BETA


2014/0257(COD) Veterinary medicinal products

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI GROSSETÊTE Françoise (icon: PPE PPE) TĂNĂSESCU Claudiu Ciprian (icon: S&D S&D), PIECHA Bolesław G. (icon: ECR ECR), FEDERLEY Fredrick (icon: ALDE ALDE), HÄUSLING Martin (icon: Verts/ALE Verts/ALE), PEDICINI Piernicola (icon: EFDD EFDD)
Committee Opinion ITRE
Committee Opinion IMCO
Committee Opinion AGRI MÜLLER Ulrike (icon: ALDE ALDE) Bas BELDER (icon: ECR ECR), Nicola CAPUTO (icon: S&D S&D), Giulia MOI (icon: EFDD EFDD), Miguel VIEGAS (icon: GUE/NGL GUE/NGL)
Lead committee dossier:
Legal Basis:
RoP 59-p4, TFEU 114, TFEU 168-p4

Events

2019/01/07
   Final act published in Official Journal
Details

PURPOSE: to adopt new rules on veterinary medicinal products with a view to ensuring a high level of protection of human and animal health and the environment and the proper functioning of the internal market.

LEGISLATIVE ACT: Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.

CONTENT: the Regulation lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products. It sets high standards of quality, safety and efficacy of veterinary drugs. At the same time, it harmonises the rules on the authorisation of veterinary medicinal products and their placing on the Union market.

Marketing authorisations

The new rules clarify and simplify the procedures for granting a marketing authorization for new medicines, which reduces the administrative burden for businesses, especially small businesses. Member States will have to take the necessary measures to advise SMEs on compliance with the requirements of the Regulation.

A veterinary medicinal product shall be placed on the market only when a competent authority or the Commission, as applicable, has granted a marketing authorisation for that product. A marketing authorisation for a veterinary medicinal product shall only be granted to an applicant established in the Union. It shall be valid for an unlimited period of time. Decisions to grant, refuse, suspend, revoke or amend by way of a variation a marketing authorisation shall be made public.

A marketing authorisation will be refused if, in particular:

- the benefit-risk balance of the veterinary medicinal product is negative;

- the applicant has not provided sufficient information on the quality, safety or efficacy of the veterinary medicinal product;

- the veterinary medicinal product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals;

- the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health

Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.

Improving the operation of the pharmacovigilance system

Holders of marketing authorisations will be responsible for continuously carrying out pharmacovigilance in order to ensure the continuous evaluation of the benefit-risk balance of the veterinary medicinal products they place on the market. They will, in particular:

- collect reports on suspected adverse events relating to their veterinary medicinal products;

- ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge, and

- record in the product database the dates when its authorised veterinary medicinal products are placed on the market, and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned.

Member States competent authorities will have the power to carry out inspections, including unannounced inspections, at all stages of the production, distribution and use of veterinary medicinal products. To ensure a harmonised approach to controls throughout the Union, the Commission will be able to carry out audits in the Member States to verify the functioning of national control systems.

Prudent use of antimicrobials

The new rules provide that certain critical antimicrobials are reserved for the treatment of certain infections in humans so that their effectiveness is preserved.

Furthermore, the Regulation provides a better framework for the use of antimicrobial agents to prevent their prophylactic (as a preventive measure) and metaphylactic use (for example to treat a group of animals, one of which presents signs of infection):

- antimicrobial medicinal products should not be used for prophylaxis other than in well-defined cases for the administration to an individual animal or restricted number of animals when the risk for infection is very high or its consequences are likely to be severe. Antibiotic medicinal products should not be used for prophylaxis other than in exceptional cases only for the administration to an individual animal;

- antimicrobial medicinal products should be used for metaphylaxis only when the risk of spread of an infection or of an infectious disease in a group of animals is high and where no appropriate alternatives are available.

A veterinary prescription for an antimicrobial medicinal product for metaphylaxis shall only be issued after a diagnosis of the infectious disease by a veterinarian. It shall be issued only after a clinical examination or any other proper assessment of the health status of the animal or group of animals by a veterinarian.

The Regulation also improves the protection of European consumers against the risk that antimicrobial resistance will spread through imports of animals and animal products.

ENTRY INTO FORCE: 27.1.2019.

APPLICATION: from 28.1.2022.

2018/12/12
   CSL - Draft final act
Documents
2018/12/11
   CSL - Final act signed
2018/12/11
   EP - End of procedure in Parliament
2018/11/26
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2018/11/26
   CSL - Council Meeting
2018/11/21
   EC - Commission response to text adopted in plenary
Documents
2018/10/25
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 583 votes to 16, with 20 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.

