REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products (‘VMP Regulation’)
Date: 2023-06-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, delegated legislation, labelling, market approval, marketing standard, pharmaceutical legislation, pharmacology, powers of the institutions (EU), veterinary inspection, veterinary medicinal product

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.6.2023  COM(2023) 295 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products (‘VMP Regulation’)  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the exercise of the power to adopt delegated acts conferred on the Commission 
pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council on 
veterinary medicinal products (‘VMP Regulation’) 

1.  INTRODUCTION 

Regulation (EU) 2019/6 on veterinary medicinal products1 was adopted on 11 December 2018 
and entered into force on 27 January 2019. It has applied since 28 January 2022. 

Regulation (EU) 2019/6 sets out a modern, innovative and fit-for-purpose legal framework on 
veterinary medicinal products (“VMPs”). It gives incentives to stimulate innovation for VMPs 
and  increase  their  availability,  whilst  also  strengthening  the  EU’s  actions  to  fight 
antimicrobial  resistance.  Regulation  (EU)  2019/6  repealed  and  replaced  Directive 
2001/82/EC,2  which  needed  to  be  adapted  to  scientific  progress  and  to  current  market 
conditions  and  economic  reality,  while  continuing  to  ensure  a  high  level  of  protection  of 
animal health and welfare, and safeguarding public health and protecting the environment.   

Regulation (EU) 2019/6 contains a common framework for the authorisation of VMPs with a 
simplified assessment procedure and the possibility to extend the data protection period up to 
18  years  under  certain  conditions.  It  provides  a  clear  definition  and  adequate  rules  for 
biological VMPs and novel therapy VMPs, which should incentivise the development of new 
VMPs  in  those  areas.  Opening  up  the  centralised  authorisation  procedure  to  any  VMP  and 
allowing for marketing authorisations  in  exceptional  circumstances  is  expected to  positively 
broaden the spectrum  of VMPs that may be brought  to  the market. Regulation  (EU) 2019/6 
brings autogeneous vaccines  within  its scope, sets  up a Union Product  Database,  specifying 
clear  and  fully  harmonised  labelling  requirements,  adopting  a  simpler  system  for  variation 
decisions  and  a  risk-based  approach  for  pharmacovigilance  and  controls.  Finally,  the 
Regulation  provides  for  a  wide  range  of  concrete  measures  to  fight  antimicrobial  resistance 
(AMR) and to promote a prudent and responsible use of antimicrobials in animals. 

Regulation  (EU)  2019/6  contains  18  empowerments  for  the  Commission  to  adopt 
implementing acts and nine empowerments to adopt delegated acts.  

1   Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary 

medicinal products and repealing Directive 2001/82/EC (OJ L4, 7.1.2019, p. 43). 

2   Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the 

Commmunity code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). Directive 
2001/82/EC applied to nationally authorised products. The previous rules for centrally authorised products 
were set out in Regulation (EC) No 726/2004 laying down Community 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), Regulation (EC) No 1901/2006 on medicinal products for paediatric use 
(OJ L 378, 27.12.2006, p. 1) and Directive 2001/83/EC on the Community code relating to medicinal 
products for human use (OJ L 311, 28.11.2001, p. 67). Regulation (EU) 2019/5 of the European Parliament 
and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 (OJ L4, 7.1.2019, p. 24) 
repealed the provisions of Regulation (EC) No 726/2004 concerning the authorisation of veterinary medicinal 
products, as Regulation (EU) 2019/6 brings together rules for both nationally and centrally authorised 
products. 

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2.  LEGAL BASIS 

Article 147(2) of Regulation (EU) 2019/6 on veterinary medicinal products confers the power 
on  the  Commission  to  adopt  the  delegated  acts  referred  to  in  the  provisions  set  out  in  that 
Article  (see  section  3,  below).  Pursuant  to  Article  147(2)  of  Regulation  (EU)  2019/6,  the 
power  to  adopt  delegated  acts  concerning  the  matters  listed  therein  is  conferred  on  the 
Commission for a period of five years from 27 January 2019. The Commission is required to 
draw up a report to the European Parliament and the Council in respect of that delegation of 
power  not  later  than  nine  months  before  the  end  of  the  five-year  period.  The  delegation  of 
power  is  to  be  tacitly  extended  for  periods  of  identical  duration,  unless  the  European 
Parliament or the Council opposes such extension not later than three months before the end 
of each period.  

3.  EXERCISE OF THE DELEGATION 

According  to  Article  147(2)  of  Regulation  (EU)  2019/6,  the  Commission  is  empowered  to 
adopt  the delegated  acts referred to  in  Articles 37(4), 57(3), 106(6), 109(1), 115(3), 118(2), 
136(7) and 146(1) and (2) of the Regulation. 

3.1.  EMPOWERMENTS USED DURING THE REPORTING PERIOD  

During the reporting period3, the Commission exercised its delegated powers, by adopting the 
following delegated acts4: 

  Commission  Delegated  Regulation  (EU)  2021/577  of  29  January  2021  supplementing 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  as  regards  the 
content and format of the information necessary to apply Articles 112(4) and 115(5) and 
to be contained in the single lifetime identification document referred to in Article 8(4) of 
that  Regulation5,  as  amended6.  This  act,  adopted  on  the  basis  of  Article  109(1)  of 
Regulation (EU) 2019/6, entered into force on 29 April 2021 and entered into application 
on 28 January 2022. 

