Activities of Nora BERRA
Plenary speeches (144)
Access of goods and services to public procurement markets (debate)
In vitro diagnostic medical devices - Medical devices (debate)
European Banking Authority and prudential supervision of credit institutions (A7-0393/2012 - Sven Giegold)
Specific tasks for the European Central Bank concerning policies relating to the prudential supervision of credit institutions (A7-0392/2012 - Marianne Thyssen)
Draft amending budget No 5/2013 - Mobilisation of the Solidarity Fund following flooding in Slovenia, Croatia and Austria in 2012 (A7-0286/2013 - Giovanni La Via)
Credit agreements relating to residential property (A7-0202/2012 - Antolín Sánchez Presedo)
Insider dealing and market manipulation (market abuse) (A7-0347/2012 - Arlene McCarthy)
Online gambling in the internal market (A7-0218/2013 - Ashley Fox)
Further macro-financial assistance for Georgia (A7-0244/2013 - Vital Moreira)
Attacks against information systems (A7-0224/2013 - Monika Hohlmeier)
Practical arrangements for the holding of the European elections in 2014 (A7-0219/2013 - Andrew Duff)
Connected TV (A7-0212/2013 - Petra Kammerevert)
Preparation of the Commission Work Programme 2014 (B7-0315/2013, B7-0316/2013, B7-0325/2013, B7-0326/2013, B7-0328/2013, B7-0329/2013)
Wheeled vehicules (Amendment of Decision 97/836/EC ('revised 1958 Agreement')) (A7-0192/2013 - Vital Moreira)
Wheeled vehicules (Amendment of Council Decision 2000/125/EC ('parallel agreement')) (A7-0194/2013 - Vital Moreira)
Laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (A7-0125/2013 - Sven Giegold)
Serious cross-border threats to health (A7-0337/2012 - Gilles Pargneaux)
Implementing enhanced cooperation in the area of financial transaction tax (A7-0230/2013 - Anni Podimata)
Reforming the structure of the EU banking sector (A7-0231/2013 - Arlene McCarthy)
Protection of the EU's financial interests - fight against fraud (A7-0197/2013 - Derek Vaughan)
Integrated internal control framework (A7-0189/2013 - Andrea Češková)
Vienna Convention on Civil Liability for Nuclear Damage (A7-0198/2013 - Alajos Mészáros)
External aviation policy (A7-0172/2013 - Marian-Jean Marinescu)
Member States' export credit agencies (A7-0193/2013 - Yannick Jadot)
Port State control (A7-0394/2012 - Brian Simpson)
Registration documents for vehicles (A7-0199/2013 - Vilja Savisaar-Toomast)
Inspection of the roadworthiness of commercial vehicles (A7-0207/2013 - Olga Sehnalová)
Roadworthiness tests for motor vehicles and their trailers (A7-0210/2013 - Werner Kuhn)
Priority substances in the field of water policy (A7-0397/2012 - Richard Seeber)
Certain categories of horizontal State aid and public passenger transport services by rail and by road (A7-0179/2013 - Herbert Dorfmann)
Blue growth - enhancing sustainable growth in the marine, maritime transport and tourism sectors (A7-0209/2013 - Spyros Danellis)
Contribution of cooperatives to overcoming the crisis (A7-0222/2013 - Patrizia Toia)
A bioeconomy for Europe (A7-0201/2013 - Paolo Bartolozzi)
Stepping-stone Economic Partnership Agreement between the EC and Central Africa (A7-0190/2013 - David Martin)
Second amendment to the Cotonou Agreement of 23 June 2000 (A7-0110/2013 - Michael Cashman)
Freedom of press and media in the world (A7-0176/2013 - Marietje Schaake)
Re-use of public sector information (A7-0404/2012 - Ivailo Kalfin)
2013 review of the organisation and functioning of the EEAS (A7-0147/2013 - Elmar Brok, Roberto Gualtieri)
A broader Transatlantic partnership (A7-0173/2013 - Francisco José Millán Mon)
Millennium development goals (A7-0165/2013 - Filip Kaczmarek)
Appointment of a member of the European Commission - Neven Mimica
Illegal, unreported and unregulated fishing (A7-0144/2013 - Raül Romeva i Rueda)
Laying down standards for the reception of applicants for international protection (recast) (A7-0214/2013 - Antonio Masip Hidalgo)
Application for international protection lodged in a Member State by a third-country national or a stateless person (recast version) (A7-0216/2013 - Cecilia Wikström)
Granting and withdrawing international protection (recast) (A7-0217/2013 - Sylvie Guillaume)
Fund for European aid to the most deprived (A7-0183/2013 - Emer Costello)
Establishment of 'Eurodac' for the comparison of fingerprints (A7-0432/2012 - Monica Luisa Macovei)
Temporary reintroduction of border control at internal borders (A7-0200/2012 - Renate Weber)
Establishment of an evaluation mechanism to verify application of the Schengen acquis (A7-0215/2013 - Carlos Coelho)
Financial statements and related reports of certain types of undertakings (A7-0278/2012 - Klaus-Heiner Lehne)
Transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market (A7-0292/2012 - Arlene McCarthy)
Adjustment rate to direct payments provided for in Regulation (EC) No 73/2009 in respect of calendar year 2013 (A7-0186/2013 - Luis Manuel Capoulas Santos)
Amendment of Schengen border code and Convention implementing the Schengen Agreement (A7-0206/2013 - Georgios Papanikolaou)
Annual report on competition policy (A7-0143/2013 - Antolín Sánchez Presedo)
Long-term plan for cod stocks and the fisheries exploiting those stocks - 1 (A7-0141/2013 - Diane Dodds)
A new agenda for European consumer policy (A7-0163/2013 - Vicente Miguel Garcés Ramón)
Legal aid in cross-border civil and commercial disputes (A7-0161/2013 - Tadeusz Zwiefka)
Health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (A7-0009/2013 - Elisabeth Morin-Chartier)
Long-term plan for cod stocks and the fisheries exploiting those stocks - 2 (A7-0146/2013 - Diane Dodds)
Organised crime, corruption and money laundering (A7-0175/2013 - Salvatore Iacolino)
Social housing in the European Union (A7-0155/2013 - Karima Delli)
Educational and occupational mobility of women (A7-0164/2013 - Licia Ronzulli)
Electronic toll service and vignette system on light private vehicles (A7-0142/2013 - Jim Higgins)
Community Customs Code as regards the date of its application (A7-0170/2013 - Constance Le Grip)
Reinstatement of Myanmar/Burma's access to generalised tariff preferences (A7-0122/2013 - David Martin)
Financial responsibility linked to investor-state dispute settlement tribunals established by international agreements to which the EU is party (A7-0124/2013 - Paweł Zalewski)
Non-commercial movement of pet animals (A7-0371/2012 - Horst Schnellhardt)
Animal health requirements governing trade in dogs, cats and ferrets (A7-0366/2012 - Horst Schnellhardt)
Future legislative proposals on EMU (B7-0250/2013)
2012 progress report on the former Yugoslav Republic of Macedonia (B7-0186/2013)
EU trade and investment agreement negotiations with the US (B7-0187/2013, B7-0195/2013)
Draft protocol on the application of the Charter of fundamental rights of the European Union to the Czech Republic (consent) (A7-0282/2012 - Andrew Duff)
Draft protocol on the application of the Charter of fundamental rights of the European Union to the Czech Republic (consultation) (A7-0174/2013 - Andrew Duff)
Mutual recognition of protection measures in civil matters (A7-0126/2013 - Antonio López-Istúriz White, Antonyia Parvanova)
EU-Canada Agreement on customs cooperation with respect to matters related to supply chain security (A7-0152/2013 - Peter Šťastný)
Pyrotechnic articles (A7-0375/2012 - Zuzana Roithová)
Implementation of the audiovisual media services directive (A7-0055/2013 - Piotr Borys)
2011 discharge: Section III, Commission (A7-0116/2013 - Jens Geier)
Court of Auditors' special reports in the context of the 2011 Commission discharge (A7-0096/2013 - Jens Geier)
2011 discharge: EU general budget, European Parliament (A7-0063/2013 - Eva Ortiz Vilella)
European Network and Information Security Agency (ENISA) (A7-0056/2013 - Giles Chichester)
Fishing opportunities and financial contribution provided for by the EU-Mauritius Fisheries Partnership Agreement (A7-0127/2013 - Antolín Sánchez Presedo)
Technical and control measures in the Skagerrak (A7-0051/2013 - Werner Kuhn)
Advancing development through trade (A7-0054/2013 - Alf Svensson)
Trade and investment-driven growth for developing countries (A7-0053/2013 - Tokia Saïfi)
Financing of EU cooperation for African, Caribbean and Pacific States and overseas countries and territories for 2014-2020 (A7-0049/2013 - Patrice Tirolien)
Composition of the European Parliament with a view to the 2014 elections (A7-0041/2013 - Rafał Trzaskowski, Roberto Gualtieri)
Decision on the opening of, and mandate for, interinstitutional negotiations on direct payments to farmers under support schemes within the framework of the CAP - 2011/0280(COD) (B7-0079/2013)
Decision on the opening of, and mandate for, interinstitutional negotiations on common organisation of the markets in agricultural products (Single CMO Regulation) - 2011/0281(COD) (B7-0080/2013)
Decision on the opening of, and mandate for, interinstitutional negotiations on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) - 2011/0282(COD) (B7-0081/2013)
Decision on the opening of, and mandate for, interinstitutional negotiations on financing, management and monitoring of the CAP - 2011/0288(COD) (B7-0082/2013)
Energy roadmap 2050 (A7-0035/2013 - Niki Tzavela)
Integration of migrants, its effects on the labour market and the external dimension of social security coordination (A7-0040/2013 - Nadja Hirsch)
Situation in Egypt (debate)
Mechanism for monitoring and reporting greenhouse gas emissions and other information relevant to climate change (A7-0191/2012 - Bas Eickhout)
Online consumer dispute resolution (A7-0236/2012 - Róża Gräfin von Thun und Hohenstein)
Alternative consumer dispute resolution (A7-0280/2012 - Louis Grech)
Association of the overseas countries and territories with the European Union (A7-0052/2013 - Patrice Tirolien)
European venture capital funds (A7-0193/2012 - Philippe Lamberts)
European social entrepreneurship funds (A7-0194/2012 - Sophie Auconie)
Impact of the economic crisis on gender equality and women's rights (A7-0048/2013 - Elisabeth Morin-Chartier)
Guidelines for the 2014 budget - sections other than the Commission (A7-0020/2013 - Monika Hohlmeier)
Corporate social responsibility: accountable, transparent and responsible business behaviour and sustainable growth (A7-0017/2013 - Raffaele Baldassarre)
Corporate social responsibility: promoting society's interests and a route to sustainable and inclusive recovery (A7-0023/2013 - Richard Howitt)
European Semester for economic policy coordination: employment and social aspects in the annual growth survey 2013 (A7-0024/2013 - Veronica Lope Fontagné)
Governance of the single market (A7-0019/2013 - Andreas Schwab)
European Investment Bank - 2011 annual report (A7-0016/2013 - Mario Mauro)
EU-US Agreement under GATT 1994: modification of concessions in the schedules of the Republic of Bulgaria and Romania in the course of their accession to the EU (A7-0430/2012 - Vital Moreira)
Guidelines for the employment policies of the Member States (A7-0010/2013 - Pervenche Berès)
Transparency of measures regulating the prices of medicinal products for human use (A7-0015/2013 - Antonyia Parvanova)
Common fisheries policy (A7-0008/2013 - Ulrike Rodust)
Sound level of motor vehicles (A7-0435/2012 - Miroslav Ouzký)
European Refugee Fund, the European Return Fund and the European Fund for the Integration of Third-Country Nationals (A7-0004/2013 - Nils Torvalds)
External Borders Fund (A7-0433/2012 - Nils Torvalds)
Conservation of fishery resources (A7-0342/2012 - Pat the Cope Gallagher)
Elimination and prevention of all forms of violence against women and girls (B7-0049/2013)
Specific measures in favour of agriculture in the smaller Aegean islands (A7-0319/2011 - Georgios Papastamkos)
Specific measures for agriculture in the outermost regions of the Union (A7-0321/2011 - Gabriel Mato Adrover)
Improving access to finance for SMEs (A7-0001/2013 - Philippe De Backer)
Credit rating agencies (A7-0221/2012 - Leonardo Domenici)
Multi-annual plan for cod stocks in the Baltic Sea (A7-0395/2012 - Jarosław Leszek Wałęsa)
Youth guarantee (B7-0007/2013)
Feasibility of introducing stability bonds (A7-0402/2012 - Sylvie Goulard)
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Shadow reports (1)
REPORT on the proposal for a decision of the European Parliament and of the Council providing macro-financial assistance to the Republic of Tunisia PDF (218 KB) DOC (307 KB)
Opinions (2)
OPINION on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Amendments (285)
Amendment 6 #
2013/0416(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The Union shall make macro-financial assistance available to Tunisia (‘the Union's macro-financial assistance’) of a maximum amount of EUR 25300 million, with a view to supporting Tunisia's economic stabilisation and reforms. The assistance shall contribute to covering Tunisia's balance of payments needs as identified in the IMF programme.
