Article 204 
Entry into force 1. This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union . 2. It shall apply from 1 January 2008. However, it shall apply: (a) as regards the cereals, seeds, hops, olive oil and table olives, flax and hemp, raw tobacco, beef and veal, pigmeat, sheepmeat and goatmeat, eggs and poultrymeat sectors, from 1 July 2008; (b) as regards the rice sector, from 1 September 2008; (c) as regards the sugar sector, from 1 October 2008 with the exception of Article 59 which shall apply as from 1 January 2008; (d) as regards the dried fodder and the silkworm sectors, from 1 April 2008; (e) as regards the wine sector as well as Article 197, from 1 August 2008; (f) as regards the milk and milk products sector, with the exception of the provisions set out in Chapter III of Title I of Part II, from 1 July 2008; (g) as regards the system of milk production limitation established in Chapter III of Title I of Part II, from 1 April 2008; (h) as regards the Community scales for carcass classification referred to in Article 42(1), from 1 January 2009. Articles 27, 39 and 172 shall apply from 1 January 2008 and Articles 149 to 152 from 1 July 2008 for all the products concerned. 3. As regards the sugar sector, Title I of Part II shall apply until the end of the marketing year 2014/2015 for sugar. 4. The provisions related to the system of milk production limitation established in Chapter III of Title I of Part II shall, in accordance with Article 66, apply until 31 March 2015. 5. As regards potato starch, Section IIIa of Chapter III of Title I of Part II shall apply until the end of the 2011/2012 marketing year for potato starch. This Regulation shall be binding in its entirety and directly applicable in all Member States.
Amendment rationale: CONTEXT OF THE PROPOSAL The Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy. The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the

|52011PC0631Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers /* COM/2011/0631 final - 2011/0285 (COD) */EXPLANATORY MEMORANDUM1.           CONTEXT OF THE PROPOSALThe Commission proposal for the Multiannual Financial Framework (MFF) for 2014-2020 (the MFF proposal)[1] sets the budgetary framework and main orientations for the Common Agricultural Policy (CAP). On this basis, the Commission presents a set of regulations laying down the legislative framework for the CAP in the period 2014-2020, together with an impact assessment of alternative scenarios for the evolution of the policy.The current reform proposals are based on the Communication on the CAP towards 2020[2] that outlined broad policy options in order to respond to the future challenges for agriculture and rural areas and to meet the objectives set for the CAP, namely 1) viable food production; 2) sustainable management of natural resources and climate action; and 3) balanced territorial development. The reform orientations in the Communication have since been broadly supported both in the inter-institutional debate[3] and in the stakeholder consultation that took place in the framework of the impact assessment.A common theme that has emerged throughout this process is the need to promote resource efficiency with a view to smart, sustainable and inclusive growth for EU agriculture and rural areas in line with the Europe 2020 strategy, keeping the structure of the CAP around two pillars that use complementary instruments in pursuit of the same objectives. Pillar I covers direct payments and market measures providing a basic annual income support to EU farmers and support in case of specific market disturbances, while Pillar II covers rural development where Member States draw up and co-finance multiannual programmes under a common framework.[4]Through successive reforms the CAP has increased market orientation for agriculture while providing income support to producers, improved the integration of environmental requirements and reinforced support for rural development as an integrated policy for the development of rural areas across the EU. However, the same reform process has raised demands for a better distribution of support among and within Member States, as well as calls for a better targeting of measures aiming at addressing environmental challenges and better addressing increased market volatility.In the past, reforms mainly responded to endogenous challenges, from huge surpluses to food safety crises; they have served the EU well both on the domestic and the international front. However, most of today's challenges are driven by factors that are external to agriculture and would thus require a broader policy response.The pressure on agricultural income is expected to continue as farmers are facing more risks, a slowdown in productivity and a margin squeeze due to rising input prices; there is therefore a need to maintain income support and to reinforce instruments to better manage risks and respond to crisis situations. A strong agriculture is vital for the EU food industry and global food security.At the same time, agriculture and rural areas are being called upon to step up their efforts to meet the ambitious climate and energy targets and biodiversity strategy that are part of the Europe 2020 agenda. Farmers, who are together with foresters the main land managers, will need to be supported in adopting and maintaining farming systems and practices that are particularly favourable to environmental and climate objectives because market prices do not reflect the provision of such public goods. It will also be essential to best harness the diverse potential of rural areas and thus contribute to inclusive growth and cohesion.The future CAP will not, therefore, be a policy that caters only for a small, albeit essential, part of the EU economy, but also a policy of strategic importance for food security, the environment and territorial balance. Therein lies the EU added value of a truly common policy that makes the most efficient use of limited budgetary resources in maintaining a sustainable agriculture throughout the EU, addressing important cross-border issues such as climate change and reinforcing solidarity among Member States, while also allowing flexibility in implementation to cater for local needs.The framework set out in the MFF proposal foresees that the CAP should maintain its two-pillar structure with the budget for each pillar maintained in nominal terms at its 2013 level and with a clear focus on delivering results on the key EU priorities. Direct payments should promote sustainable production by assigning 30 % of their budgetary envelope to mandatory measures that are beneficial to climate and the environment. Payment levels should progressively converge and payments to large beneficiaries be subject to progressive capping. Rural development should be included in a Common Strategic Framework with other EU shared management funds with a reinforced outcome-orientated approach and subject to clearer, improved ex-ante conditionalities. Finally, on market measures the financing of the CAP should be reinforced with two instruments outside the MFF: 1) an emergency reserve to react to crisis situations; and 2) the extension of the scope of the European Globalization Adjustment Fund.On this basis, the main elements of the legislative framework for the CAP during the period 2014-2020 are set out in the following regulations:–                         Proposal for a Regulation of the European Parliament and of the Council establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy ('the direct payments regulation');–                         Proposal for a Regulation of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products (Single CMO Regulation) ('the Single CMO regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) ('the rural development regulation');–                         Proposal for a Regulation of the European Parliament and of the Council on the financing, management and monitoring of the common agricultural policy ('the horizontal regulation');–                         Proposal for a Council regulation determining measures on fixing certain aids and refunds related to the common organisation of the markets in agricultural products;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 73/2009 as regards the application of direct payments to farmers in respect of the year 2013;–                         Proposal for a Regulation of the European Parliament and of the Council amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers.The rural development regulation builds on the proposal presented by the Commission on 6 October 2011 that sets out common rules for all funds operating under a Common Strategic Framework[5]. A regulation will follow on the scheme for most deprived persons, for which funding is now placed under a different heading of the MFF.In addition, new rules on the publication of information on beneficiaries taking account of the objections expressed by the Court of Justice of the European Union are also under preparation with a view to finding the most appropriate way to reconcile beneficiaries' right to protection of personal data with the principle of transparency.

