Relevant legal documents

8 May 2008

Registration fees in the EU Member States

20 December 2006

Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

Homeopathic and traditional herbal medicinal products are excluded from the scope of this Regulation

31 March 2004

Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products

Publication in the Official Journal

31 March 2004

Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use

Publication in the Official Journal

31 March 2004

Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use

Publication in the Official Journal

16 August 2003

Consolidation of Regulation (EEC) No 2377/90 Laying down a Community Procedure for the Establishment of Maximum Residue Limits of Veterinary Medicinal Products in Foodstuffs of Animal Origin

6 November 2001

Directive 2001/83/EC on the Community code relating to medicinal products for human use

Codification of existing legislation on medicinal products into a single document

6 November 2001

Directive 2001/82/EC on the Community code relating to veterinary medicinal products

Codification of existing legislation on medicinal products into a single document

22 September 1992

Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products

Veterinary homeopathic medicinal products were regulated for the first time as veterinary medicinal products within the European Communities

22 September 1992

Council Directive 92/73/EEC widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and establishing complementary provisions for homeopathic medicinal products

Homeopathic medicinal products were regulated for the first time as medicinal products within the European Communities

Crucial articles were: Art. 7 (simplified registration procedure) and 9.2 market authorisation procedure with specific rules. See for more information EU Legal framework for homeopathic and anthroposophic medicinal products

26 June 1990

Regulation (EEC) No 2377/90 Laying down a Community Procedure for the Establishment of Maximum Residue Limits of Veterinary Medicinal Products in Foodstuffs of Animal Origin

This regulation has been consolidated (16 August 2003)

28 September 1981

Directive 81/851/EEC on the approximation of laws of the Member States relating to veterinary medicinal products

20 May 1975

Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products

Rules relating to preclinical testing and clinical trials

20 May 1975

Second Council Directive on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

Expands general basis of Directive 65/65/EEC
(The manufacture, control, supervision, import and export rules were later on also binding for homeopathic and anthroposophic medicinal products later Directive 92/73/EEC refers to 75/319/EEC)

26 January 1965

Council Directive 65/65/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

General basis for market authorisation of medicinal products