would in no way change the regulatory 
system or the decision -making procedures in the area of medical devices already in 
place in the Union, which should remain clearly distinct f rom the one for medicinal 
products.  
(25) In order to facilitate the work and the exchange of information under this Regulation, 
provision should be made for the establishment and management of IT infrastructures 
and synergies with other existing IT systems  or systems under development, including 
the EUDAMED IT platform for medical devices. That work should also be facilitated 
by, where appropriate, emerging digital technologies such as computational models 
and simulations for clinical trials, as well as dat a from the EU Space Programme such 
as the Galileo geolocation services, and Copernicus earth observation data.  
(26) Rapid access and exchange of health data, including real world data i.e. health data 
generated outside of clinical studies, is essential to ensure effective management of 
public health emergencies and other major events. This Regulation should allow the 
                                                 
12 Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for 
the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards 
the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. 23  
13 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117, 5.5.2017, p. 1.  
14 Regulation (EU) 2017/746 of the Eu ropean Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
OJ L 117, 5.5.2017, p. 176.  EN 13  EN Agency to use and facilitate such exchange and be part of the establishment and 
operation of the European Health Data Space infrastructure.  
(27) During a public health emergency or in relation to a major event, the Agency should 
ensure cooperation with the European Centre for Disease Prevention and Control and 
other Union Agencies as appropriate. Such cooperation should include data sharing, 
including data on epidemiological forecasting, regular communication at an executive 
level, and invitations to representatives of the European Centre for Disease Prevention 
and Control and other Union Agencies to attend meetings of the Emergency Task 
Force, the Medicines Steering Group, and the Medical Devices Steering Group, as 
appropriate.  
(28) Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States alone due to the cross -border dimension of public health emergencies an d major 
events and can, therefore, be better achieved at Union level, the Union may adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionalit y, as set 
out in that Article, this Regulation does not go beyond what is necessary in order to 
achieve those objectives.  
(29) In order to ensure that sufficient resources are available for the work provided for 
under this Regulation, expenditure of the A gency should be covered by the 
contribution from the Union to the Agency’s revenue.  
(30) The European Data Protection Supervisor has been consulted in accordance with 
Article 42(1) of Regulation (EU) No 2018/172515 and has adopted an opinion.16 
(31) In acco rdance with Article 168(7) of the Treaty, this Regulation fully respects the 
responsibilities of the Member States for the definition of their public health policy 
and for the organisation and delivery of health services and medical care as well as  the 
fundamental rights and principles recognised by the Charter of Fundamental Rights of 
the European Union including the protection of personal data,  
HAVE ADOPTED THIS REGULATION:  
Chapter I  
General Provisions  
Article 1  
Subject Matter  
This Regulation provides for , within the European Medicines Agency (‘the Agency’), a 
framework for and the means to:  
                                                 
15 Regulation (EU) 2018/1725 of the European Parliament and of the C ouncil of 23 October 2018 on the 
protection of natural persons with regard to the processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decisi on No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).  
16 [insert reference once available]  EN 14  EN (a) prepare for and manage the impact of major events on medicinal products for human 
use and of public health emergencies on medicinal products for human use and on 
medical devices;  
(b) monitor and report on shortages of medicinal products for human use and medical 
devices;  
(c) provide advice on medicinal products for human use with the potential to address 
public health emergencies;  
(d) provide support for the exper t panels designated in accordance with Implementing 
Decision (EU) 2019/1396.  
Article 2  
Definitions  
For the purposes of this Regulation, the following definitions shall apply:  
(a) ‘public health emergency’ means a public health emergency at Union level 
recognised by the European Commission in accordance with Article 23(1) of 
Regulation (EU) 2020/[…]17; 
(b) ‘medicinal product’ means a medicinal product as defined in point (2) of Article 1 of 
Directive 2001/83/EC of the European Parliament and of the Council;  
(c) ‘medical device’ means both a medical device as defined in point (1) of Article 2 of 
Regulation (EU) 2017/745, read in conjunction with point (a) of Article 1(6) of that 
Regulation, and an in vitro  diagnostic medical device as defined in point (2) of 
Article 2 of Regulation (EU) 2017/746;  
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical 
device does not meet demand for that medicinal product or medical device;  
(e) ‘developer’ means any legal or natural person seeking to g enerate scientific data with 
regard to the quality, safety and efficacy of a medicinal product as part of that 
product’s development;  
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in 
relation to medicinal products  in more than one Member State. Such an event 
concerns a deadly threat or otherwise serious threat to health of biological, chemical, 
environmental or other origin or incident that can affect the supply or quality, safety, 
and efficacy of medicinal product s. Such an event may lead to shortages of medicinal 
products in more than one Member State and necessitates urgent coordination at 
Union level in order to ensure a high level of human health protection.  
                                                 
17 [insert reference to the Regulation of the European Parliament and of the Council on serious cross -
border threats to health and repealing Decision No 1082/2013/EU] OJ C  […], […], p. […].  EN 15  EN Chapter II  
Monitoring and mitigating shortages of critical medicinal 
products and management of major events  
Article 3  
The Executive Steering Group on Shortages and Safety of Medicinal Products  
1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the 
Medicines Steering Group’) is hereby established as part of the Agency. It shall meet 
either in person or remotely, in preparation for or during a public health emergency 
or following a request for assistance referred to in Article 4(3). The Agency shall 
provide its secretariat.  
2. The Medicines Steering Group shall be composed of a representative of the Agency, 
a representative of the Commission and one senior representative per Member State. 
Each Member State shall appoint their representative. Members may be accompanied 
by experts  in specific scientific or technical fields.  
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite 
third parties, including representatives of medicinal product interest groups and 
marketing authorisation holders to attend it s meetings.  
4. The Medicines Steering Group shall establish its rules of procedure including 
procedures relating to the working party referred to the paragraph 5 and on the 
adoption of lists, sets of information, and recommendations. The rules of procedure  
shall enter into force after receiving a favourable opinion from the Commission and 
the Management Board of the Agency.  
5. The Medicines Steering Group shall be supported in its work by a working party 
comprised of single points of contact related to shor tages from national competent 
authorities for medicinal products established in accordance with Article 9(1).  
6. The Medicines Steering Group shall be responsible for fulfilling the tasks referred to 
in Article 4(4) and Articles 5 to 8.  
Article 4  
Monitori ng of events and preparedness for major events and public health emergencies  
1. The Agency shall continuously monitor any event that is likely to lead to a major 
event or a public health emergency.  
2. To facilitate the monitoring task referred to in paragraph 1, the national competent 
authorities, through the single points of contact referred to in Article 3(5), shall, 
based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), 
report to the Agency on any event, including a sh ortage of a medicinal product in a 
given Member State, that is likely to lead to a major event or a public health 
emergency. Where a national competent authority informs the Agency of a shortage 
of a medicinal product in a given Member State, it shall prov ide the Agency with any 
information received from the marketing authorisation holder pursuant to Article 23a 
of Directive 2001/83/EC. Based on a report of an event from a national competent EN 16  EN authority and in order to understand the impact of the event in ot her Member States, 
the Agency may request information from the national competent authorities, 
through the working party referred to in Article 3(5).  
3. Where the Agency considers that an actual or imminent major event needs to be 
addressed, it shall infor m the Commission and the Member States thereof. The 
Commission, on its own initiative or following a request from one or more Member 
States, or the Executive Director of the Agency may request the assistance of the 
Medicines Steering Group to address the m ajor event.  
4. The Medicines Steering Group shall inform the Commission and the Executive 
Director of the Agency, once it considers that the major event has been sufficiently 
addressed. On the basis of that information or on its own initiative, the Commis sion 
or the Executive Director may confirm that the assistance of the Medicines Steering 
Group is no longer needed.  
5. In the case of a major event or public health emergency, Articles 5 to 12 shall apply 
as follows:  
(a) where the major event or public h ealth emergency may affect the safety, 
quality, and efficacy of medicinal products, Article 5 shall apply;  
(b) where the major event or public health emergency may lead to shortages of 
medicinal products in more than one Member State, Articles 6 to 12 shal l 
apply.  
Article 5  
Evaluation of information and the provision of advice on action in relation to the safety, 
quality, and efficacy of medicinal products related to public health emergencies and major 
events  
Following the recognition of a public health em ergency or a request for assistance referred to 
in Article 4(3), the Medicines Steering Group shall evaluate the information related to the 
major event or the public health emergency and consider the need for urgent and coordinated 
action with regard to th e safety, quality, and efficacy of the medicinal products concerned.   
The Medicines Steering Group shall provide advice to the Commission and Member States on 
any appropriate action it believes should be taken at Union level on the medicinal products 
conc erned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 
726/2004.18  
Article 6  
Lists of critical medicinal products and information to be provided  
1. Following a request for assistance referred to in Article 4(3) and after cons ultation of 
its working party, the Medicines Steering Group shall adopt a list of medicinal 
products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 
726/2004 which it considers as critical during the major event (‘the major event 
critical medicines list ’). The list shall be updated whenever necessary until the major 
event has been sufficiently addressed.  
                                                 
