OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

2002/0008 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use

(Text with EEA relevance)

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out below its opinion on the two amendments proposed by Parliament.

2. Background

Transmission of the proposal to the Council and to the European Parliament - COM(2002) 1 final - 2002/0008 (COD) // 17 January 2002

Opinion of the European Economic and Social Committee // 18 September 2002

Opinion of the European Parliament - first reading // 21 November 2002

Amended proposal sent to the Council and the European Parliament COM(2003) 161 final - 2002/0008 (COD) // 9 April 2003

Council common position // 4 November 2003

Commission Communication on the common position // 5 November 2003

Opinion of the European Parliament - second reading // 17 December 2003

3. Objective of the proposal

The proposal aims to guarantee a high level of health protection for European patients by giving them access to medicines of their choice, provided all the necessary safeguards are met. It will also ensure a single market for traditional herbal medicines by introducing harmonised rules and procedures and encouraging cross-border trade in these products, which at the moment is very limited. The proposal provides for a simplified registration system for traditional herbal products. The quality requirements which will have to be met are the same as those for all medicinal products. However, to avoid unnecessary testing and burdens on firms, the legislation foresees that new pre-clinical and clinical trials will not be necessary when sufficient knowledge already exists about a particular product.

4. Commission's opinion on the European Parliament's amendments

4.1 General assessment

The Commission can accept in full the two amendments to the Council's common position adopted by Parliament. The Council's common position and Parliament's amendments make certain changes to the Commission's amended proposal, which are nevertheless in line with the objectives and general principles on which the proposal is based.

4.2 Analysis of the second reading

The amendments adopted by Parliament serve mainly to clarify the text of the Directive.

Amendment 1 confirms that foodstuffs, including plant-based foodstuffs, will continue to be governed by legislation on foodstuffs. Amendment 2 clarifies the type of herbal substances that the Committee should include in the future list, the purpose of which is to provide a harmonised list of the herbal substances likely to be used in traditional herbal medicinal products.

5. Conclusion

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out above.