Commission amendments

The Commission amended Annex II on 27 June 2002 and the decisions of the amendment are in force since 1 January 2003. The amendment clarifies the need of such an Annex, which in some respect reverses the good provisions of Article 4 (2) (a). According to the Commission certain materials and compounds continue being exempt from phase-out because they are still unavoidable. The body has, however, decided to delete lead that is used for coating inside petrol tanks from this Annex, since the use of this element is already avoidable. 

Kanavos P. World Generics Impact of Regulation and Market Development. Richmond, Surrey, U.K. PJB Publications, 2003. The author examines the current status of the generics market, in both developed and developing countries, and discusses key intellectual property, antitrust, and supply/demand issues that affect it. This Scrip Report also provides details regarding European Commission amendments and devotes three chapters to the differences among price-regulated nations. As an alternative to hardcopy format, PJB also offers electronic (HTML or PDF) subscriptions to this publication. 

Over the next few years, following the Health and Social Care Act 2001, supplementary prescribing by nurses and pharmacists was introduced. After much consultation with the medical, pharmacy and nursing professions and the Department of Health and the Medicines Control Agency as well as meetings of the Committee on Safety of Medicines and the Medicines Commission, amendments were made to the legislation to allow nurses and pharmacists to become supplementary prescribers as from April 2003. 

EUROPEAN COMMISSION, Commission Directive 2003/82/EC -of Commission Amending Council Directive 91/414/EEC as Regards Standard Phrases for Special Risks and Safety Precautions for Plant Protection Products, SANCO/10376/2002 rev 9. 

IntemationtJ ElectrotechnicsJ Commission, Amendments to lEC Publication 238 by Working Group EPCI, Technical Committee No. 34, Subcommittee 34B Ammonia Vapor Test for Stress Corrosion, December 1987. 

Rules and Regulations Under the Textile Fibers Product Identification xict, as amended July 9, 1986, Eederal Trade Commission, Washington, D.C. 

In a sense, the articles equate to what you might expect to find in an Act at national level, while the content of Annexes would be more akin to what would be placed in regulations. There is also a parallel in terms of authorisation, in that amendments to the articles usually require the approval of the political institutions, whereas adaptation of the Annexes to technical progress is possible via a decision of the Commission, functioning as the executive body. You can see this in practice by just looking at the title of each instrument that you read. 

Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use... 

FRG (2001) Notification of a draft Order amending Chemicals Orders (organotin compounds) pursuant to Article 95(5) of the EC Treaty. Cemmunicatien frem the Government of the Federal Republic ef Germany te the Eurepean Commission, 9 January. 

Part V contains amendments to the Radioactive Substances Act 1960, Part VI controls the use, import, containment or release of genetically modified organisms to the environment, and Part VII provided for the reorganization of the Nature Conservancy Council and Countryside Commission. 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

There is one additional general requirement included in Directive 75/318/EEC as amended, which affects all parts of the pharmaceutical section of the dossier. This is a blanket requirement that all analytical methods are to have been adequately validated and the validation data included in the submission. This applies to all analytical methods including those used in connection with preclinical and clinical parts of the dossier. Additional guidance on how to meet these requirements is included in the two notes for guidance developed on the topic of analytical validation through the ICH process, available at the EMEA web site or at the Commission s web site, mentioned earlier. 

Volume 2A Notice to applicants—Medicinal products for human use—Procedures for marketing authorisation Volume 2B Notice to applicants—Medicinal products for human use—Presentation and content of the dossier Volume 2C Notice to applicants—Medicinal products for human use—Regulatory guidelines Commission of the European Communities, Luxembourg, 1998/1998/ 1999 (and amendments)... 

Article 6 of the RoHS Directive (recast 2011 [9]) says 1. With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and amendment of the list of restricted substances in Annex II shall be considered by the Commission before 22 July 2014, and periodically thereafter on its own initiative or following the submission of a proposal by a Member State. .. . 

European Commission (2009) Regulation No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction (REACH) as regards Annex XVII... 

CEC, Commission of the European Communities (2006) Proposal for a Directive of the European Parliament and of the Council establishing a framework for the protection of soil and amending Directive 2004/35/EC. 2006/0086(COD). Brussels (Belgium). http //ec. europa.eu/environment/soil/pdf/com 2006 0232 en.pdf... 

EC, European Commission (2011) Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the restriction of use of Bisphenol A in plastic infant feeding bottles, Brussels (Belgium)... 

EU (2001) European Commission decision no. 2455/2001/EC of the European Parliament and of the council of 20 November 2001 establishing the list of priority substances in the field of water policy and amending directive 2000/60/EC. Off J L331... 

EC (European Commission) (2002a), Commission Regulation No 472/2002 of 12 March 2002 amending regulation (EC) No 466/2001 setting maximum limits for certain contaminants in food stuffs , Official J. Europ. Union, L77, 1-13. 

EC (European Commission) (2002), Commission directive 2002/27/EC of 13 March 2002 amending directive 98/53/EC laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs , Official J. Europ. Communities, L75, 44-45. 

EEC, Seventh Amendment to EEC Directive 67/548/EEC, "Directive on Classification, Packaging, and Labelling of Dangerous Substances," European Union Commission, Brussels, Belgium (June 5,1992). 

State Emergency Response Commission State commissions required under the Superfund Amendments and Reauthorization Act (SARA) which designates emergency planning districts, and appoint local emergency planning committees and supervise and coordinate their activities. 

In Proposal for a Directive of The European Parliament and of The Council on the quality of petrol and diesel fuels and amending Directive 98/70/EC by Commission of The European Communities, Brussels, 2001. 

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