|52012PC0051Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards pharmacovigilance /* COM/2012/051 final - 2012/0023 (COD) */EXPLANATORY MEMORANDUMThe Commission presents a proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmamacovigilance, Regulation (EC) No 726/2004. It is complemented by parallel changes to Directive 2001/83/EC.1.           CONTEXT OF THE PROPOSALOn 15 December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation shall apply in July 2012.The adopted measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns.However, recent pharmacovigilance events in the European Union, in particular the so-called “Mediator case”, have shown the need for a further improvement of the pharmacovigilance system.Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system which should be addressed.In particular, Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatism being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level.Moreover, marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns.Finally, the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance.2.           OBJECTIVE OF THE COMMISSION'S PROPOSALSThe general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are in line with the overall objectives of the EU pharmaceutical legislation. These are intended to ensure the proper functioning of the internal market for medicinal products for human use and to better protect health of EU citizens. Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.3.           BUDGETARY IMPLICATIONThe proposals have no implication for the budget of the Union.The proposals only make minor changes to the system set forth by the 2010 pharmacovigilance legislation. They do not require additional human or administrative resources for the functioning of the pharmacovigilance system.2012/0023 (COD)Proposal for aREGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILamending Regulation (EC) No 726/2004 as regards pharmacovigilance(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,Having regard to the proposal from the European Commission[1],Having regard to the opinion of the European Economic and Social Committee[2],Having regard to the opinion of the Committee of the Regions[3],Acting in accordance with the ordinary legislative procedure,Whereas:(1)       In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[4], as amended by Regulation (EU) No 1235/2010[5], should systematically include medicinal products that are subject to post-authorisation safety conditions.(2)       In addition, voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provisions should be made for the marketing authorisation holder to inform the Agency of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.(3)       Regulation (EC) No 726/2004 should therefore be amended accordingly.(4)       Since the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004 cannot be sufficiently achieved by Member States and can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective,
Revised version (Article 204 ):
Entry into force 1. This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Union . 2. It shall apply from 1 January 2008. However, it shall apply: (a) as regards the cereals, seeds, hops, olive oil and table olives, flax and hemp, raw tobacco, beef and veal, pigmeat, sheepmeat and goatmeat, eggs and poultrymeat sectors, from 1 July 2008; (b) as regards the rice sector, from 1 September 2008; (c) as regards the sugar sector, from 1 October 2008 with the exception of Article 59 which shall apply as from 1 January 2008; (d) as regards the dried fodder and the silkworm sectors, from 1 April 2008; (e) as regards the wine sector as well as Article 197, from 1 August 2008; (f) as regards the milk and milk products sector, with the exception of the provisions set out in Chapter III of Title I of Part II, from 1 July 2008; (g) as regards the system of milk production limitation established in Chapter III of Title I of Part II, from 1 April 2008; (h) as regards the Community scales for carcass classification referred to in Article 42(1), from 1 January 2009. Articles 27, 39 and 172 shall apply from 1 January 2008 and Articles 149 to 152 from 1 July 2008 for all the products concerned. 3. As regards the sugar sector, Title I of Part II shall apply until the end of the marketing year 2014/2015 for sugar. 4. The provisions related to the system of milk production limitation established in Chapter III of Title I of Part II shall, in accordance with Article 66, apply until 31 March 2015. 5. As regards potato starch, Section IIIa of Chapter III of Title I of Part II shall apply until the end of the 2011/2012 marketing year for potato starch. 6. Article 27 shall apply from 1 January 2012 until the completion of the annual plan for 2013. 7. As regards the milk and milk products sector, point (iiia) of point (a) of the first paragraph of Article 122, Article 123(4) and Articles 126a, 126b, 126e, and 177a shall apply from 2 April 2012 until 30 June 2020 and Articles 126c, 126d, 185e and 185f shall apply from 3 October 2012 until 30 June 2020. This Regulation shall be binding in its entirety and directly applicable in all Member States.