Ec200394 commission directive 200394ec laying down the. Directive 20034ec of the european parliament and of the. Commission directive 2003 63 ec of 25 june 2003 amending directive 200183 ec of the european parliament and of the council on the community code relating to medicinal products for human use text with eea relevance the commission of the european communities, having regard to the treaty establishing the european community, having regard to directive 200183 ec of the european. Until such time as the corresponding gmp directive for veterinary medicinal products, dire ctive 91412 eec, is amended accordingly, gmp inspectorates dealing exclusively with veterinary medicinal products have voluntarily agreed to abide by it, although it is. Application guide to the amended recreational craft directive a consolidated guide to the application of directive 94 25 ec on the approximation of the laws, regulations and administrative provisions of the member states relating to recreational craft, as amended by directive 2003 44 ec. Commission directive 200394ec laying down the principles and guidelines. Atex european community directive 94 9 ec applied throughout the european economic area eea since 1 july 2003 the european union eu the european free trade association efta switzerland, turkey became national law in each country by adoption follows. Council directive 200396ec restructuring the community. Directive 94 34 ec of the european parliament and of the council 2, and in particular article 33a thereof, after consulting the. Council directive 2003 109 ec of 25 november 2003 concerning the status of thirdcountry nationals who are longterm residents the council of the european union, having regard to the treaty establishing the european community, and in particular article 633 and 4 thereof, having regard to the proposal from the commission 1. Commission directive 2003 94 ec of 8 october 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use text with eea relevance the commission of the european communities, having regard to the treaty establishing the european community. This document is meant purely as a documentation tool and.
Member states shall establish databases on packaging and packaging waste to enable monitoring of the. Commission directive 200363ec of 25 june 2003 amending. Commission directive 200394ec, of 8 october 2003, laying down the principles and. Eu guide to good manufacturing practice for medicinal products for. The recreational craft directive 9425 ec, as amended by directive 2003 44 ec is intended to ensure a high level of safety for users, as well as regulate exhaust and noise emissions of certain types of enginepropelled recreational craft. The directive aims to harmonise the rules governing the sale of recreational craft within the eu. The responsibility of the mqcc is to convene a team, the reduced european group for product defects recg and to coordinate an effective assessment of the reported issue and reach a conclusion on. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b regulation ec no 1829 2003 of the european parliament and of the. Directive 94 20 ec of the european parliament and of the council of may 30, 1994 relating to the mechanical coupling devices of motor vehicles and their trailers and their attachment to those vehicles. Ec 2003 94 commission directive 2003 94 ec laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Directive 2003 115 ec of the european parliament and of the council of 22 december 2003 amending directive 94 35 ec on sweeteners for use in foodstuffs the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 95 thereof.
The term pharmaceutical quality system is used in this chapter in the interests of consistency with ich q10 terminology. Commission directive 200394ec of 8 october 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products. Commission directive 2003 95 ec of 27 october 2003 amending directive 9677 ec laying down specific purity criteria on food additives other than. Commission directive 200366ec of 3 july 2003 amending. Part ii directive 988 ec of the european parliament and of the council concerning the placing of biocidal products on the market commission regulation ec no 1488 94 on risk assessment for existing substances commission directive 9367eec on risk assessment for new notified substances in support of tgd part ii institute for health and. Standard operating procedure european medicines agency. Having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the commission 1, having regard to the opinion.
Official journal no page date m1 directive 9683 ec of the european parliament and of the council of 19 december 1996 l 48 16 19. Directive as amended by directive 94 34 ec of the european parliament and of the. Council directive 2003 96 ec of 27 october 2003 restructuring the community framework for the taxation of energy products and electricity. Commission directive 2003 94 ec of 8 october 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use text with eea relevance the commission of the european communities, having regard to the treaty establishing the european. Pay securely by credit card and your documents are delivered directly and immediately to your computer as pdf files. Council directive 20038ec of 27 january 2003 to improve access to justice in crossborder disputes by establishing minimum common rules relating to legal aid for such disputes the council of the european union, having regard to the treaty establishing the european community, and. After filling out the form, you will be able to create and print out a pdf file. Quality manual or equivalent documentation should be established and should contain. European parliament and council directive 94 62 ec of 20 december 1994. European commission health and consumers pharmaceuticals. Commission directive 200394ec, of 8 october 2003, laying down the principles and guidelines of good manufacturing.