Amendment 316 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that the organiser isand/or the retailer is/are responsible for the performance of the travel services included in the contract, irrespective of whether those services are to be performed by the organiser and/or the retailer or by other service providers.
Amendment 322 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. If any of the services are not performed in accordance with the contract, the organiser and/or the retailer shall remedy the lack of conformity, unless this is disproportionate.
Amendment 325 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Where a significant proportion of the services cannot be provided as agreed in the contract, the organiser and/or the retailer shall make suitable alternative arrangements, at no extra cost to the traveller, for the continuation of the package, including where the traveller'’s return to the place of departure is not provided as agreed.
Amendment 329 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 4
Article 11 – paragraph 4
4. If it is impossible for the organiser and/or the retailer to offer suitable alternative arrangements or the traveller does not accept the alternative arrangements proposed because they are not comparable to what was agreed in the contract, the organiser and/or the retailer shall, insofar as the package includes the carriage of passengers, provide the traveller at no extra cost with equivalent transport to the place of departure or to another place to which the traveller has agreed and shall, where appropriate, compensate the traveller in accordance with Article 12.
Amendment 337 #
2013/0246(COD)
Proposal for a directive
Article 11 – paragraph 5
Article 11 – paragraph 5
5. As long as it is impossible to ensure the traveller'’s timely return because of unavoidable and extraordinary circumstances, the organiser and/or the retailer shall not bear the cost for the continued stay exceeding EUR 100 per night and three nights per traveller.
Amendment 350 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The traveller shall be entitled to receive compensation from the organiser and/or the retailer for any damage, including non- material damage, which the traveller sustains as a result of any lack of conformity.
Amendment 356 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 3 – point a – introductory part
Article 12 – paragraph 3 – point a – introductory part
(a) the organiser and/or the retailer proves(s) that the lack of conformity is:
Amendment 369 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 3 – point b
Article 12 – paragraph 3 – point b
(b) the traveller fails to inform the organiser and/or the retailer without undue delay of any lack of conformity which the traveller perceives on the spot if that information requirement was clearly and explicitly stated in the contract and is reasonable, taking into account the circumstances of the case.
Amendment 374 #
2013/0246(COD)
Proposal for a directive
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Insofar as international conventions binding the Union limit the extent of or the conditions under which compensation is to be paid by a provider carrying out a service which is part of a package, the same limitations shall apply to the organiser and/or the retailer. Insofar as international conventions not binding the Union limit compensation to be paid by a service provider, Member States may limit compensation to be paid by the organiser and/or the retailer accordingly. In other cases, the contract may limit compensation to be paid by the organiser and/or the retailer as long as that limitation does not apply to personal injury and damage caused intentionally or with gross negligence and does not amount to less than three times the total price of the package.
Amendment 39 #
2013/0103(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Following the review, certain provisions of the Regulations should be amended in order to improve transparency and predictability, provide for effective measures to fight against retaliation, improve effectiveness and enforcement and optimise review practice, and to facilitate access to the instruments for SMEs. To this end, the function of the Export Helpdesk should be adapted. In addition, certain practices that in recent years have been applied in the context of anti- dumping and anti-subsidy investigations should be included in the Regulations.
Amendment 45 #
2013/0103(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) To ensure the effectiveness of the instrument, it should shorten the time for the imposition of anti-dumping and countervailing provisional measures to 7 months and 12 months for the definitive duties. To this end, it is important that the Unit in charge of anti-dumping and anti- subsidy investigations has adequate resources, including human resources.
Amendment 65 #
2013/0103(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Within the Union, countervailable subsidies are in principle prohibited pursuant to Article 107 (1) TFEU. Therefore, countervailable subsidies granted by third countries are particularly distortive of trade. The amount of State aid authorized by the Commission has steadily been reduced over time. For the anti- subsidy instrument, the lesser duty rule should hence no longer be applied to imports from a country/countries engaged in subsidisation.
Amendment 67 #
2013/0103(COD)
Proposal for a regulation
Recital 10
Recital 10
Amendment 75 #
2013/0103(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 77 #
2013/0103(COD)
Proposal for a regulation
Recital 18
Recital 18
Amendment 87 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
Regulation (EC) No 1225/2009
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
4a. A raw material shall be considered to be subject to structural distortion when its price is not solely the result of a normal operation of market forces reflecting supply and demand. Such distortions are the outcome of interference from third countries, which includes, inter alia, export taxes, export restrictions and dual pricing schemes.
Amendment 88 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point -1 (new)
Article 1 – paragraph 1 – point -1 (new)
-1. Third countries increasingly interfere in trade with a view to benefitting domestic producers, for instance by imposing export taxes or operating dual pricing schemes. Such interferences create additional distortions of trade. As a consequence, Union producers are not only harmed by dumping, but suffer, compared to producers from third countries engaged in such practices, additional distortions of trade. Differences in the level of labour and environmental standards can also result in additional distortions of trade. Therefore, the lesser duty rule shall not apply in such cases, when the exporting country has an insufficient level of social and environmental standards. A sufficient level is defined by the ratification of core ILO Conventions and of Multilateral Environmental Agreements (MEAs) the EU is party to. Small-and-medium-sized enterprises (SMEs) particularly suffer from unfair competition because their small size prevents them from adapting thereto. Therefore, the lesser duty rule shall not apply when the complaint has been presented on behalf of a sector largely composed of SMEs. The lesser duty rule shall always apply, however, when structural raw material distortions are the result of a deliberate choice made by a least developed country to protect public interest.
Amendment 98 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 1225/2009
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
1a. In Article 5, a new paragraph 3a is added : 3. The Commission shall facilitate the access to the instrument for diverse and fragmented industry sectors, largely composed of small and medium-sized enterprises through the Export Help Desk. The Export Help Desk shall provide information and explanations on how to fill a compliant in particular through: standardising forms for statistics and diminishing the burden caused by language barriers in a proportionate manner
Amendment 105 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 b (new)
Article 1 – paragraph 1 – point 1 b (new)
Regulation (EC) No 1225/2009
Article 5 – paragraph 6
Article 5 – paragraph 6
1b. In Article 5, paragraph 6 shall be replaced by the following : 6. If, in special circumstances or in the case of diverse and fragmented industry sectors, largely composed of small- and medium-sized enterprises, it is decided to initiate an investigation without having received a written complaint by or on behalf of the CommunityUnion industry for the initiation of such investigation, this shall be done on the basis of sufficient evidence of dumping, injury and a causal link, as described in paragraph 2, to justify such initiation.
Amendment 108 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 c (new)
Article 1 – paragraph 1 – point 1 c (new)
Regulation (EC) No 1225/2009
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
1c. In Article 6, a new paragraph 6a is added : 6a. The Commission shall adopt implementing acts to ensure the possible access to information to all interested parties by allowing for an information system whereby interested parties are notified when new non-confidential information is added to the investigation file.
Amendment 109 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 d (new)
Article 1 – paragraph 1 – point 1 d (new)
Regulation (EC) No 1225/2009
Article 6 – paragraph 9
Article 6 – paragraph 9
1d. Article 6, paragraph 9 shall be replaced by the following: For proceedings initiated pursuant to Article 5(9), an investigation shall be concluded within one year, in accordance with the findings made pursuant to Article 8 for undertakings or the findings made pursuant to Article 9 for definitive action.
Amendment 123 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1225/2009
Article 6 – paragraph 10 a (new)
Article 6 – paragraph 10 a (new)
2a. In Article 6, the following new paragraph 10a is added: "10a. Throughout the investigation, the Export Helpdesk should provide to SMEs information and explanations on the case and how to better present evidences, and guidance on additional possibilities to liaise with the Hearing Officer and national customs authorities."
Amendment 130 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Regulation (EC) No 1225/2009
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 160 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 1225/2009
Article 7 – paragraph 2
Article 7 – paragraph 2
The amount of the provisional anti- dumping duty shall not exceed the margin of dumping as provisionally established. Unless structural raw material distor, but it should be less than the margin if such lesser duty would be adequate to remove the injury to the Community industry. 2b) Such a lesser duty shall not apply in any of the following circumstances: - structural distortions or significant State interferences regarding, inter alia, prices, costs and inputs, including for instance raw materials and energy, research and labour, outputs, sales and investments, currency exchange rate and fair trade finance conditions, were found to exist with regard to the product concerned in the exporting country, it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the Union industry. ; - the exporting country does not have a sufficient level of social and environmental standards, where sufficient levels are determined on the basis of the ratification and effective implementation by the third country of Multilateral Environmental Agreements, and protocols thereunder, the EU is party to at any point in time and of ILO Conventions listed in Annex I; - the complainant represents a diverse and fragmented industry, largely composed of small-and-medium-sized enterprises; - the investigation or a separate anti- subsidy investigation has established at least provisionally that the exporting country provides one or more subsidies to exporting producers of the product concerned. 2 c) However, such a lesser duty shall always be granted when structural raw materials distortions are found to exist with regard to the product concerned in the exporting country and such country is a least-developed country listed in Annex IV to Regulation (EU) No 978/2012 of the European Parliament and of the Council.