18 Regulation (EC) No 726/2004  EN 17  EN 2. Immediately following the recognition of a public health emergency  and after 
consultation of its working party, the Medicines  Steering Group shall adopt a list of 
medicinal products authorised in accordance with Directive 2001/83/EC or 
Regulation (EC) No 726/2004  which it considers as critical during the public health 
emergency (‘the public health emergency critical medicines li st’). The list shall be 
updated whenever necessary until the termination of the recognition of the public 
health emergency.  
3. The Medicines  Steering Group shall adopt a set of information necessary to monitor 
the supply and demand of medicinal products included on the lists referred to in 
paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party 
thereof.  
4. The Agency shall immediately publish the critical medicines lists and any updates to 
those lists on its web -portal  referred to  in Article 26 of Regulation (EC) No 
726/2004.  
Article 7  
Monitoring shortages of medicinal products on the critical medicines lists  
On the basis of the critical medicines lists and the information and data provided in 
accordance with Articles 10 and 11, th e Medicines Steering Group shall monitor supply and 
demand of medicinal products included on those lists with a view to identifying any potential 
or actual shortages of those medicinal products. As part of that monitoring, the Medicines  
Steering Group sha ll liaise, where relevant, with the Health Security Committee established in 
Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the 
Advisory Committee on public health emergencies established pursuant to Article 24 of tha t 
Regulation.  
Article 8  
Reporting and recommendations on shortages of medicinal products  
1. For the duration of a public health emergency or following a request for assistance 
referred to in Article 4(3) and until its closure, the Medicines Steering Group shall 
regularly report the results of its monitoring to the Commission and the sub -network 
referred to in Article 9(2), and, in particular, signal any potential or actual shortages 
of medicinal products included on the critical medicines lists.  
2. Where re quested by the Commission or the sub -network referred to in Article 9(2), 
the Medicines Steering Group shall provide aggregated data  and forecasts of demand 
to substantiate its findings. In that regard, the Medicines Steering Group shall liaise 
with the Eu ropean Centre for Disease Prevention and Control to obtain 
epidemiological data to help forecast medicinal product needs, and with the 
Executive Steering Group on Shortages of Medical Devices referred to in Article 19 
where medicinal products included on t he critical medicines lists are administered 
with a medical device.  
3. As part of that reporting, the Medicines Steering Group may also provide 
recommendations on measures, which may be taken by the Commission, Member 
States, marketing authorisation holder s and other entities to prevent or mitigate 
                                                 
19 [insert reference to adopted text referred to in footnote 4]  EN 18  EN potential or actual shortages. In that regard the Group shall liaise, as relevant, with 
the Health Security Committee  and, in the case of a public health emergency, the 
Advisory Committee on public health emergen cies. 
4. The Medicines Steering Group may, on its own initiative or upon request from the 
Commission, provide recommendations on measures, which may be taken by the 
Commission, Member States, marketing authorisation holders and other entities to 
ensure pre paredness to deal with potential or actual shortages of medicinal products 
caused by public health emergencies or major events.  
5. The Medicines Steering Group may upon request from the Commission coordinate 
measures, where relevant, between the national competent authorities, the marketing 
authorisation holders and other entities to prevent or mitigate potential or actual 
shortages in the context of a major event or public health emergency.  
Article 9  
Working methods and provision of information on medicin al products  
1. In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, the Agency 
shall:  
(a) specify the procedures for establishing the critical medicines lists;  
(b) specify the methods of and criteria for the monitoring, data collect ion and 
reporting provided for in Articles 4, 7 and 8;  
(c) develop streamlined electronic monitoring and reporting systems;  
(d) establish and maintain membership of the working party referred to in Article 
3(5) comprised of single points of contacts from n ational competent authorities 
for medicinal products;  
(e) establish and maintain a list of single points of contact from marketing 
authorisation holders for all medicinal products for human use authorised in the 
Union, through the database provided for in Article 57(1)(l) of Regulation 
726/2004;  
(f) specify the methods for the provision of recommendations, advice and 
coordination of measures provided for in Articles 5 and 8.  
2. Following the recognition of a public health emergency or a request for assistan ce 
referred to in Article 4(3) the Agency shall:  
(a) establish and maintain for the duration of the public health emergency or major 
event, a sub -network of single points of contact from marketing authorisation 
holders based on the medicinal products inclu ded on the critical medicines 
lists;  
(b) request information from the points of contact included in the sub -network 
referred to in point (a) and set a deadline for its submission;  
(c) request information from the single points of contact from Member States ’ 
national competent authorities based on the set of information agreed on by the 
Medicines Steering Group and set a deadline for its submission.  
3. The information referred to in point (b) of paragraph 2 shall include at least:  
(a) the name of the marketi ng authorisation holder;  EN 19  EN (b) the name of the medicinal product;  
(c) the country of authorisation and marketing status in each Member State;  
(d) details of the potential or actual shortage such as actual or estimated start and 
end dates and suspected or known cause;  
(e) sales and market share data;  
(f) details of available alternative medicinal products;  
(g) mitigation plans including production and supply capacity;  
(h) information from the wholesale distributors and legal person entitled to supply 
the me dicinal product to the public.   
Article 10  
Obligations on marketing authorisation holders  
1. In order to facilitate the monitoring referred to in Article 7 and following a request 
from the Agency, marketing authorisation holders for medicinal products inc luded on 
the critical medicines lists shall submit the information referred to in Article 9(3) by 
the deadline set by the Agency. They shall submit the information through the points 
of contact designated in accordance with Article 9(2) and using the repor ting 
methods and system established pursuant to Article 9(1). They shall provide updates 
where necessary.  
2. Marketing authorisation holders of medicinal products authorised in the Union shall, 
within 6 months from the date of application of this Regulatio n, provide the 
information required pursuant to Article 9(1)(e) in the form of an electronic 
submission in the database referred to in  Article 57(1)(l) of Regulation (EC) No 
726/2004. Those marketing authorisation holders shall update their submission 
wherever necessary.  
3. Marketing authorisation holders shall justify the absence of any requested 
information and any delays in providing it by the deadline set by the Agency.  
4. Where marketing authorisation holders  for medicinal products included on the 
critical medicines lists indicate that the submitted information contains information 
of a commercially confidential nature, they shall identify the relevant parts  and 
clarify the reasons for such an indication. The Agency shall assess the merits of each 
request and protect commercially confidential information against unjustified 
disclosure.  
5. Where marketing authorisation holders for medicinal products included on the 
critical medicines lists are in possession of any additional information, which 
provide s evidence of a potential or actual shortage they shall immediately provide 
such information to the Agency.  
6. Following the reporting on the results of the monitoring and any recommendations 
on preventive or mitigating measures in accordance with Article 8, marketing 
authorisation holders for medicinal products included on the critical medicines list 
shall:  
(a) provide any comments they have to the Agency;  EN 20  EN (b) take into account any recommendations and guidelines  and comply with any 
measures taken at Union  and Member State -level pursuant to Articles 11 and 
12; 
(c) inform the Medicines Steering Group of any measures taken and report on the 
results of those measures, including information on the resolution of the 
potential or actual shortage.  
Article 11  
Oblig ations on Member States in the monitoring and mitigation of shortages of medicinal 
products  
1. In order to facilitate the monitoring referred to in Article 7 and following a request 
from the Agency, Member States shall, by the deadline set by the Agency:  
(a) submit the set of information requested by the Agency including available and 
estimated data on volume of demand, through its designated point of contact 
and using the reporting methods and system established pursuant to Article 
9(1);  
(b) indicate the e xistence of any commercially confidential information and clarify 
the reasons for such an indication;  
(c) indicate the absence of any requested information, and any delays in providing 
requested information by the deadline set by the Agency.  
2. Where neces sary to fulfil their reporting obligations set out in paragraph 1, Member 
States, with the support of the Agency, shall gather information and data on stock 
levels from wholesale distributors and other legal entities entitled to supply the 
public with medi cinal products included on the critical medicines lists.  
3. Where Member States are in possession of any additional information on volume of 
sales and volumes of prescriptions, including data based on Article 23a of Directive 
2001/83/EC, which provides evi dence of a potential or actual shortage of a medicinal 
product included on the critical medicines lists, they shall immediately provide such 
information to the Medicines Steering  Group through their designated points of 
contact.  
4. Following the reporting on the results of the monitoring and any recommendations 
on preventive or mitigating measures in accordance with Article 8, Member States 
shall:  
(a) take into account any recommendations and guidelines and comply with any 
measures taken at Union -level purs uant to Article 12;  
(b) inform the Medicines Steering  Group of any measures taken and report on the 
results of those measures, including information on the resolution of the 
potential or actual shortage.  
Article 12  
Role of the Commission in the monitoring and mitigation of shortages of medicinal products  
The Commission shall take into account the information from and recommendations of the 
Medicines Steering Group and shall:  EN 21  EN (a) take all necessary action within the limits of the powers conferred on it, with  a view 
to mitigating potential or actual shortages of medicinal products included on the 
critical medicines lists;  
(b) consider the need for guidelines addressed to Member States, marketing 
authorisation holders, and other entities;  
(c) inform the Medicin es Steering Group of any measures taken and report on the 
results;  
(d) request the Medicines Steering Group to provide recommendations or coordinate 
measures as provided for in Article 8(3), (4) and (5);  
(e) consider the need for medical countermeasures in  accordance with Articles 12 and 
25(b) of Regulation (EU) 2020/[…];20  
(f) liaise with third countries and relevant international organisations, as appropriate, to 
mitigate potential or actual shortages of medicinal products included on the critical 
medicin es list or their active pharmaceutical ingredients, where those products or 
ingredients are imported into the Union and where such potential or actual shortages 
have international implications.  
Article 13  
Communication on the Medicines Steering Group  
The A gency shall, via its web -portal and other appropriate means, in conjunction with 
national competent authorities, inform the public and interest groups with regard to the work 
of the Medicines  Steering Group.  
Chapter III  
Medicinal Products with the potential to address public health 
emergencies  
Article 14  
The Emergency Task Force  
1. The Emergency Task Force is hereby established as part of the Agency. It shall be 
convened during public health emergencies, either in person or remotely. The 
Agency shal l provide its secretariat.  
2. During public health emergencies, the Emergency Task Force shall undertake the 
following tasks:  
(a) providing scientific advice and reviewing the available scientific data on 
medicinal products with the potential to address th e public health emergency, 
including requesting data from developers and engaging with them in 
preliminary discussions;  
(b) reviewing clinical trial protocols and providing advice to developers on clinical 
trials to be conducted in the Union for medicinal products intended to treat, 
                                                 
20 [insert reference to adopted text referred to in footnote 4]  EN 22  EN prevent, or diagnose the disease causing the public health emergency, in 
accordance with Article 15;  
(c) providing scientific support to facilitate clinical trials to be conducted in the 
Union for medicinal products intended to treat, prevent, or diagnose the disease 
causing the public health emergency. Such support shall include advice to 
sponsors of similar or linked planned clinical trials on the establishment, in 
their place, of joint clinical trials and may include advice on  establishing 
agreements to act as a sponsor or as co -sponsor in accordance with Articles 
2(14) and 72 of Regulation (EU) 536/2014;  
(d) contributing to the work of the scientific committees, working parties and 
scientific advisory groups of the Agency;  
(e) providing scientific recommendations with regard to the use of  any medicinal 
product, which may have the potential to address public health emergencies, in 
accordance with Article 16;  
(f) cooperating with Union bodies and agencies, the World Health Orga nization, 
third countries, and international scientific organisations on scientific and 
technical issues relating to the public health emergency and to medicinal 
products which may have the potential to address public health emergencies, as 
necessary.  
3. The Emergency Task Force shall be composed of representatives of the scientific 
committees, working parties, and staff members of the Agency, the coordination 
group established in accordance with Article 27 of Directive 2001/83/EC, and the 
Clinical Trials C oordination and Advisory Group established in accordance with 
Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and 
representatives of other Union bodies and agencies be invited on an ad hoc basis, as 
necessary. It shall be chaired  by the Agency.  
4. The composition of the Emergency Task Force shall be approved by the 
Management Board of the Agency. The Executive Director of the Agency or their 
representative and representatives of the Commission shall be entitled to attend all 
meeti ngs. 
5. The Chair may invite representatives of Member States, members of scientific 
committees of the Agency and working parties, and third parties, including 
representatives of medicinal product interest groups, marketing authorisation holders, 
developer s of medicinal products, clinical trial sponsors, representatives of clinical 
trial networks, and interest groups representing patients and healthcare professionals 
to attend its meetings.  
6. The Emergency Task Force shall establish its rules of procedure including rules on 
the adoption of recommendations. The rules of procedure shall enter into force after 
receiving a favourable opinion from the Commission and the Management Board of 
the Agency.  
7. The Emergency Task Force shall perform its tasks as a body  separate from, and 
without prejudice to the tasks of the scientific committees of the Agency as regards 
                                                 
