Homeopathic Medicines

"Homeopathy is a system of complementary medicine in which disease is treated by minute doses of substances that in large quantities would produce symptoms of the disease." 1

Even though homeopathic medicines are not conventional medicines, they still require a licence. In the UK there are two regulatory schemes for homeopathic medicines.  They may be:

  • registered under the Simplified Scheme
  • registered under the National Rules Scheme (as from 1 September 2006)

Under the Simplified Scheme, safety and quality must be demonstrated but medical claims and disease descriptions or conditions are not allowed.  In order to qualify for registration under the Simplified Scheme the products must:

  • be for oral or external use (excluding injections)
  • be sufficiently dilute to guarantee their safety
  • make no therapeutic claims

In 2006 the National Rules Scheme was implemented following public consultation. This Scheme allows for homeopathic medicines to be registered with claims to relieve or treat minor symptoms and conditions i.e. those which don't require the supervision of a doctor. Data has to be submitted which demonstrates quality, safety and efficacy and must also include labelling details and product literature.

When the Medicines Act 1968 was implemented in 1971, homeopathic medicines were covered by Product Licences of Right (PLRs).  PLR holders are now encouraged to transfer certain homeopathic products with PLRs to either homeopathic marketing authorisations under the National Rules Scheme or homeopathic registration certificates under the Simplified Registration Scheme.

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.

1Source: MHRA