How to register Homeopathic Medicines
What is a Homeopathic Medicine?
Homeopathic medicines are distinct from other medicines. The difference is in their method of preparation and 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 succussed (mixed vigorously) to activate their healing potential, while simultaneously eliminating side effects that could arise from use of the original substances.
How do I register a Homeopathic Medicine?
Homeopathic medicines must be licensed by the HPRA before being placed on the Irish market to fulfil EU and Irish legislative requirements. Three options are available for registration of homeopathic medicines as follows:
- A Simplified Registration Scheme for homeopathic medicines without therapeutic indications and in a form and dosage which do not present risk to the patient, e.g., oral tablets with very dilute active ingredients and no reference to patient symptoms. Further information can be found in the HPRA Guide to Registration of Homeopathic Medicinal Products.
- A National Rules Scheme for homeopathic medicines which do not qualify for the simplified scheme, e.g., homeopathic medicines with therapeutic claims for mild self-limiting conditions. Further information can be found in the HPRA Guide to National Rules Scheme for Homeopathic Medicinal Products for human use.
- Alternatively, a full medicinal Product Authorisation (PA) can be obtained when the appropriate data is submitted. Visit our Licencing Procedures page for more.
How do I find additional guidance?
The HPRA actively participates in the European Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA), which has published some additional guidance in relation to Homeopathic Medicines.