Document on the basis of article 16i of Directive 2001/83/EC.

Question 1: What will be the situation for homeopathic medicinal product (as defined in Article 14 of Directive 2001/83/EC) if no agreement could be reached at the end of a MRP or DCP?

Question 2: What will be the situation for homeopathic medicinal product (as defined in Article 14 of Directive 2001/83/EC) if no agreement could be reached at the end of the CMD(h)-Referral?

Part of the conclusion states: “The level of participation was high and it was greatly appreciated that representatives from users, patients, healthcare professionals, industry and regulators were willing to attend the workshop and have a frank exchange of views concerning current challenges and potential solutions.

This report will be transmitted to the European Commission for consideration of the next steps in the area of homeopathic medicinal products.”

Installation of the Herbal Committee (HMPC) at the EMEA.

See for more information the HMPC Section and the Herbal Medicines Section at the EMEA Website.

Installation of the Homeopathic Medicinal Products Working Group (HMPWG) at the Heads of Agencies (See the Mandate of the HMPWG).

Publication in the Official Journal of Directive 2004/24/EC and Directive 2004/27/EC.

This reflects the position of the Commission already stated to the European Parliament on the 17^th of December 2003

The Plenary Session voting in Strasbourg ended in a weak compromise: Only in the case of homeopathy Council and EP were of differing opinions. Therefore the EP agreed to drop all respective amendments in order to avoid a conciliation procedure. This step was criticised by patients and practitioners’ associations.

European Parliament repeated the amendments of the First Reading regarding homeopathic medicinal products.

The Council once more rejected the proposal of a compulsory version of ‘Territory specific rules’ for pre-clinical tests and clinical trials for homeopathic medicinal products not eligible for a special simplified registration in second reading. An extension of the routes of administration under the special simplified registration procedure was also rejected. The proposed amendment introducing a mutual recognition procedure for registered homeopathic medicinal products was only accepted after a compromise proposal (the Council took a negative stance towards a MR for HMP’s during earlier stages of the codecision, but found both Parliament and Commission on its way).

The plenary of the EP voted in favour of most of the amendment proposals regarding homeopathic medicinal products.

Rapporteur Françoise Grossetête mainly repeated the amendments of the EP proposed in 1998 during the creation of Directives 2001/82/EC and 2001/83/EC.

Commission presented three modified proposals to amend the existing pharmaceutical legislation for human and veterinary medicinal products.

Codification of existing legislation on medicinal products into a single document.

The two main recommendations by the Commission in the Report are the adoption of a Mutual Recognition procedure for homeopathic medicinal products, and to change the optional character of Article 9(2) of Directive 92/73/EEC (Now Article 16(2) of Directive 2001/83/EC) into a compulsory one.

Basis for the Review of the system for market authorisation of medicinal products. In parallel codification process: Directive 92/73/EEC is
integrated.

The resolution proposed in the Report of 28 October 1998 was adopted without substantial changes.

Reference Number: 12483/98
Unanimous position of the Member States. This issue is not an issue of priority. Therefore no legislative action.

This document can be requested at the Register of the Council

The report and the proposed resolution underlined all conclusions of the European Commission and asked for expansion of research funding.

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Homeopathic medicinal products are for the first time recognised 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.

Reference Number: 4167/92 + ADD

This document can be requested at the Register of the Council.

Rules relating to preclinical testing and clinical trials.

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)

General basis for market authorisation of medicinal products.