DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND …

1 DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE. COUNCIL OF 6 NOVEMBER 2001 ON THE COMMUNITY CODE RELATING TO. medicinal PRODUCTS FOR HUMAN USE. Official Journal L 311, 28/11/2004, p. 67 128. as amended by DIRECTIVE 2002/98/EC of the EUROPEAN 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 . Official Journal L 33, 08/02/2003, p. 30 40. DIRECTIVE 2004/24/EC of the EUROPEAN PARLIAMENT and the Council of 31 March 2004.

2 Amending, as regards traditional herbal medicinal products, DIRECTIVE 2001/83/EC on the Community code relating to medicinal products for human use Official Journal L 136, 30/04/2004, p. 85 90. DIRECTIVE 2004/27/EC of the EUROPEAN PARLIAMENT and the Council of 31 March 2004. 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 Community code relating to medicinal products for human use (Official Journal L 159, 27/6/2003 p.)

3 46 - 94). DISCLAIMER: THIS TEXT IS AN INFORMAL CODIFICATION TO FACILITATE WORK WITH THE RELEVANT. LEGISLATION. ONLY THE VERSIONS AS PUBLISHED IN THE OFFICIAL JOURNAL OF THE. EUROPEAN COMMUNITY ARE BINDING. THE EUROPEAN PARLIAMENT AND THE Having regard to the Treaty establishing the COUNCIL OF THE EUROPEAN UNION, EUROPEAN Community, and in particular Article 95 thereof, 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.

4 152(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.

5 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.

6 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.

7 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, , p.

8 11. products within the Community. 2. 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 3. OJ 22, , p. 369/65. DIRECTIVE as last Community is hindered by disparities between amended by DIRECTIVE 93/39/EEC (OJ L 214, 7. , p. 22). OJ L 142, , p. 16. 4. OJ L 147, , p. 1. DIRECTIVE as last amended 8. by Commission DIRECTIVE 1999/83/EC (OJ L 243, OJ L 181, , p. 44. 9. , p. 9). OJ L 113, , p. 1. 5 10. OJ L 147, , p. 13. DIRECTIVE as last amended OJ L 113, , p.

9 5. 11. by Commission DIRECTIVE 2000/38/EC (OJ L 139, OJ L 113, , p. 8. 12. , p. 28). OJ L 113, , p. 13. 6 13. OJ L 142, , p. 14. OJ L 297, , 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.

10 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.