Amendment 185 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point b
Article 1 – paragraph 1 – point 4 – point b
Regulation (EC) No 1225/2009
Article 9 – paragraph 4
Article 9 – paragraph 4
The amount of the anti-dumping duty shall not exceed the margin of dumping established. Unless structural raw material distor but it should be less than the margin if such lesser duty would be adequate to remove the injury to the Community industry. 2 b) Such a lesser duty shall not apply in any of the following circumstances: - structural distortions or significant State interferences regarding, inter alia, prices, costs and inputs, including for instance raw materials and energy, research and labour, outputs, sales and investments, currency exchange rate and fair trade finance conditions, were found to exist with regard to the product concerned in the exporting country, it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the Union industry; -the exporting country does not have a sufficient level of social and environmental standards, where sufficient levels are determined on the basis of the ratification and effective implementation by the third country of Multilateral Environmental Agreements, and protocols thereunder, the EU is party to at any point in time and of ILO Conventions listed in Annex I; - the complainant represents a diverse and fragmented industry, largely composed of small-and-medium-sized enterprises; - the investigation or a separate anti- subsidy investigation has established that the exporting country provides one or more subsidies to exporting producers of the product concerned. 2 c) However, such a lesser duty shall always be granted when structural raw materials distortions are found to exist with regard to the product concerned in the exporting country and such country is a least-developed country listed in Annex IV to Regulation (EU) No 978/2012 of the European Parliament and of the Council.
Amendment 193 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 1225/2009
Article 11 – paragraph 5
Article 11 – paragraph 5
Amendment 204 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Regulation (EC) No 1225/2009
Article 17 – paragraph 1
Article 17 – paragraph 1
In cases where the number of Union producers, exporters or importers, that cooperate in the investigation, or types of product or transactions is large, the investigation may be limited to a reasonable number of parties, products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection, or to the largest representative volume of production, sales or exports which can reasonably be investigated within the time available.
Amendment 207 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Amendment 215 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8 – point 1 (new)
Article 1 – paragraph 1 – point 8 – point 1 (new)
Regulation (EC) No 1225/2009
Article 21
Article 21
1. Article 21 shall be replaced by the following: 1. Without prejudice to the priority given to the interests of the domestic industry affected by the unfair trade practice, a determination as to whether the CommunityUnion interest calls for intervention shall be based on an appreciation of all the various interests takenpresented as a whole, including the interests of the domestic industry and users and consumers, and a determination pursuant to this Article shall only be made where all parties have been given the opportunity to make their views known pursuant to paragraph 2. In such an examination, the need to eliminate the trade distorting effects of injurious dumping and to restore effective competition shall be given special consideration. Measures, as determined on the basis of the dumping and injury found, may not be applied where the authorities, on the basis of all the information submitted, can clearly conclude that it is not in the Community interest to apply such measurUnion interest to apply such measures. A determination that measures are not in the Union interest should not be made if an industry has been seriously injured by dumped imports to an extent that its survival may be in question or if an industry is small and involve mainly Small and Medium sized Enterprises. 2. In order to provide a sound basis on which the authorities can take account of all views and information in the decision as to whether or not the imposition of measures is in the CommunityUnion interest, the complainants, importers and their representative associations, representative users and representative consumer organisations may, within the time-limits specified in the notice of initiation of the anti-dumping investigation, make themselves known and provide information to the Commission. Such information, or appropriate summaries thereof, shall be made available to the other parties specified in this Article, and they shall be entitled to respond to such information. 3. TOnly information which is submitted by interested parties in full conformity with this sub-paragraph shall be taken into account for the final determination on Union Interest. 3. Only the parties which have acted in conformity with paragraph 2 may request a hearing. Such requests shall be granted when they are submitted within the time- limits set in paragraph 2, and when they set out the reasons, in terms of the CommunityUnion interest, why the parties should be heard. 4. TOnly the parties which have acted in conformity with paragraph 2 may provide comments on the application of any provisional duties imposed. Such comments shall be received within one month of the application of such measures if they are to be taken into account and they, or appropriate summaries thereof, shall be made available to other parties who shall be entitled to respond to such comments. 5. The Commission shall examine the information which is properly submitted and the extent to which it is representative and the results of such analysis, together with an opinion on its merits, shall be transmitted to the Advisory Committee. The balance of views expressed in the Committee insofar as they are based on the evidence submitted shall be taken into account by the Commission in any proposal made pursuant to Article 9. 6. TOnly the parties which have acted in conformity with paragraph 2 may request the facts and considerations on which final decisions are likely to be taken to be made available to them. Such information shall be made available to the extent possible and without prejudice to any subsequent decision taken by the Commission or the Council. 7. Information shall only be taken into account for a determination of Union Interest under this paragraph when it is presented and where it is supported by actual evidence which substantiates its validity and is subsequently verified.
Amendment 221 #
2013/0103(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 a (new)
Article 1 – paragraph 1 – point 9 a (new)
Regulation (EC) No 1225/2009
Article 21 – paragraph 5
Article 21 – paragraph 5
9a. Article 21(5) shall be replaced by following: 5. The Commission shall examine the information which is properly submitted and the extent to which it is representative and the results of such analysis, together with an opinion on its merits, shall be transmitted to the Advisory Committee. The balance of views expressed in the Committee shall be taken into account by the Commission in any proposal made pursuant to Article 9. The Commission shall propose termination of investigation or review under this article only if it is absolutely clear that under no possible scenarios would measures help the Union industry to any degree. Criteria to determine Union interest should be specified in a delegated act.
Amendment 237 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 b (new)
Article 2 – paragraph 1 – point 1 b (new)
Regulation (EC) No 597/2009
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
1b. In Article 10, a new paragraph 3a is added: "The Commission shall facilitate the access to the instrument for diverse and fragmented industry sectors, largely composed of small and medium-sized enterprises through the Export Help Desk. The Export Help Desk shall provide information and explanations on how to fill a compliant in particular through: standardising forms for statistics and diminishing the burden caused by language barriers in a proportionate manner"
Amendment 241 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
Regulation (EC) No 597/2009
Article 10 – paragraph 8
Article 10 – paragraph 8
Amendment 251 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Article 2 – paragraph 1 – point 2 a (new)
Regulation (EC) No 597/2009
Article 11 – paragraph 11 a (new)
Article 11 – paragraph 11 a (new)
2a. In Article 11, a new paragraph 11a is added: Throughout the investigation, the Export Helpdesk should provide to SMEs informations and explanations on the case and how to better present evidences, and guidance on additional possibilities to liaise with the Hearing Officer and national customs authorities.
Amendment 255 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 b (new)
Article 2 – paragraph 1 – point 2 b (new)
Regulation (EC) No 597/2009
Article 11 – paragraph 11b (new)
Article 11 – paragraph 11b (new)
Amendment 259 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 c (new)
Article 2 – paragraph 1 – point 2 c (new)
Regulation (EC) No 597/2009
Article 11 – paragraph 9
Article 11 – paragraph 9
2c. In Article 11 (9) shall be replaced by the following: 9. For proceedings initiated pursuant to Article 10(11), an investigation shall, whenever possible, be concluded within one year. In any event, such investigations shall in all cases be concluded within 13 months of their initiation, in accordance with the findings made pursuant to Article 13 for undertakings or the findings made pursuant to Article 15 for definitive action.
Amendment 262 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point -a (new)
Article 2 – paragraph 1 – point 3 – point -a (new)
Regulation (EC) No 597/2009
Article 12 – paragraph 1 – subparagraph 2
Article 12 – paragraph 1 – subparagraph 2
Amendment 272 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point b
Article 2 – paragraph 1 – point 3 – point b
Regulation (EC) No 597/2009
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
Amendment 303 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6 – point a
Article 2 – paragraph 1 – point 6 – point a
Regulation (EC) No 597/2009
Article 22 – paragraph 1
Article 22 – paragraph 1
Amendment 317 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
Regulation (EC) No 597/2009
Article 29b
Article 29b
Amendment 334 #
2013/0103(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
Regulation (EC) No 597/2009
Article 31 – paragraph 5
Article 31 – paragraph 5
10a. In Article 31 (5) shall be replaced by the following: 5. The Commission shall examine the information which is properly submitted and the extent to which it is representative, and the results of such analysis, together with an opinion on its merits, shall be transmitted to the Advisory Committee. The balance of views expressed in the Committee shall be taken into account by the Commission in any proposal made pursuant to Articles 14 and 15 9. The Commission shall propose termination of investigation or review under this article only if it is absolutely clear that under no possible scenarios would measures help the Union industry to any degree. Criteria to determine Union interest should be specified in a delegated act.
Amendment 210 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, carry out representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by each Member State, investigate complaints and keep a register of complaints, non- conforming products and product recalls, and shall keep distributors informed of any such monitoring.
Amendment 211 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. When the products made available on the market are or have been subject to a decision by the Commission on the basis of article 12 of [Regulation on market surveillance of products], manufacturers, or when appropriate importers, shall, to protect the health and safety of consumers, carry out at least once a year representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by each Member State.
Amendment 252 #
2013/0049(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken and of the results of such corrective action.
Amendment 261 #
2013/0049(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. They shall ensure that any additional label does not obscure any information on the labelnot obscure any compulsory information or safety-related information provided by the manufacturer.
Amendment 274 #
2013/0049(COD)
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken, and of the results of such corrective action.
Amendment 285 #
2013/0049(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable. Distributors shall not obscure compulsory information or safety-related information provided by the manufacturer or the importer.
Amendment 298 #
2013/0049(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall immediately make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken and of the results of such corrective action.
Amendment 281 #
2013/0048(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
1. Risk assessment shall be based on available scientific or technical evidence. Risk assessment shall be carried out in accordance with the general risk assessment methodology established by the Commission and, as appropriate, in accordance with the application made by the Commission for a specific category of products.
