Directive 2001 83 Ec Of The European Parliament And Of The-Books Pdf

DIRECTIVE 2001 83 EC OF THE EUROPEAN PARLIAMENT AND OF THE
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65 65 EEC and 75 319 EEC and laying down, Having regard to the Treaty establishing the additional provisions for radiopharmaceuticals7. European Community and in particular Article Council Directive 89 381 EEC of 14 June 1989. 152 4 a thereof legal basis of Directive extending the scope of Directives 65 65 EEC. 2002 98 EC and 75 319 EEC on the approximation of, provisions laid down by law regulation or. Having regard to the proposal from the administrative action relating to medicinal. Commission products and laying down special provisions for. proprietary medicinal products derived from, Having regard to the opinion of the Economic human blood or human plasma8 Council. and Social Committee1 Directive 92 25 EEC of 31 March 1992 on the. wholesale distribution of medicinal products for, Acting in accordance with the procedure laid human use9 Council Directive 92 26 EEC of 31. down in Article 251 of the Treaty2 March 1992 concerning the classification for the. supply of medicinal products for human use10, Whereas Council Directive 92 27 EEC of 31 March 1992.
on the labelling of medicinal products for human, 1 Council Directive 65 65 EEC of 26 January use and on package leaflets11 Council Directive. 1965 on the approximation of provisions laid 92 28 EEC of 31 March 1992 on the advertising. down by law regulation or administrative action of medicinal products for human use12 Council. relating to medicinal products3 Council Directive 92 73 EEC of 22 September 1992. Directive 75 318 EEC of 20 May 1975 on the widening the scope of Directives 65 65 EEC and. approximation of the laws of Member States 75 319 EEC on the approximation of provisions. relating to analytical pharmaco toxicological laid down by law regulation or administrative. and clinical standards and protocols in respect of action relating to medicinal products and laying. the testing of proprietary medicinal products4 down additional provisions on homeopathic. Council Directive 75 319 EEC of 20 May 1975 medicinal products13 have been frequently and. on the approximation of provisions laid down by substantially amended In the interests of clarity. law regulation or administrative action relating and rationality the said Directives should. to proprietary medicinal products5 Council therefore be codified by assembling them in a. Directive 89 342 EEC of 3 May 1989 extending single text. the scope of Directives 65 65 EEC and, 75 319 EEC and laying down additional 2 The essential aim of any rules governing the. provisions for immunological medicinal production distribution and use of medicinal. products consisting of vaccines toxins or serums products must be to safeguard public health. and allergens6 Council Directive 89 343 EEC of, 3 May 1989 extending the scope of Directives 3 However this objective must be attained by. means which will not hinder the development of, 1 the pharmaceutical industry or trade in medicinal. OJ C 75 15 3 2000 p 11 products within the Community. Opinion of the European Parliament of 3 July 2001, not yet published in the Official Journal and Council.
Decision of 27 September 2001 4 Trade in medicinal products within the. OJ 22 9 2 1965 p 369 65 Directive as last Community is hindered by disparities between. amended by Directive 93 39 EEC OJ L 214, 24 8 1993 p 22 OJ L 142 25 5 1989 p 16. OJ L 147 9 6 1975 p 1 Directive as last amended, by Commission Directive 1999 83 EC OJ L 243 OJ L 181 28 6 1989 p 44. 15 9 1999 p 9 OJ L 113 30 4 1992 p 1, OJ L 147 9 6 1975 p 13 Directive as last amended OJ L 113 30 4 1992 p 5. by Commission Directive 2000 38 EC OJ L 139 OJ L 113 30 4 1992 p 8. 10 6 2000 p 28 OJ L 113 30 4 1992 p 13, OJ L 142 25 5 1989 p 14 OJ L 297 13 10 1992 p 8. certain national provisions in particular between 10 However there are reasons of public policy. provisions relating to medicinal products for not conducting repetitive tests on humans or. excluding substances or combinations of animals without over riding cause. substances which are foods animal feeding, stuffs or toilet preparations and such disparities 11 The adoption of the same standards and.
directly affect the functioning of the internal protocols by all the Member States will enable. market the competent authorities to arrive at their. decisions on the basis of uniform tests and by, 5 Such hindrances must accordingly be reference to uniform criteria and will therefore. removed whereas this entails approximation of help to avoid differences in evaluation. the relevant provisions, 12 With the exception of those medicinal. 6 In order to reduce the disparities which products which are subject to the centralized. remain rules should be laid down on the control Community authorization procedure established. of medicinal products and the duties incumbent by Council Regulation EEC No 2309 93 of 22. upon the Member States competent authorities July 1993 laying down Community procedures. should be specified with a view to ensuring for the authorization and supervision of. compliance with legal requirements medicinal products for human and veterinary use. and establishing a European Agency for the, 7 The concepts of harmfulness and therapeutic Evaluation of Medicinal Products14 a marketing. efficacy can only be examined in relation to each authorization for a medicinal product granted by. other and have only a relative significance a competent authority in one Member State. depending on the progress of scientific ought to be recognized by the competent. knowledge and the use for which the medicinal authorities of the other Member States unless. product is intended The particulars and there are serious grounds for supposing that the. documents which must accompany an authorization of the medicinal product concerned. application for marketing authorization for a may present a risk to public health In the event. medicinal product demonstrate that potential of a disagreement between Member States about. risks are outweighed by the therapeutic efficacy the quality the safety or the efficacy of a. of the product medicinal product a scientific evaluation of the. matter should be undertaken according to a, 8 Standards and protocols for the performance Community standard leading to a single. of tests and trials on medicinal products are an decision on the area of disagreement binding on. effective means of control of these products and the Member States concerned Whereas this. hence of protecting public health and can decision should be adopted by a rapid procedure. facilitate the movement of these products by ensuring close cooperation between the. laying down uniform rules applicable to tests and Commission and the Member States. trials the compilation of dossiers and the, examination of applications 13 For this purpose a Committee for.