The European Parliament’s position adopted at first reading under the ordinary legislative procedure amended the Commission proposal as follows:

Purpose : the Regulation shall establish rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products. It shall set high standards of quality, safety and efficacy for veterinary medicinal products in order to meet common concerns as regards the protection of public and animal health and of the environment. At the same time, it shall harmonise the rules for the authorisation of veterinary medicinal products and the placing of them on the Union market.

It shall not apply to veterinary medicinal products which have not undergone an industrial process such as, for example, non-processed blood.

Marketing authorisations : a veterinary medicinal product may only be placed on the market when a marketing authorisation for that product has been granted by a competent authority or by the Commission. Authorisations may only be granted to applicants established in the Union. Decisions to grant, refuse, suspend, revoke or amend a marketing authorisation shall be made public.

Exemptions may be granted for veterinary medicinal products for animals that are exclusively pets, provided that these medicinal products are not subject to a veterinary prescription.

Decisions to grant marketing authorisations : a marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period. By way of derogation, a marketing authorisation for a limited market shall be valid for five years.

Where the application concerns an antimicrobial veterinary medicinal product, the competent authority or the Commission, as applicable, may require the marketing authorisation holder to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive given the potential development of antimicrobial resistance.

A marketing authorisation shall be refused if : (i) the applicant has not sufficiently demonstrated efficacy on the target species; (ii) the risks to public or animal health or the environment are not sufficiently addressed; (iii) the medicinal product is an antimicrobial veterinary medicinal product presented for use as a performance promoter to accelerate the growth or increase the yield of treated animals ; (iv) the active substance contained in the medicinal product meets the criteria to be considered persistent, bioaccumulative and toxic or very persistent and very bioaccumulative.

Responsibilities of marketing authorisation holders : the marketing authorisation holder shall be responsible for the placing on the market of his veterinary medicinal product. The designation of a representative shall note relieve the marketing authorisation holder of legal liability. In particular, the authorisation holder shall:

ensure, within the limits of its responsibilities, an appropriate and continuous supply of its veterinary medicinal products; ensure that the summary of product characteristics, package leaflet and labelling is kept up to date with current scientific knowledge; not place generic veterinary medicinal products and hybrid veterinary medicinal products on the Union market until the period of the protection of technical documentation for the reference veterinary medicinal product has elapsed; record in the product database the dates when its authorised veterinary medicinal products are placed on the market, information on the availability for each veterinary medicinal product in each relevant Member State and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned; record in the product database the annual volume of sales for each of its veterinary medicinal products.

Prudent use of antibiotics : given that resistance to antimicrobial drugs for human and veterinary use is a growing health problem in the EU and worldwide, the amended text emphasised the need to limit the veterinary use of critically important antimicrobial agents to the prevention or treatment of life-threatening human infections and to encourage and facilitate the development of new antimicrobials.

According to the amended text:

antimicrobial drugs shall only be used for prophylactic purposes (as a preventive measure) in well-defined cases of treatment of an animal or a limited number of animals, if the risk of infection is very high or if the consequences of such infection can have serious consequences. Antibiotic drugs shall only be used for prophylactic purposes in exceptional cases and only for a specific animal; antimicrobial drugs should only be used for metaphylaxis (e. g. to treat a group of animals, one of which shows signs of infection) if there is a high risk of spreading an infection or infectious disease in a group of animals and no other solution exists.

Veterinarians shall always issue a veterinary prescription when supplying a veterinary medicinal product subject to a veterinary prescription only and not administering it themselves. Whenever the veterinarians administer such medicinal products themselves it shall be left up to national provisions to specify whether a veterinary prescription needs to be issued. However, veterinarians shall always keep records of the medicinal products that they have administered.

The amended text provides that third country operators will have to comply with certain basic conditions relating to antimicrobial resistance for animals and products of animal origin exported to the Union. It also provides incentives to encourage research and innovation , in particular on antimicrobials.

Documents
2018/10/24
   EP - Debate in Parliament
2017/06/12
   CSL - Debate in Council
Documents
2017/06/12
   CSL - Council Meeting
2016/03/10
   EP - Results of vote in Parliament
2016/03/10
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted amendments to the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.

The matter has been referred back to the committee. The vote on the legislative resolution has been postponed to a subsequent sitting .

The main elements adopted in plenary are as follows:

Aim : this Regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. Therefore, the precautionary principle should be applied.

Member States may impose stricter conditions, justified on grounds of public health, animal health and environmental protection , for the use and retail of veterinary medicinal products on their territory, provided that these conditions are proportionate to the risk and do not unduly restrict the functioning of the internal market

Antibacterial resistance : in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, Members considered it necessary to reserve those antimicrobials for humans only . The Commission shall, by means of implementing acts and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO, designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans.

Therefore, the Union should be active in advocating the creation of an international strategy to combat antimicrobial resistance, in line with the recent Global Action Plan adopted by the WHO.

Use of prophylactic and metaphylactic medicines : Members considered that the routine prophylactic (preventive) and metaphylactic (mass medication of a group of animals to eliminate or minimize an expected outbreak of disease) use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing and sound management practices.

Routine prophylactic use of antimicrobials is therefore prohibited . Prophylactic use of antimicrobial veterinary medicines will only be permitted on single animals and when fully justified by a veterinarian in exceptional indications, of which a list shall be drafted by the Agency.

Metaphylactic use of antimicrobial veterinary medicines will be restricted to use in clinically-ill animals and to those single animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group.

According to the amended text, antimicrobial veterinary medicines shall not under any circumstances serve to improve performance or compensate for poor animal husbandry.

Research and innovation : to encourage research into new antimicrobials, Parliament advocated the following incentives:

longer periods of protection for technical documentation on new medicines; commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market.

A new article on the period of protection of new data packages related to existing veterinary medicinal products stipulated that any new studies and trials , submitted by the applicant for a marketing authorisation to the competent authorities for an existing veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years under certain conditions.

Animals under the care of veterinary professionals : Parliament narrowed the definition of persons entitled to retail veterinary medicines and states that persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their immediate care, subject to an appropriate veterinary diagnosis and examination of the animals concerned, and only in the amount required for the treatment concerned. In the case of food-producing animals , the continuation of the treatment with antimicrobial products shall be decided based on a renewed clinical examination by a veterinarian

On-line sales : a ntimicrobials, psychotropic and biological or immunological veterinary medicinal products may not be offered on the internet . Other products may be sold online under strict criteria e.g that the veterinary medicinal products and the prescriptions comply with the law of the destination Member State.

The Commission shall adopt guidelines supporting the Member States in the development of a harmonised system of digital prescription across the Union, including measures for controlling cross-border veterinary prescriptions.

Environmental protection : no later than six months before the date of application of the Regulation, the Commission must present a report on a feasibility study of a substance-based review system ('monographs') and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.

Documents
2016/03/10
   EP - Matter referred back to the committee responsible
2016/03/09
   EP - Debate in Parliament
2016/02/29
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on the Environment, Public Health and Food Safety adopted the report by Françoise GROSSETÊTE (EPP, FR) on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products.

The committee recommended that Parliament make the following amendments to the Commission proposal:

Antibacterial resistance for humans only: the Committee agreed with the Commission that in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, those antimicrobials should be reserved for humans only. By means of implementing acts and taking into consideration the scientific advice of the Agency as well as the work already carried out by the WHO, the Commission will designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans.

Prophylactic use of medicines: Members considered that the routine prophylactic and metaphylactic use of antimicrobials on groups of food-producing animals should be brought to an end. Disease should be prevented not by routine recourse to antimicrobials but by good hygiene, husbandry and housing and sound management practices. Routine prophylactic use of antimicrobials is therefore prohibited. Prophylactic use of antimicrobial veterinary medicines will only be permitted on single animals and when fully justified by a veterinarian in exceptional indications, of which a list shall be drafted by the Agency.

Metaphylactic use of antimicrobial veterinary medicines will be restricted to use in clinically-ill animals and to those single animals that are identified as being at a high risk of contamination, to prevent further spread of the disease in the group.

Innovation: to encourage research into new antimicrobials, Members advocate incentives, including:

longer periods of protection for technical documentation on new medicines; commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market.

A new article on data protection for redevelopment of veterinary medicinal products states that where the data protection period has elapsed, any applicant may apply for a data protection period for additional innovations to existing veterinary medicinal products, which shall amount to two years for an additional species and one year for an additional indication , additional pharmaceutical form or new withdrawal period.

Any new studies and trials , submitted by the applicant for a marketing authorisation for an existing antimicrobial veterinary medicinal product no longer covered by any protection period shall benefit from a stand-alone period of protection of four years, provided that they fulfil certain conditions.

Animals under the care of veterinary professionals: the committee narrowed the definition of persons entitled to retail veterinary medicines and states that persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their immediate care, subject to an appropriate veterinary diagnosis and examination of the animals concerned, and only in the amount required for the treatment concerned. In the case of food-producing animals , the continuation of the treatment with antimicrobial products shall be decided based on a renewed clinical examination by a veterinarian.