Amendment 7 #
2012/2711(RSP)
- having regard to its resolution of 13 June 2012 on EU trade negotiations with Japan,
Amendment 8 #
2012/2711(RSP)
Paragraph B a (new)
Whereas in 2011 the Japanese trade surplus with the European Union was worth €18,5 billion, 30% of which only in automotive products
Amendment 9 #
2012/2711(RSP)
Paragraph F
F. whereas the European Union and Japan agreed at the joint summit on 28 May 2011 to launch a scoping exercise to investigate the feasibility and shared ambition towards launching negotiations for a free trade agreement on condition of a successful outcome; whereas the scoping exercise has been concluded, without satisfactory results on some of the priority areas defined in the annex to the Joint Report on the scoping exercise;
Amendment 12 #
2012/2711(RSP)
Paragraph 2
2. Is concerned, in this regard, that the EU's bilateral trading volume with Japan is dramatically lower than with other partners such as the USA, China and Russia and in structural deficit; concludes that the huge potential of the EU-Japanese commercial relationship has not yet been realised to the benefit of EU businesses, workers and consumers, mainly due to the negative impact of Japanese non-tariff barriers on market access opportunities for European businesses;
Amendment 17 #
2012/2711(RSP)
Paragraph 4
4. Notes the conclusion of the EU-Japan scoping exercise to the mutual satisfaction of the Commission and Japanese Government, but regrets the fact that insufficient progress has been made in reducing Japanese non-tariff barriers;
Amendment 19 #
2012/2711(RSP)
Paragraph 6
6. Cautions that, while the roadmaps represent a step forward, greater ambition must be demonstrated by Japan inbefore any future negotiations; emphasises that the implementation on these commitments is crucial and, therefore, calls for concrete results as soon as possible, ideally in advance of the dates established;
Amendment 30 #
2012/2711(RSP)
Paragraph 7
7. Accordingly, requests that, as a condition for authorising the Commission to negotiate an FTA with Japan, the Council insists on a binding review clause to allow for a thorough assessment of the implementation of the roadmaps for NTBs and the roadmap on public procurement for railways and urban transport agreed in the scoping exercise; this clause should contain a precise definition of the minimum progress expected from Japan, failing which the Commission will suspend the negotiations;
Amendment 31 #
2012/2711(RSP)
Paragraph 7 a (new)
7a. Notes that, in spite of the commitments undertaken by Japan as part of the scoping exercise, many of these commitments, such as the opening- up of public procurement in the railway sector in particular, have not been acted on;
Amendment 34 #
2012/2711(RSP)
Paragraph 8
8. Calls on the Council to authorisewait Japan has shown real efforts, such as harmonization with international standards and opening public procurements, before authorising the Commission to start negotiations for a free trade agreement with Japan on the basis of the scoping exercise;
Amendment 36 #
2012/2711(RSP)
Paragraph 8
8. Calls on the Council not to authorise the Commission to start negotiations for a free trade agreement with Japan on the basis of the scoping exercisuntil Japan has given clear and credible commitments to eliminate NTBs within a specific timetable;
Amendment 41 #
2012/2711(RSP)
Paragraph 9
9. Underlines that such an agreement must be comprehensive, ambitious and fully binding in all its commercial provisions; stresses an FTA must lead to a genuine openness on the ground for EU businesses rather than just a hypothetical, legal openness; considers that if, during the negotiations, Japan does not demonstrate sufficient ambitionthe Commission, in agreement with the Council and European Parliament, should determine the specific objectives that have to be achieved within the first year of the negotiations, including some of the main demands of the various European economic sectors submitted as part of the scoping exercise; considers that if, during the negotiations, Japan does not demonstrate sufficient ambition in meeting the priority demands of the Commission – through concrete commitments backed up by a clear timetable, the Commission should suspend negotiations after consultations with the European Parliament and the Council;
Amendment 52 #
2012/2711(RSP)
Paragraph 11, first indent
- Concrete and wide-ranging commitments from the Japanese government on NTBs with a view to eliminating a substantial percentage ofll barriers hindering EU-Japan trade as a precondition for dismantling EU tariffs; underlines that these commitments should go considerably further than the roadmaps already agreed under the scoping exercise;
Amendment 55 #
2012/2711(RSP)
Paragraph 11, first indent b (new)
- Removal of the preferential treatment for “kei cars” to allow foreign competition on this segment, which represents 35% of the Japanese car market;
Amendment 36 #
2012/2322(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, in the absence of harmonisation and with due regard to the principle of subsidiarity, the Member States maintain a margin of discretion to regulate online gambling in accordance with their own values and pursued objectives of general interest, as well as their own level of protection of consumers;
Amendment 73 #
2012/2322(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. Whereas a sustainable financing model for the promotion of horseracing and sport and the organisation of sport events, on which bets are placed and gambling operators earn an income, must be ensured;
Amendment 94 #
2012/2322(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recognises that the Member States have the right to determine, on grounds of pursuing objectives of general interest, how the offer of online gambling services is to be organised and regulated at the national level, while observing the basic EU Treaty principles;
Amendment 124 #
2012/2322(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission, in carrying out the ongoing infringement procedures and the analyses of national regulations, to recognise that Member States are allowed to ensure that a fair share of the benefits of gambling are directed towards the financing of professional and grass- roots sports and the equine sector; calls for the specific features and the sustainable contributions from lotteries to society to be recognised and taken into account in any coordinated approach at EU level;
Amendment 163 #
2012/2322(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes the risks associated with a general prohibition of online gambling services and with excessive restrictions for consumerconsumers having access to illegal gambling services; calls on the Commission and the Member States to weigh, as part of the work of the group of experts on gambling services, the social costs of permitting regulated gambling activities against the harmful effects of consumers resorting to illicit marketegal operators;
Amendment 208 #
2012/2322(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses the importance ofor the expert group to work towards removing unnecessary administrative burdens that prevent legal online operators from offering their services to consumersas a step forward towards cooperation between Member States and the Commission;
Amendment 230 #
2012/2322(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Believes that national regulators should be able to agree on equivalence clauses that would facilitate the application of national licenses, including agreement on technical standards for gaming equipmentcommon agreements between national regulators, including agreements, in the fields of application of national licenses and enforcement measures against illegal offers, technical standards and gaming equipment, identification and antifraud systems, assessment of the potential risks of every gambling product and gambling moderators would contribute to increase the level of regulation in the EU, security and citizens protection, in particular minors and vulnerable persons;
Amendment 249 #
2012/2322(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Agrees with the Commission that a fair offer of gambling services, as defined by each Member State, is necessary for consumer protection, because in its absence consumers are more likely to turn to unreliableillegal gambling websiteoperators;
Amendment 266 #
2012/2322(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission to continue to explore measures at the EU level to protect vulnerable consumers, including formalised cooperation between regulatornational competent authorities, and theo introduction of an online trustmark for legal operatorsvite Member States to oblige the operators working with a licence of the Member State to carry in a prominent fixed position the logo of the regulatory authority on its website;
Amendment 272 #
2012/2322(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Reaffirms that protecting consumers, notably by preventing underage gambling and safeguarding vulnerable persons, as well as curbing compulsive gambling, for example by introducing online gambling moderators, should be the first and foremost objective of any EU common action in the online gambling sector;
Amendment 277 #
2012/2322(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Believes that the unquantifiable scopale of compulsive gambling points to the need forrequires additional research and data, and therefore calls on all Member States to carry out further studies to understand problem gambling ; calls on the Commission to prompt the creation of a network of relevant national organizations, which undertake studies and research in this field, as well as provide formation and treatment of gambling addiction, and recommend Member States to launch yearly prevalence surveys and to collect and promote the gathering by independent sources of statistics on gambling addiction and the undertaking of studies on its dramatic social and financial consequences for pathological gamblers;
Amendment 285 #
2012/2322(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls for the strict regulation or the prohibition, after an evaluation conducted at the level of each Member State, of dangerous forms of gambling;
Amendment 318 #
2012/2322(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes that the workshop agreement published in February 2011 by the European Committee for Standardisation (CEN)12 could serve as a basiscontribution for identifying the content of common standards;
Amendment 354 #
2012/2322(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Recommends the introduction of uniform and pan-EuropeanEU common standards for electronic identification and cross border e- verification services; notes that the different registration procedures across the EU undermine regulated operators, and can push consumers as well as for enforcement measures such as the blacklisting and the blocking of illegal websites, definition of safe and traceable payment solutions and blocking measures for transactions in order to ensure that consumers cannot turn into the hands of illegal operators; calls, therefore, on Member States for registration and identification procedures to be streamlined and made more efficient, notably to prevent unidentified users and underage gamblers from accessing online gambling products;
Amendment 397 #
2012/2322(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Considers that establishing a legal link between sports event organisers and online gambling operators, with a view to exerting an ethical and financial control over bets that are placed on sports events, will help strengthen the integrity of sport;
Amendment 407 #
2012/2322(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Highlights the importance of the support of the European Union to the ongoing work within the Council of Europe towards the negotiation of an international Convention on the Protection and the promotion of sports integrity, and calls on the European Commission to propose a uniform definition of sports fraud as a criminal offence, which should be included in the law of all Member States;
Amendment 416 #
2012/2322(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
18c. Calls for the adoption at national level of effective measures in order to prevent conflicts of interests, notably by avoiding wagers of all stakeholders from the world of sports on bets organized on competitions in which they are involved; invites Member States to ban the most dangerous forms of betting, in particular betting exchanges and spread betting;
Amendment 4 #
2012/2259(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that the EU's policy on renewable energy has benefitted the economy of the EU and has contributed to the creation of more than 500,000 domestic jobs1; Encourages the Commission to continue pursuing an ambitious but also structured and forward- looking approach to renewables that includes support mechanisms, measures to boost technological innovation and the identification of new strategic areas; __________________ 1 Eurostat 2010
Amendment 30 #
2012/2259(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Welcomes the pillar on international cooperation; recognises the potential that notably the Southern-Mediterranean countries represent in terms of production of renewable energy; believes that the EU's proposed DCFTAs could be a useful means to integrate the countries of this region into the EU's energy market and to invest into their technological development in a way that is beneficial to the sustainability of their economies;
Amendment 27 #
2012/2225(INI)
Motion for a resolution
Recital E
Recital E
E. whereas, in 2010, South-South trade came to account for 23% of world trade; whereas, according to the WTO’s 2011 World Trade Report, preferential South- South agreements represented two-thirds of all such agreements, and North-South agreements only one quarter; whereas, according to the World Investment Report 2012, the emerging economies between them attract almost half of the world’s foreign direct investment (FDI); whereas, nonetheless, in spite of a high economic growth rate, the 49 LDCs still account for only 1.12% of world trade;
Amendment 36 #
2012/2225(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Supports the Commission’s aim of enhancing synergies between trade and development policies; recommends that it award priority, in these policies, to measures aimed at creating jobs, facilitating trade, improving the trade and investment climate, resistance to economic shocks, fiscal governance and diversification of trade and investment flows, and promoting sustainable development; calls on the EU to display greater consistency in the implementation of its trade, agricultural, environmental, energy and development policies;
Amendment 122 #
2012/2225(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Welcomes the WTO’s decision to facilitate accession for LDCs; points to the importance of services for the global economy, but also for development in general; calls on the developed countries and the major emerging countries which are WTO members to use the derogation applicable to services in the case of LDCs and to apply preferential treatment to services and service providers from LDCs;
Amendment 51 #
2012/2149(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses the importance of continuing with the strengthening of transatlantic economic relations but without threatening EU policies, including in fields such as environmental standards, cultural diversity, social rights, public services or geographical indications, among others; emphasises that while the specific interests and sensitivities of both partners must be safeguarded in a balanced way, there are many areas where progress would be greatly beneficial, in particular as regards the removal of trade barriers, the introduction of measures to ensure better market access and appropriate investment conditions, the protection of intellectual property rights (IPR), the opening up of public procurement markets to ensure full reciprocity regarding the clarification, simplification and harmonisation of origin rules, and the convergence on mutual recognition of regulatory standards; considers that such an intensification of economic relations would also allow for greater alignment of EU and US approaches towards addressing global economic challenges;
Amendment 62 #
2012/2149(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reiterates its call for the completion if possible of a transatlantic market by 2015, based on the principle of a social market economy, the realisation of which – alongside the completion of the EU’s own single market – will be a core factor in re- launching global economic growth and recovery;
Amendment 75 #
2012/2149(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Supports the view that given the low average tariffs, the key to unlocking the potential of the transatlantic relationship lies in the tackling of non-tariff barriers (NTBs), consisting mainly of customs procedures and behind-the-border regulatory restrictions; notes accordingly that a tariff agreement alone will not be sufficient for either side; supports the ambition proposed by the HLWG to move progressively towards an even more integrated transatlantic marketplace, while recognising that ano agreement could not a priori resolve all existing regulatory issues immediately and must be negotiated while fully respecting the right of each side to regulate in a manner that ensures the protection of health, safety and environment at the level that each side deems appropriate;
Amendment 47 #
2012/2098(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines that future bilateral investment treaties signed by the EU must guarantee a fair balance between investors’ protection and the potential for State intervention, especially as regards social, health and environmental standards;
Amendment 52 #
2012/2098(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Regrets that the current reform of the Transparency Directive (2004/109/EG) and of the Accounting Directive (2003/51/EG) does not address the issue of corporate societal responsibility sufficiently; calls on the Commission to ensure that companies falling under these directives are obliged to report regularly on their CSR activities, particularly in non-EU states.
Amendment 47 #
2012/2097(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines that future bilateral investment treaties signed by the EU must guarantee a fair balance between investors’ protection and the potential for State intervention, especially as regards social, health and environmental standards;
Amendment 52 #
2012/2097(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Regrets that the current reform of the Transparency Directive (2004/109/EG) and of the Accounting Directive (2003/51/EG) does not address the issue of corporate societal responsibility sufficiently; calls on the Commission to ensure that companies falling under these directives are obliged to report regularly on their CSR activities, particularly in non-EU states.
Amendment 30 #
2012/0366(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Considerable volumes of illicit products, which do not comply with the requirements laid down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In addition, the FCTC obliges the Union to fight against illicit products, as part of a comprehensive tobacco control policy. Provision should thus be made for unit packets and any outside packaging of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic.
Amendment 32 #
2012/0366(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Cross-border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this Directive. Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014Therefore, cross-border distance sales of tobacco should be prohibited.
Amendment 54 #
2012/0366(COD)
Proposal for a directive
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) the prohibition of cross-border distance sales of tobacco products;
Amendment 72 #
2012/0366(COD)
Proposal for a directive
Recital 18
Recital 18
Amendment 89 #
2012/0366(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Considerable volumes of illicit products, which do not comply with the requirements laid down in Directive 2001/37/EC, are placed on the market and indications are that these volumes might increase. Such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations. In addition, the FCTC obliges the Union to fight against illicit products, as part of a comprehensive tobacco control policy. Provision should thus be made for unit packets and outside packaging of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the Union and their compliance with this Directive can be monitored and better enforced. In addition, provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic.
Amendment 94 #
2012/0366(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Cross-border distance sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this Directive. Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014ross-border distance sales of tobacco should therefore be prohibited.
Amendment 99 #
2012/0366(COD)
Proposal for a directive
Recital 34
Recital 34
(34) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use42 provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of a nicotine containing product previously authorised under Directive 2001/83/EC, toApplying the same legal framework clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
Amendment 100 #
2012/0366(COD)
Proposal for a directive
Recital 35
Recital 35
Amendment 117 #
2012/0366(COD)
Proposal for a directive
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) the prohibition of cross-border distance sales of tobacco products;
Amendment 172 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 a (new)
Article 14 – paragraph 2 a (new)
2a. Member States shall ensure that the unique identifiers on the packets are linked to the unique identifiers on the outside packaging. Any change made to the link between unit packets and outside packaging must be entered into the database referred to in paragraph 6.
Amendment 178 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, record the entry of all unit packets and outside packaging into their possession, as well as all intermediate movements and the final exit from their possession. This obligation can be fulfilled by recording in aggregated form, e.g. of outside packaging, provided that tracking and tracing of unit packets remains possible.
Amendment 183 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 6
Article 14 – paragraph 6
6. Member States shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, which shall host the data storage facility for data relating to the manufacturer and importer concerned. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the contract, shall be approved and monitored by an external auditor, who is proposed and paishall be appointed by the Commission. The costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and approved by the Commissionimporters. Member States shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the Member States, the Commission and the independent third party on a permanent basis. In duly justified cases Member States or the Commission can provide manufacturers or importers access to this information, provided commercially sensitive information remains adequately protected in conformity with the relevant national and Union legislations.
Amendment 192 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage inprohibit cross- border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potentialof tobacco to consumer is located. All retail outlets intend ing to engage in cross- border distance sales shall submit at least the following information to the competent authorities:he Union.
Amendment 194 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 196 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 197 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
Amendment 198 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 203 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 205 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 207 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 209 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 353 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 2 a (new)
Article 14 – paragraph 2 a (new)
Amendment 355 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet, record the entry of all unit packets and outside packaging into their possession, as well as all intermediate movements and the final exit from their possession. This obligation can be fulfilled by recording in aggregated form, e.g. of outside packaging, provided that tracking and tracing of unit packets remains possible.
Amendment 360 #
2012/0366(COD)
Proposal for a directive
Article 14 – paragraph 6
Article 14 – paragraph 6
6. Member States shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, which shall host the data storage facility for data relating to the manufacturer and importer concerned. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the contract, shall be approved and monitored by an external auditor, who is proposed and paishall be appointed by the Commission. The costs incurred as a result of the contract with the auditor and the database management services shall be covered by the tobacco manufacturers and approved by the Commissionimporters. Member States shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the Member States, the Commission and the independent third party on a permanent basis. In duly justified cases Member States or the Commission can provide manufacturers or importers access to this information, provided commercially sensitive information remains adequately protected in conformity with the relevant national and Union legislations.
Amendment 375 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage inprohibit cross- border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potentialof tobacco to consumer is located. All retail outlets intend ing to engage in cross- border distance sales shall submit at least the following information to the competent authorities:he Union.
Amendment 380 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
Amendment 384 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point b
Article 16 – paragraph 1 – point b
Amendment 388 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
Amendment 393 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 398 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 403 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 408 #
2012/0366(COD)
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 423 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:.
Amendment 432 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
Amendment 434 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
Amendment 436 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
Amendment 438 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 440 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 445 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 4
Article 18 – paragraph 4
Amendment 446 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 4 – point a
Article 18 – paragraph 4 – point a
Amendment 447 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 4 – point b
Article 18 – paragraph 4 – point b
Amendment 449 #
2012/0366(COD)
Proposal for a directive
Article 18 – paragraph 5
Article 18 – paragraph 5
Amendment 49 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase- policy and stock- management by hospitals, and, where possible, the system should be compatible with the other authentication systems already in place in such environments.
Amendment 52 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
Article 2 – paragraph 1 – subparagraph 1 – point 6
(6) ‘companion diagnostic’ means a device specifically intended to and essential in selecting patients with a previously diagnosed condition or predisposition as suitable or not suitable eligible for a targeted therapy with a medicinal product or a range of medicinal products;
Amendment 62 #
2012/0267(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2 a (new)
Article 4 – paragraph 5 – subparagraph 2 a (new)
In addition, devices classified as class D and required to be used for transfusion or transplantation purposes, when not available as CE marked, or available as CE marked but not reaching the appropriate standards or specifications required by the users, may be manufactured and used within a single health institution without fulfilling the requirements of this Regulation, provided they comply with the conditions defined in the first subparagraph, and the essential requirements (Annex I), and applicable harmonized standards (Article 6), and applicable common technical specifications (Article 7).
Amendment 73 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
Amendment 99 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 106 #
2012/0267(COD)
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point e
Annex 8 – section 2 – point 6 – point 6.2 – point e
(e) The notified body shall give due consideration to the opinion, if any, expressed by the medicinal products competent authority concerned or the EMA when making its decision. It shall convef the notified body deviates from that position, it shall justify its final decision to the medicinal products competent authority concerned or to the EMA. If no compromise is reached, the matter shall be referred to the MDCG. The design-examination certificate shall be delivered in accordance with point (d) of Section 6.1.
Amendment 132 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 48
Article 2 – paragraph 1 – subparagraph 5 – point 48
(48) ‘device deficiency’ means any inadequacy in the identity, quality, durstability, reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;
Amendment 335 #
2012/0267(COD)
Proposal for a regulation
Article 78 – paragraph 2 – point i
Article 78 – paragraph 2 – point i
(i) to contribute to the development of standards atcommon technical specifications (CTS) as well as of international level;standards
Amendment 90 #
2012/0266(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) The traceability of medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase- policy and stock- management by hospitals, and, where possible, the system should be compatible with the other authentication systems already in place in such environments.
Amendment 96 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, as well as products using external physical agents, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 122 #
2012/0266(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 b (new)
Article 16 – paragraph 1 – subparagraph 1 b (new)
The first subparagraph of paragraph 1 shall not apply to dental filling material, staples or sutures.
Amendment 138 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
Amendment 153 #
2012/0266(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. If necessary, the Commission may decide, when necessary, as for example when for a same product the decisions taken at national level vary between Member States, on a case-by- case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU- wide decision regarding the regulatory status of a product should also be introduced in Regulation No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Amendment 159 #
2012/0266(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can bewhich are intended to be intentionally released toin the human body and those devices should be subject to the most severe conformity assessment procedure.
Amendment 165 #
2012/0266(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices and that the payers are liable for the cost of treatment, manufacturers shall be obliged to take liability insurance with appropriate minimum coverage.
Amendment 172 #
2012/0266(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, call for regulation of the reprocessing of single- use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device. For more clarity, only 'intended single-use device' should be reprocessed and not 'single-use device'. Therefore, with regard to reprocessing, 'multiple-use device', 'intended single-use device' and 'single- use device' should be defined in this Regulation and those terms should be distinguished one from another.
Amendment 178 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 188 #
2012/0266(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) For innovative high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, oin scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies,absence of common technical specification or guideline for the conduct of clinical evaluation, to assess clinical data and proceed with a scientific assessment in particular regarding novel devices, devices for which a novel technology is being used, devices belonging to a category of devices with increased serious incident rates, or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices. The process foreseen in this Regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body.
Amendment 190 #
2012/0266(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) High-risk devices manufacturer concerned by the scientific assessment should be provided with an advice for an appropriate assessment of the conformity of their devices, in particular with regard to the clinical data required for the clinical evaluation. This scientific advice could be provided by the Scientific Advisory Board or by an EU reference laboratory and published on a public database.
Amendment 204 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Devices that are composed of substances or combination of substances primarily intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by orand dispersed in the human body in order to achieve their intended purpose are in class III.
Amendment 207 #
2012/0266(COD)
Proposal for a regulation
Recital 54 a (new)
Recital 54 a (new)
(54a) Manufacturers should report periodically on medical devices classified as class III as regards the data relevant to the risk benefit ratio and the exposition of the population in order to evaluate whether any action concerning the medical device concerned is necessary.
Amendment 209 #
2012/0266(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. The Commission should clearly define the way these inspections should be conducted in order to ensure a full and harmonized implementation within the Union.
Amendment 211 #
2012/0266(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) […/….../...] on in vitro diagnostic medical devices, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation. That experts committee should be supported by a Scientific Advisory Board composed of expert panels for specific medical disciplines in order to proceed with the assessment of high risk device and provide guidelines and common technical specifications for clinical evaluation.
Amendment 212 #
2012/0266(COD)
Proposal for a regulation
Annex 15 – point 4
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;
Amendment 237 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, and products using external physical agents, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 244 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
(4) ‘'active device’' means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices.
Amendment 249 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 8 – introductory part
(8) ‘'single-use device’' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse.
Amendment 250 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 8 a (new)
(8a) "intended for single-use device" means a device that is intended to be used on an individual patient during a single procedure for which impossibility of reuse has not been demonstrated;
Amendment 251 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 b (new)
Article 2 – paragraph 1 – subparagraph 1 – point 8 b (new)
(8b) 'multiple-use device' means a device which is reusable and must be provided with information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be re- sterilized, and any restriction on the number of reuses;
Amendment 272 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘'medical device’' or ‘'accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 289 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficientthere is a need to address public health concerns, tThe Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 292 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
Amendment 295 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1 b (new)
Article 7 – paragraph 1 b (new)
1b. Commission shall adopt CTS referred to in paragraph 1 after consulting the MDCG, which shall also include a representative of the European standardisation organisations.
