BETA


2022/0053(COD) Packaging and labelling of veterinary medicinal products: transitional rules

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI
Lead committee dossier:
Legal Basis:
RoP 163, TFEU 114, TFEU 168-p4

Events

2022/06/08
   EC - Commission response to text adopted in plenary
Documents
2022/05/31
   Final act published in Official Journal
2022/05/30
   CSL - Draft final act
Documents
2022/05/30
   CSL - Final act signed
2022/05/16
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2022/05/05
   EP - Results of vote in Parliament
2022/05/05
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 589 votes to 5, with 2 abstentions, a legislative resolution on the 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 726/200.

Parliament adopted its position at first reading under the ordinary legislative procedure.

The proposed regulation responds to the need to provide for transitional rules for the packaging and labelling of veterinary medicinal products authorised or registered in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 in order to ensure the continued availability of these veterinary medicinal products in the Union and to create legal certainty.

The transitional rules are limited to veterinary medicinal products that do not comply with the packaging and labelling requirements of Regulation (EU) 2019/6 but comply with all other provisions of Regulation (EU) 2019/6.

The Regulation provides that veterinary medicinal products which have been authorised or registered 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, in the version applicable on 27 January 2022, may be placed on the market until 29 January 2027 , even if their labelling and, where appropriate, package leaflets do not comply with Articles 10 to 16 of Regulation (EU) 2019/6.

The regulation will apply from 28 January 2022.

Documents
2022/04/25
   EP - Decision by committee, without report
2022/03/23
   ESC - Economic and Social Committee: opinion, report
Documents
2022/03/07
   EP - Committee referral announced in Parliament, 1st reading
2022/03/02
   EC - Legislative proposal published
Details

PURPOSE: to avoid the risk of shortages of veterinary medicine products which would have led to a serious impact on animal health and welfare, both in farm and companion animals.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Regulation (EU) 2019/6 on veterinary medicinal products entered into force on 28 January 2022. Holders of marketing authorisations for veterinary medicinal products authorised under Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products or Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use, are not in a position to comply with the requirements set out in Articles 10 to 16 of Regulation (EU) 2019/6 with effect from 28 January 2022.

Therefore, it is necessary to take urgent measures to address the concerns raised by Member States' competent authorities and stakeholders about the practical application of Regulation (EU) 2019/6 in order to remove any legal uncertainty and to avoid possible disruptions in the supply of veterinary medicines.

CONTENT: the proposal provides for transitional rules in the proposal allow marketing authorisation holders to continue to place veterinary medicinal products 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.

Documents

History

(these mark the time of scraping, not the official date of the change)

docs/0/docs/0/url
https://dmsearch.eesc.europa.eu/search/public?k=(documenttype:AC)(documentnumber:1391)(documentyear:2022)(documentlanguage:EN)
docs/1
date
2022-05-05T00:00:00
docs
title: T9-0198/2022
type
Text adopted by Parliament, 1st reading/single reading
body
EP
docs/2
date
2022-06-08T00:00:00
docs
url: /oeil/spdoc.do?i=58253&j=0&l=en title: SP(2022)324
type
Commission response to text adopted in plenary
body
EC
events/0/docs/0
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2022&nu_doc=0076
title
EUR-Lex
events/3
date
2022-05-05T00:00:00
type
Results of vote in Parliament
body
EP
docs
url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=58253&l=en title: Results of vote in Parliament
events/3
date
2022-05-05T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
title: T9-0198/2022
events/4
date
2022-05-05T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2022-0198_EN.html title: T9-0198/2022
summary
events/6
date
2022-05-31T00:00:00
type
Final act published in Official Journal
events/7
date
2022-05-31T00:00:00
type
Final act published in Official Journal
events/7/docs
  • title: Regulation 2022/839 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32022R0839
  • title: OJ L 148 31.05.2022, p. 0006 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2022:148:TOC
procedure/final
title
Regulation 2022/839
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32022R0839
docs/0
date
2022-03-02T00:00:00
docs
title: COM(2022)0076
summary
type
Legislative proposal
body
EC
events/0
date
2022-03-02T00:00:00
type
Legislative proposal published
body
EC
docs
title: COM(2022)0076
summary
events/6
date
2022-05-31T00:00:00
type
Final act published in Official Journal
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
docs/1
date
2022-03-23T00:00:00
docs
title: CES1391/2022
type
Economic and Social Committee: opinion, report
body
ESC
docs/2
date
2022-05-05T00:00:00
docs
title: T9-0198/2022
type
Text adopted by Parliament, 1st reading/single reading
body
EP
docs/3
date
2022-05-30T00:00:00
docs
title: 00019/2022/LEX
type
Draft final act
body
CSL
events/1
date
2022-04-25T00:00:00
type
Decision by committee, without report
body
EP
events/2
date
2022-05-05T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
title: T9-0198/2022
events/3
date
2022-05-16T00:00:00
type
Act adopted by Council after Parliament's 1st reading
body
EP/CSL
events/4
date
2022-05-30T00:00:00
type
Final act signed
body
CSL
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
procedure/legal_basis/0
Rules of Procedure EP 163
procedure/stage_reached
Old
Awaiting committee decision
New
Procedure completed, awaiting publication in Official Journal
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
commission
  • body: EC dg: Health and Food Safety commissioner: KYRIAKIDES Stella
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
docs/0/summary
  • PURPOSE: to avoid the risk of shortages of veterinary medicine products which would have led to a serious impact on animal health and welfare, both in farm and companion animals.
  • PROPOSED ACT: Regulation of the European Parliament and of the Council.
  • ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
  • BACKGROUND: Regulation (EU) 2019/6 on veterinary medicinal products entered into force on 28 January 2022. Holders of marketing authorisations for veterinary medicinal products authorised under Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products or Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use, are not in a position to comply with the requirements set out in Articles 10 to 16 of Regulation (EU) 2019/6 with effect from 28 January 2022.
  • Therefore, it is necessary to take urgent measures to address the concerns raised by Member States' competent authorities and stakeholders about the practical application of Regulation (EU) 2019/6 in order to remove any legal uncertainty and to avoid possible disruptions in the supply of veterinary medicines.
  • CONTENT: the proposal provides for transitional rules in the proposal allow marketing authorisation holders to continue to place veterinary medicinal products 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.
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
events
  • date: 2022-03-07T00:00:00 type: Committee referral announced in Parliament, 1st reading body: EP
procedure/dossier_of_the_committee
  • ENVI/9/08473
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision