13_22_-3_Homeopathics_BB_2023-24
Page 1: Introduction
Title: MANCHESTER 1824 Herbal & Homeopathic Remedies Law relating to pharmacy
Presenter: MPharm Professor Ellen Schafheutle
Page 2: Intended Learning Outcomes
Understanding and explaining the legal requirements for herbal and homeopathic remedies (HMR 2012).
Definitions of herbal and homeopathic remedies.
Types of herbal remedies.
Herbalist exemption for certain practitioners.
Restrictions on supply of herbal and homeopathic products.
System of licensing for herbal and homeopathic products.
Specific schemes:
Traditional Herbal Medicines Registration.
Homeopathic medicinal products.
Page 3: Homeopathic Medicinal Products
Historical Overview:
Dr. Samuel Hahnemann (1755-1846): Founder of homeopathy.
Basic principle of homeopathy:
"Like cures like" or "law of similars" ("Ähnliches soll durch Ähnliches geheilt werden").
Use of high dilutions of substances.
Page 4: Licensing of Homeopathic Products
Product Licence of Right:
For products available before the Medicines Act.
Indications for treating minor conditions suitable for self-treatment.
Simplified Registration Scheme:
For new products since the Medicines Act 1968.
Consolidated in HMR 2012.
Assessed for safety and quality.
No therapeutic indication allowed; cannot make medical claims.
Restricted to oral and external use.
Page 5: National Rules Scheme for Homeopathic Products
Introduced on 1 September 2006.
Allows indications for relief or treatment of minor (not major) symptoms and conditions.
Application process similar to Marketing Authorisation but with special rules for safety and efficacy.
All rules applicable to Marketing Authorisation holders apply.
Authorisation number prefixed with NR instead of MA.
Page 6: Examples of Homeopathic Products
Simplified Registration Scheme example:
Nux Vomica 6C-200C pillules (HR 14756/0013).
National Rules Scheme examples:
Teetha® teething gel (NR 01175/0184).
Weleda muscular pain relief oromucosal spray (NR 00298/0270).