DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE .
DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THECOUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TOMEDICINAL PRODUCTS FOR HUMAN USEOfficial Journal L – 311, 28/11/2004, p. 67 – 128as amended byDirective 2002/98/EC of the European Parliament and of the Council of 27 January 2003setting standards of quality and safety for the collection, testing, processing, storage anddistribution of human blood and blood components and amending Directive 2001/83/ECOfficial Journal L – 33, 08/02/2003, p. 30 – 40Directive 2004/24/EC of the European Parliament and the Council of 31 March 2004amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on theCommunity code relating to medicinal products for human useOfficial Journal L – 136, 30/04/2004, p. 85 – 90Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004amending Directive 2001/83/EC on the Community code relating to medicinal products forhuman useOfficial Journal L – 136, 30/04/2004, p. 34 – 57.This text does not contain the Annex to Directive 2001/83/EC. The Annex currently in forceis laid down in Commission Directive 2003/63/EC of 25 June 2003 amending Directive2001/83/EC of the European Parliament and of the Council on the Community coderelating to medicinal products for human use (Official Journal L 159, 27/6/2003 p. 46 - 94).DISCLAIMER:THIS TEXT IS AN INFORMAL CODIFICATION TO FACILITATE WORK WITH THE RELEVANTLEGISLATION. ONLY THE VERSIONS AS PUBLISHED IN THE OFFICIAL JOURNAL OF THEEUROPEAN COMMUNITY ARE BINDINGTHE EUROPEAN PARLIAMENT AND THECOUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing theEuropean Community, and in particular Article95 thereof,
Having regard to the Treaty establishing theEuropean Community, and in particular Article152(4)(a) thereof, [legal basis of Directive2002/98/EC]Having regard to the proposal from theCommission,Having regard to the opinion of the Economicand Social Committee1,Acting in accordance with the procedure laiddown in Article 251 of the Treaty2,Whereas:(1) Council Directive 65/65/EEC of 26 January1965 on the approximation of provisions laiddown by law, regulation or administrative actionrelating to medicinal products3, CouncilDirective 75/318/EEC of 20 May 1975 on theapproximation of the laws of Member Statesrelating to analytical, pharmaco-toxicologicaland clinical standards and protocols in respect ofthe testing of proprietary medicinal products4,Council Directive 75/319/EEC of 20 May 1975on the approximation of provisions laid down bylaw, regulation or administrative action relatingto proprietary medicinal products5, CouncilDirective 89/342/EEC of 3 May 1989 extendingthe scope of Directives 65/65/EEC and75/319/EEC and laying down additionalprovisions for immunological medicinalproducts consisting of vaccines, toxins or serumsand allergens6, Council Directive 89/343/EEC of3 May 1989 extending the scope of Directives1OJ C 75, 15.3.2000, p. 11.Opinion of the European Parliament of 3 July 2001(not yet published in the Official Journal) and CouncilDecision of 27 September 2001.3OJ 22, 9.2.1965, p. 369/65. Directive as lastamended by Directive 93/39/EEC (OJ L 214,24.8.1993, p. 22).4OJ L 147, 9.6.1975, p. 1. Directive as last amendedby Commission Directive 1999/83/EC (OJ L 243,15.9.1999, p. 9).5OJ L 147, 9.6.1975, p. 13. Directive as last amendedby Commission Directive 2000/38/EC (OJ L 139,10.6.2000, p. 28).6OJ L 142, 25.5.1989, p. 14.265/65/EEC and 75/319/EEC and laying downadditional provisions for radiopharmaceuticals7,Council Directive 89/381/EEC of 14 June 1989extending the scope of Directives 65/65/EECand 75/319/EEC on the approximation ofprovisions laid down by law, regulation oradministrative action relating to medicinalproducts and laying down special provisions forproprietary medicinal products derived fromhuman blood or human plasma8, CouncilDirective 92/25/EEC of 31 March 1992 on thewholesale distribution of medicinal products forhuman use9, Council Directive 92/26/EEC of 31March 1992 concerning the classification for thesupply of medicinal products for human use10,Council Directive 92/27/EEC of 31 March 1992on the labelling of medicinal products for humanuse and on package leaflets11, Council Directive92/28/EEC of 31 March 1992 on the advertisingof medicinal products for human use12, CouncilDirective 92/73/EEC of 22 September 1992widening the scope of Directives 65/65/EEC and75/319/EEC on the approximation of provisionslaid down by law, regulation or administrativeaction relating to medicinal products and layingdown additional provisions on homeopathicmedicinal products13 have been frequently andsubstantially amended. In the interests of clarityand rationality, the said Directives shouldtherefore be codified by assembling them in asingle text.