ddrg/super_eurlex huggingface dataset:
P8_TA(2017)0129

Third countries whose nationals are subject to or exempt from a visa requirement: Ukraine ***I

European Parliament legislative resolution of 6 April 2017 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 539/2001 listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (Ukraine) (COM(2016)0236 — C8-0150/2016 — 2016/0125(COD))

(Ordinary legislative procedure: first reading)

(2018/C 298/44)

The European Parliament,

— having regard to the Commission proposal to Parliament and the Council (COM(2016)0236),

— having regard to Article 294(2) and Article 77(2)(a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0150/2016),

— having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

— having regard to the provisional agreement approved by the responsible committee under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 2 March 2017 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union

— having regard to Rule 59 of its Rules of Procedure,

— having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Foreign Affairs and the Committee on Legal Affairs (A8-0274/2016),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
P8_TA(2017)0078

EU-Brazil Agreement: modification of concessions in the schedule of Croatia in the course of its accession ***

European Parliament legislative resolution of 15 March 2017 on the draft Council decision on the conclusion of the Agreement in the form of an Exchange of Letters between the European Union and the Federative Republic of Brazil pursuant to Article XXIV:6 and Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions in the schedule of the Republic of Croatia in the course of its accession to the European Union (13037/2016 — C8-0490/2016 — 2016/0307(NLE))

(Consent)

(2018/C 263/33)

The European Parliament,

— having regard to the draft Council decision (13037/2016),

— having regard to the draft Agreement in the form of an Exchange of Letters between the European Union and the Federative Republic of Brazil pursuant to Article XXIV:6 and Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions in the schedule of the Republic of Croatia in the course of its accession to the European Union (13038/2016),

— having regard to the request for consent submitted by the Council in accordance with the first subparagraph of Article 207(4) and Article 218(6), second subparagraph, point (a)(v), of the Treaty on the Functioning of the European Union (C8-0490/2016),

— having regard to Rule 99(1) and (4) and Rule 108(7) of its Rules of Procedure,

— having regard to the recommendation of the Committee on International Trade (A8-0052/2017),

1. Gives its consent to conclusion of the agreement;
—

having regard to Article 39(1) of the Treaty on European Union, as amended by the Treaty of Amsterdam, and Article 9 of Protocol No 36 on transitional provisions, pursuant to which the Council consulted Parliament (C8-0520/2016),
P8_TC1-COD(2016)0345

Position of the European Parliament adopted at first reading on 27 April 2017 with a view to the adoption of Regulation (EU) 2017/… of the European Parliament and of the Council on the European Union trade mark (codification)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2017/1001.)
P8_TA(2017)0249

Participation of the Union in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) ***I

European Parliament legislative resolution of 13 June 2017 on the proposal for a decision of the European Parliament and of the Council on the participation of the Union in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) jointly undertaken by several Member States (COM(2016)0662 — C8-0421/2016 — 2016/0325(COD))

(Ordinary legislative procedure: first reading)

(2018/C 331/26)

The European Parliament,

— having regard to the Commission proposal to Parliament and the Council (COM(2016)0662),

— having regard to Article 294(2) and Articles 185 and 188 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0421/2016),

— having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

— having regard to the opinion of the European Economic and Social Committee of 26 January 2017 (1),

— having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 26 April 2017 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

— having regard to Rule 59 of its Rules of Procedure,

— having regard to the report of the Committee on Industry, Research and Energy and the opinion of the Committee on the Environment, Public Health and Food Safety (A8-0112/2017),

1. Adopts its position at first reading hereinafter set out;

2. Takes note of the Commission statement annexed to this resolution;

3. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

4. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) OJ C 125, 21.4.2017, p. 80.
P8_TA(2017)0203

EU-Norway Agreement on supplementary rules in relation to the instrument for financial support for external borders and visa ***

European Parliament legislative resolution of 16 May 2017 on the draft Council decision on the conclusion on behalf of the Union of the Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (13710/2016 — C8-0005/2017 — 2016/0322(NLE))

(Consent)

(2018/C 307/34)

The European Parliament,

— having regard to the draft Council decision (13710/2016),

— having regard to the draft Agreement between the European Union and the Kingdom of Norway on supplementary rules in relation to the instrument for financial support for external borders and visa, as part of the Internal Security Fund for the period 2014 to 2020 (13711/2016),

— having regard to the request for consent submitted by the Council in accordance with Article 77(2) and Article 218(6), second subparagraph, point (a)(v), of the Treaty on the Functioning of the European Union (C8-0005/2017),

— having regard to the letter from the Committee on Foreign Affairs,

— having regard to Rule 99(1) and (4) and Rule 108(7) of its Rules of Procedure,

— having regard to the recommendation of the Committee on Civil Liberties, Justice and Home Affairs (A8-0174/2017),

