EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10220/2022 feedback 
(POOL/E5/2022/10220/10220 -EN 
feedback.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
designating antimicrobials or groups of antimicrobials reserved for treatment of certain 
infections in humans, in accordance with Regulation (EU) 2019/6 of the European 
Parliament and of the Council  
 
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
designating antimicrobials or groups of antimicrobials reserved for treatment of certain 
infections in humans, in accordance with Regulation (EU) 2019/6 of the European 
Parliament and of the Council  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulat ion (EU) 2019/6 of the European Parliament and of the Council of 
11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC1, 
and in particular Article 37(5)  thereof,  
Whereas:  
(1) Regulation (EU) 2019/6 sets a broad range of concrete measures to fight antimicrobial 
resistance and to promote a more prudent and responsible use of antimicrobial 
medicinal products in animals, including very strict rules on their veterinary 
prescription for prophylactic and metaphylactic use. That Regulatio n also recalls that 
antimicrobial  medicinal products  should not be administered routinely nor used to 
compensate for poor hygiene, inadequate animal husbandry, lack of care or to 
compensate for poor farm management .  
(2) Certain a ntimicrobial  medicinal products  or groups of antimicrobial  medicinal 
products  should be reserved for treatment of certain infections in humans, with a view 
to better preserve their efficacy for human medicine and to supporting the fight against 
antimicrobial resistanc e, which is a major threat to global health .  
(3) The antimicrobial medicinal products or groups of antimicrobial medicinal products to  
be reserved for treatment of certain infections in humans are to be designated on the 
basis of the criteria set for this pur pose in Commission Delegated Regulation (EU) 
2021/17602.  
(4) The European Medicines Agency (‘the Agency’)  evaluated3 antimicrobials and  group s 
of antimicrobial s used in medicinal products authorised in Member States and in third 
countries. It identified which  antimicrobials and groups of antimicrobials fulfilled the 
criteria set in Delegated Regulation (EU) 2021/1760 , taking into consideration the 
latest available scientific evidence . The Agency’s advice is based, in accordance with 
                                                 
1 OJ L 4, 7.1.2019, p. 43 .  
2 Commission Delegated Regulation (EU) 2021/1760 of 26  May 2021 supplementing Regulation (EU) 
2019/6 of the European Parliament and of the Council by establishing the criteria for the designat ion of 
antimicrobials to be reserved for the treatment of certain infections in humans ( OJ L 353, 6.10.2021, p. 
1). 
3 Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain 
infections in humans - in relati on to implementing measures under Article 37(5) of Regulation (EU) 
2019/6 on veterinary medicinal products  (EMA/CVMP/678496/2021 , 16 February 2022 )  
EN 2  EN Article 37(6) of Regulation  (EU) 2019/6, on the joint opinion  of experts in human 
medicine and of experts in veterinary medicine from national competent authorities, 
the Eu ropean Food Safety Authority , the European Centre for  Disease Prevention and 
Control and the Agency itself,  as well as of external experts on human infectious 
diseases from learned societies and academia . 
(5) Pursuant to the Agency’s advice, several antibiotics, several antivirals and one 
antiprotozoal fulfilled the criteria established under Delegated Regulation (EU) 
2021/1760  and should therefore be reserved for the treatment of certain infections in 
humans. Pursuant to the Agency’s advice, none of the antifungals evaluated met those 
criteria . 
(6) The antimicrobials and group of antimicrobials listed in this Regulation should not be 
used in veterinary medicinal products. Thus, marketing authorisation applications for 
veterinary medicinal products that contain any of the antimicrobials or groups of 
antimicrobials listed in this Regulation should be refused. In addition, existing 
marketing authorisations of veterinary medicinal products containing such 
antimicrobials or groups of antimicrobials should cease to be valid .  
(7) Veterinary medicinal products are sometimes  administered to animals through 
medicated feed. The use of veterinary medicinal products that contain antimicrobials 
or groups of antimicrobials listed in this Regulation in medicated feed should not be 
possible .  
(8) Moreover, medicinal products that contain any of the antimicrobials or groups of 
antimicrobials listed in this Regulation should not be used in animals, even  under  the 
conditions set in Articles 112, 113 and 114 of Regulation (EU) 2019/6 . 
(9) With a view to giving veterinarians, owners of  animals and economic operators 
concerned the necessary time to adjust to the consequences referred to above, this 
Regulation should apply six months after its entry into force . 
(10) The list of antimicrobials or groups of antimicrobials to be reserved  for treatment of 
certain infections in humans, as provided for in this Regulation  may be reviewed, as 
necessary, in the light of new scientific evidence or emerging information, including 
the emergence of new diseases, changes in the epidemiology of existing disea ses, 
changes in antimicrobial drug resistance or changes in availability or patterns of 
antimicrobial use . 
(11) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing  Committee  on Veterinary Medicinal Products referred t o in Article 145 of 
Regulation (EU) 2019/6 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Antimicrobials or groups of antimicrobials designated as reserved for treatment of certain 
infections in humans  
1. The antimicrobials and groups of antimicrobials listed in the  Annex shall not be used 
in veterinary medicinal products or medicated feed . 
2. The use in animals of medicinal products for human use that contain any of the 
antimicrobials or groups of antimicrobials listed in the Annex is prohibited .  
EN 3  EN Article  2 
Entry into f orce and application  
This Regulatio n shall enter into force on the twentieth day following that of  its publication in 
the Official Journal of the European Union . 
It shall apply from [OP please insert the date = 6 months after the date of entry into force of 
this Regulation] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN