Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive 2001/82/EC and Regulation (EC) No 726/2004
Date: 2022-03-02
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer information, labelling, market approval, marketing standard, packaging, pharmaceutical legislation, product designation, veterinary medicinal product

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   EUROPEAN COMMISSION  Brussels, 2.3.2022  COM(2022) 76 final 2022/0053 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down transitional rules for the packaging and labelling of veterinary medicinal products authorised in accordance with Directive 2001/82/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

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CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

This  proposal  addresses  the  serious  concerns  raised  by  Member  State  competent  authorities 
and stakeholders in relation to the practical application of Article 152(2) of Regulation (EU) 
2019/6  on  veterinary  medicinal  products  and  the  need  to  ensure  continued  supply  of 
veterinary medicinal  products  (VMPs) authorised under the preceding legislation on the EU 
market.  It  is  necessary  to  take  urgent  steps  to  address  the  interpretation  problems  raised,  to 
remove any legal uncertainty and avoid any disruption in the supply of VMPs, as Regulation 
(EU) 2019/6 entered into application on 28 January 2022. The proposal aims to avoid the risk 
of  shortages  of  VMPs,  which  would  have  led  to  a  serious  impact  on  animal  health  and 
welfare,  both  in  farm  and  companion  animals.  It  therefore  provides  for  transitional  rules 
allowing marketing authorisation holders to  place VMPs complying with the packaging and 
labelling  requirements  of  Directive  2001/82/EC  or  Regulation  (EC)  No  726/2004  on  the 
market until 29 January 2027, even if they do not comply with  the relevant requirements of 
Regulation (EU) 2019/6. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The legal bases of this proposal  are, Articles 114 and 168(4), point (b) of the Treaty on the 
Functioning of the European Union. 

• 

Subsidiarity (for non-exclusive competence)  

The  authorisation  of  veterinary  medicinal  products,  including  requirements  concerning 
packaging  and  labelling,  have  been  comprehensively  regulated  at  Union  level.  Therefore,  it 
would not be possible to address the issue at national level. 

• 

Proportionality 

Laying  down  transitional  rules  for  the  packaging  and  labelling  of  veterinary  medicinal 
products  authorised  in  accordance  with  Directive  2001/82/EC  or  Regulation  (EC)  No 
726/2004 is indispensable in order to ensure the continued availability of veterinary medicinal 
products and to establish legal certainty. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

From  a  Better  Regulation  perspective,  a  roadmap,  stakeholder  consultation  or  impact 
assessment are not necessary, as the proposal sets out transitional rules that are necessary for 
the  entry  into  application  of  Regulation  (EU)  2019/6,  which  already  started  to  apply  on  28 
January 2022. It is therefore required as a matter of urgency. The proposal does not introduce 
any burden on economic operators  or on Member States. DG SANTE’s statement issued on 
28  January  2022,  indicating  its  intention  to  prepare  this  proposal,  responded  to  concerns 
raised by both industry and Member State competent authorities. 

4. 

BUDGETARY IMPLICATIONS 

The proposal has no implications on the Union budget.  

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 5. 

OTHER ELEMENTS 

• 

Detailed explanation of the specific provisions of the proposal 

The  transitional  rules  in  the  proposal  allow  marketing  authorisation  holders  to  continue  to 
place  VMPs  complying  with  the  packaging  and  labelling  requirements  of  Directive 
2001/82/EC  or  Regulation  (EC)  No  726/2004  on  the  market  until  29  January  2027,  even  if 
they do not comply with the relevant requirements of Regulation 2019/6. 

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2022/0053 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

laying down transitional rules for the packaging and labelling of veterinary medicinal 
products authorised in accordance with Directive 2001/82/EC and Regulation (EC) No 
726/2004 

(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), point (b), 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 Committee1, 
After consulting the Committee of the Regions2, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council3  started 
applying on 28 January 2022. 

(2)  Marketing  authorisation  holders  of  veterinary  medicinal  products  authorised  under 
Directive 2001/82/EC of the European Parliament  and of the Council4 or Regulation 
(EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council5  are  not  able  to 
comply,  by  28  January  2022,  with  the  requirements  set  out  in  Articles  10  to  16  of 
Regulation  (EU)  2019/6.  Furthermore,  competent  authorities  are  not  in  a  position  to 
process  all the necessary variations  as defined in Article 4, point (39), of Regulation 
(EU) 2019/6  of marketing  authorisations  granted  in  accordance with  either Directive 
2001/82/EC or Regulation (EC) No 726/2004 to ensure compliance with Articles 10 to 
16 of Regulation (EU) 2019/6 in a timely manner.  

(3) 

Therefore, it is necessary to provide for transitional rules in relation to packaging and 
labelling  of  products  authorised  in  accordance  with  either  Directive  2001/82/EC  or 
Regulation (EC) No 726/2004 to ensure the continued availability of those veterinary 

1 
2 
3 

4 

5 

OJ C , , p. . 
OJ C , , p. . 
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 L 4, 7.1.2019, p.43). 
Directive  2001/82/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 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). 

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(4) 

(5) 

(6) 

medicinal products in the Union and to establish legal certainty. The transitional rules 
should  be  limited  to  veterinary  medicinal  products  that  do  not  comply  with  the 
packaging  and  labelling  requirements  of  Regulation  (EU)  2019/6  but  which  comply 
with all other provisions of that Regulation. 

Regulation  (EC)  No  726/2004  does  not  lay  down  specific  requirement  for  labelling 
and  packaging.  However,  it  follows  from  Articles  31(1),  34(1)(c),  34(4)(e)  and  37  of 
Regulation  (EC)  No  726/2004,  as  applicable  on  27  January  2022,  that  products 
authorised  under  that  Regulation  are  to  comply  with  Articles  58  to  64  of  Directive 
2001/82/EC. 

This  Regulation  lays  down  transitional  rules,  which  should  apply  from  the  date  of 
application of Regulation (EU) 2019/6, that is, from 28 January 2022. Therefore, this 
Regulation should apply from that same date.  

Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States, but  can rather, by  reason of its effects,  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 
proportionality, as set out in that Article, this Regulation does not go beyond  what is 
necessary in order to achieve those objectives, 

HAVE ADOPTED THIS REGULATION: 

Article 1 
Definitions 

For  the  purposes  of  this  Regulation,  the  definitions  in  Article  4(1),  (24),  (27)  and  (35)  of 
Regulation (EU) 2019/6 shall apply. 

Article 2 

Veterinary  medicinal  products  which  were  authorised  in  accordance  with  Directive 
2001/82/EC  or  Regulation  (EC)  No  726/2004  and  which  comply  with  Articles  58  to  64  of 
Directive 2001/82/EC, as applicable on 27 January 2022, can be placed on the market until 29 
January  2027,  even  if  their  labelling  and,  where  applicable,  package  leaflet  are  not  in 
compliance with Articles 10 to 16 of Regulation (EU) 2019/6. 

Article 3 

This Regulation 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 28 January 2022. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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