(2) The essential aim of any rules governing theproduction, distribution and use of medicinalproducts must be to safeguard public health.(3) However, this objective must be attained bymeans which will not hinder the development ofthe pharmaceutical industry or trade in medicinalproducts within the Community.(4) Trade in medicinal products within theCommunity is hindered by disparities between78OJ L 142, 25.5.1989, p. 16.OJ L 181, 28.6.1989, p. 44.OJ L 113, 30.4.1992, p. 1.10OJ L 113, 30.4.1992, p. 5.11OJ L 113, 30.4.1992, p. 8.12OJ L 113, 30.4.1992, p. 13.13OJ L 297, 13.10.1992, p. 8.9
certain national provisions, in particular betweenprovisions relating to medicinal products(excluding substances or combinations ofsubstances which are foods, animal feedingstuffs or toilet preparations), and such disparitiesdirectly affect the functioning of the internalmarket.(5) Such hindrances must accordingly beremoved; whereas this entails approximation ofthe relevant provisions.(6) In order to reduce the disparities whichremain rules should be laid down on the controlof medicinal products and the duties incumbentupon the Member States' competent authoritiesshould be specified with a view to ensuringcompliance with legal requirements.(7) The concepts of harmfulness and therapeuticefficacy can only be examined in relation to eachother and have only a relative significancedepending on the progress of scientificknowledge and the use for which the medicinalproduct is intended. The particulars anddocuments which must accompany anapplication for marketing authorization for amedicinal product demonstrate that potentialrisks are outweighed by the therapeutic efficacyof the product.(8) Standards and protocols for the performanceof tests and trials on medicinal products are aneffective means of control of these products andhence of protecting public health and canfacilitate the movement of these products bylaying down uniform rules applicable to tests andtrials, the compilation of dossiers and theexamination of applications.(9) Experience has shown that it is advisable tostipulate more precisely the cases in which theresults of toxicological and pharmacologicaltests or clinical trials do not have to be providedwith a view to obtaining authorization for amedicinal product which is essentially similar toan authorized product, while ensuring thatinnovative firms are not placed at adisadvantage.(10) However, there are reasons of public policyfor not conducting repetitive tests on humans oranimals without over-riding cause.(11) The adoption of the same standards andprotocols by all the Member States will enablethe competent authorities to arrive at theirdecisions on the basis of uniform tests and byreference to uniform criteria and will thereforehelp to avoid differences in evaluation.(12) With the exception of those medicinalproducts which are subject to the centralizedCommunity authorization procedure establishedby Council Regulation (EEC) No 2309/93 of 22July 1993 laying down Community proceduresfor the authorization and supervision ofmedicinal products for human and veterinary useand establishing a European Agency for theEvaluation of Medicinal Products14 a marketingauthorization for a medicinal product granted bya competent authority in one Member Stateought to be recognized by the competentauthorities of the other Member States unlessthere are serious grounds for supposing that theauthorization of the medicinal product concernedmay present a risk to public health. In the eventof a disagreement between Member States aboutthe quality, the safety or the efficacy of amedicinal product, a scientific evaluation of thematter should be undertaken according to aCommunity standard, leading to a singledecision on the area of disagreement binding onthe Member States concerned. Whereas thisdecision should be adopted by a rapid procedureensuring close cooperation between theCommission and the Member States.(13) For this purpose, a Committee forProprietary Medicinal Products should be set upattached to the European Agency for theEvaluation of Medicinal Products established inthe abovementioned Regulation (EEC) No2309/93.14OJ L 214, 24.8.1993, p. 1. Regulation as amendedby Commission Regulation (EC) No 649/98 (OJ L 88,24.3.1998, p. 7).