Amendment 307 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall ensure that the device is accompanied by the instructions and safety information to be supplied in accordance with Section 19 of Annex I in an official Union language which can be easily understood by the intended user or patient. The language(s) of the information to be supplied by the manufacturer may be, as determined by the law of the Member -State where the device is made available to the user or patientconcerned.
Amendment 314 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service. If a competent authority considers or has reason to believe that a device has caused damages, it shall ensure that the potentially harmed user, the user's successor in title, the user's health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer.
Amendment 316 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
10a. Manufacturers shall have an appropriate liability insurance covering any damages that may be caused by their medical devices to patients or users. That insurance shall at least cover damage in the following cases: (a) in the event of the death of or injury to patient or user; or, (b) in the event of the death of or injury to multiple patients or users due to the use of the same medical device.
Amendment 323 #
2012/0266(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point b
Article 11 – paragraph 2 – subparagraph 1 – point b
(b) that the manufacturer is identified and that an authorised representative in accordance with Article 9 has been designated by the manufacturer;
Amendment 324 #
2012/0266(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
(fa) that the manufacturer has taken out appropriate liability insurance coverage pursuant to Article 8 (10) unless the importer himself can ensure sufficient coverage corresponding to the same requirements.
Amendment 327 #
2012/0266(COD)
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer, and where applicable his authorised representative and, if appropriate, takeensure that the necessary corrective action to bring that device into conformity, withdraw or recall it, is taken and, implement that action. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non- compliance and of any corrective action takenhey have implemented.
Amendment 381 #
2012/0266(COD)
Proposal for a regulation
Article 15 – title
Article 15 – title
Amendment 383 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses an intended single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 389 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Only intended single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed.
Amendment 397 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The Commission, by means of implementingdelegated acts, shall establish and regularly update a list of categories or groups of intended single-use devices for critical use which may be reprocessed in accordance with paragraph 3. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 88(3)9.
Amendment 399 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 5 – subparagraph 2
Article 15 – paragraph 5 – subparagraph 2
The name and address of the manufacturer of the original intended single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
Amendment 403 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 6 – subparagraph 1 – point a
Article 15 – paragraph 6 – subparagraph 1 – point a
(a) the reprocessing of intended single-use devices and the transfer of intended single- use devices to another Member State or to a third country with a view to their reprocessing;
Amendment 404 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 6 – subparagraph 1 – point b
Article 15 – paragraph 6 – subparagraph 1 – point b
(b) the making available of reprocessed intended single-use devices.
Amendment 408 #
2012/0266(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. This paragraph shall not apply to clips, sutures and dental fillings.
Amendment 409 #
2012/0266(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall providmake available in advance toge ther with the device an implant card which shall be made available healthcare professional or where relevant, to the particular patient who has beenis going to be implanted with the device, the information to be included in an implant passport or in an implant card.
Amendment 432 #
2012/0266(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.
Amendment 456 #
2012/0266(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. It shall be written in a way that is clear to the intended user and shall update it with the conclusions of the post market clinical follow-up evaluation report referred to in point 3 of Part B of Annex XIII. It shall be written in a way that is clear to the intended use and in the language of the country where the medical device is made available on the market. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.
Amendment 535 #
2012/0266(COD)
Proposal for a regulation
Article 41 – paragraph 3 – subparagraph 1
Article 41 – paragraph 3 – subparagraph 1
The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States.
Amendment 547 #
2012/0266(COD)
Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Amendment 565 #
2012/0266(COD)
Proposal for a regulation
Article 44 – title
Article 44 – title
Amendment 568 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments forFor implantable devices, classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicatethe notified body, before delivering the certificate of conformity, shall request a scientific assessment provided by MDCG on the clinical evaluation and the eposti-mated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCGrket clinical follow-up.
Amendment 571 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 1 (new)
Article 44 – paragraph 1 – subparagraph 1 (new)
Notwithstanding subparagraph 1 of Article 44(1), this requirement shall not apply to devices for which specifications referred to in Articles 6 and 7 have been published for the clinical evaluation and the post-market clinical follow-up and devices for which the application for certification only aims at supplementing or renewing existing certificates.
Amendment 575 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Article 44 – paragraph 2 – subparagraph 1
Amendment 577 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 2
Article 44 – paragraph 2 – subparagraph 2
Amendment 582 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. The MDCG may submit comments on the summary of the preliminary conformityscientific assessment is based on an assessment atof the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of commentsdossier by the Scientific Advisory Board referred to in Article 80a. If for a device concerned, the manufacturer requested a scientific advice following the procedure referred to in Article 82a, the outcome of that procedure shall be submitted together with the notification or as soon as that procedure is completed. The scientific advice shall be duly taken into account by the MDCG and the Commission in the course of the implementation of this Article.
Amendment 585 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The CommissIn case of a favourable scientific assessment, the notified body may proceed with the certification. However, if the favourable scientific assessment is dependant on the application of specific measures (e.g. adaptation of the post- market clinical follow-up plan, certification with a time limit), the notified body shall issue the certificate of conformity only on the condition sthall immediately transmit this information to the MDCGt those measures are implemented.
Amendment 586 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 4 – subparagraph 1 (new)
Article 44 – paragraph 4 – subparagraph 1 (new)
In case of unfavourable scientific assessment, the notified body shall not deliver the certificate of conformity. Nevertheless, the notified body may submit new information in response to the explanation included in the MDCG scientific assessment. At the request of the manufacturer, the Commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the MDCG concerns
Amendment 587 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 1
Article 44 – paragraph 5 – subparagraph 1
Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific devices, categories or groups of devices, other than devices of class III,referred to in paragraph 1 to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 590 #
2012/0266(COD)
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 2 – point a
Article 44 – paragraph 5 – subparagraph 2 – point a
(a) the novelty of the device or of the technology on which it is based and thechnological novelty or new therapeutic use, which can have significant clinical or public health impact thereof;
Amendment 597 #
2012/0266(COD)
Proposal for a regulation
Article 44 a (new)
Article 44 a (new)
Article 44 a Notification before placing on the market 1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, except applications to supplement or renew existing certificates. Those notifications shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notifications the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to extend the scope of devices which must be notified before placing on the market as referred to in paragraph 1.
Amendment 633 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 639 #
2012/0266(COD)
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 2
Article 61 – paragraph 3 – subparagraph 2
The Member States shall coordinate between them the development of standard web-based structured forms for reporting of serious incidents by healthcare professionals, users and patients. The Member States shall also provide healthcare professionals, users and patients with another forms for reporting of suspected incidents to national competent authorities.
Amendment 643 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 1 – point d a (new)
Article 62 – paragraph 1 – point d a (new)
(d a) the periodic safety update reports drawn by manufacturers, as referred to in Article 63a;
Amendment 649 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 5 a (new)
Article 62 – paragraph 5 a (new)
5 a. The reports and information referred to in Article 62(5), shall also be automatically transmitted as regards the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 45.
Amendment 651 #
2012/0266(COD)
Proposal for a regulation
Article 63 a (new)
Article 63 a (new)
Article 63 a Periodic safety update reports 1. Manufacturers of medical devices classified as class III shall report to the electronic system referred to in Article 62: (a) summaries of data relevant to the benefits and risks of the medical devices, including results of all studies with a consideration of their potential impact on the certification; (b) a scientific evaluation of the risk- benefit ratio of the medical device; (c) all data relating to the volume of sales of the medical devices including an estimate of the population exposed to the medical device. 2. The frequency with which the manufacturers shall make the report referred to in the paragraph 1 shall be specified in the MDCG scientific assessment referred to in Article 44. Manufacturers shall submit periodic safety update reports to the competent authorities immediately upon request or at least once a year during the first 2 years following initial placing on the market of that medical device. 3. The MDCG shall assess periodic safety update reports to determine whether there are new risks or whether risks have changed, or whether there are changes to the risk-benefit ratio of the medical device. 4. Following the assessment of periodic safety update reports, the MDCG shall consider whether any action regarding the medical device concerned is necessary. The MDCG shall inform the notified body in case of unfavourable scientific assessment. In this case, the notified body shall maintain, vary, suspend or revoke the authorisation as appropriate.
Amendment 653 #
2012/0266(COD)
Proposal for a regulation
Article 63 – paragraph 1 – subparagraph 2
Article 63 – paragraph 1 – subparagraph 2
If in the case of reports received in accordance with Article 61(3) the competent authority ascertains that the reports relate to a seriousn incident it shall notify without delay those reports to the electronic system referred to in Article 62, unless the same incident has already been reported by the manufacturer.
Amendment 670 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 672 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 1 a (new)
Article 67 – paragraph 1 a (new)
1 a. The competent authorities shall designate inspectors who shall be empowered to carry out the checks referred to in paragraph 1. Those checks may be assisted by experts appointed by the competent authorities. The checks shall be carried out by the inspectors of the Member State in which the economic operator is located.
Amendment 676 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 5 a (new)
Article 67 – paragraph 5 a (new)
5 a. Without prejudice to any international agreements concluded between the Union and third countries, checks as referred in paragraph 1 can also take place in the premises of an economic operator located in a third country, if the device is intended to be made available on the Union market.
Amendment 677 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 5 b (new)
Article 67 – paragraph 5 b (new)
5 b. After every check, as referred in paragraph 1, the concerned competent authority shall report to the inspected economic operator on the level of compliance with this Regulation. Before adopting the report, the competent authority shall give the inspected economic operator the possibility to submit comments.
Amendment 678 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 5 c (new)
Article 67 – paragraph 5 c (new)
5 c. The Commission shall establish detailed guidelines on the principles for carrying out the checks referred to in this Article including in particular on the qualifications of inspectors, and on inspection arrangements and access to data and information held by economic operators.
Amendment 708 #
2012/0266(COD)
Proposal for a regulation
Article 78 – paragraph 7 a (new)
Article 78 – paragraph 7 a (new)
7 a. The MDCG shall establish a stakeholder dialogue group made up of stakeholders representatives organised at Union level. Such group shall act in parallel and work with the Medical Device Coordination Group (MDCG), advising the Commission and Member States on various aspects of medical technology and implementation of the Regulation.
Amendment 721 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
(b) to contribute to the scrutinyprovide a scientific assessment ofn certain conformity assessmenttypes of medical devices pursuant to Article 44;
Amendment 738 #
2012/0266(COD)
Proposal for a regulation
Article 80 a (new)
Article 80 a (new)
Article 80 a Scientific Advisory Board 1. The Commission shall set up and provide the logistic support for a Scientific Advisory Board made up of not more than 15 scientific and/or clinical experts in the field of medical devices, appointed in their personal capacity by the MDCG. 2. When appointing these experts, the Commission shall ensure a broad, appropriate and balanced coverage of the medical disciplines relevant for medical devices, the publication of any interests which might affect the conduct of their work and the signature of a confidentiality clause. The Scientific Advisory Board may establish under its responsibility expert panels for specific medical disciplines. The Commission or the MDCG may request the Scientific Advisory Board to provide scientific advice on any issue related to the implementation of this Regulation 3. The Scientific Advisory Board shall appoint one chairperson and one vice chairperson from among its members for a term of three years, renewable once. In duly justified situations, the majority of its members may request the chairperson and/or vice-chairperson to resign. 4. The Scientific Advisory Board shall establish its rules of procedure which shall, in particular, lay down procedures for: a) the functioning of expert panel; b) the appointment and replacement of its chairperson and vice-chairperson, c) the scientific assessment foreseen in Article 44, including in cases of urgency, The rules of procedure shall enter into force after receiving a favourable opinion from the Commission.
Amendment 746 #
2012/0266(COD)
Proposal for a regulation
Article 82 a (new)
Article 82 a (new)
Article 82 a Scientific advice 1. The Commission shall facilitate the access of manufacturers of innovative devices concerned by the scientific assessment laid down in Article 44 to scientific advice provided by the Scientific Advisory Board or by an EU reference laboratory to information concerning the criteria for an appropriate assessment of the conformity of a device, in particular with regard to the clinical data required for the clinical evaluation. 2. The scientific advice provided by the Scientific Advisory Board or by an EU reference laboratory shall not be binding. 3. The Commission shall publish summaries of the scientific advice referred to in paragraph 1, providing that all information of commercial confidential nature have been deleted.
Amendment 791 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.2 – point a a (new)
Annex 1 – part III – point 19 – point 19.2 – point a a (new)
(a a) the mention "This product is a medical device".
Amendment 800 #
2012/0266(COD)
Proposal for a regulation
Annex 6 – heading 1
Annex 6 – heading 1
Amendment 848 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot beintended to be intentionally released into the patient's or user's body when the device is used within its intended purposehuman body are classified as class III.
Amendment 858 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Devices that are composed of substances or combination of substances primarily intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by orand dispersed in the human body in order to achieve their intended purpose are in class III.
Amendment 867 #
2012/0266(COD)
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part
Annex 8 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced factory inspections ato the relevant manufacturering sites and, if appropriate, ofat the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred toThe notified body shall establish a plan for the unannounced in Sspection 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturers which must not be disclosed to the manufacturer. At the time of such inspections, the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and with a test report.
Amendment 893 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – point 5
Annex 13 – point 5
5. In the case of implantable devices and devices falling within class III, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone. DFor novel products, demonstration of equivalence in accordance with Section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph. However, for iteration of devices already on the market and for which clinical data are available and for which the data from the post-market surveillance are not indicating any safety concerns, demonstration of equivalence may be considered as a sufficient justification. For devices submitted to the scientific assessment foreseen in this Regulation, demonstration of equivalence shall be assessed by the MDCG.
Amendment 906 #
2012/0266(COD)
Proposal for a regulation
Annex 15 – point 4
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;
Amendment 86 #
2012/0192(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Directive 2001/20/EC aimed to simplify and harmonise the administrative provisions governing clinical trials in the European Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a clinical trial in several Member States. Scientific development however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information. In order to include a sufficient number of patients for such trials it may be necessary to involve many, or all, Member States. The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible. Therefore, in order to simplify submission procedures, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the Member States concerned. Given that clinical trials carried out in a single Member State are equally indispensable to European clinical research, the procedure under this regulation should also cover such trials. The application dossier for such clinical trials should also be sent via the single European portal.
Amendment 124 #
2012/0192(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The human dignity and right to the integrity of the person are recognized in the Charter of Fundamental rights of the European Union. In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned. Directive 2001/20/EC contained an extensive set of rules for the protection of subjects. These rules should be upheld. Regarding tThe rules concerning the determination of the legal representative of incapacitated persons and minors, those rulese definition of incapacitated and vulnerable persons and the provisions resulting from that definition, diverge in Member States. It should therefore be left to Member States to determine the legal representative of incapacitated persons and minors and where necessary to enact rules affording greater protection at national level.
Amendment 232 #
2012/0192(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 17
Article 2 – paragraph 2 – point 17
(17) ‘Incapacitated subject’: a subject who is, for other reasons than the age of legal competence to give informed consent, legally legally or de facto incapable of giving informed consent according to the laws of the Member State concerned;
Amendment 262 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member State. The Member States concerned shall be free to choose one of their number as the reporting Member State.
Amendment 266 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3 a (new)
Article 5 – paragraph 1 – subparagraph 3 a (new)
If the sponsor submits an application dossier to just one of the Member States concerned, that Member State shall automatically be designated as the reporting Member State.
Amendment 360 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. Where the Member State concerned disagrees with the conclusion of the reporting Member State on the basis of points (a) and (b) of the second subparagraph of paragraph 2, the clinical trial shall not take place in the Member State concerned.
Amendment 383 #
2012/0192(COD)
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Where the clinical trial concerns other categories of subjects who are considered vulnerable under national law, the application to conduct the clinical trial shall be assessed on the basis of the national law of the Member States concerned.
Amendment 393 #
2012/0192(COD)
Proposal for a regulation
Article 13
Article 13
Amendment 508 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point b
Article 32 – paragraph 1 – point b
(b) nothe consent of the legal representative is availablecannot be given within a period consistent with the methodological requirements of the research;
Amendment 24 #
2012/0060(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Promoting mutual openness of international procurement markets is the key objective of this regulation. Ensuring mutually advantageous competition among the EU and its trading partners will allow to enhance the competitiveness of the European internal market and support the growth of our economy.
Amendment 29 #
2012/0060(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) For this purpose rules of origin should be established so that contracting authorities/entities know whether goods and services are covered by the international commitments of the European Union. The origin of a good should be determined in accordance with Article 252 to 2655 of Regulation (EC) No 2913/1992 of the EuropeanNo XXXX/2013 of Parliament and of the Council of 12 October 1992 establishing the CommunityUnion Customs Code2, including the additional provisions to be adopted under Article 55. According to this Regulation goods should be considered to be Union goods when they are wholly obtained or produced in the Union. Goods whose production involved one or more third countries should be deemed to originate in the country where they underwent their last, substantial, economically justified processing or working in an undertaking equipped for that purpose and resulting in the manufacture of a new product or representing an important stage of manufacture. The origin of a service should be determined on the basis of the origin of the natural or legal person providing it. The guidance referred to in recital 9 should cover the application in practice of the rules of origin.
Amendment 47 #
2012/0060(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation lays down rules on the access of third-country goods and services to the award of contracts for the execution of works or a work, the supply of goods and the provision of services by Union contracting authorities/entities, and establishes procedures supporting negotiations on access of Union goods and services to the public procurement markets of third countries, in view of promoting mutual openness of procurement markets between the Union and its trading partners.
Amendment 53 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) ‘lack of substantial reciprocity’ means the existence of restrictive measures in the field of procurement or the award of concessions resulting in serious and recurring discrimination against EU economic operators, goods and services. This lack of substantial reciprocity may result, for example, in: (a) a lack of international commitment on the part of the third country regarding procurement and concessions to ensure transparency and prohibit any kind of discrimination against EU economic operators, goods or services; (b) laws or regulations – whether or not concerning public procurement or concessions – adopted by the third country which lead, deliberately or otherwise, to a lack of transparency or to discrimination against EU economic operators, goods or services; (c) the adoption or implementation of discriminatory practices by public authorities or individual procuring entities in the third country aimed at EU economic operators, goods or services.
Amendment 55 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g b (new)
Article 2 – paragraph 1 – point g b (new)
(gb) "Satisfactory remedial or corrective measures" means removal of the restrictive measures targeted by European Commission's investigation.
Amendment 62 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
Article 2 – paragraph 2 – point e a (new)
(ea) "Market access reservations" means any exception and derogation to an international agreement in the field of public procurement including market access commitments.
Amendment 63 #
2012/0060(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The origin of a good shall be determined in accordance with Article 22 to 26 of Regulation (EC) No 2913/1992 of the European52 to 55, including the delegated acts to be adopted under Article 55, of Regulation No XXXX/2013 of Parliament and of the Council of 12 October 1992 establishing the CommunityUnion Customs Code18 .
Amendment 77 #
2012/0060(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 82 #
2012/0060(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In view of the fact that the access of third country goods and services to the public procurement market of the Union falls within the scope of the common commercial policy, Member States or their contracting authorities/entities should not be able to restrict the access of third country goods or services to their tendering procedures by any other measure than the ones provided for in this Regulationunder EU law.
Amendment 93 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
Amendment 94 #
2012/0060(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) It is imperative that contracting authorities/entities have access to a range of high-quality products meeting their purchasing requirements at a competitive price. Therefore contracting authorities/entities should be able to set aside measures limiting access of non- covered goods and services in case there are no Union and/or covered goods or services available which meet the requirements of the contracting authority/entity to safeguard essential public needs for example health and public safety, or application of the measure would lead to a disproportionate increase in the price or costs of the contract.
Amendment 97 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Article 6 – paragraph 5 – introductory part
5. When assessing whether a lack of substantial reciprocity as defined in Article 2(1)(ga) exists, the Commission shall examine the following:
Amendment 99 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 5 – point a
Article 6 – paragraph 5 – point a
(a) to what degree public procurement laws of the country concernedlaws or regulatory measures of the country concerned on public procurement or concessions ensure transparency in line with international standards in the field of public procurement and preclude any discrimination against Union goods, services and economic operators;
Amendment 100 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 5 – point a a (new)
Article 6 – paragraph 5 – point a a (new)
(aa) to what degree the laws or regulatory measures of the country concerned, other than those referred to in point (a) of this paragraph, lead, deliberately or otherwise, to a lack of transparency or to discrimination against EU economic operators, goods and services;
Amendment 102 #
2012/0060(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation lays down rules on the access of third-country goods and services to the award of contracts for the execution of works or a work, the supply of goods and the provision of services by Union contracting authorities/entities, and establishes procedures supporting negotiations on access of Union goods and services to the public procurement markets of third countries. Member States or their contracting authorities/entities may restrict the access of third-country goods and services to their tendering procedures only by means of measures provided for under Union law.
Amendment 113 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
Article 2 – paragraph 1 – point g a (new)
(ga) ‘lack of substantial reciprocity’ means the existence of restrictive measures in the field of procurement or the award of concessions resulting in serious and recurring discrimination against EU economic operators, goods and services. This lack of substantial reciprocity may result, for example, in: (a) a lack of international commitment by the third country, with regard to procurement and concessions, to ensuring transparency and prohibiting any kind of discrimination against EU economic operators, goods or services; (b) laws or regulations – whether or not concerning public procurement or concessions – adopted by the third country which lead, deliberately or otherwise, to a lack of transparency or to discrimination against EU economic operators, goods or services; (c) the adoption or implementation of discriminatory practices by public authorities or individual contracting entities in the third country aimed at EU economic operators, goods or services.
Amendment 115 #
2012/0060(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
Article 2 – paragraph 2 – point e a (new)
(ea) ‘specific market access reservation’ means any exception to or derogation from an international agreement in the field of public procurement, including market access commitments.
Amendment 126 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Upon request of contracting authorities/entities the Commission shall assess, on the basis of the procedure provided for in Article 8, whether to approve, for contracts with an estimated value equal or above EUR 5.000.000 exclusive of value-added tax (VAT) the exclusion from procedures for the award of contracts tenders comprising goods or services originating outside the Union, if the value of the non- covered goods or services exceeds 50 % of the total value of the goods or services constituting the tender, under the following conditions.
Amendment 126 #
2012/0060(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 138 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 143 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
Amendment 157 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
Amendment 168 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
Amendment 171 #
2012/0060(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. Contracting authorities/entities which have excluded tenders pursuant to paragraph 1Article 8 shall indicate this in the contract award notice they publish pursuant to Article 35 of Directive 2004/18/EC, Article 42 of Directive 2004/17/EC, or Article 27 of the Directive on the award of concession contracts. The Commission shall adopt implementing acts establishing the standard forms for contract award notices. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 17 (3).
