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 three regulatory schemes for homeopathic medicines:

• Product Licences of Right (PLRs)
• Simplified Scheme (1992)
• National Rules Scheme (2006)

Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented in 1971. Homeopathic products covered by PLRs may include indications.

Under the Simplified Scheme, safety and quality must be demonstrated but medical claims are not allowed.

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.

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

1. Source: MHRA