1. Gives its consent to the conclusion of the agreement;
—

having regard to the request for consent submitted by the Council in accordance with Article 207(4), first subparagraph, Article 218(6), second subparagraph, point (a)(v), and Article 218(7) of the Treaty on the Functioning of the European Union (C8-0123/2017),
—

having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the United Kingdom House of Commons and the United Kingdom House of Lords, asserting that the draft legislative act does not comply with the principle of subsidiarity,
P8_TC1-COD(2016)0221

Position of the European Parliament adopted at first reading on 14 September 2017 with a view to the adoption of Regulation (EU) 2017/… of the European Parliament and of the Council amending Regulation (EU) No 345/2013 on European venture capital funds and Regulation (EU) No 346/2013 on European social entrepreneurship funds

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2017/1991.)
(3) The assessment of those special schemes as introduced on 1 January 2015 has identified a number of areas for improvement. First, the burden for micro-businesses established in a Member State occasionally supplying such services to other Member States of having to comply with VAT obligations in Member States other than their Member State of establishment should be reduced. A Community-wide threshold should therefore be introduced up to which these supplies remain subject to VAT in their Member State of establishment. Second, the requirement of having to comply with the invoicing and record keeping requirements of all Member States to which supplies are made is very burdensome. Hence, to minimise burdens on business, the rules concerning invoicing and record keeping should be those applicable in the Member State of identification of the supplier making use of the special schemes. Third, taxable persons not established in the Community but having a VAT registration in a Member State (e.g. because they carry out occasional transactions subject to VAT in that Member State) can use neither the special scheme for taxable persons not established in the Community, nor the special scheme for taxable persons established in the Community. As a consequence, it is proposed that such taxable persons should be permitted to use the special scheme for taxable persons not established within the Community.

(3) The assessment of those special schemes as introduced on 1 January 2015 has identified a number of areas for improvement. First, the burden for micro-businesses established in a Member State occasionally supplying such services to other Member States of having to comply with VAT obligations in Member States other than their Member State of establishment should be reduced. A Community-wide threshold should therefore be introduced up to which these supplies remain subject to VAT in their Member State of establishment. Second, the requirement of having to comply with the invoicing requirements of all Member States to which supplies are made is very burdensome. Hence, to minimise burdens on business, the rules concerning invoicing should be those applicable in the Member State of identification of the supplier making use of the special schemes. Third, taxable persons not established in the Community but having a VAT registration in a Member State (e.g. because they carry out occasional transactions subject to VAT in that Member State) can use neither the special scheme for taxable persons not established in the Community, nor the special scheme for taxable persons established in the Community. As a consequence, it is proposed that such taxable persons should be permitted to use the special scheme for taxable persons not established within the Community.
Official Journal of the European Union

P8_TA(2017)0362

Restriction of the use of certain hazardous substances in electrical and electronic equipment ***I

European Parliament legislative resolution of 3 October 2017 on the proposal for a directive of the European Parliament and of the Council amending Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (COM(2017)0038 — C8-0021/2017 — 2017/0013(COD))

(Ordinary legislative procedure: first reading)

(2018/C 346/30)

The European Parliament,

— having regard to the Commission proposal to Parliament and the Council (COM(2017)0038),

— having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0021/2017),

— having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

— having regard to the opinion of the European Economic and Social Committee of 5 July 2017 (1),

— after consulting the Committee of the Regions,

— having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 28 June 2017 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

— having regard to Rule 59 of its Rules of Procedure,

— having regard to the report of the Committee on the Environment, Public Health and Food Safety (A8-0205/2017),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) Not yet published in the Official Journal.
P8_TC1-COD(2017)0017

Position of the European Parliament adopted at first reading on 12 December 2017 with a view to the adoption of Regulation (EU) …/… of the European Parliament and of the Council amending Directive 2003/87/EC to continue current limitations of scope for aviation activities and to prepare to implement a global market-based measure from 2021

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2017/2392.)
P8_TC1-COD(2017)0060

Position of the European Parliament adopted at first reading on 15 November 2017 with a view to the adoption of Decision (EU) 2017/… of the European Parliament and of the Council amending Directive 2010/40/EU as regards the period for adopting delegated acts

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Decision (EU) 2017/2380.)
—

having regard to Article 39(1) of the Treaty on European Union, as amended by the Treaty of Amsterdam, and Article 9 of Protocol No 36 on transitional provisions, pursuant to which the Council consulted Parliament (C8-0419/2017),
Official Journal of the European Union

Corrigendum to ‘Accord de coopération et d’assistance administrative mutuelle en matière douanière entre l’Union européenne et la Nouvelle-Zélande ***

Résolution législative du Parlement européen du 13 mars 2018 sur le projet de décision du Conseil relative à la conclusion, au nom de l’Union européenne, de l’accord de coopération et d’assistance administrative mutuelle en matière douanière entre l’Union européenne et la Nouvelle-Zélande (07712/2016 – C8-0237/2017 – 2016/0006(NLE))’