(14) This Directive represents an important steptowards achievement of the objective of the freemovement of medicinal products. Furthermeasures may abolish any remaining barriers tothe free movement of proprietary medicinalproducts will be necessary in the light ofexperience gained, particularly in theabovementioned Committee for ProprietaryMedicinal Products.(15) In order better to protect public health andavoid any unnecessary duplication of effortduring the examination of application for amarketing authorization for medicinal products,Member States should systematically prepareassessment reports in respect of each medicinalproduct which is authorized by them, andexchange the reports upon request. Furthermore,a Member State should be able to suspend theexamination of an application for authorizationto place a medicinal product on the marketwhich is currently under active consideration inanother Member State with a view torecognizing the decision reached by the latterMember State.(16) Following the establishment of the internalmarket, specific controls to guarantee the qualityof medicinal products imported from thirdcountries can be waived only if appropriatearrangements have been made by theCommunity to ensure that the necessary controlsare carried out in the exporting country.(17) It is necessary to adopt specific athicmedicinalproducts,radiopharmaceuticals, and medicinal productsbased on human blood or human plasma.(18) Any rules governing radiopharmaceuticalsmust take into account the provisions of CouncilDirective 84/466/Euratom of 3 September 1984laying down basic measures for the radiationprotection of persons undergoing medicalexamination or treatment15. Account should also15OJ L 265, 5.10.1984, p. 1. Directive repealed witheffect from 13 May 2000 by Directive 97/43/Euratom(OJ L 180, 9.7.1997, p. 22).be taken of Council Directive 80/836/Euratom of15 July 1980 amending the Directives layingdown the basic safety standards for the healthprotection of the general public and workersagainst the dangers of ionizing radiation16, theobjective of which is to prevent the exposure ofworkers or patients to excessive or unnecessarilyhigh levels of ionizing radiation, and inparticular of Article 5c thereof, which requiresprior authorization for the addition of radioactivesubstances to medicinal products as well as forthe importation of such medicinal products.(19) The Community entirely supports theefforts of the Council of Europe to promotevoluntary unpaid blood and plasma donation toattainself-sufficiencythroughouttheCommunity in the supply of blood products, andto ensure respect for ethical principles in trade intherapeutic substances of human origin.(20) The rules designed to guarantee the quality,safety and efficacy of medicinal productsderived from human blood or human plasmamust be applied in the same manner to bothpublic and private establishments, and to bloodand plasma imported from third countries.(21) Having regard to the particularcharacteristics of these homeopathic medicinalproducts, such as the very low level of activeprinciples they contain and the difficulty ofapplying to them the conventional statisticalmethods relating to clinical trials, it is desirableto provide a special, simplified registrationprocedure for those homeopathic medicinalproducts which are placed on the market withouttherapeutic indications in a pharmaceutical formand dosage which do not present a risk for thepatient.(22) The anthroposophic medicinal productsdescribed in an official pharmacopoeia andprepared by a homeopathic method are to be16OJ L 246, 17.9.1980, p. 1. Directive as amended byDirective 84/467/Euratom (OJ L 265, 5.10.1984, p.4), repealed with effect from 13 May 2000 byDirective 96/29/Euratom (OJ L 314, 4.12.1996, p.20).
