BETA

285 Amendments of Nora BERRA

Amendment 6 #

2013/0416(COD)

Proposal for a decision
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.
2014/01/27
Committee: INTA
Amendment 316 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 322 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 325 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 329 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 337 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 350 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 356 #

2013/0246(COD)

Proposal for a directive
Article 12 – paragraph 3 – point a – introductory part
(a) the organiser and/or the retailer proves(s) that the lack of conformity is:
2013/12/19
Committee: IMCO
Amendment 369 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 374 #

2013/0246(COD)

Proposal for a directive
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.
2013/12/19
Committee: IMCO
Amendment 39 #

2013/0103(COD)

Proposal for a regulation
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.
2013/12/20
Committee: INTA
Amendment 45 #

2013/0103(COD)

Proposal for a regulation
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.
2013/12/20
Committee: INTA
Amendment 65 #

2013/0103(COD)

Proposal for a regulation
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.
2013/12/20
Committee: INTA
Amendment 67 #

2013/0103(COD)

Proposal for a regulation
Recital 10
(10) In order to optimise the review practice, duties coldelected during the investigation should be reimbursed to importers, where measures are not prolonged after the conclusion of an expiry review investigation. This is appropriate given that the conditions required for the continuation of the measures have not been found to exist during the investigation period.
2013/12/20
Committee: INTA
Amendment 75 #

2013/0103(COD)

Proposal for a regulation
Recital 17
(17) Where the number of producers in the Union is so large that resort must be made to sampling, a sample of producers should be chosen from among all producers in the Union and not just from among producers lodging the complaint.deleted
2013/12/20
Committee: INTA
Amendment 77 #

2013/0103(COD)

Proposal for a regulation
Recital 18
(18) In making the Union interest assessment, the opportunity to provide comments should be given to all producers in the Union and not just those producers lodging the complaint.deleted
2013/12/20
Committee: INTA
Amendment 87 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph -1 (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 88 #

2013/0103(COD)

Proposal for a regulation
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.
2013/12/20
Committee: INTA
Amendment 98 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) No 1225/2009
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
2013/12/20
Committee: INTA
Amendment 105 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 b (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 108 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 c (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 109 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 d (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 123 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 1225/2009
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."
2013/12/20
Committee: INTA
Amendment 130 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a
Regulation (EC) No 1225/2009
Article 7 – paragraph 1
(a) in paragraph 1, the following sentence is added: "Provisional duties shall not be applied within a period of two weeks after the information is sent to interested parties under Article 19a. The provision of such information shall not prejudice any subsequent decision that may be taken by the Commission."deleted
2013/12/20
Committee: INTA
Amendment 160 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 185 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point b
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 193 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point a
Regulation (EC) No 1225/2009
Article 11 – paragraph 5
(a) in paragraph 5, the following subparagraph is added: ‘If following an investigation pursuant to paragraph 2, the measure expires, any duties collected from the date of the initiation of such investigation shall be repaid provided that this is requested from national customs authorities and granted by those authorities in accordance with the applicable Union customs legislation concerning repayment and remission of duty. Such repayment does not give rise to the payment of interest by the national customs authorities concerned.’deleted
2013/12/20
Committee: INTA
Amendment 204 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 7
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 207 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 8
8. After Article 19, the following Article is inserted: ‘Article 19a Information about provisional measures 1. The Union producers, importers and exporters and their representative associations, and representatives of the exporting country, may request information on the planned imposition of provisional duties. Requests for such information shall be made in writing within the time limit prescribed in the notice of initiation. Such information shall be provided to those parties, at least two weeks before the expiry of the deadline mentioned in Article 7(1) for the imposition of provisional duties. Such information shall include: (a) a summary of the proposed duties for information purposes only, and (b) details of the calculation of the dumping margin and the margin adequate to remove the injury to the Union industry, due account being taken of the need to respect the confidentiality obligations contained in Article 19. Parties shall have a period of three working days to provide comments on the accuracy of the calculations. 2. In cases where it is intended not to impose provisional duties but to continue the investigation, interested parties shall be informed of the non-imposition of duties two weeks before the expiry of the deadline mentioned in Article 7(1) for the imposition of provisional duties.’deleted
2013/12/20
Committee: INTA
Amendment 215 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 8 – point 1 (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 221 #

2013/0103(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 9 a (new)
Regulation (EC) No 1225/2009
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.
2013/12/20
Committee: INTA
Amendment 237 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 1 b (new)
Regulation (EC) No 597/2009
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"
2013/12/20
Committee: INTA
Amendment 241 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Regulation (EC) No 597/2009
Article 10 – paragraph 8
8. If, in special circumstances, the Commission1a. Article 10 (8) shall be replaced by the following : 8. If, in special circumstances or in the case of diverse and fragmented industry sectors, largely composed of small- and medium-sized enterprises, it is decidesd 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 the existence of countervailable subsidiesdumping, injury and a causal link, as described in paragraph 2, to justify such initiation.
2013/12/20
Committee: INTA
Amendment 251 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Regulation (EC) No 597/2009
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.
2013/12/20
Committee: INTA
Amendment 255 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 2 b (new)
Regulation (EC) No 597/2009
Article 11 – paragraph 11b (new)
2b. In Article 11, a new paragraph 11b is added: 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.
2013/12/20
Committee: INTA
Amendment 259 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 2 c (new)
Regulation (EC) No 597/2009
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.
2013/12/20
Committee: INTA
Amendment 262 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point -a (new)
Regulation (EC) No 597/2009
Article 12 – paragraph 1 – subparagraph 2
"The provisional duties shall be imposed no earlier than 60 days from the initiation of (-a) In Article 12(1), the second subparagraph shall be replaced by the following: "The provisional duties shall be imposed in the seven-monthe proceedings but no later than nine monthseriod starting from the initiation of the proceedings."
2013/12/20
Committee: INTA
Amendment 272 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point b
Regulation (EC) No 597/2009
Article 12 – paragraph 1 – point b
(b) the following subparagraph is added at the end: ‘Provisional duties shall not be applied within a period of two weeks after the information is sent to interested parties under Article 29b. The provision of such information shall not prejudice any subsequent decision that may be taken by the Commission.’deleted
2013/12/20
Committee: INTA
Amendment 303 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 6 – point a
Regulation (EC) No 597/2009
Article 22 – paragraph 1
(a) in paragraph 1 the following subparagraph is added: "If following an investigation pursuant to Article 18, the measure expires, any duties collected after the date of the initiation of such investigation shall be reimbursed. The reimbursement should be requested from national customs authorities in accordance with the applicable Union customs legislation."deleted
2013/12/20
Committee: INTA
Amendment 317 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 9
Regulation (EC) No 597/2009
Article 29b
9. After Article 29, the following Article is inserted: "Article 29b Information about provisional measures 1. The Union producers, importers and exporters and their representative associations, and the country of origin and/or export, may request information on the planned imposition of provisional duties. Requests for such information shall be made in writing within the time limit prescribed in the notice of initiation. Such information shall be provided to those parties, at least two weeks before the expiry of the deadline mentioned in Article 12(1) for the imposition of provisional duties. Such information shall include: (a) a summary of the proposed duties for information purposes only, and (b) details of the calculation of the subsidy margin and the margin adequate to remove the injury to the Union industry, due account being taken of the need to respect the confidentiality obligations contained in Article 29. Parties shall have a period of three working days to provide comments on the accuracy of the calculations. 2. In cases where it is intended not to impose provisional duties but to continue the investigation, interested parties shall be informed of the non-imposition of duties two weeks before the expiry of the deadline mentioned in Article 12(1) for the imposition of provisional duties."deleted
2013/12/20
Committee: INTA
Amendment 334 #

2013/0103(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Regulation (EC) No 597/2009
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.
2013/12/20
Committee: INTA
Amendment 210 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 211 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 252 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 261 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 274 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 285 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 298 #

2013/0049(COD)

Proposal for a regulation
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.
2013/09/16
Committee: IMCO
Amendment 281 #

2013/0048(COD)

Proposal for a regulation
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.
2013/09/11
Committee: IMCO
Amendment 7 #

2012/2711(RSP)

- having regard to its resolution of 13 June 2012 on EU trade negotiations with Japan,
2012/09/20
Committee: INTA
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
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
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;
2012/09/20
Committee: INTA
Amendment 36 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 73 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 94 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 124 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 163 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 208 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 230 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 249 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 266 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 272 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 277 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 285 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 318 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 354 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 397 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 407 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 416 #

2012/2322(INI)

Motion for a resolution
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;
2013/04/18
Committee: IMCO
Amendment 4 #

2012/2259(INI)

Draft opinion
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
2013/01/29
Committee: INTA
Amendment 30 #

2012/2259(INI)

Draft opinion
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;
2013/01/29
Committee: INTA
Amendment 27 #

2012/2225(INI)

Motion for a resolution
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;
2013/01/31
Committee: INTA
Amendment 36 #

2012/2225(INI)

Motion for a resolution
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;
2013/01/31
Committee: INTA
Amendment 122 #

2012/2225(INI)

Motion for a resolution
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;
2013/01/31
Committee: INTA
Amendment 51 #

2012/2149(INI)

Motion for a resolution
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;
2012/09/21
Committee: INTA
Amendment 62 #

2012/2149(INI)

Motion for a resolution
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;
2012/09/21
Committee: INTA
Amendment 75 #

2012/2149(INI)

Motion for a resolution
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;
2012/09/21
Committee: INTA
Amendment 47 #

2012/2098(INI)

Draft opinion
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;
2012/11/26
Committee: INTA
Amendment 52 #

2012/2098(INI)

Draft opinion
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.
2012/11/26
Committee: INTA
Amendment 47 #

2012/2097(INI)

Draft opinion
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;
2012/11/20
Committee: INTA
Amendment 52 #

2012/2097(INI)

Draft opinion
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.
2012/11/20
Committee: INTA
Amendment 30 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 32 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 54 #

2012/0366(COD)

Proposal for a directive
Article 1 – paragraph 1 – point d
(d) the prohibition of cross-border distance sales of tobacco products;
2013/05/29
Committee: INTA
Amendment 72 #

2012/0366(COD)

Proposal for a directive
Recital 18
(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.deleted
2013/05/08
Committee: IMCO
Amendment 89 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/08
Committee: IMCO
Amendment 94 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/08
Committee: IMCO
Amendment 99 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/08
Committee: IMCO
Amendment 100 #

2012/0366(COD)

Proposal for a directive
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directive drawing the attention of consumers to potential health risks.deleted
2013/05/08
Committee: IMCO
Amendment 117 #

2012/0366(COD)

Proposal for a directive
Article 1 – paragraph 1 – point d
(d) the prohibition of cross-border distance sales of tobacco products;
2013/05/08
Committee: IMCO
Amendment 172 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 178 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 183 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 192 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/29
Committee: INTA
Amendment 194 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point a
(a) name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;deleted
2013/05/29
Committee: INTA
Amendment 196 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point b
(b) the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society services;deleted
2013/05/29
Committee: INTA
Amendment 197 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.deleted
2013/05/08
Committee: IMCO
Amendment 198 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point c
(c) the address of the website/-s used for that purpose and all relevant information necessary to identify the website.deleted
2013/05/29
Committee: INTA
Amendment 203 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 2
2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member States.deleted
2013/05/29
Committee: INTA
Amendment 205 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 3
3. If it is necessary in order to ensure compliance and facilitate enforcement, Member States of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this Directive in the Member State of destination.deleted
2013/05/29
Committee: INTA
Amendment 207 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 4
4. Retail outlets engaged in distance sales shall be equipped with an age verification system, which verifies at the time of sale, that the purchasing consumer respects the minimum age foreseen under the national legislation of the Member State of destination. The retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system.deleted
2013/05/29
Committee: INTA
Amendment 209 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 5
5. Personal data of the consumer shall only be processed in accordance with Directive 95/46/EC and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties. Personal data shall not be used or transferred beyond the purpose of this actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.deleted
2013/05/29
Committee: INTA
Amendment 353 #

2012/0366(COD)

