This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

By way of derogation from the first paragraph, Titles I, II, III and V shall apply from 20 November 2005 and point 3, fifth and sixth indent of the Annex shall apply from 20 May 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg 31 March 2004.
For the European Parliament
The President
P. Cox
For the Council
The President
D. Roche
(1) OJ C 75 E, 26.3.2002, p. 189 and OJ C ... (not yet published in the Official Journal).
(2) OJ C 61, 14.3.2003, p. 1.
(3) Opinion of the European Parliament of 23 October 2002 (OJ C 300 E, 11.12.2003, p. 308), Council Common Position of 29 September 2003 (OJ C 297 E, 9.12.2003, p. 1), Position of the European Parliament of 17 December 2003 (not yet published in the Official Journal) and Council Decision of 11 March 2004.
(4) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation (EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).
(5) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Council Directive 2004/27/EC (see p. 34 of this Official Journal).
(6) OJ L 311, 28.11.2001, p. 1. Directive as amended by Council Directive 2004/28/EC (see p. 58 of this Official Journal).
(7) OJ L 15, 17.1.1987, p. 38. Directive repealed by Directive 93/41/EEC (OJ L 214, 24.8.1993, p. 40).
(8) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of β-agonists (OJ L 125, 23.5.1996, p. 3).
(9) OJ L 121, 1.5.2001, p. 34.
(10) OJ C 172, 18.6.1999, p. 1.
(11) OJ L 18, 22.1.2000, p. 1.
(12) OJ C 218, 31.7.2000, p. 10.
(13) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 24).
(14) OJ L 184, 17.7.1999, p. 23.
(15) OJ L 245, 29.9.2003, p. 19.
(16) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive 2001/18/EC, but continues to have certain legal effects.
(17) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 1029/2003 (OJ L 149, 17.6.2003, p. 15).
(18) OJ L 125, 23.5.1996, p. 10. Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(19) Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (OJ L 248, 16.9.2002, p. 1).
(20) OJ L 357, 31.12.2002, p. 72.
(21) OJ L 136, 31.5.1999, p. 1.
(22) OJ L 145, 31.5.2001, p. 43.
(23) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
ANNEX
MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY
1. Medicinal products developed by means of one of the following biotechnological processes:
- recombinant DNA technology,
- controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,
- hybridoma and monoclonal antibody methods.
2. Medicinal products for veterinary use intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals.
3. Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the following diseases:
- acquired immune deficiency syndrome,
- cancer,
- neurodegenerative disorder,
- diabetes,
and with effect from 20 May 2008
- auto-immune diseases and other immune dysfunctions,
- viral diseases.
After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal modifying this point and the Council shall take a decision on that proposal by qualified majority.
4. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.