Homeopathic Medicines (Europe)
“Homeopathy is a system of medicine which involves treating the individual with highly diluted substances, given mainly in tablet form. Based on their specific symptoms, a homeopath will match the most appropriate medicine to each patient.
All homeopathic products must comply with the definition given in EU Directive 2001/83/EC” (Source: MHRA).
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.
Please contact us with your specific regulatory compliance requirements. We look forward to working with you.