Proprietary Medicinal Products should be set up, 9 Experience has shown that it is advisable to attached to the European Agency for the. stipulate more precisely the cases in which the Evaluation of Medicinal Products established in. results of toxicological and pharmacological the abovementioned Regulation EEC No. tests or clinical trials do not have to be provided 2309 93. with a view to obtaining authorization for a, medicinal product which is essentially similar to. an authorized product while ensuring that, innovative firms are not placed at a 14. disadvantage OJ L 214 24 8 1993 p 1 Regulation as amended. by Commission Regulation EC No 649 98 OJ L 88, 24 3 1998 p 7. 14 This Directive represents an important step be taken of Council Directive 80 836 Euratom of. towards achievement of the objective of the free 15 July 1980 amending the Directives laying. movement of medicinal products Further down the basic safety standards for the health. measures may abolish any remaining barriers to protection of the general public and workers. the free movement of proprietary medicinal against the dangers of ionizing radiation16 the. products will be necessary in the light of objective of which is to prevent the exposure of. experience gained particularly in the workers or patients to excessive or unnecessarily. abovementioned Committee for Proprietary high levels of ionizing radiation and in. Medicinal Products particular of Article 5c thereof which requires. prior authorization for the addition of radioactive. 15 In order better to protect public health and substances to medicinal products as well as for. avoid any unnecessary duplication of effort the importation of such medicinal products. during the examination of application for a, marketing authorization for medicinal products 19 The Community entirely supports the.
Member States should systematically prepare efforts of the Council of Europe to promote. assessment reports in respect of each medicinal voluntary unpaid blood and plasma donation to. product which is authorized by them and attain self sufficiency throughout the. exchange the reports upon request Furthermore Community in the supply of blood products and. a Member State should be able to suspend the to ensure respect for ethical principles in trade in. examination of an application for authorization therapeutic substances of human origin. to place a medicinal product on the market, which is currently under active consideration in 20 The rules designed to guarantee the quality. another Member State with a view to safety and efficacy of medicinal products. recognizing the decision reached by the latter derived from human blood or human plasma. Member State must be applied in the same manner to both. public and private establishments and to blood, 16 Following the establishment of the internal and plasma imported from third countries. market specific controls to guarantee the quality, of medicinal products imported from third 21 Having regard to the particular. countries can be waived only if appropriate characteristics of these homeopathic medicinal. arrangements have been made by the products such as the very low level of active. Community to ensure that the necessary controls principles they contain and the difficulty of. are carried out in the exporting country applying to them the conventional statistical. methods relating to clinical trials it is desirable. 17 It is necessary to adopt specific provisions to provide a special simplified registration. for immunological medicinal products procedure for those homeopathic medicinal. homeopathic medicinal products products which are placed on the market without. radiopharmaceuticals and medicinal products therapeutic indications in a pharmaceutical form. based on human blood or human plasma and dosage which do not present a risk for the. 18 Any rules governing radiopharmaceuticals, must take into account the provisions of Council 22 The anthroposophic medicinal products. Directive 84 466 Euratom of 3 September 1984 described in an official pharmacopoeia and. laying down basic measures for the radiation prepared by a homeopathic method are to be. protection of persons undergoing medical, examination or treatment15 Account should also.
OJ L 246 17 9 1980 p 1 Directive as amended by, Directive 84 467 Euratom OJ L 265 5 10 1984 p. OJ L 265 5 10 1984 p 1 Directive repealed with 4 repealed with effect from 13 May 2000 by. effect from 13 May 2000 by Directive 97 43 Euratom Directive 96 29 Euratom OJ L 314 4 12 1996 p. OJ L 180 9 7 1997 p 22 20, treated as regards registration and marketing plasma can be granted the manufacturer must. authorization in the same way as homeopathic also demonstrate the absence of specific viral. medicinal products contamination to the extent that the state of. 23 It is desirable in the first instance to provide technology permits. users of these homeopathic medicinal products, with a very clear indication of their homeopathic 29 The conditions governing the supply of. character and with sufficient guarantees of their medicinal products to the public should be. quality and safety harmonized, 24 The rules relating to the manufacture 30 In this connection persons moving around. control and inspection of homeopathic medicinal within the Community have the right to carry a. products must be harmonized to permit the reasonable quantity of medicinal products. circulation throughout the Community of lawfully obtained for their personal use It must. medicinal products which are safe and of good also be possible for a person established in one. quality Member State to receive from another Member. State a reasonable quantity of medicinal products, 25 The usual rules governing the authorization intended for his personal use.
to market medicinal products should be applied, to homeopathic medicinal products placed on the 31 In addition by virtue of Regulation EC No. market with therapeutic indications or in a form 2309 93 certain medicinal products are the. which may present risks which must be balanced subject of a Community marketing authorization. against the desired therapeutic effect In In this context the classification for the supply. particular those Member States which have a of medicinal products covered by a Community. homeopathic tradition should be able to apply marketing authorization needs to be established. particular rules for the evaluation of the results It is therefore important to set the criteria on the. of tests and trials intended to establish the safety basis of which Community decisions will be. and efficacy of these medicinal products taken, provided that they notify them to the. amending Directive 2001 83 EC on the Community code relating to medicinal products for human use Official 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 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

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