treated, as regards registration and marketingauthorization, in the same way as homeopathicmedicinal products.(23) It is desirable in the first instance to provideusers of these homeopathic medicinal productswith a very clear indication of their homeopathiccharacter and with sufficient guarantees of theirquality and safety.plasma can be granted, the manufacturer mustalso demonstrate the absence of specific viralcontamination, to the extent that the state oftechnology permits.(24) The rules relating to the manufacture,control and inspection of homeopathic medicinalproducts must be harmonized to permit thecirculation throughout the Community ofmedicinal products which are safe and of goodquality.(30) In this connection persons moving aroundwithin the Community have the right to carry areasonable quantity of medicinal productslawfully obtained for their personal use. It mustalso be possible for a person established in oneMember State to receive from another MemberState a reasonable quantity of medicinal productsintended for his personal use.(25) The usual rules governing the authorizationto market medicinal products should be appliedto homeopathic medicinal products placed on themarket with therapeutic indications or in a formwhich may present risks which must be balancedagainst the desired therapeutic effect. Inparticular, those Member States which have ahomeopathic tradition should be able to applyparticular rules for the evaluation of the resultsof tests and trials intended to establish the safetyand efficacy of these medicinal productsprovided that they notify them to theCommission.(26) In order to facilitate the movement ofmedicinal products and to prevent the controlscarried out in one Member State from beingrepeated in another, minimum requirementsshould be laid down for manufacture and importscoming from third countries and for the grant ofthe authorization relating thereto.(27) It should be ensured that, in the MemberStates, the supervision and control of themanufacture of medicinal products is carried outby a person who fulfils minimum conditions ofqualification.(28) Before an authorization to market animmunological medicinal product or derivedfrom human blood or human plasma can begranted, the manufacturer must demonstrate hisability to attain batch-to-batch consistency.Before an authorization to market a medicinalproduct derived from human blood or human(29) The conditions governing the supply ofmedicinal products to the public should beharmonized.(31) In addition, by virtue of Regulation (EC) No2309/93, certain medicinal products are thesubject of a Community marketing authorization.In this context, the classification for the supplyof medicinal products covered by a Communitymarketing authorization needs to be established.It is therefore important to set the criteria on thebasis of which Community decisions will betaken.(32) It is therefore appropriate, as an initial step,to harmonize the basic principles applicable tothe classification for the supply of medicinalproducts in the Community or in the MemberState concerned, while taking as a starting pointthe principles already established on this subjectby the Council of Europe as well as the work ofharmonization completed within the frameworkof the United Nations, concerning narcotic andpsychotropic substances.(33) The provisions dealing with theclassification of medicinal products for thepurpose of supply do not infringe the nationalsocial security arrangements for reimbursementor payment for medicinal products onprescription.(34) Many operations involving the wholesaledistribution of medicinal products for human usemaycoverseveralMemberStatessimultaneously.
(35) It is necessary to exercise control over theentire chain of distribution of medicinalproducts, from their manufacture or import intothe Community through to supply to the public,so as to guarantee that such products are stored,transported and handled in suitable conditions.The requirements which must be adopted for thispurpose will considerably facilitate thewithdrawal of defective products from themarket and allow more effective efforts againstcounterfeit products.(36) Any person involved in the wholesaledistribution of medicinal products should be inpossession of a special authorization.Pharmacists and persons authorized to supplymedicinal products to the public, and whoconfine themselves to this activity, should beexempt from obtaining this authorization. It ishowever necessary, in order to control thecomplete chain of distribution of medicinalproducts, that pharmacists and personsauthorized to supply medicinal products to thepublic keep records showing transactions inproducts received.(37) Authorization must be subject to certainessential conditions and it is the responsibility ofthe Member State concerned to ensure that suchconditions are met; whereas each Member Statemust recognize authorizations granted by otherMember States.