( Official Journal of the European Union C 162 of 10 May 2019 )

(2020/C 254/09)

On page 128 and on the cover page:

for:

‘Accord de coopération et d’assistance administrative mutuelle en matière douanière entre l’Union européenne et la Nouvelle-Zélande *** Résolution législative du Parlement européen du 13 mars 2018 sur le projet de décision du Conseil relative à la conclusion, au nom de l’Union européenne, de l’accord de coopération et d’assistance administrative mutuelle en matière douanière entre l’Union européenne et la Nouvelle-Zélande (07712/2016 – C8-0237/2017 – 2016/0006(NLE))’,

read:
P8_TC1-COD(2016)0304

Position of the European Parliament adopted at first reading on 15 March 2018 with a view to the adoption of Decision (EU) 2018/… of the European Parliament and of the Council on a common framework for the provision of better services for skills and qualifications (Europass) and repealing Decision No 2241/2004/EC

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Decision (EU) 2018/646.)
P8_TA(2018)0038

EU guarantee to the European Investment Bank against losses under financing operations supporting investment projects outside the Union ***I

European Parliament legislative resolution of 8 February 2018 on the proposal for a decision of the European Parliament and of the Council amending Decision No 466/2014/EU granting an EU guarantee to the European Investment Bank against losses under financing operations supporting investment projects outside the Union (COM(2016)0583 — C8-0376/2016 — 2016/0275(COD))

(Ordinary legislative procedure: first reading)

(2018/C 463/24)

The European Parliament,

— having regard to the Commission proposal to Parliament and the Council (COM(2016)0583),

— having regard to Article 294(2) and Articles 209 and 212 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0376/2016),

— having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

— having regard to the report from the Commission to the European Parliament and the Council on the mid-term review of the application of the Decision No 466/2014/EU as regards the EU guarantee to the European Investment Bank against losses under financing operations supporting investment projects outside the Union (COM(2016)0584),

— having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 1 December 2017 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

— having regard to Rule 59 of its Rules of Procedure,

— having regard to the report of the Committee on Budgets and the opinions of the Committee on Development, the Committee on Foreign Affairs, the Committee on International Trade and the Committee on the Environment, Public Health and Food Safety (A8-0135/2017),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
P8_TC1-COD(2016)0381

Position of the European Parliament adopted at first reading on 17 April 2018 with a view to the adoption of Directive (EU) 2018/… of the European Parliament and of the Council amending Directive 2010/31/EU on the energy performance of buildings and Directive 2012/27/EU on energy efficiency

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2018/844.)
P8_TC1-COD(2015)0276

Position of the European Parliament adopted at first reading on 18 April 2018 with a view to the adoption of Directive (EU) 2018/… of the European Parliament and of the Council amending Directive 94/62/EC on packaging and packaging waste

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2018/852.)
—

having regard to Article 39(1) of the Treaty on European Union, as amended by the Treaty of Amsterdam, and Article 9 of Protocol No 36 on transitional provisions, pursuant to which the Council consulted Parliament (C8-0278/2018),
P8_TC1-COD(2016)0404

Position of the European Parliament adopted at first reading on 14 June 2018 with a view to the adoption of Directive (EU) 2018/… of the European Parliament and of the Council on a proportionality test before adoption of new regulation of professions

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2018/958).
clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, may be carried out in exceptional cases and shall be fully justified;

the information to be provided by the health technology developer relates to the most up-to-date and public data. Failure to comply with that requirement may trigger a penalty mechanism;

for medicinal products, the technology developers, for the purpose of clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That dossier shall include the clinical study report;

the comparators are the reference comparators for the clinical entity concerned and the best and/or most commonly used technological or process based comparator;

the methodologies take into account the specificities of new procedures and certain types of medicinal products with less clinical evidence available at the time of the marketing authorisation (such as orphan medicinal products or conditional marketing authorisations). However, any such lack of evidence does not prevent the generation of additional evidence required to be post monitored and which may require post-assessment and shall not affect patients security or scientific quality;

the assessments of relative effectiveness are based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned;

the methodologies are based on high standards of quality, the best available scientific evidence, stemming, where practically feasible and ethically justifiable, primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews;

1a. Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:
P8_TC1-COD(2017)0348

Position of the European Parliament adopted at first reading on 29 May 2018 with a view to the adoption of Regulation (EU) 2018/… of the European Parliament and of the Council amending Regulation (EU) 2016/1139 as regards fishing mortality ranges and safeguard levels for certain herring stocks in the Baltic Sea

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/976.)
—

having regard to the draft Protocol to the Framework Agreement between the European Union and its Member States, on the one part, and the Republic of Korea, on the other part, to take account of the accession of the Republic of Croatia to the European Union (07730/2016),