On-line sales: Members tightened the rules on sales online. Antimicrobials, psychotropic and biological or immunological veterinary medicinal products may not be offered on the internet . Other products may be sold online under strict criteria e.g that the veterinary medicinal products and the prescriptions comply with the law of the destination Member State.

Environmental protection: no later than six months before the date of application of the Regulation, the Commission must present a report on a feasibility study of a substance-based review system ('monographs') and other potential alternatives for the environmental risk assessment of veterinary medicinal products, to be accompanied, if appropriate, by a legislative proposal.

Documents
2016/02/17
   EP - Vote in committee, 1st reading
2015/12/08
   CSL - Debate in Council
Documents
2015/12/08
   CSL - Council Meeting
2015/11/20
   EP - Amendments tabled in committee
Documents
2015/10/02
   EP - Amendments tabled in committee
Documents
2015/09/04
   EP - Amendments tabled in committee
Documents
2015/07/23
   EP - Committee opinion
Documents
2015/06/17
   EP - Amendments tabled in committee
Documents
2015/06/17
   EP - Amendments tabled in committee
Documents
2015/06/17
   EP - Amendments tabled in committee
Documents
2015/04/14
   EP - Committee draft report
Documents
2015/01/21
   ESC - Economic and Social Committee: opinion, report
Documents
2014/12/03
   IT_SENATE - Contribution
Documents
2014/11/26
   ES_PARLIAMENT - Contribution
Documents
2014/11/13
   EP - GROSSETÊTE Françoise (PPE) appointed as rapporteur in ENVI
2014/11/07
   EP - MÜLLER Ulrike (ALDE) appointed as rapporteur in AGRI
2014/10/20
   EP - Committee referral announced in Parliament, 1st reading
2014/09/10
   EC - Legislative proposal
Details

PURPOSE: to ensure a high level of public health protection, high standards of quality and safety of veterinary medicinal products and the optimal functioning of the internal market.

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

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: in 2001, all the rules on production, marketing, distribution and use were consolidated in a veterinary medicines code (Directive 2001/82/EC); this was followed by Regulation (EC) No 726/2004 .

The current EU legislation on veterinary medicinal products provides the legal environment on authorisation, production, marketing, distribution and use of veterinary medicinal products. It brought some harmonisation to the procedures and rules required to place veterinary medicinal products on the EU market.

However, the Commission considers that there is evidence that the existing provisions do not deliver a functioning internal market:

diverging or incomplete transposition of the rules and the existence of numerous national requirements imply that companies are confronted with different rules and interpretation in countries and have also led to different levels of public and animal health protection; that needs of the veterinary sector differ substantially from those of the human sector in relation to medicines: in the veterinary sector there are many different animal species , which creates both a fragmented market and the need for major investments in order to extend the authorisation of medicines existing for one animal species to another; the price-setting mechanisms in the veterinary sector follow a completely different logic. Consequently, prices for veterinary medicines are typically substantially lower than for medicinal products for human use; the size of the animal pharmaceutical industry is only a small fraction of the size of the pharmaceutical industry for human medicines.

The Commission considers that it is critically important to have a single market for veterinary medicinal products . The current confined and fragmented markets do not allow the pharmaceutical sector to have a positive return on investments for developing new products for certain animal species.

The ambition to improve the availability of medicines in the Union and the functioning of the internal market and market competition can only be carried out at EU level.

IMPACT ASSESSMENT: the consultation and a study, An assessment of the impact of the revision of veterinary pharmaceutical legislation, formed the basis of an impact assessment carried out for the Commission between November 2009 and June 2011. The Commission’s Impact Assessment Board (IAB) released its final opinion in September 2013.

CONTENT: the revision of Directive 2001/82/EC and other legislation on veterinary medicinal products seek to put in place, while safeguarding public health, animal health, food safety and the environment, an up-to-date, proportionate body of legislation tailored to the specificities of the veterinary sector.

Specific objectives aim to:

expand the market beyond the top four animal species, simplify procedures for obtaining a marketing authorisation in multiple national markets, review data requirements in marketing authorisation procedures, simplify post authorisation requirements, review incentives for breakthrough medicines.

The proposal also tackles the issue of antimicrobial resistance and introduces provisions to minimise risks to public health arising from the use of antimicrobials in veterinary medicine.

BUDGETARY IMPLICATION: the costs for the EMA for implementing and applying the new rules are entirely covered by fees charged to industry. Therefore, the proposal is not expected to have any financial impact on the budget of the EU .