Commission directive 2003100ec amending annex i to. Atex atex is the term used when referring to the european unions eu directive 94 9 ec. Order instruction to process, package andor ship a certain number of units of investigational medicinal products. B european parliament and council directive 9435ec of 30. Commission directive 2003 94 ec of 8 october 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use text with eea relevance oj l 262, 14. Directive 2003 4 ec of the european parliament and of the council of 28 january 2003 on public access to environmental information and repealing council directive 903eec official journal l 041, 1402 2003 p. Commission directive 2003 100 ec of 31 october 2003 amending annex i to directive 200232 ec of the european parliament and of the council on undesirable substances in animal feed text with eea relevance the commission of the european communities, having regard to the treaty establishing the european community. Commission directive 200394ec of 8 october 2003 laying down the principles and. Directive on the control of volatile organic compound voc emissions resulting from the storage of petrol and its distribution from terminals to service stations directive 9463ec. Addition of part iii gmp related documents december 2010 which. Commission directive 200394ec the commission of the. Commission directive 2003 40 ec of 16 may 2003 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozoneenriched air for the treatment of natural mineral waters and spring waters the commission of the european communities, having regard to the treaty. Commission directive 2003 94ec, of 8 october 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Ec no 1829 2003 of the european parliament and of the council.
Directive 2003 10 ec noise of 6 february 2003 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents noise seventeenth individual directive within the meaning of article 161 of directive 89391eec. Pt chapter 5 production european commission health and consumers directorategeneral public health and risk assessment medicinal products quality, safety and efficacy. The european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 2003 99 ec of the european parliament and of the council of 17 november 2003 on the monitoring of zoonoses and zoonotic agents, amending council decision 90424eec and repealing council directive 92117eec.
B european parliament and council directive 94 35 ec of 30 june 1994 on sweeteners for use in foodstuffs oj l 237, 10. Equipment and protective systems intended for use in potentially explosi ve atmospheres keywords. Directive 2003 35 ec of the european parliament and of the council of 26 may 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment and amending with regard to public participation and access to justice council directives 85337eec and 9661 ec. The atex directive main objectives are to guarantee the free circulation of goods within the european union by aligning the technical and legal requirements of the member states. For the purposes of this chapte r these terms can be considered interchangeable. Commission directive 2003 66 ec of 3 july 2003 amending directive 94 2 ec implementing council directive 9275eec with regard to energy labelling of household electric refrigerators, freezers and their combinations text with eea relevance official journal l 170, 0907 2003 p. Directive 200398ec of the european parliament and of the council of 17 november 2003 on the reuse of public sector information also the public sector information directive or briefly the psi directive. This pdf does not include any changes made by corrigenda.
Europa application guide to the amended recreational. Reports on the implementation of the directive according to directive 91692 ec and decision 97662 ec within 9. Industrial refrigeration systems in potentially explosive. This item of legislation is only available to download and view as pdf. Product specification file a reference file containing, or referring to files containing, all the information necessary to. Directive 2003 108 ec of the european parliament and of the council of 8 december 2003 amending directive 200296 ec on waste electrical and electronic equipment weee the european parliament and the council of the european union, having regard to the treaty establishing the european com. Directive 949ec of the european parliament and the. Directive 2003 44 ec of the european parliament and of the council of 16 june 2003 amending directive 94 25 ec on the approximation of the laws, regulations and administrative provisions of the member states relating to recreational craft text with eea relevance oj l 214, 26. Directive 94 9 ec of the european parliament and the council of 23 march 1994 author.
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