Regulation of pharmaceuticals in the EU

EU pharmaceutical legislation was set up in the early 1960s, as a reaction to the thalidomide disaster.1 To avoid further scandals, the European Economic Community intended to preclude market access of medicinal products without prior authorisation. This has resulted in the adoption of a legislative framework for the assessment of medicinal products.

Harmonisation of the national laws applicable to medicinal products started with the adoption of Directive 65/65/EEC.2 In the mid-1970s, landmark Directives 75/318/EE3 and 75/319/EE4 introduced a mutual recognition procedure for Member States to recognise each others’ national marketing authorisations. To facilitate mutual recognition, a Committee for Proprietary Medicinal Products (CPMP) was set up, which first assessed whether candidate products complied with Directive 65/65/EEC. By seeking to ensure the free movement of medicinal products throughout the Community, in line with Treaty provisions on the free movement of goods, these directives marked the first step in the creation of a Community-wide single market5 in pharmaceuticals. Since 1987, after the adoption of the Single European Act,6 a large number of directives has been adopted, putting together more pieces of the puzzle. Although, for reasons of regulatory competence, the attainment of the Internal Market has been postulated as the primary aim of EU pharmaceutical legislation, its underlying objective of guaranteeing a high degree of health protection may be considered equally important.

The regulation of homeopathic anthroposophic medicinal products in the EU dates back only as far as the 1990s, when 92/73/EEC7 on homeopathic medicinal products was adopted in 1992.8 Anthroposophic medicinal products produced in accordance with a homeopathic manufacturing procedure were included under the scope of this Directive. Prior to the acceptance of Directive 92/73/EEC, homeopathic medicinal products were explicitly excluded from the scope of the EU pharmaceutical legislation.9

By the end of the 1990s, EU pharmaceutical legislation could be typecast as fragmented and thus highly complex, due to the step-by-step process of regulation that had been followed. In reaction to this fragmentation, the existing legislation was codified in Directive 2001/83/EC,10 including the existing legislation on homeopathic medicinal products. Directive 2001/83/EC has subsequently been amended several times. Noteworthy are Directive 2003/63/EC amending “Annex I Analytical, Pharmacotoxicological and Clinical Standards and Protocols in respect of the Testing of Medicinal Products”, Directive 2004/24/EC11 introducing rules on “traditional herbal medicinal products”, and Directive 2004/27/EC providing general amendments to Directive 2001/83/EC.

Although the fragmentation of medicinal products legislation has been resolved to a great extend, many problematic issues for homeopathic and anthroposophic medicinal products wait to be resolved. For example, the regulation of anthroposophic medicinal products remains ambiguous and incomplete due to the fact that they are partly considered homeopathic, partly traditional herbal, and partly conventional medicinal products.12 Such fragmentation has negative implications for the attainment of the internal market as envisaged by the EC Treaty.


1 A. Daemmrich, ‘Regulatory Laws and Political Culture in the United States and Germany’, in J. Abraham and H. Lawton Smith, Regulation of the Pharmaceutical Industry, Palgrave Macmillan 2003, pp. 15 and 21.

2 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products, OJ L 22/369  [1965].

3 Council Directive 75/318/EEC of 20 May 1975 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, OJ L 147/1 [1975].

4 Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products, OJ L 147/13 [1975].

5 To avoid misconceptions: currently the terms “common market” and “single market” are replaced by the term “internal market” as mentioned in Art 95 EC.

6 The Single European Act was the result of the initiative of former Commission President Jacques Delors to revive the European Politics. It improved the decision-making process with qualified majority voting (Article 18 SEA) instead of unanimity, and it set the first steps towards the creation of the European Union in 1992.

7 Council Directive 92/73/EEC of 22 September 1992 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 medicinal products and laying down additional provisions on homeopathic medicinal products, OJ L 297/8 [1992].

8 In parallel Council Directive 92/74/EEC of 22 September 1992 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, OJ L 297/12 [1992], was adopted.

9 See Article 34 of Directive 75/319/EEC

10 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 OJ L 311/67 [2001].

11 Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 136/85 [2004].

12 The European Count of Justice ruled that those anthroposophic medicinal products, which cannot be registered or authorised as traditional herbal or homeopathic medicinal products, are covered by the general authorisation procedure laid down in Article 6 of Directive 2001/83/EC: Case C-84/06, Reference for a preliminary ruling from the Hoge Raad der Nederlanden, lodged on 10 February 2006 — Staat der Nederlanden (Ministerie van Volksgezondheid, Welzijn en Sport) v 1. Antroposana, Patiëntenvereniging voor Antroposofische Gezondheidszorg, 2. Nederlandse Vereniging van Antroposofische Artsen, 3. Weleda Nederland NV and 4. Wala Nederland NV, OJ C 108/3 [2006]. 

Consolidated legislation in the EU for the Medicinal Products for Human Use, please click here