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to public consultation on "Which are the TOP10 most burdensome EU legislative acts for SMEs"
Follow up to meeting with European Health Commissioner
An experimental protocol for investigating the nature of homeopathic medicines has been able to detect the presence of homeopathic potencies.
Speaker presentations from HRI’s conference in Rome are now available online.
Requirements for Braille in the Member States
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).
Literature review on the cost-effectiveness of homeopathy and anthroposophic medicine showing how homeopathy and anthroposophic medicine can contribute to a sustainable health system.
Newly published documents give a welcome update on the work of the Homeopathic Medicinal Products Working Group of the Heads of Medicines Agencies (HMPWG), including the minutes of its most recent meeting, and important feedback on its work on the justification of homeopathic use and on first safe dilutions.
ECHAMP’s new position paper explains why fixing the supplier of raw materials in registration dossiers for homeopathic medicinal products does not in general add to the quality of the product.
to Better Regulation Agenda
to public Consultation on Patient Safety and Quality of Care
on conference on '50 Years of EU Pharma legislation: Achievements and future perspectives'
to the 'External Study Report on the Availability of Medicinal Products for Human Use,’ by Matrix Insight
to the communication from the Commission on effective, accessible and resilient health systems
to Staff Working Document 'Investing in Health' Accompanying the Document Towards Social Investment for Growth
to the consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the EMA
to the public consultation on the review of Regulation (EC) 1234/2008 article 4: variations guidelines
Proposal for a Regulation of the European Parliament and the Council on establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020
to the European Commission public consultation on the Concept paper " Implementing measures in order to harmonise the performance of pharmacovigilance activities provided for in Directive 2011/83/EC and Regulation (EC) No 726/2004"
to EU reflection on chronic disease carried out by the EU Member States and the European Commission
to European Commission public consultation on the concept paper "Delegated Act on the detailed rules for a unique identifier for medicinal products for human use, and its verification"
The report and the proposed resolution underlined all conclusions of the European Commission and asked for expansion of research funding.
The resolution proposed in the Report of 28 October 1998 was adopted without substantial changes.
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.”
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
Study on the Availability of Medicinal Products for Human Use, Matrix Insight report
A new publication from EUROCAM provides information about Complementary and Alternative Medicine (CAM) in the EU.