EU legislation and regulation documents

Study on the Availability of Medicinal Products for Human Use, Matrix Insight report

Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products - Document on the basis of article 16i of Directive 2001/83/EC

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.”

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

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