21 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 1 6 April 2014 on 
clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 
27.5.2014, p. 1  EN 23  EN the authorisation, supervision and pharmacovigilance of the concerned medicinal 
products and related regulatory actions to ensure the quality, safety a nd efficacy of 
those medicinal products. The Emergency Task Force shall take account of any 
scientific opinion issued by those committees in accordance with Regulation (EC) 
No 726/2004 and Directive 2001/83/EC.  
8. Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency Task Force 
as regards transparency and the independence of its members.  
9. The Agency shall publish information about the medicinal products that the 
Emergency Task Force considers may have the potential to address public heal th 
emergencies and any updates on its web -portal.  
Article 15  
Advice on clinical trials  
1. During a public health emergency, the Emergency Task Force shall review clinical 
trial protocols submitted or intended to be submitted in a clinical trial applicatio n by 
developers of medicinal products as part of an accelerated scientific advice process.  
2. Where a developer engages in an accelerated scientific advice process, the 
Emergency Task force shall provide such advice free of charge at the latest 20 days 
following the submission to the Agency of a complete set of requested information 
and data by the developer. The advice shall be endorsed by the Committee for 
Medicinal Products for Human Use.  
3. The Emergency Task Force shall establish procedures for the re quest and submission 
of the set of information and data required, including information on the Member 
State or States where an application for authorisation of a clinical trial is submitted or 
is intended to be submitted.  
4. The Emergency Task Force shall involve representatives of the Member State or 
States where an application for authorisation of a clinical trial is submitted or is 
intended to be submitted in the preparation of the scientific advice.  
5. When authorising a clinical trial application for w hich scientific advice has been 
given, Member States shall take that advice duly into account.  
6. Where a developer is the recipient of scientific advice, the developer shall 
subsequently submit the data resulting from clinical trials to the Agency followi ng a 
request made pursuant to Article 16.  
7. Without prejudice to the provisions of this Article, the scientific advice shall 
otherwise be provided to those developers in accordance with the procedures 
established pursuant to Article 57 of Regulation EC ( No) 726/2004.  
Article 16  
Review of medicinal products and recommendations on their use  
1. Following the recognition of a public health emergency, the Emergency Task Force 
shall undertake a review of the available scientific data on medicinal products, which 
may have the potential to be used to address the public health emergency. The review 
shall be regularly updated during the public health emergency.  EN 24  EN 2. In preparation of the review, the Emergency Task Force may request information and 
data from market ing authorisation holders and from developers and engage with 
them in preliminary discussions.  The Emergency Task Force may also, where 
available, make use of observational studies of health data generated outside of 
clinical studies taking into account th eir reliability.  
3. Based on a request from one or more Member States, or the Commission, the 
Emergency Task Force shall provide recommendations to the Committee for 
Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on 
the fol lowing:  
(a) the compassionate use of medicinal products falling under the scope of 
Directive 2001/83/EC or Regulation (EC) No 726/2004;  
(b) the use and distribution of an unauthorised medicinal product in accordance 
with Article 5(2) of Directive 2001/83/E C. 
4. Following receipt of the recommendation, the Committee for Medicinal Products for 
Human Use shall adopt an opinion on the conditions for use, the conditions for 
distribution and the patients targeted. The opinion shall be updated where necessary.  
5. Member States shall take account of the opinions referred to in paragraph 4. Where 
Member States make use of such an opinion, Article 5(3) and (4) of Directive 
2001/83/EC shall apply.  
6. In the preparation of its recommendations provided pursuant to paragr aphs 3, the 
Emergency Task Force may consult the concerned Member State and request it to 
provide any information and data, which informed the Member State’s decision to 
make the medicinal product available for compassionate use. Following such a 
request, the Member State shall provide all of the requested information.  
7. The Agency shall publish the opinions adopted pursuant to paragraph 4 including 
any updates on its web -portal.  
Article 17  
Communication on the Emergency Task Force  
The Agency shall, via it s web -portal and other appropriate means and, in conjunction with 
national competent authorities, inform the public and relevant interest groups with regard to 
the work of the Emergency Task Force.  
Article 18  
IT tools and data  
To prepare for and support the work of the Emergency Task Force during public health 
emergencies, the Agency shall:  
(a) develop and maintain electronic tools for the submission of information and data, 
including electronic health data generated outside the scope of clinical studies;  
(b) coordinate independent vaccine effectiveness and safety monitoring studies using 
relevant data held by public authorities. Such coordination shall be conducted jointly 
with the European Centre for Disease Prevention and Control and notably through 
a new vaccine monitoring platform;  EN 25  EN (c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate 
the rapid access to or analysis of available electronic health data generated outside 
the scope of clinical studies, and the ex change of such data between Member States, 
the Agency, and other Union bodies;  
(d) provide access to the Emergency Task Force to external sources of electronic health 
data including, health data generated outside the scope of clinical studies, to which 
the Agency has access.  
Chapter IV  
Monitoring and mitigating shortages of critical medical devices 
and support for expert panels  
Article 19  
The Executive Steering Group on Medical Devices  
1. The Executive Steering Group on Medical Devices (‘the Medical Devices  Steering 
Group’) is hereby established as part of the Agency. It shall meet either in person or 
remotely, in preparation for or during a public health emergency. The Agency shall 
provide its secretariat.  
2. The Medical Devices Steering Group shall be comp osed of a representative of the 
Agency, a representative of the Commission and one senior representative per 
Member State. Each Member State shall appoint their representative. Members may 
be accompanied by experts in specific scientific or technical field s. 
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may 
invite third parties, including representatives of medical device interest groups to 
attend its meetings.  
4. The Medical Devices Steering Group shall establish its rules  of procedure including 
procedures relating to the working party referred to in paragraph 5, and on the 
adoption of lists, sets of information and recommendations. The rules of procedures 
shall enter into force after receiving a favourable opinion from the  Commission and 
the Management Board of the Agency.  
5. The Medical Devices Steering Group shall be supported in its work by a working 
party comprised of single points of contact from national competent authorities for 
medical devices established in accorda nce with Article 23(1).  
6. The Medical Devices Steering Group shall be responsible for fulfilling the tasks 
referred to in Articles 20, 21, and 22.  
Article 20  
List of critical medical devices and information to be provided  
1. Immediately following the recognition of a public health emergency and after 
consultation of its working party, the Medical Devices Steering Group shall adopt a 
list of medical devices which it considers as critical during the public health 
emergency (‘the  public health emergency critical devices list’). The list shall be 
updated whenever necessary until the termination of the recognition of the public 
health emergency.  EN 26  EN 2. The Medical Devices Steering Group shall adopt a set of information necessary to 
monitor the supply and demand of medical devices included on the public health 
emergency critical devices list and inform its working party thereof.  
3. The Agency shall publish the public health emergency critical devices list and any 
updates to that list on its web -portal.  
Article 21  
Monitoring shortages of medical devices on the public health emergency critical devices list  
1. On the basis of the public health emergency critical devices list and the information 
and data provided in accordance with Articles 2 4 and 25, the Medical Devices 
Steering Group shall monitor supply and demand of medical devices included on that 
list with a view to identifying any potential or actual shortages of those medical 
devices. As part of that monitoring, the Medical Devices Ste ering Group shall liaise, 
where relevant, with the Health Security Committee established in Article 4 of 
Regulation (EU) 2020/[…]22 and the Advisory Committee on public health 
emergencies established pursuant to Article 24 of that Regulation.  
2. As part of the monitoring, the Medical Devices Steering Group may also make use of 
data from device registries and databanks where such data is available to the Agency. 
In so doing, the Medical Devices Steering Group shall take into account the data 
generated pursuan t to Article 108 of Regulation (EU) 2017/745 and Article 101 of 
Regulation (EU) 2017/746.  
Article 22  
Reporting and recommendations on shortages of medical devices  
1. For the duration of the public health emergency, the Medical Devices Steering Group 
shall  regularly report the results of its monitoring to the Commission and the sub -
network referred to in Article 23(1)(b), and, in particular, signal any potential or 
actual shortages of medical devices included on the public health emergency critical 
devices list. 
2. Where requested by the Commission or the sub -network referred to in Article 
23(2)(b), the Medical Devices Steering Group shall provide aggregated data and 
forecasts  of demand to support its findings. In that regard, the Steering Group shall 
liaise with the European Centre for Disease Prevention and Control to obtain 
epidemiological data to help forecast medical device needs, and with the Medicines 
Steering Group refe rred to in Article 3 where medical devices included on the public 
health emergency critical devices list are used to jointly with a medicinal product.  
3. As part of the reporting referred to in paragraphs 1 and 2, the Medical Devices 
Steering Group may als o provide recommendations on measures, which may be 
taken by the Commission, Member States, medical device manufacturers, notified 
bodies and other entities to prevent or mitigate potential or actual shortages. In that 
regard the Group shall liaise, where relevant, with the Health Security Committee 
and the Advisory Committee on public health emergencies.  
                                                 
