Homeopathic Medicines are distinct from other types of medicines, such as Herbal Medicines or Pharmaceutical Drugs, although they can be prepared from these sources. This distinction comes from the methods used in their preparation as well as the principles on which they are prescribed.
Preparation of Homeopathic Medicines involves the use of minute amounts of substances, which are dissolved, further diluted and succused (mixed) in a manner designed to activate their healing potential, while concomitantly eliminating side effects; which could arise from using the original substances.
In 1992 the EC Directive 92/73/EEC, taking into account the unique nature of Homeopathic Medicines, (high dilution factor), made provision for a simplified registration procedure, for these medicines, to be implemented in Member States.
This registration procedure is specific for Homeopathic Medicines placed on the market without therapeutic indications and in a form and dosage, which do not present risk to the patient.
This directive was transposed into Irish law under S.I. 142 of 1998. The Health Products Regulatory Authority as the competent authority is responsible for the implementation of this registration scheme in Ireland. Accordingly in 2002 the Simplified Registration Scheme for Homeopathic Medicinal Products was launched.
In addition to the Simplified Scheme the EC Directive also allowed for the introduction of ‘Specific Rules’ in Member States ‘relating to the toxicological and pharmacological tests and clinical trials of homeopathic medicines in accordance with the principles and characteristics of homeopathy as practised in that Member State’. This facilitated the establishment of National Rules for a New National Rules Scheme that can be applied to homeopathic medicines that do not qualify for the simplified scheme; e.g. Homeopathic Medicines making therapeutic claims. The National Rules Scheme was given a legal basis by the publication in July 2007 of the Medicinal Products (Control of Placing on the Market) Regulations, S.I. 540 of 2007.
Homeopathic medicinal products can be licensed in three ways:-
- by registration under the Simplified Registration Scheme
- authorisation under the National Rules Scheme
- where appropriate products can also be submitted for full product authorisation (PA)
For more information, please see the HPRA Guide to the Registration of Homeopathic Medicinal Products and the HPRA Guide to the National Rules Scheme for Homeopathic Medicinal Products for Human use.
To download the Application for Renewal of a Marketing Authorisation / Simplified Registration Homepathic Medicinal Product please visit the HMA site here