The additional resource needs for EMA are approximately 8 staff plus expenditure for meetings, translation, IT, etc. The level of fees, their structure and modalities and exceptions will be set at a later stage by the Commission by way of implementing acts.

DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the treaty on the Functioning of the European Union.

2014/09/10
   EC - Document attached to the procedure
2014/09/10
   EC - Document attached to the procedure

Documents

Activities

Votes

A8-0046/2016 - Françoise Grossetête - Am 74/2 #

2016/03/10 Outcome: +: 586, -: 44, 0: 25
DE IT ES GB PL RO FR PT BE CZ BG SE AT NL HU SK HR DK IE FI LT SI EL LV LU MT CY EE
Total
87
61
49
58
42
29
63
19
20
18
16
18
16
22
15
12
11
11
10
10
11
8
20
7
6
6
6
3
icon: PPE PPE
191

Denmark PPE

For (1)

1
2

Luxembourg PPE

3

Cyprus PPE

1

Estonia PPE

For (1)

1
icon: S&D S&D
171

Czechia S&D

3
3

Netherlands S&D

2

Croatia S&D

2

Ireland S&D

For (1)

1

Finland S&D

1

Slovenia S&D

For (1)

1

Latvia S&D

1

Luxembourg S&D

For (1)

1

Malta S&D

3

Cyprus S&D

2

Estonia S&D

For (1)

1
icon: ALDE ALDE
63

United Kingdom ALDE

1

Romania ALDE

3

Austria ALDE

For (1)

1

Croatia ALDE

2

Denmark ALDE

2

Ireland ALDE

For (1)

1

Finland ALDE

2

Slovenia ALDE

For (1)

1

Latvia ALDE

1

Luxembourg ALDE

For (1)

1

Estonia ALDE

For (1)

1
icon: ECR ECR
58

Italy ECR

1

Romania ECR

For (1)

1

Czechia ECR

2

Bulgaria ECR

2

Netherlands ECR

For (1)

1

Slovakia ECR

2

Croatia ECR

For (1)

1
2

Lithuania ECR

1

Greece ECR

Against (1)

1

Cyprus ECR

1
icon: Verts/ALE Verts/ALE
42

United Kingdom Verts/ALE

4

Belgium Verts/ALE

2

Sweden Verts/ALE

3

Austria Verts/ALE

2

Netherlands Verts/ALE

2

Hungary Verts/ALE

For (1)

1

Croatia Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Finland Verts/ALE

For (1)

1

Lithuania Verts/ALE

For (1)

1

Slovenia Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: GUE/NGL GUE/NGL
44

Italy GUE/NGL

2

United Kingdom GUE/NGL

1

France GUE/NGL

1

Czechia GUE/NGL

1

Netherlands GUE/NGL

3

Denmark GUE/NGL

For (1)

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

Abstain (1)

2
icon: EFDD EFDD
39

Poland EFDD

1

France EFDD

Abstain (1)

1

Czechia EFDD

Abstain (1)

1

Sweden EFDD

2

Lithuania EFDD

Against (1)

1
icon: NI NI
12

Germany NI

2

United Kingdom NI

For (1)

1

Poland NI

Against (1)

1

France NI

Against (1)

2

Hungary NI

Against (1)

1
icon: ENF ENF
34

United Kingdom ENF

Against (1)

1

Poland ENF

2

Romania ENF

Against (1)

1

Belgium ENF

Against (1)

1

Austria ENF

3

Netherlands ENF

4

A8-0046/2016 - Françoise Grossetête - Am 74/4 #

2016/03/10 Outcome: -: 354, +: 281, 0: 21
PL HU SK HR CZ BG SI LV PT AT LU MT EE BE CY LT IE DK RO FI EL DE GB SE NL ES FR IT
Total
41
16
12
11
18
16
8
7
19
16
6
6
3
20
6
11
10
11
29
10
20
87
58
18
22
49
64
61
icon: PPE PPE
190

Luxembourg PPE

3

Estonia PPE

For (1)

1

Cyprus PPE

1
2

Denmark PPE

For (1)

1

Finland PPE

Against (1)

3
icon: ECR ECR
58

Slovakia ECR

2

Croatia ECR

For (1)

1

Czechia ECR

2

Bulgaria ECR

2

Cyprus ECR

1

Lithuania ECR

1

Romania ECR

For (1)

1

Finland ECR

For (1)

2

Greece ECR

For (1)

1

Netherlands ECR

For (1)

1

Italy ECR

1
icon: NI NI
13

Poland NI

1

Hungary NI

For (1)

Against (1)

2

Germany NI

2

United Kingdom NI

For (1)

1

France NI

Against (1)

2
icon: EFDD EFDD
39

Poland EFDD

1

Czechia EFDD

Abstain (1)

1

Lithuania EFDD

For (1)

1

Sweden EFDD

2

France EFDD

Against (1)

1
icon: ENF ENF
34
2

Austria ENF

3

Belgium ENF

Against (1)

1

Romania ENF

Against (1)

1

United Kingdom ENF

Against (1)

1

Netherlands ENF

4
icon: GUE/NGL GUE/NGL
45

Czechia GUE/NGL

Against (1)

1

Portugal GUE/NGL

Against (1)

4

Cyprus GUE/NGL

2
4

Denmark GUE/NGL

Against (1)

1

Finland GUE/NGL

Against (1)

1

United Kingdom GUE/NGL

Against (1)

1

Netherlands GUE/NGL

Against (1)

3

France GUE/NGL

2

Italy GUE/NGL

2
icon: Verts/ALE Verts/ALE
42

Hungary Verts/ALE

Against (1)

1

Croatia Verts/ALE

Against (1)

1

Slovenia Verts/ALE

Against (1)

1

Latvia Verts/ALE

Against (1)

1

Austria Verts/ALE

Against (2)

2

Luxembourg Verts/ALE

Against (1)

1

Belgium Verts/ALE

2

Lithuania Verts/ALE

Against (1)

1

Denmark Verts/ALE

Against (1)

1

Finland Verts/ALE

Against (1)

1

United Kingdom Verts/ALE

4

Sweden Verts/ALE

3

Netherlands Verts/ALE

2
icon: ALDE ALDE
63

Croatia ALDE

For (1)

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2

Slovenia ALDE

Against (1)

1

Latvia ALDE

1

Austria ALDE

Against (1)

1

Luxembourg ALDE

Against (1)

1

Estonia ALDE

Against (1)

1
4

Ireland ALDE

Against (1)

1

Denmark ALDE

2

Romania ALDE

3

Finland ALDE

2

United Kingdom ALDE

Against (1)

1
icon: S&D S&D
171

Croatia S&D

2

Czechia S&D

For (1)

3

Bulgaria S&D

3

Slovenia S&D

Against (1)

1

Latvia S&D

Against (1)

1

Luxembourg S&D

Against (1)

1

Malta S&D

3

Estonia S&D

Against (1)

1

Cyprus S&D

2

Lithuania S&D

2

Ireland S&D

Against (1)

1
3

Finland S&D

Against (1)

1

Netherlands S&D

Against (2)

2

A8-0046/2016 - Françoise Grossetête - Am 291 #

2016/03/10 Outcome: -: 558, +: 69, 0: 23
EE LV IE LU CY MT SI LT FI AT HR DK NL EL SK HU BG SE IT CZ BE PT FR RO PL GB ES DE
Total
3
6
10
6
6
6
7
11
10
16
11
11
22
20
12
15
16
17
60
18
20
19
64
29
42
57
48
87
icon: ENF ENF
34

Austria ENF

3

Belgium ENF

For (1)

1

Romania ENF

1
2

United Kingdom ENF

Abstain (1)

1
icon: EFDD EFDD
38

Lithuania EFDD

For (1)

1

Sweden EFDD

2

Czechia EFDD

Abstain (1)

1

France EFDD

1

Poland EFDD

1
icon: NI NI
12

Hungary NI

1

France NI

For (1)

Against (1)

2

Poland NI

1

United Kingdom NI

For (1)

1

Germany NI

For (1)

Against (1)

2
icon: GUE/NGL GUE/NGL
44

Ireland GUE/NGL

4

Cyprus GUE/NGL

2

Finland GUE/NGL

Against (1)

1

Denmark GUE/NGL

Against (1)

1

Netherlands GUE/NGL

For (1)

3

Italy GUE/NGL

2

Czechia GUE/NGL

Against (1)

1

France GUE/NGL

2

United Kingdom GUE/NGL

1
icon: Verts/ALE Verts/ALE
42

Latvia Verts/ALE

Against (1)

1

Luxembourg Verts/ALE

Against (1)

1

Slovenia Verts/ALE

Against (1)

1

Lithuania Verts/ALE

Against (1)

1

Finland Verts/ALE

Against (1)

1

Austria Verts/ALE

Against (2)

2

Croatia Verts/ALE

Against (1)

1

Denmark Verts/ALE

Against (1)

1

Netherlands Verts/ALE

2

Hungary Verts/ALE

Against (1)

1

Sweden Verts/ALE

3

Belgium Verts/ALE

2

United Kingdom Verts/ALE

4
icon: ECR ECR
58

Cyprus ECR

Against (1)