(38) Certain Member States impose onwholesalers who supply medicinal products topharmacists and on persons authorized to supplymedicinal products to the public certain publicservice obligations. Those Member States mustbe able to continue to impose those obligationson wholesalers established within their territory.They must also be able to impose them onwholesalers in other Member States on conditionthat they do not impose any obligation morestringent than those which they impose on theirown wholesalers and provided that suchobligations may be regarded as warranted ongrounds of public health protection and areproportionate in relation to the objective of suchprotection.(39) Rules should be laid down as to how thelabelling and package leaflets are to bepresented.(40) The provisions governing the informationsupplied to users should provide a high degree ofconsumer protection, in order that medicinalproducts may be used correctly on the basis offull and comprehensible information.(41) The marketing of medicinal products whoselabelling and package leaflets comply with thisDirective should not be prohibited or impeded ongrounds connected with the labelling or packageleaflet.(42) This Directive is without prejudice to theapplication of measures adopted pursuant toCouncil Directive 84/450/EEC of 10 September1984 relating to the approximation of the laws,regulations and administrative provisions of 43) All Member States have adopted furtherspecific measures concerning the advertising ofmedicinal products. There are disparitiesbetween these measures. These disparities arelikely to have an impact on the functioning of theinternal market, since advertising disseminatedin one Member State is likely to have effects inother Member States.(44) Council Directive 89/552/EEC of 3 October1989 on the coordination of certain provisionslaid down by law, regulation or administrativeaction in Member States concerning the pursuitof television broadcasting activities18 prohibitsthe television advertising of medicinal productswhich are available only o
This text does not contain the Annex to Directive 2001/83/EC. The Annex currently in force is laid down in 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 (Official Journal L 159, 27/6/2003 p. 46 - 94).
(f.2) “Directive 050” means Directive 050: Drilling Waste Management; (g) “Directive 056” means Directive 056: Energy Development Applications and Schedules; (g.1) “Directive 058” means Directive 058: Oilfield Waste Management Requirements for the Upstream Petroleum Industry; (h) “Directive 060” means Directive 060: Upstream
In addition to the Pressure Equipment Directive (97/23/EC), there is the Simple Pressure Vessel Directive (87/404/EC, for vessels containing air and nitrogen), the Transportable Pressure Equipment Directive (99/36/EC), and the Aerosol Dispensers Directive (75/324/EEC). This publication provides an outline of the Pressure Equipment Directive only.
Directive 75/443/EEC UNECE Regulation 39.00 Speedometer and reverse gear Directive 70/311/EEC UNECE Regulation 79.01 Steering effort Directive 71/320/EEC UNECE Regulation 13.10 Braking Directive 2003/97/EC UNECE Regulation 46.02 Indirect vision Directive 76/756/EEC UNECE Regulation 48.03 Lighting installation
Directive 67/548/EEC (dangerous substances Directive, DSD), and Directive 1999/45/EEC (dangerous preparations Directive, DPD), and Regulation 1272/2008 (CLP – Classification, labelling and packaging of substances and mixtures) The CLP –regulation will replace the two directives
designing and developing new systems for digital tadio eommunkralaju in the Amateur Radio Sen. icc. and for disseminating information required duimg. and obtained from. Such research. Article submission deadlines for upcoming issues: Spring 2001 March IS, 2001 Summer 2001 June 15,2001 Fall 2001 September 15,2001 Winter 2001 December 15,2001
Law 1 of 1971-15th December, 1970 Law 7 of 2000- 20th July, 2000 Law 7 of 1973-28th June, 1973 Law 5 of 2001-20th April, 2001 Law 24 of 1974-22nd November, 1974 Law 10 of 2001-25th May, 2001 Law 25 of 1975-9th December, 1975 Law 29 of 2001-26th September, 2001 Law 19 of 1977-10th November, 1977 Law 46 of 2001-14th January, 2002
THE COMPANIES ACT 2001 Act 15/2001 Proclaimed by [Proclamation No. 21 of 2001] w.e.f. 1st December 2001 SAVINGS 1. Please refer to schedule 15 as per section 364 of [Act No.15 of 2001] for sections which are still in force in [Act No. 57 of 1984] 2.
ASP.Net – MV3 asic Discussion 7 Page Figure:-dynamic keyword Session variables: - By using session variables we can maintain data from any entity to any entity. Hidden fields and HTML controls: - Helps to maintain data from UI to controller only. So you can send data from HTML controls or hidden fields to the controller using POST or GET HTTP methods. Below is a summary table which shows .