Proposal for a directive
Article 14 – paragraph 2 a (new)
2a. Member States shall ensure that the unique identifiers of unit packets are linked to the unique identifier on the outside packaging. Any changes in the links between unit packets and the outside packaging shall be recorded in the database mentioned in paragraph 6.
2013/05/13
Committee: IMCO
Amendment 355 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/13
Committee: IMCO
Amendment 360 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/13
Committee: IMCO
Amendment 375 #

2012/0366(COD)

Proposal for a directive
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.
2013/05/13
Committee: IMCO
Amendment 380 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point a
(a) name or corporate name and permanent address of the place of activity from where the tobacco products are supplied;deleted
2013/05/13
Committee: IMCO
Amendment 384 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point b
(b) the starting date of the activity of offering tobacco products for cross-border distance sales to the public by means of information society services;deleted
2013/05/13
Committee: IMCO
Amendment 388 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – point c
(c) the address of the website/-s used for that purpose and all relevant information necessary to identify the website.deleted
2013/05/13
Committee: IMCO
Amendment 393 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 2
2. The competent authorities of the Member States shall publish the complete list of all retail outlets registered with them in accordance with the rules and safeguards laid down in Directive 95/46/EC Retail outlets may only start placing tobacco products on the market in form of distance sales as of the moment the name of the retail outlet is published in the relevant Member States.deleted
2013/05/13
Committee: IMCO
Amendment 398 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 3
3. If it is necessary in order to ensure compliance and facilitate enforcement, Member States of destination may require that the retail outlet nominates a natural person who is responsible for verifying the tobacco products before reaching the consumer comply with the national provisions adopted pursuant to this Directive in the Member State of destination.deleted
2013/05/13
Committee: IMCO
Amendment 403 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 4
4. Retail outlets engaged in distance sales shall be equipped with an age verification system, which verifies at the time of sale, that the purchasing consumer respects the minimum age foreseen under the national legislation of the Member State of destination. The retailer or nominated natural person shall report to the competent authorities a description of the details and functioning of the age verification system.deleted
2013/05/13
Committee: IMCO
Amendment 408 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 5
5. Personal data of the consumer shall only be processed in accordance with Directive 95/46/EC and not be disclosed to the manufacturer of tobacco products or companies forming part of the same group of companies or to any other third parties. Personal data shall not be used or transferred beyond the purpose of this actual purchase. This also applies if the retail outlet forms part of a manufacturer of tobacco products.deleted
2013/05/13
Committee: IMCO
Amendment 423 #

2012/0366(COD)

Proposal for a directive
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:.
2013/05/13
Committee: IMCO
Amendment 432 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point a
(a) products with a nicotine level exceeding 2 mg per unit, ordeleted
2013/05/13
Committee: IMCO
Amendment 434 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point b
(b) products with a nicotine concentration exceeding 4 mg per ml ordeleted
2013/05/13
Committee: IMCO
Amendment 436 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point c
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.deleted
2013/05/13
Committee: IMCO
Amendment 438 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to update the nicotine quantities set out in paragraph 1 taking into account scientific developments and marketing authorisations granted to nicotine- containing products pursuant to Directive 2001/83/EC.
2013/05/13
Committee: IMCO
Amendment 440 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 3
3. Each unit packet and any outside packaging of nicotine-containing products below the thresholds set out in paragraph 1 shall carry the following health warning: This product contains nicotine and can damage your health.deleted
2013/05/13
Committee: IMCO
Amendment 445 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 4
4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10(4). In addition, it shall: (a) be printed on the two largest surfaces of the unit packet and any outside packaging; (b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.deleted
2013/05/13
Committee: IMCO
Amendment 446 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 4 – point a
(a) be printed on the two largest surfaces of the unit packet and any outside packaging;deleted
2013/05/13
Committee: IMCO
Amendment 447 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 4 – point b
(b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with three official languages.deleted
2013/05/13
Committee: IMCO
Amendment 449 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 5
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to adapt the requirements in paragraphs 3 and 4 taking into account scientific and market developments and to adopt and adapt the position, format, layout, designand rotation of the health warnings.
2013/05/13
Committee: IMCO
Amendment 49 #

2012/0267(COD)

Proposal for a regulation
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.
2013/05/07
Committee: IMCO
Amendment 52 #

2012/0267(COD)

Proposal for a regulation
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;
2013/05/07
Committee: IMCO
Amendment 62 #

2012/0267(COD)

Proposal for a regulation
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).
2013/05/07
Committee: IMCO
Amendment 73 #

2012/0267(COD)

Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
2013/05/07
Committee: IMCO
Amendment 99 #

2012/0267(COD)

Proposal for a regulation
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.
2013/05/07
Committee: IMCO
Amendment 106 #

2012/0267(COD)

Proposal for a regulation
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.
2013/05/07
Committee: IMCO
Amendment 132 #

2012/0267(COD)

Proposal for a regulation
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;
2013/05/13
Committee: ENVI
Amendment 335 #

2012/0267(COD)

Proposal for a regulation
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
2013/05/13
Committee: ENVI
Amendment 90 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/17
Committee: IMCO
Amendment 96 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/17
Committee: IMCO
Amendment 122 #

2012/0266(COD)

Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 b (new)
The first subparagraph of paragraph 1 shall not apply to dental filling material, staples or sutures.
2013/05/17
Committee: IMCO
Amendment 138 #

2012/0266(COD)

Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
2013/05/17
Committee: IMCO
Amendment 153 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 159 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 165 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 172 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 178 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/17
Committee: IMCO
Amendment 188 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 190 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 204 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/17
Committee: IMCO
Amendment 207 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 209 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 211 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 212 #

2012/0266(COD)

Proposal for a regulation
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;
2013/05/17
Committee: IMCO
Amendment 237 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 244 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 249 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 250 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 251 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 272 #

2012/0266(COD)

Proposal for a regulation
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).
2013/05/14
Committee: ENVI
Amendment 289 #

2012/0266(COD)

Proposal for a regulation
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).
2013/05/14
Committee: ENVI
Amendment 292 #

2012/0266(COD)

Proposal for a regulation
Article 7 – paragraph 1 a (new)
1a. When adopting CTS referred to in paragraph 1, the Commission shall not undermine the coherence of the European standardisation system. CTS are coherent if they do not conflict with European standards, that is to say they cover areas where no harmonised standards exist, the adoption of new European standards is not foreseen within a reasonable period, where existing standards have not gained market uptake or where those standards have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data, and where the transposition of the technical specifications into European standardisation deliverables is not foreseen within a reasonable period.
2013/05/14
Committee: ENVI
Amendment 295 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 307 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 314 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 316 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 323 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 324 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 327 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 381 #

2012/0266(COD)

Proposal for a regulation
Article 15 – title
SIntended single-use devices and their reprocessing
2013/05/14
Committee: ENVI
Amendment 383 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 389 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 397 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 399 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 403 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 404 #

2012/0266(COD)

Proposal for a regulation
Article 15 – paragraph 6 – subparagraph 1 – point b
(b) the making available of reprocessed intended single-use devices.
2013/05/14
Committee: ENVI
Amendment 408 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 409 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 432 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 456 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 535 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 547 #

2012/0266(COD)

Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – indent 2
– the minimum frequency of unannounced factory inspections and sample checks to be conducted by notified bodies in accordance with Section 4.4 of Annex VIII, taking into account the risk- class and the type of device;deleted
2013/05/14
Committee: ENVI
Amendment 565 #

2012/0266(COD)

Proposal for a regulation
Article 44 – title
Mechanism for scrutiny of certain conformity assessmentsScientific assessment provided by MDCG
2013/05/14
Committee: ENVI
Amendment 568 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 571 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 575 #

2012/0266(COD)

Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall The MDCG shall communicate the result of its scientific assessment at the latest 45 days after submission of the clinical evaluation report as referred to in Part A of Annex XIII, including the results of clinical investigations as referred to in Annex XIV; the post-market clinical follow-up referred to in Part B of Annex XIII; the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clindicate the scientifically valil performance referred to in Article 26 and thealth reason for having selected th technical documentation related to annex XIII. Within that time specific file for submission of a sumriod and at the latest 45 days after submission of those documents, the MDCG mary of the preliminary conformity assessment. When selecting a specific file for submissrequest the submission of additional information necessary for the scientific assessment. Until the submission of additional information, that time perinciple of equal treatment shall be duly taken into accouod of 45 days shall be suspended. Subsequent requests of MDGC for additional information shall not suspend the period for MDCG scientific assessment.
2013/05/14
Committee: ENVI
Amendment 577 #

2012/0266(COD)

Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 2
Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof.deleted
2013/05/14
Committee: ENVI
Amendment 582 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 585 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 586 #

2012/0266(COD)

Proposal for a regulation
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
2013/05/14
Committee: ENVI
Amendment 587 #

2012/0266(COD)

Proposal for a regulation
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).
2013/05/14
Committee: ENVI
Amendment 590 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 597 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 633 #

2012/0266(COD)

Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
2013/05/14
Committee: ENVI
Amendment 639 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 643 #

2012/0266(COD)

Proposal for a regulation
Article 62 – paragraph 1 – point d a (new)
(d a) the periodic safety update reports drawn by manufacturers, as referred to in Article 63a;
2013/05/14
Committee: ENVI
Amendment 649 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 651 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 653 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 670 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 672 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 676 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 677 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 678 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 708 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 721 #

2012/0266(COD)

Proposal for a regulation
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;
2013/05/14
Committee: ENVI
Amendment 738 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 746 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 791 #

2012/0266(COD)

Proposal for a regulation
Annex 1 – part III – point 19 – point 19.2 – point a a (new)
(a a) the mention "This product is a medical device".
2013/05/14
Committee: ENVI
Amendment 800 #

2012/0266(COD)

Proposal for a regulation
Annex 6 – heading 1
MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES
2013/05/14
Committee: ENVI
Amendment 848 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 858 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 867 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 893 #

2012/0266(COD)

Proposal for a regulation
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.
2013/05/14
Committee: ENVI
Amendment 906 #

2012/0266(COD)

Proposal for a regulation
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;
2013/05/14
Committee: ENVI
Amendment 86 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/01
Committee: ENVI
Amendment 124 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/01
Committee: ENVI
Amendment 232 #

2012/0192(COD)

Proposal for a regulation
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;
2013/03/06
Committee: ENVI
Amendment 262 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/06
Committee: ENVI
Amendment 266 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/06
Committee: ENVI
Amendment 360 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/06
Committee: ENVI
Amendment 383 #

2012/0192(COD)

Proposal for a regulation
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.
2013/03/06
Committee: ENVI
Amendment 393 #

2012/0192(COD)

Proposal for a regulation
Article 13
This Chapter is without prejudice to the possibility for the sponsor to submit, fFollowing the refusal to grant an authorisation or the withdrawal of an application, anthe sponsor may submit a new application for authorisation to any intended Member State concerned. That application shall be considered as a new application for authorisation of another clinical trial. The new application shall, however, specify the grounds on which the original application was rejected or withdrawn and the changes made to the original version of the protocol.
2013/03/06
Committee: ENVI
Amendment 508 #

2012/0192(COD)

Proposal for a regulation
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;
2013/03/01
Committee: ENVI
Amendment 24 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 29 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 47 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 53 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 55 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 62 #

2012/0060(COD)

Proposal for a regulation
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.
2013/07/11
Committee: IMCO
Amendment 63 #

2012/0060(COD)

Proposal for a regulation
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 .
2013/07/11
Committee: IMCO
Amendment 77 #

2012/0060(COD)

Proposal for a regulation
Recital 17
(17) The Commission should be able to prevent the possible negative impact of an intended exclusion on on-going trade negotiations with the country concerned. Therefore, the Commission may, where a country is engaging in substantive negotiations with the Union concerning market access in the field of public procurement and the Commission considers that there is a reasonable prospect of removing the restrictive procurement practices in the near future, it should be able to adopt a implementing act providing that goods and services from that country should not be excluded from procedures for the award of contracts for a period of one year.deleted
2013/10/03
Committee: INTA
Amendment 82 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 93 #

2012/0060(COD)

Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
For the purposes of point (b), a lack of substantial reciprocity is presumed where restrictive procurement measures result in serious and recurring discriminations of Union economic operators, goods and services.deleted
2013/07/11
Committee: IMCO
Amendment 94 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 97 #

2012/0060(COD)

Proposal for a regulation
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:
2013/07/11
Committee: IMCO
Amendment 99 #

2012/0060(COD)

Proposal for a regulation
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;
2013/07/11
Committee: IMCO
Amendment 100 #

2012/0060(COD)

Proposal for a regulation
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;
2013/07/11
Committee: IMCO
Amendment 102 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 113 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 115 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 126 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 126 #

2012/0060(COD)

Proposal for a regulation
Article 20 – paragraph 1
AThe Commission shall assess whether if articles 58 and 59 of Directive 2004/17/EC shall be repealedmaintained. In view of the conclusions of this assessment, the Commission shall submit a legislative proposal repealing those articles with effect from the entry into force of this Regulation.
2013/07/11
Committee: IMCO
Amendment 138 #

2012/0060(COD)

Proposal for a regulation
Article 6 – paragraph 3
3. For contracts referred to in paragraph 1, the Commission shall adopt an implementing act concerning the approval of the intended exclusion within a period of two months commencing on the first working day following the date on which it receives the notification. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2). This period may be extended once by a maximum of two months in duly justified cases, in particular if the information contained in the notification or in the documents annexed thereto is incomplete or inexact or if the facts as reported undergo any substantive changes. If, at the end of this two-month period, or the extended period the Commission has not adopted a decision approving or disapproving the exclusion, the exclusion shall be deemed to have been disapproved by the Commission.deleted
2013/10/03
Committee: INTA
Amendment 143 #

2012/0060(COD)

Proposal for a regulation
Article 6 – paragraph 4
4. When adopting implementing acts pursuant to paragraph 3, the Commission shall approve the intended exclusion in the following cases: (a) if 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 taken by the Union; (b) where an agreement referred to in point (a) does not exist and the third country maintains restrictive procurement measures leading to a lack of substantial reciprocity in market opening between the Union and the third country concerned. For the purposes of point (b), a lack of substantial reciprocity should be presumed where restrictive procurement measures result in serious and recurring discriminations of EU economic operators, goods and services. When adopting implementing acts pursuant to paragraph 3, the Commission shall not approve an intended exclusion where it would violate market access commitments entered into by the Union in its international agreements.deleted
2013/10/03
Committee: INTA
Amendment 157 #

2012/0060(COD)

Proposal for a regulation
Article 6 – paragraph 5
5. When assessing whether a lack of substantial reciprocity exists, the Commission shall examine the following: (a) to what degree public procurement laws of the country concerned ensure transparency in line with international standards in the field of public procurement and preclude any discrimination against Union goods, services and economic operators; (b) to what degree public authorities and/or individual procuring entities maintain or adopt discriminatory practices against Union goods, services and economic operators.deleted
2013/10/03
Committee: INTA
Amendment 168 #

2012/0060(COD)

Proposal for a regulation
Article 6 – paragraph 6
6. Before the Commission takes a decision pursuant to paragraph 3 it shall hear the tenderer or tenderers concerned.deleted
2013/10/03
Committee: INTA
Amendment 171 #

2012/0060(COD)

Proposal for a regulation
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).
2013/10/03
Committee: INTA
Amendment 185 #

2012/0060(COD)

Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 1
Where tThe Commission considers it to be in the interest of the Union, it may at any time, on its own inishall, upon application of interested parties, a contracting authority/entity or Member State, initiate an external investigative or upon application of interested parties or a Member State, may initiate an external procurementon into an alleged lack of substantial reciprocity as regards procurement. Should the Commission decline to initiate an investigation, into alleged restrictive procurement measurest shall justify its decision to the Member State, interested party or the contracting entity that submitted the application.
2013/10/03
Committee: INTA
Amendment 191 #

2012/0060(COD)

Proposal for a regulation
Article 8 – paragraph 1 – subparagraph 2
In particular, the Commission shall take into account whether a number of intended exclusions have been approved pursuant to Article 6(3) of this Regulation.deleted
2013/10/03
Committee: INTA
Amendment 203 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 208 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 221 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 230 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 233 #

2012/0060(COD)

Proposal for a regulation
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:
2013/10/03
Committee: INTA
Amendment 236 #

2012/0060(COD)

Proposal for a regulation
Article 9 – paragraph 5 – subparagraph 2
The consultation may also be terminated in cases where the restrictive procurement measures are still in place at the time these commitments are undertaken, as long as they include detailed provisions relating to the phasing-out of those practices.deleted
2013/10/03
Committee: INTA
Amendment 269 #

2012/0060(COD)

Proposal for a regulation
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.
2013/10/03
Committee: INTA
Amendment 46 #

2012/0035(COD)

Proposal for a directive
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.
2012/10/10
Committee: IMCO
Amendment 60 #

2012/0035(COD)

Proposal for a directive
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.
2012/10/10
Committee: IMCO
Amendment 67 #

2012/0035(COD)

Proposal for a directive
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.
2012/10/10
Committee: IMCO
Amendment 70 #

2012/0035(COD)

Proposal for a directive
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.
2012/10/10
Committee: IMCO
Amendment 72 #

2012/0035(COD)

Proposal for a directive
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).
2012/10/10
Committee: IMCO
Amendment 77 #

2012/0035(COD)

Proposal for a directive
Article 8 – paragraph 2
2. For the purposes of the remedies procedure Member States shall designate a body and entrust it with the powers to: a) take, at the earliest opportunity and by way of interlocutory procedures, interim measures with the aim of correcting the alleged infringement or preventing further damage to the interests concerned; b) award damages to the applicant in case of non-compliance with time limits set in Article 7 where damages are claimed, unless the competent authority may prove that the delay is not imputable to it; c) impose a penalty payment, calculated by day of delay. For the purposes of point (c), the penalty payment shall be calculated depending on the seriousness of the infringement, its duration, the need to ensure that the penalty itself is a deterrent to further infringements. Member States may provide that the body referred to in the first subparagraph may take into account the probable consequences of potential measures taken under the present paragraph for all interests likely to be harmed, as well as the public interest, and may decide not to take such measures when their negative consequences could exceed their benefits.deleted
2012/10/10
Committee: IMCO
Amendment 111 #

2012/0035(COD)

Proposal for a directive
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.
2012/10/10
Committee: IMCO
Amendment 27 #

2011/0438(COD)

Proposal for a directive
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.
2012/08/29
Committee: INTA
Amendment 261 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 265 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 266 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 347 #

2011/0371(COD)

Proposal for a regulation
Article 2 – point 28 a (new)
28a. ‘grassroots sport’ means all sports developed, promoted and/or organised for the largest possible number of beneficiaries;
2012/10/11
Committee: CULT
Amendment 392 #

2011/0371(COD)

Proposal for a regulation
Article 5 – point a – indent 1 – subindent 1 a (new)
- % of young people who lived abroad;
2012/10/11
Committee: CULT
Amendment 411 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 504 #

2011/0371(COD)

Proposal for a regulation
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).
2012/10/11
Committee: CULT
Amendment 513 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 549 #

2011/0371(COD)

Proposal for a regulation
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).
2012/10/11
Committee: CULT
Amendment 564 #

2011/0371(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. This action shall also support policy dialogue with third countries (particularly the southern Mediterranean countries) and international organizsations.
2012/10/11
Committee: CULT
Amendment 692 #

2011/0371(COD)

Proposal for a regulation
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;
2012/10/11
Committee: CULT
Amendment 767 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 780 #

2011/0371(COD)

Proposal for a regulation
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).
2012/10/11
Committee: CULT
Amendment 789 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 814 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 836 #

2011/0371(COD)

Proposal for a regulation
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.
2012/10/11
Committee: CULT
Amendment 840 #

2011/0371(COD)

Proposal for a regulation
Article 30 – paragraph 1 a (new)
1a. The committees may meet in various configurations to discuss matters of common interest.
2012/10/11
Committee: CULT