Homeopathic medicinal products can be licensed in three ways:-
by registration under the Simplified Registration Scheme
authorisation under the National Rules Scheme
or where appropriate products can also be submitted for full product authorisation (PA)
For more information please see the IMB Guide to the Registration of Homeopathic Medicinal Products.
Simplified Registration Scheme In 1992 Directive 92/73/EC introduced a Simplified Scheme for homoeopathic products. It is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims. The Scheme is restricted to products for oral and external use and does not allow indications.
In order to qualify for registration the products must:
Be for oral or external use - this includes all methods of administration with the exception of injections
Be sufficiently dilute to guarantee their safety
Make no therapeutic claims
If you wish to read more information on this scheme please see the 'Simplified Registration Scheme' (due for publication shortly) together with the new Application Form.
The National Rules Scheme The purpose of the Scheme is to enable homoeopathic medicinal products to be authorised with indications for the relief or treatment of minor symptoms and self limiting conditions.
In order to obtain an authorisation under this scheme the applicant must demonstrate:
That the product is a homeopathic product that conforms with the principles and characteristics of homeopathy as practised in the State;
That the indication sought is appropriate;
That any such indication is suitable for use without the intervention of a registered medical practitioner for diagnosis, treatment or monitoring;
That the efficacy of the product is based on evidence that the particular class of product has been in use in the state as a homeopathic treatment for the indication sought and
That the safety of the product has been established as set down in the relevant regulations.
Product Authorisation In cases where clinical trial support data is available, homeopathic medicinal products can be submitted for full product authorisations (PA) as is the case for all medicinal products.
In this instance submission should be made under the guidance documents for all PA’s on the section under human medicines licensing.
It is important to note that the requirements for pharmacovigilance specified in S.I. 540 of 2007 are also applicable in the case of homeopathic medicinal products that are authorised. These requirements include the need for the person responsible for placing a homeopathic medicinal product on the market, which is the subject of a marketing authorization, to have permanently and continuously at his disposal an appropriately qualified person responsible for Pharmacovigilance (QPPV), as required by Title 1X of Directive 2001/83/EC, as amended. The responsibilities of the QPPV are described in both national and EU legislation and include the requirements to establish and maintain a system for collection and collation of adverse reaction data, record and report suspected adverse reactions electronically, provide usage data, submit Periodic Safety Update Reports (PSURs) and other pharmacovigilance data, as necessary.
Further details of the requirements for safety reporting may be found in the Safety & Quality section of this website.