22 [insert reference to adopted text referred to in footnote 4 ] EN 27  EN 4. The Medical Devices Steering Group may, on its own initiative or upon request from 
the Commission, provide recommendations on measures which may be tak en by the 
Commission, Member States, medical device manufacturers, notified bodies and 
other entities to ensure preparedness to deal with potential or actual shortages of 
medical devices caused by public health emergencies.  
5. The Medical Devices Steering Group may, upon request from the Commission 
coordinate measures, where relevant, between the national competent authorities, 
manufacturers of medical devices, notified bodies, and other entities to prevent or 
mitigate potential or actual shortages in the c ontext of a public health emergency.  
Article 23  
Working methods and provision of information on medical devices  
1. In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, the 
Agency shall:  
(a) specify the procedures for establ ishing the public health emergency critical 
devices list;  
(b) develop streamlined electronic monitoring and reporting systems;  
(c) establish and maintain membership of the working party referred to in Article 
19(5) comprised of single points of contact fr om Member States’ national 
competent authorities for medical devices;  
(d) establish and maintain a list of single points of contact from medical device 
manufacturers, authorised representatives and notified bodies;  
(e) specify the methods for the provision  of recommendations and coordination of 
measures provided for in Article 22.  
2. Following the recognition of a public health emergency the Agency shall:  
(a) establish and maintain for the duration of the public health emergency, a sub -
network of single poi nts of contact from medical device manufacturers and 
notified bodies based on the medical devices included on the public health 
emergency critical devices list;  
(b) request information from the points of contact included in the sub -network 
based on the set  of information agreed on by the Medical Devices Steering 
Group and set a deadline for its submission;  
(c) request information from the single points of contact from Member States’ 
national competent authorities based on the set of information agreed on by  the 
Medical Devices Steering Group and set a deadline for its submission.  
3. The information referred to in point (b) of paragraph 2 shall include at least:  
(a) the name of the manufacturer and, if applicable, the name of the authorised 
representative;  
(b) identification of the medical device and the intended purpose;  
(c) if applicable, the name and number of the notified body and information on the 
relevant certificate or certificates;  
(d) details of the potential or actual shortage such as actual or esti mated start and 
end dates, and the known or suspected cause;  EN 28  EN (e) sales and market share data;  
(f) mitigation plans including production and supply capacity;  
(g) information from concerned notified bodies about their resource capacity to 
process applicatio ns and carry out and complete conformity assessments in 
relation to medical devices included in the public health emergency critical 
devices list;  
(h) information on the number of applications received by concerned notified 
bodies in relation to medical de vices included in the public health emergency 
critical devices list and relevant conformity assessment procedures;  
(i) where conformity assessments are on -going, the status of the conformity 
assessment by the concerned notified bodies in relation to medic al devices 
included in the public health emergency critical devices list and possible issues 
which need to be resolved in order to complete the conformity assessment 
process.  
Article 24  
Obligations on medical device manufacturers, authorised representative s, and notified bodies  
1. In order to facilitate the monitoring referred to in Article 21 and following a request 
from the Agency, medical device manufacturers of the medical devices included on 
the public health emergency critical devices list and, where necessary, concerned 
notif ied bodies, shall submit the information requested by the deadline set by the 
Agency. They shall submit the information requested through the points of contact 
designated in accordance with Article 23(2) and using the reporting methods and 
system establish ed pursuant to Article 23(1). They shall provide updates wherever 
necessary.  
2. Medical device manufacturers and notified bodies shall justify the absence of any 
requested information and any delays in providing it by the deadline set by the 
Agency.  
3. Where manufacturers of medical devices included on the public health emergency 
critical devices list and concerned notified bodies indicate that the submitted 
information contains information of a commercially confidential nature, they shall 
identify the rel evant parts and clarify the reasons for such an indication. The Agency 
shall assess the merits of each request and protect such commercially confidential 
information against unjustified disclosure.  
4. Where manufacturers of medical devices included on the  public health emergency 
critical devices list and concerned notified bodies are in possession of any additional 
information, which provides evidence of a potential or actual shortage, they shall 
immediately provide such information to the Agency.  
5. Follo wing the reporting on the results of the monitoring and any recommendations 
on preventive or mitigating measures in accordance with Article 22, manufacturers 
of medical devices included on the public health emergency critical devices list and 
concerned not ified bodies shall:  
(a) provide any comments they have to the Agency;  
(b)  EN 29  EN (c) take into account any recommendations and guidelines and comply with any 
measures taken at Union and Member State -level pursuant to Articles 25 and 
26; 
(d) inform the Medical De vices Steering Group of any measures taken and report 
on the results, including information on the resolution of the potential or actual 
shortage.  
6. Where manufacturers of medical devices included on the public health emergency 
critical devices list are e stablished outside the Union and are unable to provide the 
information required, in accordance with this Article, it shall be provided by the 
authorised representatives.  
Article 25  
Obligations on Member States in the monitoring and mitigation of shortages  of medical 
devices  
1. In order to facilitate the monitoring  referred to in Article 21 and following a request 
from the Agency, Member States shall, by the deadline set by the Agency:  
(a) submit the set of information requested by the Agency, including in formation 
about needs related to the medical devices included in the public health 
emergency critical devices list, and available and estimated data on the volume 
of demand, through its designated point of contact and using the reporting 
methods and  syste m established pursuant  to Article 23(1);  
(b) indicate the existence of any commercially confidential information, and,  
clarify the reasons for such an indication;  
(c) indicate the absence of any requested information, and any delays in providing 
requeste d information by the deadline set by the Agency.  
2. Where necessary to fulfil their reporting obligations set out in paragraph 1, Member 
States shall gather information from manufacturers, importers, distributors and 
notified bodies on medical devices incl uded on the public health emergency critical 
devices list.  
3. Where Member States are in possession of any additional information, which 
provides evidence of a potential or actual shortage, they shall immediately provide 
such information to the Medical Dev ices Steering Group through their designated 
points of contact.  
4. Following the reporting on the results of the monitoring  and any recommendations 
on preventive or mitigating measures in accordance with Article 22, Member States 
shall:  
(b) consider the n eed to provide for temporary exemptions at Member State level 
pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of 
Regulation (EU) 2017/746 with a view to mitigating potential or actual 
shortages of medical devices included on the publ ic health emergency critical 
devices list;  
(c) take into account any recommendations and guidelines and comply with any 
measures taken at Union -level pursuant to Article 26;  EN 30  EN (d) inform the Medical Devices Steering Group of any measures taken and report 
on the results of those measures, including information on the resolution of the 
potential or actual shortage.  
Article 26  
Role of the Commission in the monitoring and mitigation of shortages of medical devices  
The Commission shall take into account the inform ation from and recommendations of the 
Medical Devices Steering Group and shall:  
(a) take all necessary action  within the limits of the powers conferred on it, with a view 
to mitigating potential or actual shortages of medical devices included on the public  
health emergency critical devices list, including, where necessary, granting 
temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 
2017/745  or Article 54(3) of Regulation (EU) 2017/746;  
(b) consider the need for guidelines addre ssed to Member States, medical device 
manufacturers, notified bodies and other entities;  
(c) request the Medical Devices Steering Group to provide recommendations or 
coordinate measures pursuant to Article 22(3), (4) and (5);  
(d) consider the need for medical countermeasures in accordance with Articles 12 and 
25(b) of Regulation (EU) 2020/[…];23 
(e) liaise with third countries and relevant international organisations, as appropriate, to 
mitigate potential or actual shortages of medical devices included o n the critical 
devices list or their component parts, where those devices or parts are imported into 
the Union,  and where such potential or actual shortages have international 
implications.  
Article 27  
Communication on the Medical Devices Steering Group  
The Agency shall, via its web -portal and other appropriate means and, in conjunction with 
national competent authorities, inform the public and relevant interest groups with regard to 
the work of the Medical Devices Steering Group.  
Article 28  
Support for the expert panels on medical devices  
The Agency shall, on behalf of the Commission, from 1 March 2022  onwards, provide the 
secretariat of the expert panels designated in accordance with Implementing Decision (EU) 
2019/1396 and provide the support necessary to  ensure that those panels can efficiently 
perform their tasks as set out in Article 106(9) and (10) of Regulation (EU) 2017/745. The 
Agency shall:  
(a) provide administrative and technical support to the expert panels for the provision of 
scientific opinio ns, views and advice;  
(b) facilitate and manage remote and physical meetings of the expert panels;  
                                                 
23 [insert reference to adopted text referred to in footnote 4 ] EN 31  EN (c) ensure that the work of the expert panels is carried out in an independent manner in 
accordance with Article 106(3), second subparagraph of Regulation ( EU) 2017/745 
and establish systems and procedures to actively manage and prevent potential 
conflicts of interest in accordance with Article 106(3), third subparagraph and Article 
107 of that Regulation;  
(d) maintain and regularly update a web -page for the expert panels and make publicly 
available on the web -page all information necessary to ensure the transparency of the 
activities of the expert panels , including justifications of notified bodies where they 
did not follow the advice of the expert panels pro vided pursuant to Article 106(9) of 
Regulation (EU) 2017/745;  
(e) publish the scientific opinions, views, and advice of the panels while ensuring 
confidentiality in accordance with Article106(12) second subparagraph and Article 
109 of Regulation (EU) 2017 /745;  
(f) ensure that remuneration and expenses are provided to the experts in accordance with 
Article 11 of Implementing Decision (EU) 2019/1396;  
(g) monitor compliance with the panels’ common rules of procedure and available 
guidelines and methodologies relevant to the functioning of the panels;  
(h) provide annual reports to the Commission on the work undertaken by the expert 
panels, including the number of opinions, views and advice delivered.  
Chapter V  
Final Provisions  
Article 29  
Cooperation between Ste ering Groups  
1. The Agency shall ensure cooperation between the Medicines and Medical Devices 
Steering Groups in relation to measures to address major events and public health 
emergencies.  
2. Members of the Medicines and Medical Devices Steering Groups and  their working 
parties may attend each other’s meetings and working parties and, where appropriate, 
cooperate on monitoring exercises, reporting and opinions.  
3. In agreement with the Chairs, joint meetings of the Medicines and Medical Devices 
Steering Gro ups may be held.  
Article 30  
Confidentiality  
1. Unless otherwise provided for in this Regulation and without prejudice to Regulation 
(EC) No 1049/200124 and existing national provisions and practices in the Member 
States on confidentiality, all parties invol ved in the application of this Regulation 
                                                 
