Towards harmonisation - the competent authorities

ECHAMP was pleased to welcome representatives from two competent authorities to its expert workshop in Bled, Slovenia on 28 April - Mag. Barbara Razinger Mihovec, Pharmacist, Head of Department for Herbal, Traditional and Homeopathic Medicinal Products at the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia and Slovene representative of the Homeopathic Medicinal Products Working Group (HMPWG) of the EU Heads of Medicines Agencies (HMA) and Dr Emiel van Galen MD, chair of the HMPWG and Head of the Unit of Botanicals and Novel Food of the Dutch Agency of Medicines Evaluation Board.

Mag. Barbara Razinger Mihovec opened the session and welcomed participants on behalf of the Slovene Presidency of the EU. She spoke about the increasing popularity of non-conventional therapies. Homeopathy has a long and rich history of use in Slovenia, that dates back to the early nineteenth century. Although use of homeopathy was discontinued after the Second World War, it is now growing in popularity again.

Slovenia has implemented the EU legislation on medicinal products. This legislation provides the possibility for simplified registration only, in accordance with Article 14(1) of EU Directive 2001/83. Although the possibility has been created by Article 16(2) of EU Directive 2001/83, Slovenia did not foresee specific rules for homeopathic medicinal products in low potencies or in administration forms other than oral or external, nor for homeopathic medicinal products with indications. The challenge for the authorities is to guarantee quality and safety on the one hand but to ensure availability on the other.

Furthermore Slovenia passed a first general law on the practice of Complementary and Alternative Medicine in October 2007.

Mag. Razinger specifically mentioned the newly clarified and restrictive legal situation as regards the authorisation of anthroposophic medicinal products, following the recent court ruling before the European Court of Justice (ECJ) in Luxemburg (Case C-84/06 Antroposana and others v The Netherlands, 20 September 2007, not yet reported). Mag. Razinger suggested that one solution would be to widen the scope of Directive 2004/24/EC in order to keep certain anthroposophic medicinal products on the market. She also said that, if this is not possible, then other legal provisions should be created to ensure availability of these remedies.

Dr Emiel van Galen followed Dr Razinger. Setting the scene, Dr van Galen argued that it is the job of politicians to work for better regulation. As a competent authority, it is his job to ensure good regulation. He agreed that better communication is important, also for the competent authorities in their quest to achieve good regulation – both better communication between the HMPWG and applicants, and between applicants and the competent authorities. As chair of the HMPWG he is working towards greater transparency as regards the group’s achievements and its plans.

Dr van Galen gave a brief summary of the progress made by the HMPWG to date – the introduction of a mandate and rules of procedure, the recent agreement to appoint an elected chair for a three year period and a new list of committed members and alternates due out in June this year. He summarised its publications - two Points to Consider documents on safety, the Guidance document on the use of Module 3 of the Common Technical Document, and Module 1.2 Administrative Part for homeopathic medicinal products. He spoke as well of the awareness of the co-ordination group of Mutual Recognition and Decentralisation Procedures (MRP/DcP) for homeopathic medicinal products (CMDh).

He also provided information about the current work programme of the HMPWG, informing participants that the group would henceforth be publishing an agenda for the meetings and making available a report afterwards. On the current agenda of the group are the need to develop a list of first safe dilutions and the subject of ‘anthroposophic use’. The HMPWG will also ensure the European Commission’s website is kept up to date. The first two procedures for the Mutual Recognition Procedure will start in May, with a clear timeline introduced in line with procedures in the mainstream pharmaceutical industry. Dr van Galen also drew a number of parallels between the obstacles perceived by the homeopathic industry with respect to MRP/DcP and those experienced by the pharmaceutical industry.

He gave further details on some of the key issues under discussion in the HMPWG – specifically nosodes, homeopathic products mainly for anthroposophic use, stability guidance, variations and first safe dilutions. He spoke about ECHAMP’s proposal for work sharing, highlighting areas in which it was optional, advisable and in some cases inevitable.

Dr van Galen finished with some views on the role of the European Pharmacopoeia, emphasising that the two working groups of the European Directorate for the Quality of Medicines (EDQM), one on homeopathic manufacturing methods and one on homeopathic raw materials and stocks, had made significant progress. He encouraged support for this work, which should be used in national submissions and in the MRP/DcP and introduced the idea of a system of certificates of suitability for homeopathic starting materials in order to simplify the registration process.

Participants welcomed the in-depth presentation and the level of detail which Dr van Galen was able to share with them.

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