COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of 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

2002/0008 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of 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

1. 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

2. Objective of the Commission 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 herbal medicines by introducing harmonised rules and procedures and encourage 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. But 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.

3. Analysis of the Common Position

3.1. General observations

The Council common position introduces a number of changes in the Commission's amended proposals. However, they are consistent with the objectives and main principles contained in the proposal.

3.2. Amendments accepted fully, in part or in principle by the Commission and the Council

The Council has accepted in full amendment 26 on the Commission's report on the functioning of the new procedure, which had also been accepted by the Commission and incorporated in its modified proposal without changes.

In addition, the Council has accepted in part or in principle amendments 2, 3, 5, 8, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22 23 and 24. The Commission in its amended proposal has accepted these amendments partially or in principle. Subject to specific comments, the Commission can support the Council changes, which refer namely to:

- Amendments 2 and 20 on the Committee for Herbal Medicinal Products responsibilities and the co-ordination between this new Committee and the existing Committee for Human Medicinal Products. The Commission agrees with the Council's amendments, in particular as regards the clear listing of the new Committee's responsibilities;

- Amendments 3 and 14 on the recognition by Member States of authorisations or registrations granted by other member States;

- Amendments 5 and 12 (second part) on herbal medicinal products that contain non-herbals ingredients;

- Amendment 8 and 15 (second part) on the dosage schedule;

- Amendment 12 (third part) on the minimum time of use within the Community;

- Amendments 16, 17 and 18 on labelling and package leaflets and amendment 19 on advertising. The Council has amended the statement to be included on any labelling, package leaflet and advertising of traditional herbal medicinal products. The Commission accepts the wording of the Council, inasmuch as it maintains the principle that consumers must be informed about the fact that the product is exclusively based on use;

- Amendment 21 on the composition of the Committee for Herbal Medicinal Products. The Commission accepts the changes introduced by the Council, aimed at aligning this directive with the agreement reached on the review of the pharmaceutical legislation;

- Amendment 22 on herbal monographs, publications or data;

- Amendment 23 pharmacovigilance;

- Amendment 24 on good manufacturing practices.

3.3. Amendments accepted fully, in part or in principle by the Commission, but not by the Council

The Council has not rejected any amendments which the Commission had accepted fully, in part or in principle in its amended proposal.

3.4. Amendments rejected by the Commission but accepted, in part or in principle by the Council

The Council has not accepted any amendments which the Commission had rejected in its amended proposal.

3.5. Amendments rejected by the Commission and by the Council

Certain amendments have not been integrated into the Commission's amended proposal, nor into the Council common position. These amendments are: 1, 4, 6, 7, 9, 10, 11, 12 (first part), 13, 15 (first part), 25 and 27.

3.6. Amendments introduced by the Council in its common position

The common position incorporates a number of changes, including editorial and linguistic changes. The Council has also introduced changes as to certain provisions, which do not respond directly to an amendment of the European Parliament or a provision of the Commission's proposal.

The Council has modified point 31 of Article 1 with a view to clarifying the definition of herbal medicinal products. The Commission supports this amendment, which does not represent a change in substance.

The common position provides Member States with the possibility to request the Committee for Herbal Medicinal Products for an opinion on the adequacy of the evidence of longstanding use (under Article 16c(1)(c)). The Commission accepts this amendment, which will permit the application of European expertise in the particular area of longstanding use of herbal medicinal products.

The common position clarifies that medicinal use related to other corresponding products than corresponding medicinal products shall be taken into account for the purposes of fulfilling the criteria of longstanding use in Article 16 c (1) c if the corresponding product falls under the definition of Article 16 c (2). The Commission agrees to the wording proposed by the Council, which does not amend the substance of the provision.

The Council has amended the scope of the competent authorities' obligation to inform the applicant and the Commission of decisions on refusals of applications for traditional use registration (Article 16e (2)). In particular, it has deleted the reference to "safety grounds", so that the obligation to inform will apply in every case of refusal, whatever the grounds. The Commission agrees with this amendment.

4. Conclusion

The Commission agrees with the text of the common position, adopted by unanimity, 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.

5. Declarations

The Council and the Commission made the following statement:

Ad Article 16 c (1) c)

"The Council and the Commission confirm that medicinal use which has taken place on the territory of a new Member State is to be taken into account for the purpose of application of Article 16c(1)c) even if it has partly or fully occurred before the accession of that State."