24 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 
regarding public access to European Parliament, Council and Commission documents, OJ L 145, 
31.05.2001, p. 43  EN 32  EN shall respect the confidentiality of information and data obtained in carrying out their 
tasks in order to protect the following:  
(a) personal data in accordance with Article 32;  
(b) commercially confidential information and trade secrets of a natural or legal 
person, including intellectual property rights;  
(c) the effective implementation of this Regulation.  
2. All parties involved in the application of this Regulation shall ensure that no 
commercially confide ntial information is shared in a way which has the potential to 
enable undertakings to restrict or distort competition in the meaning of Article 101 
TFEU.  
3. Without prejudice to paragraph 1, information exchanged on a confidential basis 
between competent authorities and between competent authorities and the 
Commission and the Agency shall not be disclosed without the prior agreement of 
the authority from which that information originates.  
4. Paragraphs 1, 2, and 3 shall not affect the rights and obligation s of the Commission, 
the Agency, Member  States and other actors identified in this Regulation with regard 
to the exchange of information and the dissemination of warnings, nor the 
obligations of the persons concerned to provide information under criminal l aw. 
5. The Commission, the Agency, and Member States may exchange commercially 
confidential information  and, where necessary to protect public health, personal data, 
with regulatory authorities of third countries with which they have concluded 
bilateral or  multilateral confidentiality arrangements.  
Article 31  
Entry into Force  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its ent irety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President  EN 33  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK OF THE PROPOSAL/INITIATIVE  ................................ ...............  35 
1.1. Title of the proposal/initiative  ................................ ................................ ....................  35 
1.2. Policy area(s) concerned  ................................ ................................ ............................  35 
1.3. The proposal relates to  ................................ ................................ ...............................  35 
1.4. Objective(s)  ................................ ................................ ................................ ................  35 
1.4.1.  General objective(s)  ................................ ................................ ................................ ... 35 
1.4.2.  Specific objective(s)  ................................ ................................ ................................ ... 35 
1.4.3.  Expected result(s) and impact  ................................ ................................ ....................  36 
1.4.4.  Indicators of performance  ................................ ................................ ..........................  36 
1.5. Grounds for the proposal/initiative  ................................ ................................ ............  37 
1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll -out of 
the implementation of the initiative  ................................ ................................ ...........  37 
1.5.2.  Added value of Union involvement (it may result from different factors, e.g. coordination 
gains, legal certainty, greater effectiveness or complementarities). For the purposes of this 
point 'added value of Union involvement' is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone.
 ................................ ................................ ................................ ................................ .... 37 
1.5.3.  Lessons learnt from similar experiences in the past  ................................ ..................  38 
1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies with other 
appropriate instruments  ................................ ................................ ..............................  39 
1.5.5.  Assessment of the different available financing options, including scope for redeployment
 ................................ ................................ ................................ ................................ .... 39 
1.6. Duration and financial impact of the proposal/initiative  ................................ ...........  40 
1.7. Management mode(s) planned  ................................ ................................ ...................  40 
2. MANAGEMENT MEASURES  ................................ ................................ ................  41 
2.1. Monitoring and reporting rules  ................................ ................................ ..................  41 
2.2. Management and control system(s)  ................................ ................................ ...........  41 
2.2.1.  Justification of the management mode(s), the funding implementation mechanism(s), the 
payment modalities and the control strategy proposed  ................................ ..............  41 
2.2.2.  Information concerning the risks identified and the internal control system(s) set up to mitigate 
them  ................................ ................................ ................................ ............................  41 
2.3. Measures to prevent fraud and irregularities  ................................ ..............................  42 
3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  ............  42 
3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
 ................................ ................................ ................................ ................................ .... 42 
3.2. Estimated impact on expenditure  ................................ ................................ ...............  43 EN 34  EN 3.2.1.  Summary of estimated impact on expenditure  ................................ ...........................  43 
3.2.2.  Estimated impact on EMA's appropriations  ................................ ...............................  45 
3.2.3.  Estimated impact on EMA's human resources  ................................ ...........................  47 
3.2.4.  Compatibility with the current multiannual financial framework  .............................  51 
3.2.5.  Third -party contributions  ................................ ................................ ...........................  51 
3.3. Estimated impact on revenue  ................................ ................................ .....................  52 
 EN 35  EN LEGISLATIVE FINANCIAL STATEMENT 'AGENCIES'  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of the European Parliament and of the Council on a reinforced role 
for the European Medicines Agency in crisis preparedness and management for medicinal 
products and medical devices  
1.2. Policy area(s) concerned  
Policy area: Cohesion, Resilience and Values  
Activity: Health  
1.3. The proposal relates to  
X a new action  
 a new action following a pilot project/preparatory action25  
X the extension of an existing action   
 a merger of one or more  actions towards another/a new action   
1.4. Objective(s)  
1.4.1.  General objective(s)  
The proposal aims to:  
– ensure a high level of huma n health protection by strengthening the Union’s ability to 
respond to and manage public health emergencies, which have an impact on medicinal 
products and medical devices;  
– contribute to ensuring the smooth functioning of the internal market for such prod ucts 
during public health emergencies.  
1.4.2.  Specific objective(s)  
Specific objectives  
1. Monitor and mitigate potential and actual shortages of medicinal products and medical 
devices considered as critical in order to address a given public health emergency or, for 
medicinal products, other major events which may have a serious impact on public health;  
2. Ensure the quality, safety and efficacy of medicinal products which may have the potential 
to address a given health emergency;  
3. Ensure smooth functioning of expert panels for the assessment of some high -risk medical 
devices and avail of essential advice in crisis preparedness and management with regard to the 
use of medical devices.  
 
                                                 
25 As referred to in Article 58(2)(a) or (b) of the Fi nancial Regulation.  EN 36  EN 1.4.3.  Expected result(s) and impact  
Specify the effects whic h the proposal/initiative should have on the beneficiaries/groups targeted.  
The initiative should contribute to ensuring that shortages of medicinal products and medical 
devices considered as critical in addressing a given health emergency and, for medicin al 
products, a major event, are avoided across the Union. By doing so, those products should 
ultimately remain available to patients in sufficient numbers even during such emergencies.  
Member States and medicines and medical device manufacturers should be nefit from a 
coordinated approach at Union level. A permanently established mechanism to be used during 
emergencies within the Agency to monitor and report on potential and actual shortages, should 
allow for a better and more timely flow of information bet ween authorities and manufacturers. 
This should allow for necessary action to be taken by the Commission, Member State 
authorities and manufacturers to mitigate potential or actual shortages. Such a framework 
should reduce the risk of uncoordinated stockpi ling of such products and allow for the 
continued flow of goods across the single market so that they reach the areas that need them 
most as the impact of public health emergencies peaks at different times across the Union.  
The initiative should also cont ribute to ensuring that medicines which may have the potential 
to treat, prevent or diagnose diseases which result in public health emergencies are identified 
early on, benefit from timely scientific advice, and are subject to a robust assessment of their 
quality, safety and efficacy. By doing so, those products should ultimately reach the market in 
a timely manner and provide safe and effective treatment and prevention options for patients.  
In the context of the European Health Data Space, the initiative should also contribute to 
providing access to health data for research and regulatory purposes, supporting better 
decision -making (regulators and policy makers) throughout the product lifecycle on medicines 
with timely, valid and reliable data from real wo rld healthcare settings. This should integrate 
the Agency into the future infrastructure for a European Health Data Space, allowing for the 
use of data for research, policy -making and evidence -based tools.  
Member States and manufacturers should benefit fr om a coordinated approach at Union level 
on the advice given on clinical trial protocols and the use of such medicines in national 
indications – so-called ‘off -label use’.  
1.4.4.  Indicators of performance  
Specify the indicators for monitoring progress an d achievements.  
Detailed objectives and expected results including performance indicators will be established by 
the annual work programme, while the Single Programming Document will set out overall 
strategic objectives, expected results and set of perform ance indicators. The key performance 
indicators for the Agencies as well as the guidelines for the Single Programming Document and 
the Consolidated Annual Activity Report developed by the Commission should be respected.  
For work on shortages of medicines a nd medical devices:  
– Number of medicines at risk of shortages or in shortages in the EU Member States  
For the work on medicines which may have the potential to address public health emergencies:  
– Number of recommendations and amount of advice issued by the Emergency Task 
Force.  
For the expert panels:  
– Number of opinions issued annually.  EN 37  EN  
For the Agency’s participation in the European Health Data Space digital infrastructure that 
supports the use of health data for better decision -making:  
– Number of studies en abled, using the future infrastructure of the European Health Data 
Space  
 
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll -out of 
the implementation of the initiative  
Upon the entry into force of the Regulation, the Agency should put in place the framework 
which will be used to manage future public health emergencies (crisis preparedness and 
response) including the development of procedures for data submission, reporti ng and 
monitoring tools, and rules of procedure and working methods for the Steering Groups and 
Emergency Task Force. This will allow for the immediate operationalisation of those groups 
as soon as a public health emergency has been recognised (crisis mana gement).  
From March 2022 at the latest the Agency should begin to host the secretariat of and ensure 
support for the medical device expert panels on a permanent basis.  
The building and deployment of European Health Data Space infrastructure within the Agen cy 
will enable the Agency to access or query real world data to better support decision -making 
throughout the product lifecycle on medicines should begin in 2021, and progress in full 
alignment with the establishment of the overall European Health Data Spa ce. 
 