  Commission  Delegated  Regulation  (EU)  2021/578  of  29  January  2021  supplementing 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  with  regard  to 
requirements  for  the  collection  of  data  on  the  volume  of  sales  and  on  the  use  of 
antimicrobial  medicinal  products  in  animals7.  This  act,  adopted  on  the  basis  of  Article 
57(3)  of  Regulation  (EU)  2019/6,  entered  into  force  on  29  April  2021  and  entered  into 
application on 28 January 2022. 

  Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to 
Regulation (EU) 2019/6 of the European Parliament and of the Council8. This act, adopted 
on the basis of Article 146(2) of Regulation (EU) 2019/6, entered into force on  10 June 
2021 and entered into application on 28 January 2022. 

3   The cut-off date for the inclusion in this section of delegated acts adopted during the reporting period is 28 

April 2023.   

4   The delegated acts are listed in the chronological order of their date of adoption.  
5   OJ L 123 9.4.2021, p. 3. 
6   Commission Delegated Regulation (EU) 2022/524 of 27 January 2022 correcting Delegated Regulation (EU) 

2021/577 as regards certain references to veterinary medicinal products; OJ L 105, 4.4.2022, p. 1. 

7   OJ L 123, 9.4.2021, p. 7. 
8   OJ L 180, 21.5.2021, p. 3. 

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  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  designation  of  antimicrobials  to  be  reserved  for  the  treatment  of  certain 
infections in humans9. This act, adopted on the basis of Article 37(4) of Regulation (EU) 
2019/6, entered into force on 26 October 2021 and entered into application on 28 January 
2022. 

  Commission  Delegated  Regulation  (EU)  2023/183  of  23  November  2022  amending 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  as  regards  the 
requirements  on  compliance  with  good  laboratory  practice  for  veterinary  medicinal 
products set out in Annex II to that Regulation10. This act, adopted on the basis of Article 
146(1)  of  Regulation  (EU)  2019/6,  entered  into  force  on  19  February  2023  and  entered 
into application on 28 January 2022. 

  Commission  Delegated  Regulation  (EU)  2023/905  of  27  February  2023  supplementing 
Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  as  regards  the 
application of the prohibition of use of certain antimicrobial medicinal products in animals 
or products of animal origin exported from third countries into the Union11. This act was 
adopted on the basis of Article 118(2) of Regulation (EU) 2019/6.   

The  Commission  notified  each  of  the  aforementioned  delegated  acts  to  the  European 
Parliament and to the Council, in accordance with Article 147(6) of Regulation (EU) 2019/6. 
The European Parliament and the Council did not extend the objection period referred to  in 
Article 147(7) of Regulation (EU) 2019/6 in relation to any of these acts, with the exception 
of  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  designation  of  antimicrobials  to  be  reserved  for  the  treatment  of  certain 
infections in humans. The European Parliament extended the objection period by two months 
with respect to the latter act. Neither the European Parliament nor the Council objected to any 
of the above acts in accordance with Article 147(7) of Regulation (EU) 2019/6.  

The Commission has so far used 6 out of the 9 empowerments in Article 147(2) of Regulation 
(EU) 2019/6 and which are therefore within the scope of this report. 

3.2.  EMPOWERMENTS NOT USED DURING THE REPORTING PERIOD  

Certain  empowerments  of  Regulation  (EU)  2019/6  have  not  been  used  during  the  reporting 
period for the reasons explained below. 

  Article 106(6) 

The  Commission  is  currently  preparing  a  delegated  act  laying  down  rules  on  appropriate 
measures to ensure the effective and safe use of veterinary medicinal products authorised and 
prescribed for oral  administration via routes other than medicated feed  and administered by 
the animal keeper to food-producing animals, in accordance with Article 106(6) of Regulation 
(EU) 2019/6.   

  Article 115(3)  

9   OJ L 353, 6.10.2021, p. 1. 
10   OJ L 26, 30.1.2023, p.7. 
11   OJ L 116, 04.05.2023, p.1. 

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There  is  currently  no  new  scientific  evidence  reported  regarding  the  areas  covered  by 
paragraphs  1  to  4  of  Article  115  of  Regulation  (EU)  2019/6.  However,  future  changes  and 
developments  may  require  proceeding  with  the  preparation  of  a  delegated  act  pursuant  to 
Article 115(3).  

  Article 136(7)  

The  Commission  has  not  yet  started  preparing  a  delegated  act  under  Article  136(7)  of 
Regulation  (EU)  2019/6,  as  the  focus  so  far  has  been  on  empowerments  with  specific 
deadlines. However, it will proceed with preparation of a delegated act in due course. 

CONCLUSION 

The Commission sees the need for a tacit extension of the delegation of power provided for in 
Article 147(2) of Regulation (EU) 2019/6 for a period of five years, in accordance with that 
Article.  This  is  due  to  the  fact  that  the  need  to  develop  rules  based  on  the  empowerments 
granted by Article 147(2) of Regulation (EU) 2019/6 will remain in the future. This will be 
particularly  important  to  provide  the  necessary  flexibility  in  the  new  legal  framework,  to 
complement  and  adjust  it  regularly  to  the  latest  scientific  standards  and  to  allow  the 
Commission to act in the areas where it did not act until now, but will need to do so in the 
future.  

With  this  report,  the  Commission  complies  with  the  reporting  requirements  established  in 
Article 147(2) of Regulation (EU) 2019/6.  

The Commission invites the European Parliament and the Council to take note of this report.  

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