Homeopathic medicines must be licensed by the HPRA. There are two main schemes available, a Simplified Registration Scheme for homeopathics without indications and a National Rules Scheme for homeopathics with indications.
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.
Homeopathic medicines must be licensed before being placed on the Irish market in order to fulfil EU and Irish legislative requirements. They can be licensed in the following ways:
- Registration under the Simplified Registration Scheme
- Authorisation under the National Rules Scheme
- Authorisation as a full product authorisation (PA) where appropriate
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; e.g. oral tablets with very dilute active ingredients with no reference to patient symptoms. For more information, please see the HPRA Guide to Registration of Homeopathic Medicinal Products.
Homeopathic medicines that do not qualify for the simplified scheme can be authorised under the national rules scheme; e.g. homeopathic medicines with therapeutic claims for mild self limiting conditions. For more information, please see the HPRA Guide to National Rules Scheme for Homeopathic Medicinal Products for Human Use.
A PA can be obtained from the HPRA when the appropriate data is submitted see Licensing Procedures page
HPRA actively participates in the European Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA), which has also published some additional guidance in relation to Homeopathics.