1.5.2.  Added value of Union involvement (it may result from different factors, e.g. coordination 
gains, legal certainty, greater effectiveness or complementarities). For the purposes of this 
point 'added value of Union involvement' is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone.  
Reasons for action at European level (ex -ante)  
Public health emergencies of the magnitude of COVID -19 have an impact on all Member 
States, which, on their own are unable to provide a sufficient response. Potential or actual 
shortages of medicines and medical devices in times of crises can lead to the risk of national 
stockpiling or restrictions to single market movements being placed on such goods, which can 
have a negative impact on the free movement of goods. An uncoordinated approach to the 
development of medicines, which may have the potential to treat, prevent, or diagnose 
diseases causing public health emergencies can caus e delays in their development during 
periods where time is of the essence. Moreover, a lack of clear, Union -level advice on the use 
of medicines in national compassionate use programmes or outside of their authorised 
indications can lead to a fragmented ap proach across the Union. Additionally, regulators 
access to EU -wide health data is limited and scattered across different partners leading to 
complex and slow analysis undermining the optimal time window for certain interventions.  
Expected generated Union added value (ex -post)  
A coordinated response at Union -level to monitoring and mitigating the risk of shortages can 
help to avoid actions such as uncoordinated stockpiling being taken and therefore have both a EN 38  EN positive impact on public health and maintain the smooth functioning of the single market. In 
the same vein, providing scientific advice on medicinal products which have the potential to 
address public health emergencies at Union -level can facilitate their market entry, ensure a 
coordinated approach t o their use across Member States, and help to ensure such treatments 
meet harmonised Union standards for their quality, safety and efficacy, whilst avoiding 
duplication of efforts and unnecessary research. Integrating the Agency into the European 
Health Da ta Space digital health infrastructure can support better decision -making throughout 
the product lifecycle on medicines and can facilitate access and analysis of real world health 
data in a timely and reliable manner. This would support health policy makin g including: 
legislative development, impact and monitoring of implementation, design of healthcare 
systems and more informed decision -making on cost -effectiveness. Ultimately, this action can 
benefit patients with a faster access to innovative medicines a nd safe and effective use.  
1.5.3.  Lessons learnt from similar experiences in the past  
The unprecedented experience of the COVID -19 pandemic has demonstrated that the Union’s 
ability to coordinate work to ensure availability of medicinal products and medica l devices 
and facilitate the development of medical countermeasures is limited, among other things, by 
the absence of a structured mechanism to monitor and quickly address shortages of such 
products.  
During the COVID -19 crisis, ad hoc solutions had to be f ound to contain the risk of shortages 
of medicines and medical devices such as ventilators and the medicines used with them (such 
as the EU Executive Steering Group and the Clearing House). The operation of these 
mechanisms during the emergency was made po ssible by contingent arrangements between 
the actors involved (the Commission, the Agency, the Member States). For these solutions to 
become efficient and predictable, it has become apparent that the respective roles and 
obligations of the different actors  should be clarified and solidly anchored in the legislative 
framework that applies to their operations.  
Equally, when a number of medicines were purported to treat or prevent COVID -19, EMA 
provided scientific advice on their development and ability to fig ht COVID -19 to the utmost 
of its ability, but outside of a formal crisis management structure and without the benefit of 
fast-track scientific advice procedures and obligations on Member States and developers to 
cooperate. In particular, developers indicat ed a lack of harmonisation on aspects related to 
clinical trials, stemming mainly from the fact that each trial needs to be authorised separately 
in each Member State.  
Integrating the Agency into the European Health Data Space digital health infrastructur e to 
support better decision -making throughout the product lifecycle on medicines  should leverage 
on the lessons learnt from other equivalent initiatives (e.g. FDA/Sentinel, Health 
Canada/CNODES, PMDA) as well as from the knowledge advances achieved by 
complementary initiatives (e.g. EHDEN, ELIXIR, VAC4EU, OHDSI).  
These lessons learnt thus provide a solid basis for the establishment of a clear framework for 
the activities to be deployed by the Agency during public health emergencies, in order to 
enhance th e Union's capacity to react quickly, efficiently and in a coordinated manner to such 
emergencies.  
 EN 39  EN 1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies with other 
appropriate instruments  
The Agency should cooperate and promo te synergies with other Union bodies and 
decentralised agencies, such as the European Centre for Disease and Control (ECDC), 
European Food Safety Authority (EFSA) and take full advantage and ensure consistency with 
the EU4Health programme and other EU prog rammes financing actions in the domain of 
public health.  
As from 2022, the Agency would take over some tasks currently performed by the 
Commission under the Health programme Expert panels (JRC).  
 
 
1.5.5.  Assessment of the different available financing opti ons, including scope for redeployment  
The European Commission has no expertise to assess medicinal products with the potential to 
treat public health emergencies. The European Medicines Agency is the suitable body to 
conduct the proposed tasks. Nevertheles s, the European Commission will participate in the 
management of the Executive Steering Groups without additional resources.  
Involvement of Member States’ national authorities will also be a crucial factor since access to 
health data may require strict re quirements to be fulfilled at national level by participating 
health data providers.  
 
 EN 40  EN 1.6. Duration and financial impact of the proposal/initiative  
 limited duration  
–  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact f rom YYYY to YYYY  
 unlimited duration  
– Implementation with a start -up period from Jan 2021 to Dec 2021 , 
– followed by full -scale operation.  
1.7. Management mode(s) planned26  
 Direct management  by the Commission through  
–  executive agencies  
 Shared management  with the Member States  
 Indirect management  by entrusting budget implementation tasks to:  
 international organisations and their agencies (to be specified);  
the EIB and the European Investment Fund;  
 bodies referred to in Articles 70 and 71 ; 
 public law bodies;  
 bodies governed by private law with a public service mission to the extent that they provide 
adequate financial guarantees;  
 bodies governed by the private law of a Member State that are entrusted with the 
implementation of a publ ic-private partnership and that provide adequate financial guarantees;  
 persons entrusted with the implementation of specific actions in the CFSP pursuant to 
Title  V of the TEU, and identified in the relevant basic act.  
Comments  
 
 
 
                                                 
26 Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: 
https://myintracomm.ec.europa.eu/b udgweb/EN/man/budgmanag/Pages/budgmanag.aspx . EN 41  EN 2. MANA GEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
All Union agencies work under a strict monitoring system involving an internal control 
coordinator, the Internal Audit Service of the Commission, the Management Board, the 
Commission, the Court of Auditors and the Budgetary Authority. This system is reflected and laid 
down in the EMA’s founding regulation.  
In accordance with the Joint Statement on the EU decentralised agencies ( the ‘Common 
Approach’), the framework financial regulation (2019/715) and related Commission 
Communication C(2020)2297, the annual work programme and Single Programming Document of 
the Agency shall comprise detailed objectives and expected results including set of performance 
indicators. The A gency will accompany its activities included in its working programme by key 
performance indicators. The activities of the Agency will be then measured against these 
indicators in the Consolidated Annual Activity Report. The annual work programme shall be 
coherent with the multi -annual work programme and both shall be included in an annual Single 
Programming Document which shall be submitted to the European Parliament, the Council, and 
the Commission. The Management Board of Agency will be responsible for s upervision of the 
administrative, operational and budgetary efficient management of the Agency.  
 
2.2. Management and control system(s)  
2.2.1.  Justification of the management mode(s), the funding implementation mechanism(s), the 
payment modalities and the control strategy proposed  
The annual EU subsidy is transferred to the Agency in accordance with its payment needs and 
upon its request.  
The Agency will be subject to administrative controls including budgetary control, internal audit, 
annual reports by the  European Court of Auditors, the annual discharge for the execution of the 
EU budget and possible investigations conducted by OLAF to ensure, in particular, that the 
resources allocated to agencies are put to proper use. The activities of the Agency will a lso be 
subject to the supervision of the Ombudsman in accordance with Article 228 of the Treaty. These 
administrative controls provide a number of procedural safeguards to ensure that account is taken 
of the interests of the stakeholders.  
2.2.2.  Informatio n concerning the risks identified and the internal control system(s) set up to 
mitigate them  
The main risk relates to under - or non -implementation of the tasks foreseen. In order to mitigate 
this, sufficient resources should be made available in both finan cial and staffing terms.  
 
  EN 42  EN 2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures, e.g. from the Anti -Fraud Strategy.  
Anti-fraud measures are provided for in Article 69 of Regulation (EC) No 726 /2004 and the 
framework financial Regulation (2019/715). The Executive Director and the Management Board 
of the Agency will take the appropriate measures in accordance with the Internal Control 
Principles applied across all EU institutions. In line with th e Common Approach and Article 42 of 
the framework financial Regulation, an anti -fraud strategy has been developed and is followed by 
the Agency.  
 
3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
Given the on -going reflection on the creation of an  ‘EU BARDA’, the Commission retains the 
right to adjust the proposed resources and staff allocation when a precise proposal for an ‘EU 
BARDA’ is tabled.  
3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) 
affected  
 Existin g budget lines  
In order  of multiannual financial framework headings and budget lines.  
Heading of 
multiannual 
financial 
framework  Budget line  Type of  
expenditure  Contribution  
Number  
 Diff./Non -
diff.27 from 
EFTA 
countries28 from 
candidate 
countries29 from  third 
countries  within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  
2 06.100301  Diff. YES  NO NO NO 
 New budget lines requested  
In order  of multiannual financial framework headings and budget lines.  
Heading of 
multiannual 
financial 
framework  Budget line  Type of  
expenditure  Contribution  
Number  
 Diff./non -
diff. from 
EFTA 
countries  from 
candidate 
countries  from third 
countries  within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  
 [XX.YY.YY.YY]  
  YES/NO  YES/NO  YES/NO  YES/NO  
                                                 
27 Diff. = Differentiated appropriations / Non -diff. = Non -differentiated appropriations.  
28 EFTA: European Free Trade Association.  
29 Candidate countries and, where applicable, potential candidates from the Western Balkans.   
EN 43  EN 3.2. Estimated impact on expenditure  
3.2.1.  Summary of estimated impact on expenditure  
EUR million (to three decimal places)  
Heading of multiannual financial  
framework  Number  Heading 2 : Cohesion, Resilience and Values  
 
