EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10274/2021 ANNEX feedback 
(POOL/E5/2021/10274/10274 -EN 
ANNEX feedback.docx)  
[…](2021) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission delegated regulation  
supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council 
by establishing the criteria for the designation of antimicrobials to be reserved for the 
treatment of certain infections in humans  
  
EN 1  EN ANNEX  
Criteria for the designation of the antimicrobials which are to be reserved for treatment 
of certain infections in humans  
PART  A: CRITERION OF HIGH IMPORTANCE TO H UMAN HEALTH  
1. The antimicrobial or group of antimicrobials meets this criterion if any of the 
following applies:  
(a) it is the sole  or last-resort antimicrobial or group of antimicrobials available in 
a patient management treatment approach f or serious, life -threatening 
infections in humans which, if inappropriately treated, would lead to significant debilitating morbidity or significant mortality ; 
(b) it is an essential component of the limited treatment alternatives available in a 
patient manage ment treatment approach for serious, life -threatening infections 
in humans which, if inappropriately treated, would lead to significant  
debilitating morbidity  or significant mortality ; 
(c) it is an antimicrobial or a group of antimicrobials, which is  authorised in the 
Union for the treatment of serious microbial infections in patients with limited 
treatment options, indicating that the antimicrobial or the group of antimicrobials  considered is recognised as addressing  an unmet medical need 
related to antimicrobial resistance.  
2. Factors considered responsible for limited treatment alternatives  for patients, as 
referred to in point  1(b),  include :  
– the virulence an d antimicrobial resistant phenotype(s) of the microorganisms  
causing infection , including multidrug resistance ;  
– the characteristics of the patient s (for example,  immunocompromised, paediatric, 
elderly) and disease ( for example,  site of infection concerned) under treatment ;  
– the proportion of patients  requiring treatment and the impact on healthcare 
services . 
PART  B: CRITERION OF R ISK OF TRANSMISSION OF RESISTANCE  
1. The antimicrobial or group of antimicrobials meets this criterion if any of the 
following applies:  
(a) for an antimicrobial or group of antimicrobials authorised for use in animals, scientific  evidence , including epidemiological evidence where available, exists 
showing  that: 
– there is an actual emergence, dissemination and transmission of 
resistance  to this antimic robial or group of antimicrobials, or induction of  
cross -resistance or co -selection of resistance to other antimicrobials , and  
– transmission of such resistance from animal  sources to humans is 
significant and linked to the use of this antimicrobial or group of 
antimicrobial in animals, whether it occurs through microorganisms 
resistant to the antimicrobial or group of antimicrobials considered or 
through the transmission of genes conferring resistance to the antimicrobial or group of antimicrobials considere d.   
EN 2  EN (b) for an antimicrobial or group of antimicrobials not authorised for use in 
animals, scientific evidence exists showing  that: 
– there is the potential for emergence, dissemination and transmission of resistance to this antimicrobial or group of antimicrobials or potential for inducing cross -resistance or co -selection of resistance to other 
antimicrobials , and  
– this transmission from animal sources  to humans would likely be 
significant and linked to the use of this antimicrobial or group of antimicrobials in animals, whether it would occur through 
microorganisms resistant to the antimicrobial or group of antimicrobials 
considered or through the transmission of genes conferring resistance to the antimicrobial or group of antimicrobials considered.  
2. Factors trigg ering  significant  transmission  of resistance between animals and humans 
linked to the use of an antimicrobial  or group of antimicrobials  in animals  include : 
– use selects for  resistance, cross -resistance or co -selection of resistance  to 
antimicrobials  that a re crucial  for human medicine ;  
– transmission of resistance occurs by vertical as well as horizontal transmission ; 
– transmission of resistance involves zoonotic pathogens ; 
– transmission can take place by different routes of exposure ;  
– transmission occurs through a number of different animal species.  
PART  C: CRITERION OF NON -ESSENTIAL NEED FOR ANIMAL HEALTH   
1. The antimicrobial or group of antimicrobials meets this criterion if any of the 
following appl ies: 
(a) there is no robust evidence of the need for the anti microbial or group of 
antimicrobials in veterinary medicine ; 
(b) the antimicrobial or group of antimicrobial s is used to treat serious , life -
threatening infection s in animals which , if inappropriately  treated , would lead 
to significant morbidity or significant mortality , or would have a major impact 
on animal welfare or public health , but adequate alternative medicinal products 
are available for the treatment of th ose infections in the animal species  
concerned ; 
(c) the antimicrobial or group of antimicrobials is used to treat serious, life -
threatening infections in animals which , if inappropriately treated , would lead 
to limited morbidity or limited mortality  and there is scientific evidence 
showing an overriding public health interest in not using it.  
2. The provisions laid down in point  1 apply when the antimicrobial or group of 
antimicrobials considered is either of the following:  
(a) an antimicrobial or group of antimicrobials present within authoris ed 
veterinary medicinal product s;  
(b) an antimicrobial or group of antimicrobials present within medicinal products authorised for use in humans , that may be  administered to an imals outside the 
terms of their marketing authorisation.