1

Lithuania ECR

Against (1)

1

Finland ECR

2

Croatia ECR

Against (1)

1

Netherlands ECR

Against (1)

1

Greece ECR

Against (1)

1

Slovakia ECR

2

Bulgaria ECR

2

Italy ECR

Against (1)

1

Czechia ECR

2

Romania ECR

Against (1)

1
icon: ALDE ALDE
62

Estonia ALDE

Against (1)

1

Ireland ALDE

Against (1)

1

Luxembourg ALDE

Against (1)

1

Slovenia ALDE

Against (1)

1
4

Finland ALDE

2

Austria ALDE

Against (1)

1

Croatia ALDE

2

Denmark ALDE

2

Portugal ALDE

2

Romania ALDE

3

United Kingdom ALDE

Against (1)

1
icon: S&D S&D
169

Estonia S&D

Against (1)

1

Latvia S&D

Against (1)

1

Ireland S&D

Against (1)

1

Luxembourg S&D

Against (1)

1

Cyprus S&D

2

Malta S&D

3

Slovenia S&D

Against (1)

1

Lithuania S&D

2

Finland S&D

Against (1)

1

Croatia S&D

2
3

Netherlands S&D

Against (2)

2

Bulgaria S&D

3

Czechia S&D

3
icon: PPE PPE
190

Estonia PPE

Against (1)

1

Luxembourg PPE

3

Cyprus PPE

Against (1)

1

Lithuania PPE

2

Finland PPE

3

Denmark PPE

Against (1)

1

A8-0046/2016 - Françoise Grossetête - Am 111/2 #

2016/03/10 Outcome: +: 485, -: 166, 0: 3
DE PL RO BG ES FR CZ BE GB IT NL AT SK HU SE PT HR LT MT LV SI LU EE IE FI CY DK EL
Total
87
42
29
16
49
64
18
20
57
61
22
16
12
16
18
19
11
11
6
7
7
6
3
10
10
6
11
19
icon: PPE PPE
190
2

Luxembourg PPE

3

Estonia PPE

For (1)

1

Finland PPE

Against (1)

3

Cyprus PPE

1

Denmark PPE

For (1)

1
icon: S&D S&D
171
3

Czechia S&D

3

Netherlands S&D

2

Croatia S&D

2

Malta S&D

3

Latvia S&D

1

Slovenia S&D

For (1)

1

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1

Ireland S&D

For (1)

1

Finland S&D

1

Cyprus S&D

2
3
icon: ECR ECR
57

Romania ECR

For (1)

1

Bulgaria ECR

2

Czechia ECR

2

Italy ECR

1

Netherlands ECR

For (1)

1

Slovakia ECR

2

Croatia ECR

For (1)

1

Lithuania ECR

1
2

Cyprus ECR

1

Greece ECR

Against (1)

1
icon: ALDE ALDE
63

Romania ALDE

3

United Kingdom ALDE

1

Austria ALDE

For (1)

1

Portugal ALDE

2

Croatia ALDE

2

Latvia ALDE

1

Slovenia ALDE

For (1)

1

Luxembourg ALDE

For (1)

1

Estonia ALDE

For (1)

1

Ireland ALDE

For (1)

1

Finland ALDE

Against (1)

2

Denmark ALDE

2
icon: NI NI
12

Germany NI

Against (1)

2

Poland NI

Against (1)

1

France NI

Against (1)

2

United Kingdom NI

Against (1)

1

Hungary NI

For (1)

Against (1)

2
icon: ENF ENF
34

Poland ENF

2

Romania ENF

Against (1)

1

Belgium ENF

Against (1)

1

United Kingdom ENF

Against (1)

1

Austria ENF

3
icon: EFDD EFDD
39

Poland EFDD

1

France EFDD

1

Czechia EFDD

Against (1)

1

Sweden EFDD

2

Lithuania EFDD

For (1)

1
icon: Verts/ALE Verts/ALE
42

Belgium Verts/ALE

2

United Kingdom Verts/ALE

For (1)

4

Netherlands Verts/ALE

2

Austria Verts/ALE

Against (2)

2

Hungary Verts/ALE

Against (1)

1

Sweden Verts/ALE

3

Croatia Verts/ALE

Against (1)

1

Lithuania Verts/ALE

Against (1)

1

Latvia Verts/ALE

Against (1)

1

Slovenia Verts/ALE

Against (1)

1

Luxembourg Verts/ALE

Against (1)

1

Finland Verts/ALE

Against (1)

1

Denmark Verts/ALE

Against (1)