Amendment 185 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1
Article 8 – paragraph 1 – subparagraph 1
Amendment 191 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
Amendment 203 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The assessment by the Commission of whether restrictive procurement measures are maintained by the third country concerned shall be made on the basis of the information supplied by interested parties and Member States and/or facts collected by the Commission during its investigation or its regular reports on existing trade barriers in third countries, and shall be concluded within a period of ninthree months after the initiation of the investigation. In duly justified cases this period may be extended by threone months.
Amendment 208 #
2012/0060(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. When the Commission concludes as a result of the externalits procurement investigation that the alleged restrictive procurement measures are not maintained by the third country concerned, the Commission shall adopt a decision terminating the investigation. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). Regarding the contracts referred to in Article 6(1), where the Commission notes that the international agreement concerning market access in the field of public procurement between the Union and the country where the goods and/or services originate contains, for the goods and/or services for which the exclusion is proposed, explicit market access reservations formulated by the Union, or finds a lack of substantial reciprocity as defined in Article 2(1), it shall adopt an implementing act approving the exclusion of the tenders concerned by the investigation in accordance with the examination procedure referred to in Article 17(2). This exclusion shall be a temporary measure pending the conclusions of the consultation procedure provided for under Article 9 and, where applicable, the adoption of any measures limiting access of non-covered goods and services to the EU public procurement market under Article 10.
Amendment 221 #
2012/0060(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 3 – introductory part
Article 9 – paragraph 3 – subparagraph 3 – introductory part
Where the remedial/corrective measures taken by the third country concerned are rescinded, suspended or improperly implemented, the Commission may: shall proceed to adopt under Article 10 implementing acts to limit the access of goods and services originating in a third country.
Amendment 230 #
2012/0060(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Where, after the initiation of a consultation, it appears that the most appropriate means to end a restrictive procurement practice is the conclusion of an international agreement, negotiations shall be carried out in accordance with the provisions of Articles 207 and 218 of the Treaty on the Functioning of the European Union. If a country has engaged in substantive negotiations with the European Union concerning market access in the field of public procurement, the Commission may adopt an implementing act providing that goods and services from that country cannot be excluded from procedures for the award of contracts pursuant to Article 6.
Amendment 233 #
2012/0060(COD)
Proposal for a regulation
Article 9 – paragraph 5 – subparagraph 1 – introductory part
Article 9 – paragraph 5 – subparagraph 1 – introductory part
The Commission may terminate the consultation if : - corrective measures have been adopted by the country concerned - the country concerned undertakes international commitments agreed with the Union with no exclusion or derogation in respect of the areas being investigated under Article 8(1) in any of the following frameworks:
Amendment 236 #
2012/0060(COD)
Proposal for a regulation
Article 9 – paragraph 5 – subparagraph 2
Article 9 – paragraph 5 – subparagraph 2
Amendment 269 #
2012/0060(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
Following adoption of this Regulation, the Commission shall establish whether Articles 58 and 59 of Directive 2004/17/EC shallmust be repealed with effect from the entry into force of this Regulationor amended accordingly and shall, if necessary submit a legislative proposal repealing or amending the provisions of the Directive.
Amendment 46 #
2012/0035(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Member States shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted, in accordance with the requirements laid down in the Member State concerned, by the holder of a marketing authorisation. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the price of the reference medicinal product has been approved by the competent authorities.
Amendment 60 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. In the event of a temporary price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a Member State, that Member State shall publish a statement of reasons for its decision based on objective and verifiable criteria, including, if applicable, a justification of the categories of products subject to the price freeze or price reduction.
Amendment 67 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system, submitted by the marketing authorisation holder in accordance with the requirements laid down in the Member State concerned, is adopted and communicated to the applicant within 60 days of its receipt. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the reference medicinal product has already been included in the public health insurance system.
Amendment 70 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the information supporting the application is inadequate, the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information. However, with respect to medicines for which Member States use health technology assessment as part of their decision-making process, the time-limit shall be 90 days. With respect to generic medicinal products, that time limit shall be 1530 days, provided that the reference medicinal product has already been included in the public health insurance system. Member States shall not request any additional information which is not explicitly required under national legislation or administrative guidelines.
Amendment 72 #
2012/0035(COD)
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Irrespective of the organisation of their internal procedures, Member States shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this Article and the price approval procedure set out in Article 3 does not exceed 120 days. However, with respect to the medicinal products for which Member States use health technology assessment as part of their decision-making process, the time limit shall not exceed 180 days. With respect to generic medicinal products, that time limit shall not exceed 360 days, provided that the reference medicinal product has already been included in the public health insurance system. Those time-limits may be extended in accordance with paragraph 5 of this Article or Article 3(5).
Amendment 77 #
2012/0035(COD)
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 111 #
2012/0035(COD)
Proposal for a directive
Article 16 – paragraph 4 – subparagraph 1
Article 16 – paragraph 4 – subparagraph 1
The Commission mayshall send its observations to the Member State which has communicated the draft measure within three months.
Amendment 27 #
2011/0438(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Public procurement plays a key role in the Europe 2020 strategy as one of the market-based instruments to be used to achieve a smart, sustainable and inclusive growth while ensuring the most efficient use of public funds. Public procurement is a vital tool in the redefinition of European industrial policy. For that purpose, the current public procurement rules adopted pursuant to Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors and Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts have to be revised and modernised in order to increase the efficiency of public spending, facilitating in particular the participation of small and medium-sized enterprises in public procurement and to enable procurers to make better use of public procurement in support of common societal goals. There is also a need to clarify basic notions and concepts to ensure better legal certainty and to incorporate certain aspects of related well-established case-law of the Court of Justice of the European Union.
Amendment 261 #
2011/0371(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To support mobility, equity and study excellence, the Union should establish, as a complement to, rather than a substitute for, a European loan guarantee facility to enable students, regardless of their social background, to take their Masters degree in another participating country. This facility should be available to financial institutions which agree to offer loans for Masters' studies in other participating countries on favourable terms for the students.
Amendment 265 #
2011/0371(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) To promote mobility and encourage fairness in study courses and exchanges, the EU should take all necessary measures to take account of the specific nature of the outermost regions of the Union, particularly their distance from continental Europe and their insularity.
Amendment 266 #
2011/0371(COD)
Proposal for a regulation
Recital 10 b (new)
Recital 10 b (new)
(10b) To strengthen the intensity and volume of European cooperation between the outermost regions of the Union and the neighbouring third countries, the administrative and financial arrangements for the implementation of measures provided for in this Regulation shall enable rules to be adapted to suit regional geographical conditions in the regional geographic context and enable resources to be increased as needed.
Amendment 347 #
2011/0371(COD)
Proposal for a regulation
Article 2 – point 28 a (new)
Article 2 – point 28 a (new)
28a. ‘grassroots sport’ means all sports developed, promoted and/or organised for the largest possible number of beneficiaries;
Amendment 392 #
2011/0371(COD)
Proposal for a regulation
Article 5 – point a – indent 1 – subindent 1 a (new)
Article 5 – point a – indent 1 – subindent 1 a (new)
- % of young people who lived abroad;
Amendment 411 #
2011/0371(COD)
Proposal for a regulation
Article 5 – point d – introductory part
Article 5 – point d – introductory part
(d) To enhance the international dimension of education, training and youth notably in higher education by increasing the attractiveness of the Union higher education institutionsand research institutions (as a complement to the Marie Curie- Skłodowska programme) and supporting the Union external action, including its development objectives through the promotion of mobility and cooperation between EU and third country higher education institutions and targeted capacity building in third countries.
Amendment 504 #
2011/0371(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) transnational mobility of higher education and vocational training students (including those at PhD level) as well as of young people involved in non-formal activities between the participating countries as referred in Article 18. This mobility may take the form of studying at a partner institution, traineeships abroad or participating in youth activities, notably volunteering. Degree mobility at Masters level shall be supported through the student loan guarantee facility as referred to in Article 14 (3).
Amendment 513 #
2011/0371(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. This action will also support the transnational mobility of students, young people and staff to and from third countries (particularly, under the European Neighbourhood Policy, Southern Mediterranean countries) as regards higher education including mobility organizsed on the basis of joint, double or multiple degrees of high quality or joint calls, as well as non-formal learning.
Amendment 549 #
2011/0371(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. This action shall also support development, capacity building, regional integration, knowledge exchanges and modernisation processes through partnerships between Union and third countries'’ higher education institutions as well as in the youth sector, notably for peer learning and joint educational projects, promoting regional cooperation, in particular with neighbourhood countries (including the Southern Mediterranean countries).
Amendment 564 #
2011/0371(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. This action shall also support policy dialogue with third countries (particularly the southern Mediterranean countries) and international organizsations.
Amendment 692 #
2011/0371(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) support to non-commercialfor European sport events involving several European countriesrun by non-profit organisations, which are recognised by national authorities or the representatives thereof and which aim to promote the widest possible access to sport both in a leisure context and otherwise;
Amendment 767 #
2011/0371(COD)
Proposal for a regulation
Article 13 – paragraph 6
Article 13 – paragraph 6
6. The funds for the learning mobility of individuals referred to in Article 6(1.a) that are to be managed by a National Agency shall be allocated in scales on the basis of the social and financial background of the participant, population and cost of living in the host Member State, distance between capitals of Member States and performance. The parameter of performance accounts for 25% of the total funds according to the criteria as referred to in paragraphs 7 and 8. The funds shall be flexibly combinable among themselves, also between formal and informal learning mobility.
Amendment 780 #
2011/0371(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Commission shall provide the funding for guarantees for loans to students resident in a participating country as defined in Article 18(1) undertaking a full Masters degree in another participating country, to be delivered through a trustee with a mandate to implement it on the basis of fiduciary agreements setting out the detailed rules and requirements governing the implementation of the financial instrument as well as the respective obligations of the parties. The loan shall be granted on the basis of social criteria such as social and financial background of the participant requesting the loan and the living costs in the Member State of destination. The loan shall be combinable with national systems. The amount of the monthly redemption should be a fixed percentage-share of the future income. The financial instrument shall comply with the provisions regarding financial instruments in the Financial Regulation and in the Delegated Act replacing the Implementing Rules. In accordance with Article 18(2) of the Regulation (EC, Euratom) No 1605/2002, revenues and repayments generated by the guarantees should be assigned to the financial instrument. This financial instrument, including market needs and take-up, will be subject to the monitoring and evaluation as referred to in Article 15(2).
Amendment 789 #
2011/0371(COD)
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6a. The actions of the Programme shall be implemented in ways that provide for adaptation of the financial rules to address the constraints created by the remoteness of the outermost regions and overseas countries and territories, and to fund area-specific mobility projects linking the Union’s outermost regions with neighbouring third countries.
Amendment 814 #
2011/0371(COD)
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
3. The Programme shall support the cooperation with partners from third countries, notably partners from neighbourhood countries (particularly the southern Mediterranean countries), in actions and activities as referred to in Articles 6 and 10.
Amendment 836 #
2011/0371(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. The Commission shall be assisted by a committee. Thatthree sector-based committees (for education/training, youth and sport). Those committees shall be a committees within the meaning of Regulation (EU) No 182/2011.
Amendment 840 #
2011/0371(COD)
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1a. The committees may meet in various configurations to discuss matters of common interest.