[Body]: EMA    Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  TOTAL  
Title 1:  Commitments  (1) 3.065  3.315  3.800  4.300  4.300  4.300  4.300  27.380  
Payments  (2) 3.065  3.315  3.800  4.300  4.300  4.300  4.300  27.380  
Title 2:  Commitments  (1a) 0.725  0.775  0.900  1.000  1.000  1.000  1.000  6.400  
Payments  (2a) 0.725  0.775  0.900  1.000  1.000  1.000  1.000  6.400  
Title 3:  Commitments  (3a) 24.000  18.000  18.000  10.000  10.000  10.000  10.000  100.000  
 Payments  (3b) 24.000  18.000  18.000  10.000  10.000  10.000  10000  100.000  
TOTAL appropriations  
for EMA  Commitments  =1+1a 
+3a 27.790  22.090  22.700  15.300  15.300  15.300  15.300  133.780  
Payments  =2+2a  
+3b 27.790  22.090  22.700  15300  15.300  15300  15.300  
133.780  
   
EN 44  EN Heading of multiannual financial  
framework  7 ‘Administrative expenditure’  
EUR million (to three decimal places)  
   Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  TOTAL  
DG: <…….>  
 Human Resources          
 Other administrative expenditure          
TOTAL DG <…….>  Appropriations          
 
TOTAL appropriations  
under HEADING  7 
of the multiannual financial framework   (Total commitments = 
Total payments)          
EUR million (to three decimal places)  
   Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  TOTAL  
TOTAL appropriations  
under HEADINGS 1 to 7  
of the multiannual financial framework   Commitments  27.790  22.090  22.700  15.300  15.300  15300  15.300  133.780  
Payments  27.790  22.090  22.700  15.300  15.300  15.300  15.300  133.780   
EN 45  EN 3.2.2.  Estimated impact on EMA's appropriations  
–  The proposal/initiative does not require the use of operational appropriations  
–  The proposal/initiative requires the use of operational appropriations, as explained below:  
Commitment appropriations in EUR million (to three decimal places)  
Indicate 
objectives and 
outputs  
 
   Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et seqq.  TOTAL  
OUTPUTS  
Type30 Average 
cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost 
No 
Cost Total 
No Total 
cost 
SPECIFIC OBJECTIVE No 1  Monitor and mitigate potential and actual shortages of medicines and medical de vices considered as critical in order to address 
a given public health emergency  
Medicines 
Steering Group     5.000   1.000   1.000   1.000   1.000   1.000   1.000   11.000  
Devices Steering 
Group     5.000   1.000   1.000   1.000   1.000   1.000   1.000   11.000  
Expert Panels     0  2.000   2.000   2.000   2.000   2.000   2.000   12.000  
Subtotal for specific objective No 1   10.000   4.000   4.000   4.000   4.000   4.000   4.000   34.000  
SPECIFIC OBJECTIVE No 2 Ensure the quality, safety and efficacy of medicinal products which may have the potential to address a given health 
emergency  
                                                 
30 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, et c.).  
EN 46  EN Emergency Task 
Force     5.000   1.000   1.000   1.000   1.000   1.000   1.000   11.000  
vaccine platform     5.000    5.000   5.000   5.000   5.000   5.000   5.000   35.000  
 Subtotal for specific  objective No 2   10.000   6.000   6.000   6.000   6.000   6.000   6.000   46.000  
SPECIFIC OBJECTIVE No 3 Allow timely access and analysis of EU -wide health data to support better decision -making throughout the product lifecycle on 
medicines (development, authorisation, performance monitoring) with valid and reliable real world evidence  
Node Reuse data     4.000   8.000   8.000   0  0  0  0  20.000  
Subtotal for specific objective No 3   4.000   8.000   8.000   0  0  0  0  20.000  
TOTAL COST   24.000   18.000   18.000   10.000   10.000   10.000   10.000   100.000   
EN 47  EN 3.2.3.  Estimated impact on EMA's human resources  
3.2.3.1.  Summary  
–  The proposal/initiative does not require the use of appropriations of an 
administrative nature  
–  The proposal/initiative requires the use of appropriations of an administrative 
nature, as explained below:  
EUR million (to three decimal places)  
 
Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  TOTAL  
 
Temporary agents (AD 
Grades)  2.700  3.000  3.450  3.750  3.750  3.750  3.750  24.150  
Temporary agents 
(AST grades)  0.450  0.450  0.450  0.750  0.750  0.750  0.750  4.350  
Contract staff  0.640  0.640  0.800  0.800  0.800  0.800  0.800  5.280  
Seconded National 
Experts  0 0 0 0 0 0 0 0 
 
TOTAL  3.790  4.090  4.700  5.300  5.300  5.300  5.300  33.780  
 
Staff requirements (FTE):  
 
Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  TOTAL  
 
Temporary agents (AD 
Grades)  18 20 23 25 25 25 25 25 
Temporary agents 
(AST grades)  3 3 3 5 5 5 5 5 
Contract staff  8 8 10 10 10 10 10 10 
Seconded National 
Experts          
 
TOTAL  29 31 36 40 40 40 40 40 
  
EN 48  EN Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment 
occurs in July, only 50  % of the average cost is taken into account) and provide further 
explanations.   
EN 49  EN 3.2.3.2.  Estimated requirements of human resources for the parent DG  
– X The proposal/initiative does not require the use of human resources.  
–  The proposal/initiative requires the use of human resources, as explained 
below:  
Estimate to be expressed in full amounts (or at most to one decimal place)  
 
Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  
 Establishment plan posts (officials and 
temporary staff)         
XX 01 01 01 (Headquarters and 
Commission’s Representation 
Offices)         
XX 01 01 02 (Delegations)         
XX 01 05 01 (Indirect research)         
10 01 05 01 (Direct research)         
        
 External staff (in Full Time Equivalent 
unit: FTE)31        
XX 01 02 01 (AC, END, INT from 
the ‘global envelope’)         
XX 01 02 02 (AC, AL, END, INT 
and JPD in the Delegations)         
XX 01 04 
yy32 - at 
Headquarters33 
        
- in 
Delegations         
XX 01 05 02 (AC, END, INT – 
Indirect research)         
10 01 05 02 (AC, END, INT – 
Direct research)         
Other budget lines (specify)         
TOTAL         
XX is the policy area or budget title concerned.  
The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if  necessary 
                                                 
31 AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JPD = 
Junior P rofessionals in Delegations .  
32 Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).  
33 Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and 
the European Fisheries Fund (EFF) .  
EN 50  EN with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints.  
Description of tasks to be carried out:  
Officials and temporary staff  Staff at EMA to perform  analysis of regulatory questions from the development, authorisation 
and supervision of medicines by EMA and NCA committees, scientific overview of the studies, 
integration of study results into the core medicinal product assessment work of the EMA, 
contr act management, legal, administration and IT support.  
External staff   
 
Description of the calculation of cost for FTE units should be included in the Annex V, 
section  3.   
EN 51  EN 3.2.4.  Compatibility with the current multiannual financial fra mework  
–  The proposal/initiative is compatible the current multiannual financial framework.  
–  The proposal/initiative will entail reprogramming of the relevant heading in the 
multiannual financial framework.  
The proposed additional budget for EMA may be f inanced by a reduction of the EU4Health budget in future 
years.  
–  The proposal/initiative requires application of the flexibility instrument or revision of 
the multiannual financial framework34. 
 
3.2.5.  Third -party contributions  
– The proposal/initiative does not provide for co -financing by third parties.  
– The proposal/initiative provides for the co -financing estimated below:  
EUR million (to three decimal places)  
 
Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  Total  
Specify the co -financing 
body   p.m.  p.m.  p.m.  p.m.  p.m.  p.m.  p.m. p.m.  
TOTAL appropriations 
co-financed  p.m.  p.m.  p.m.  p.m.  p.m.  p.m.  p.m. p.m.  
                                                 
34 See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial 
framework for the years 2014 -2020.   
EN 52  EN 3.3. Estimated impact on revenue  
–  The proposal/initiative has no financial impact on revenue.  
–  The proposal/initiative has the following financial impact:  
–  on own resources  
–  on other revenue  
–  please indicate, if the revenue is assigned to expenditure lines  
EUR million (to three decimal places)  
Budget revenue line:  Appropriation
s ava ilable for 
the current 
financial year  Impact of the proposal/initiative35 
Year 
2021  Year 
2022  Year 
2023  Year 
2024  Year 
2025  Year 
2026  Year  
2027 et 
seqq.  
Article ………….   p.m. p.m. p.m. p.m. p.m. p.m.  
For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected.  
 
Specify the method for calculating the impact on revenue.  
 
                                                 
35 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. 
gross amounts after deduction of 20  % for collection costs.