1
icon: GUE/NGL GUE/NGL
45

France GUE/NGL

2

Czechia GUE/NGL

Against (1)

1

United Kingdom GUE/NGL

Against (1)

1

Italy GUE/NGL

2

Netherlands GUE/NGL

3
4

Finland GUE/NGL

Against (1)

1

Cyprus GUE/NGL

2

Denmark GUE/NGL

Against (1)

1

A8-0046/2016 - Françoise Grossetête - Am 113/2 #

2016/03/10 Outcome: +: 579, 0: 40, -: 25
DE IT FR ES GB PL RO NL CZ BE PT SE AT BG SK HU LT HR IE FI EL LV SI LU CY MT DK EE
Total
85
60
63
49
56
41
29
22
18
18
19
18
16
15
12
16
11
11
10
10
19
7
7
6
6
6
10
3
icon: PPE PPE
186
2

Luxembourg PPE

3

Cyprus PPE

1

Estonia PPE

For (1)

1
icon: S&D S&D
168

Netherlands S&D

2

Czechia S&D

3
3

Croatia S&D

2

Ireland S&D

For (1)

1

Finland S&D

1

Latvia S&D

1

Slovenia S&D

For (1)

1

Luxembourg S&D

For (1)

1

Cyprus S&D

2

Malta S&D

3
3

Estonia S&D

For (1)

1
icon: ECR ECR
56

Italy ECR

1

Romania ECR

For (1)

1

Netherlands ECR

For (1)

1

Czechia ECR

2

Bulgaria ECR

2

Slovakia ECR

2

Lithuania ECR

1

Croatia ECR

For (1)

1
2

Greece ECR

For (1)

1

Cyprus ECR

1
icon: ALDE ALDE
62

United Kingdom ALDE

1

Romania ALDE

3

Portugal ALDE

2

Austria ALDE

For (1)

1

Croatia ALDE

2

Ireland ALDE

For (1)

1

Finland ALDE

2

Latvia ALDE

1

Slovenia ALDE

For (1)

1

Luxembourg ALDE

For (1)

1

Denmark ALDE

2

Estonia ALDE

For (1)

1
icon: Verts/ALE Verts/ALE
41

United Kingdom Verts/ALE

4

Netherlands Verts/ALE

2

Belgium Verts/ALE

2

Sweden Verts/ALE

3

Austria Verts/ALE

2

Hungary Verts/ALE

For (1)

1

Lithuania Verts/ALE

For (1)

1

Croatia Verts/ALE

For (1)

1

Finland Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Slovenia Verts/ALE

For (1)

1

Luxembourg Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1
icon: GUE/NGL GUE/NGL
45

Italy GUE/NGL

2

France GUE/NGL

2

United Kingdom GUE/NGL

1

Netherlands GUE/NGL

For (1)

3

Czechia GUE/NGL

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2

Denmark GUE/NGL

For (1)

1
icon: EFDD EFDD
39

France EFDD

1

Poland EFDD

1

Czechia EFDD

Abstain (1)

1

Sweden EFDD

2

Lithuania EFDD

For (1)

1
icon: ENF ENF
34

United Kingdom ENF

Abstain (1)

1

Poland ENF

2

Romania ENF

Abstain (1)

1

Belgium ENF

Abstain (1)

1

Austria ENF

3
icon: NI NI
12

Germany NI

For (1)

Against (1)

2

France NI

Abstain (1)

2

United Kingdom NI

Against (1)

1

Poland NI

Against (1)

1

Hungary NI

2

A8-0046/2016 - Françoise Grossetête - Am 293 #

2016/03/10 Outcome: -: 542, +: 79, 0: 29
LV EE IE SI LU CY MT LT AT DK HR HU EL FI SE SK BE NL FR BG PT CZ RO GB ES PL IT DE
Total
7
3
10
7
6
6
6
11
16
11
11
16
18
10
18
12
19
22
64
16
19
18
29
57
48
41
61
87
icon: Verts/ALE Verts/ALE
42

Latvia Verts/ALE

1

Slovenia Verts/ALE

For (1)

1

Luxembourg Verts/ALE

Abstain (1)

1

Lithuania Verts/ALE

For (1)

1

Austria Verts/ALE

For (1)

Abstain (1)

2

Denmark Verts/ALE

For (1)

1

Croatia Verts/ALE

For (1)

1

Hungary Verts/ALE

For (1)

1

Finland Verts/ALE

Against (1)

1

Sweden Verts/ALE

Abstain (1)

3

Belgium Verts/ALE

2

Netherlands Verts/ALE

2

United Kingdom Verts/ALE

4